Trial Outcomes & Findings for Minitouch Endometrial Ablation System Treatment for Menorrhagia: An Evaluation of Safety & Effectiveness (NCT NCT04267562)
NCT ID: NCT04267562
Last Updated: 2024-11-18
Results Overview
The primary effectiveness endpoint is a clinical change in menstrual blood loss as assessed by the Pictorial Blood Loss Assessment Chart (PBLAC) data, a validated, patient self-reported menstrual diary scoring system. Success for the primary effectiveness endpoint was defined as reduction in menstrual bleeding to a PBLAC (Pictorial Blood Loss Assessment Chart) score of ≤75. Scale information for PBLAC (Pictorial Blood Loss Assessment Chart): The scale minimum is 0, which indicates amenorrhea, i.e., no bleeding. There is no scale maximum. A score of 100 indicates eumenorrhea, i.e., normal menstrual bleeding. A lower PBLAC score indicates less bleeding and a higher PBLAC score indicates more bleeding.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
219 participants
Primary outcome timeframe
Month 12 post-procedure
Results posted on
2024-11-18
Participant Flow
A total of 219 subjects were screened for the Trial, and 114 subjects were considered treated-enrolled. The remaining 105 subjects were excluded prior to treatment assignment for the following reasons: 1. Trial enrollment reached: 21.9% (23/105) 2. Withdrawn consent: 8.6% (9/105) 3. Site closure: 5.7% (6/105) 4. Lost to follow-up: 1.9% (2/105) 5. Physician decision: 1.0% (1/105) 6. Screen failure (met one or more exclusion criterion(ia)): 61.0% (64/105)
Participant milestones
| Measure |
Single-Arm, Open-Label Treatment With the Minitouch System
Eligible participants will undergo a single treatment (endometrial ablation) with the Minitouch System
Minitouch System: The investigational treatment (endometrial ablation) will be performed utilizing the Minitouch System
|
|---|---|
|
Assessed for Eligibility
STARTED
|
219
|
|
Assessed for Eligibility
COMPLETED
|
114
|
|
Assessed for Eligibility
NOT COMPLETED
|
105
|
|
Treated-Enrolled
STARTED
|
114
|
|
Treated-Enrolled
COMPLETED
|
114
|
|
Treated-Enrolled
NOT COMPLETED
|
0
|
|
24-Hour Contact
STARTED
|
114
|
|
24-Hour Contact
COMPLETED
|
114
|
|
24-Hour Contact
NOT COMPLETED
|
0
|
|
Week 2
STARTED
|
114
|
|
Week 2
COMPLETED
|
114
|
|
Week 2
NOT COMPLETED
|
0
|
|
Month 3
STARTED
|
114
|
|
Month 3
COMPLETED
|
114
|
|
Month 3
NOT COMPLETED
|
0
|
|
Month 6
STARTED
|
114
|
|
Month 6
COMPLETED
|
114
|
|
Month 6
NOT COMPLETED
|
0
|
|
Month 12
STARTED
|
114
|
|
Month 12
COMPLETED
|
114
|
|
Month 12
NOT COMPLETED
|
0
|
|
Month 24
STARTED
|
114
|
|
Month 24
COMPLETED
|
112
|
|
Month 24
NOT COMPLETED
|
2
|
|
Month 36
STARTED
|
112
|
|
Month 36
COMPLETED
|
107
|
|
Month 36
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Single-Arm, Open-Label Treatment With the Minitouch System
Eligible participants will undergo a single treatment (endometrial ablation) with the Minitouch System
Minitouch System: The investigational treatment (endometrial ablation) will be performed utilizing the Minitouch System
|
|---|---|
|
Assessed for Eligibility
Screen Failure
|
64
|
|
Assessed for Eligibility
Trial enrollment reached
|
23
|
|
Assessed for Eligibility
Withdrawal by Subject
|
9
|
|
Assessed for Eligibility
Site closure
|
6
|
|
Assessed for Eligibility
Lost to Follow-up
|
2
|
|
Assessed for Eligibility
Physician Decision
|
1
|
|
Month 24
Elective hysterectomy
|
1
|
|
Month 24
Lost to Follow-up
|
1
|
|
Month 36
Elective hysterectomy
|
2
|
|
Month 36
Lost to Follow-up
|
3
|
Baseline Characteristics
Minitouch Endometrial Ablation System Treatment for Menorrhagia: An Evaluation of Safety & Effectiveness
Baseline characteristics by cohort
| Measure |
Single-Arm, Open-Label Treatment With the Minitouch System
n=114 Participants
Eligible participants will undergo a single treatment (endometrial ablation) with the Minitouch System
Minitouch System: The investigational treatment (endometrial ablation) will be performed utilizing the Minitouch System
|
|---|---|
|
Age, Continuous
|
41.8 years
STANDARD_DEVIATION 4.66 • n=39 Participants
|
|
Sex/Gender, Customized
Premenopausal females
|
114 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
100 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
108 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
114 Participants
n=39 Participants
|
|
Baseline PBLAC (Pictorial Blood Loss Assessment Chart) Score
|
264.9 score
STANDARD_DEVIATION 161.39 • n=39 Participants
|
PRIMARY outcome
Timeframe: Month 12 post-procedurePopulation: The Intent-to-Treat (ITT) Analysis Cohort is comprised of all subjects who met all Trial eligibility criteria and in whom the procedure was initiated.
The primary effectiveness endpoint is a clinical change in menstrual blood loss as assessed by the Pictorial Blood Loss Assessment Chart (PBLAC) data, a validated, patient self-reported menstrual diary scoring system. Success for the primary effectiveness endpoint was defined as reduction in menstrual bleeding to a PBLAC (Pictorial Blood Loss Assessment Chart) score of ≤75. Scale information for PBLAC (Pictorial Blood Loss Assessment Chart): The scale minimum is 0, which indicates amenorrhea, i.e., no bleeding. There is no scale maximum. A score of 100 indicates eumenorrhea, i.e., normal menstrual bleeding. A lower PBLAC score indicates less bleeding and a higher PBLAC score indicates more bleeding.
Outcome measures
| Measure |
Single-Arm, Open-Label Treatment With the Minitouch System
n=114 Participants
Eligible participants will undergo a single treatment (endometrial ablation) with the Minitouch System
Minitouch System: The investigational treatment (endometrial ablation) will be performed utilizing the Minitouch System
|
|---|---|
|
Number of Trial Participants With Reduction in Menstrual Bleeding (PBLAC Score of ≤75)
|
102 Participants
|
PRIMARY outcome
Timeframe: Month 12 post-procedurePopulation: The Intent-to-Treat (ITT) Analysis Cohort is comprised of all subjects who met all Trial eligibility criteria and in whom the procedure was initiated.
The primary safety endpoint is the incidence of device or procedure-related serious adverse events.
Outcome measures
| Measure |
Single-Arm, Open-Label Treatment With the Minitouch System
n=114 Participants
Eligible participants will undergo a single treatment (endometrial ablation) with the Minitouch System
Minitouch System: The investigational treatment (endometrial ablation) will be performed utilizing the Minitouch System
|
|---|---|
|
Number of Trial Participants With Device or Procedure-related Serious Adverse Events
|
0 Participants
|
SECONDARY outcome
Timeframe: Month 12 post-procedurePopulation: The Intent-to-Treat (ITT) Analysis Cohort is comprised of all subjects who met all Trial eligibility criteria and in whom the procedure was initiated.
Secondary safety outcome measures are the number of trial participants that underwent medical or surgical intervention to treat abnormal bleeding.
Outcome measures
| Measure |
Single-Arm, Open-Label Treatment With the Minitouch System
n=114 Participants
Eligible participants will undergo a single treatment (endometrial ablation) with the Minitouch System
Minitouch System: The investigational treatment (endometrial ablation) will be performed utilizing the Minitouch System
|
|---|---|
|
Number of Trial Participants That Underwent Subsequent Medical or Surgical Intervention to Treat Abnormal Bleeding
|
0 Participants
|
SECONDARY outcome
Timeframe: >Month 12 through Month 24 post-procedurePopulation: The Intent-to-Treat (ITT) Analysis Cohort is comprised of all subjects who met all Trial eligibility criteria and in whom the procedure was initiated.
Secondary safety outcome measures are the number of trial participants that underwent medical or surgical intervention to treat abnormal bleeding.
Outcome measures
| Measure |
Single-Arm, Open-Label Treatment With the Minitouch System
n=112 Participants
Eligible participants will undergo a single treatment (endometrial ablation) with the Minitouch System
Minitouch System: The investigational treatment (endometrial ablation) will be performed utilizing the Minitouch System
|
|---|---|
|
Number of Trial Participants That Underwent Subsequent Medical or Surgical Intervention to Treat Abnormal Bleeding
|
2 Participants
|
SECONDARY outcome
Timeframe: >Month 24 through Month 36 post-procedurePopulation: The Intent-to-Treat (ITT) Analysis Cohort is comprised of all subjects who met all Trial eligibility criteria and in whom the procedure was initiated.
Secondary safety outcome measures are the number of trial participants that underwent medical or surgical intervention to treat abnormal bleeding.
Outcome measures
| Measure |
Single-Arm, Open-Label Treatment With the Minitouch System
n=114 Participants
Eligible participants will undergo a single treatment (endometrial ablation) with the Minitouch System
Minitouch System: The investigational treatment (endometrial ablation) will be performed utilizing the Minitouch System
|
|---|---|
|
Number of Trial Participants That Underwent Subsequent Medical or Surgical Intervention to Treat Abnormal Bleeding
|
1 Participants
|
SECONDARY outcome
Timeframe: Month 6 and Month 12 post-procedurePopulation: The Per Protocol (PP) Analysis Cohort is comprised of all Intent-to-Treat (ITT) subjects who are treatable, completed the ablation procedure, and attended the 12-month follow-up visit.
Secondary Effectiveness Outcome Measure - Amenorrhea rates where PBLAC = 0 (no bleeding)
Outcome measures
| Measure |
Single-Arm, Open-Label Treatment With the Minitouch System
n=114 Participants
Eligible participants will undergo a single treatment (endometrial ablation) with the Minitouch System
Minitouch System: The investigational treatment (endometrial ablation) will be performed utilizing the Minitouch System
|
|---|---|
|
Number of Trial Participants With Amenorrhea
Month 6
|
50 participants
|
|
Number of Trial Participants With Amenorrhea
Month 12
|
59 participants
|
SECONDARY outcome
Timeframe: Month 24 post-procedurePopulation: The Per Protocol (PP) Analysis Cohort is comprised of all Intent-to-Treat (ITT) subjects who are treatable, completed the ablation procedure, and attended the 12-month follow-up visit.
Secondary Effectiveness Outcome Measure - Amenorrhea rates per the Investigator Global Evaluation (IGE)
Outcome measures
| Measure |
Single-Arm, Open-Label Treatment With the Minitouch System
n=112 Participants
Eligible participants will undergo a single treatment (endometrial ablation) with the Minitouch System
Minitouch System: The investigational treatment (endometrial ablation) will be performed utilizing the Minitouch System
|
|---|---|
|
Number of Trial Participants With Amenorrhea
|
49 participants
|
SECONDARY outcome
Timeframe: Month 36 post-procedurePopulation: The Per Protocol (PP) Analysis Cohort is comprised of all Intent-to-Treat (ITT) subjects who are treatable, completed the ablation procedure, and attended the 12-month follow-up visit.
Secondary Effectiveness Outcome Measure - Amenorrhea rates per the Investigator Global Evaluation (IGE)
Outcome measures
| Measure |
Single-Arm, Open-Label Treatment With the Minitouch System
n=107 Participants
Eligible participants will undergo a single treatment (endometrial ablation) with the Minitouch System
Minitouch System: The investigational treatment (endometrial ablation) will be performed utilizing the Minitouch System
|
|---|---|
|
Number of Trial Participants With Amenorrhea
|
48 participants
|
SECONDARY outcome
Timeframe: Baseline, Month 6 and Month 12 post-procedurePopulation: The Per Protocol (PP) Analysis Cohort is comprised of all Intent-to-Treat (ITT) subjects who are treatable, completed the ablation procedure, and attended the 12-month follow-up visit.
Change in quality of life as measured by Dysmenorrhea-related pain score using the Numerical Rating Scale (NRS) (scale of minimum 0 to maximum 10, where 0 = no pain, 5 = moderate pain, 10 = worst pain). A higher score indicates a worse outcome.
Outcome measures
| Measure |
Single-Arm, Open-Label Treatment With the Minitouch System
n=114 Participants
Eligible participants will undergo a single treatment (endometrial ablation) with the Minitouch System
Minitouch System: The investigational treatment (endometrial ablation) will be performed utilizing the Minitouch System
|
|---|---|
|
Dysmenorrhea-related Pain Score
Baseline
|
6.1 score on a scale
Standard Deviation 2.6
|
|
Dysmenorrhea-related Pain Score
Month 6
|
0.9 score on a scale
Standard Deviation 1.5
|
|
Dysmenorrhea-related Pain Score
Month 12
|
0.8 score on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Baseline and Month 24 post-procedurePopulation: The Per Protocol (PP) Analysis Cohort is comprised of all Intent-to-Treat (ITT) subjects who are treatable, completed the ablation procedure, and attended the 12-month follow-up visit.
Change in quality of life as measured by Dysmenorrhea-related pain score using the Numerical Rating Scale (NRS) (scale of minimum 0 to maximum 10, where 0 = no pain, 5 = moderate pain, 10 = worst pain). A higher score indicates a worse outcome.
Outcome measures
| Measure |
Single-Arm, Open-Label Treatment With the Minitouch System
n=112 Participants
Eligible participants will undergo a single treatment (endometrial ablation) with the Minitouch System
Minitouch System: The investigational treatment (endometrial ablation) will be performed utilizing the Minitouch System
|
|---|---|
|
Dysmenorrhea-related Pain Score
Baseline
|
6.2 score on a scale
Standard Deviation 2.6
|
|
Dysmenorrhea-related Pain Score
Month 24
|
1.0 score on a scale
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Baseline and Month 36 post-procedurePopulation: The Per Protocol (PP) Analysis Cohort is comprised of all Intent-to-Treat (ITT) subjects who are treatable, completed the ablation procedure, and attended the 12-month follow-up visit.
Change in quality of life as measured by Dysmenorrhea-related pain score using the Numerical Rating Scale (NRS) (scale of minimum 0 to maximum 10, where 0 = no pain, 5 = moderate pain, 10 = worst pain). A higher score indicates a worse outcome.
Outcome measures
| Measure |
Single-Arm, Open-Label Treatment With the Minitouch System
n=107 Participants
Eligible participants will undergo a single treatment (endometrial ablation) with the Minitouch System
Minitouch System: The investigational treatment (endometrial ablation) will be performed utilizing the Minitouch System
|
|---|---|
|
Dysmenorrhea-related Pain Score
Baseline
|
6.2 score on a scale
Standard Deviation 2.6
|
|
Dysmenorrhea-related Pain Score
Month 36
|
0.9 score on a scale
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Baseline, Month 6 and Month 12 post-procedurePopulation: The Per Protocol (PP) Analysis Cohort is comprised of all Intent-to-Treat (ITT) subjects who are treatable, completed the ablation procedure, and attended the 12-month follow-up visit.
Change in quality of life as measured by Menorrhagia Impact Questionnaire (MIQ 2): Subjects were asked if they had any limitations in work outside or inside the home based on the following categories: not at all, slightly, moderately, quite a bit, extremely
Outcome measures
| Measure |
Single-Arm, Open-Label Treatment With the Minitouch System
n=114 Participants
Eligible participants will undergo a single treatment (endometrial ablation) with the Minitouch System
Minitouch System: The investigational treatment (endometrial ablation) will be performed utilizing the Minitouch System
|
|---|---|
|
Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home
Month 6 · Moderately
|
2 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home
Month 6 · Quite a bit
|
0 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home
Baseline · Not at all
|
9 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home
Baseline · Slightly
|
17 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home
Baseline · Moderately
|
34 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home
Baseline · Quite a bit
|
34 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home
Baseline · Extremely
|
20 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home
Month 6 · Not at all
|
105 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home
Month 6 · Slightly
|
7 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home
Month 6 · Extremely
|
0 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home
Month 12 · Not at all
|
108 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home
Month 12 · Slightly
|
3 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home
Month 12 · Moderately
|
3 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home
Month 12 · Quite a bit
|
0 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home
Month 12 · Extremely
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and Month 24 post-procedurePopulation: The Per Protocol (PP) Analysis Cohort is comprised of all Intent-to-Treat (ITT) subjects who are treatable, completed the ablation procedure, and attended the 12-month follow-up visit.
Change in quality of life as measured by Menorrhagia Impact Questionnaire (MIQ 2): Subjects were asked if they had any limitations in work outside or inside the home based on the following categories: not at all, slightly, moderately, quite a bit, extremely
Outcome measures
| Measure |
Single-Arm, Open-Label Treatment With the Minitouch System
n=112 Participants
Eligible participants will undergo a single treatment (endometrial ablation) with the Minitouch System
Minitouch System: The investigational treatment (endometrial ablation) will be performed utilizing the Minitouch System
|
|---|---|
|
Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home
Month 24 · Slightly
|
7 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home
Month 24 · Moderately
|
1 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home
Month 24 · Quite a bit
|
3 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home
Month 24 · Extremely
|
0 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home
Baseline · Not at all
|
9 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home
Baseline · Slightly
|
17 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home
Baseline · Moderately
|
33 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home
Baseline · Quite a bit
|
33 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home
Baseline · Extremely
|
20 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home
Month 24 · Not at all
|
101 Participants
|
SECONDARY outcome
Timeframe: Baseline and Month 36 post-procedurePopulation: The Per Protocol (PP) Analysis Cohort is comprised of all Intent-to-Treat (ITT) subjects who are treatable, completed the ablation procedure, and attended the 12-month follow-up visit.
Change in quality of life as measured by Menorrhagia Impact Questionnaire (MIQ 2): Subjects were asked if they had any limitations in work outside or inside the home based on the following categories: not at all, slightly, moderately, quite a bit, extremely
Outcome measures
| Measure |
Single-Arm, Open-Label Treatment With the Minitouch System
n=107 Participants
Eligible participants will undergo a single treatment (endometrial ablation) with the Minitouch System
Minitouch System: The investigational treatment (endometrial ablation) will be performed utilizing the Minitouch System
|
|---|---|
|
Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home
Baseline · Not at all
|
8 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home
Baseline · Slightly
|
15 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home
Baseline · Moderately
|
32 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home
Baseline · Quite a bit
|
32 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home
Baseline · Extremely
|
20 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home
Month 36 · Not at all
|
100 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home
Month 36 · Slightly
|
5 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home
Month 36 · Moderately
|
1 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home
Month 36 · Quite a bit
|
1 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home
Month 36 · Extremely
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Month 6 and Month 12 post-procedurePopulation: The Per Protocol (PP) Analysis Cohort is comprised of all Intent-to-Treat (ITT) subjects who are treatable, completed the ablation procedure, and attended the 12-month follow-up visit.
Change in quality of life as measured by Menorrhagia Impact Questionnaire (MIQ 3): Subjects were asked if they had any limitations in physical activity based on the following categories: not at all, slightly, moderately, quite a bit, extremelylimitations in social and leisure activities: not at all, slightly, moderately, quite a bit, extremely
Outcome measures
| Measure |
Single-Arm, Open-Label Treatment With the Minitouch System
n=114 Participants
Eligible participants will undergo a single treatment (endometrial ablation) with the Minitouch System
Minitouch System: The investigational treatment (endometrial ablation) will be performed utilizing the Minitouch System
|
|---|---|
|
Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity
Baseline · Extremely
|
25 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity
Month 6 · Not at all
|
107 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity
Month 6 · Slightly
|
6 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity
Month 6 · Moderately
|
1 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity
Baseline · Not at all
|
2 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity
Baseline · Slightly
|
20 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity
Baseline · Moderately
|
27 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity
Baseline · Quite a bit
|
40 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity
Month 6 · Quite a bit
|
0 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity
Month 6 · Extremely
|
0 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity
Month12 · Not at all
|
106 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity
Month12 · Slightly
|
5 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity
Month12 · Moderately
|
2 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity
Month12 · Quite a bit
|
1 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity
Month12 · Extremely
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and Month 24 post-procedurePopulation: The Per Protocol (PP) Analysis Cohort is comprised of all Intent-to-Treat (ITT) subjects who are treatable, completed the ablation procedure, and attended the 12-month follow-up visit.
Change in quality of life as measured by Menorrhagia Impact Questionnaire (MIQ 3): Subjects were asked if they had any limitations in physical activity based on the following categories: not at all, slightly, moderately, quite a bit, extremelylimitations in social and leisure activities: not at all, slightly, moderately, quite a bit, extremely
Outcome measures
| Measure |
Single-Arm, Open-Label Treatment With the Minitouch System
n=112 Participants
Eligible participants will undergo a single treatment (endometrial ablation) with the Minitouch System
Minitouch System: The investigational treatment (endometrial ablation) will be performed utilizing the Minitouch System
|
|---|---|
|
Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity
Baseline · Slightly
|
20 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity
Baseline · Not at all
|
2 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity
Baseline · Moderately
|
27 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity
Baseline · Quite a bit
|
38 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity
Baseline · Extremely
|
25 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity
Month 24 · Not at all
|
98 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity
Month 24 · Slightly
|
10 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity
Month 24 · Moderately
|
1 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity
Month 24 · Quite a bit
|
3 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity
Month 24 · Extremely
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and Month 36 post-procedurePopulation: The Per Protocol (PP) Analysis Cohort is comprised of all Intent-to-Treat (ITT) subjects who are treatable, completed the ablation procedure, and attended the 12-month follow-up visit.
Change in quality of life as measured by Menorrhagia Impact Questionnaire (MIQ 3): Subjects were asked if they had any limitations in physical activity based on the following categories: not at all, slightly, moderately, quite a bit, extremelylimitations in social and leisure activities: not at all, slightly, moderately, quite a bit, extremely
Outcome measures
| Measure |
Single-Arm, Open-Label Treatment With the Minitouch System
n=107 Participants
Eligible participants will undergo a single treatment (endometrial ablation) with the Minitouch System
Minitouch System: The investigational treatment (endometrial ablation) will be performed utilizing the Minitouch System
|
|---|---|
|
Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity
Baseline · Slightly
|
19 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity
Baseline · Moderately
|
25 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity
Baseline · Quite a bit
|
37 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity
Baseline · Extremely
|
25 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity
Baseline · Not at all
|
1 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity
Month 36 · Not at all
|
100 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity
Month 36 · Slightly
|
4 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity
Month 36 · Moderately
|
2 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity
Month 36 · Quite a bit
|
1 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity
Month 36 · Extremely
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Month 6 and Month 12 post-procedurePopulation: The Per Protocol (PP) Analysis Cohort is comprised of all Intent-to-Treat (ITT) subjects who are treatable, completed the ablation procedure, and attended the 12-month follow-up visit.
Change in quality of life as measured by Menorrhagia Impact Questionnaire (MIQ 4): Subjects were asked if they had any limitations in social or leisure activities based on the following categories: not at all, slightly, moderately, quite a bit, extremely
Outcome measures
| Measure |
Single-Arm, Open-Label Treatment With the Minitouch System
n=114 Participants
Eligible participants will undergo a single treatment (endometrial ablation) with the Minitouch System
Minitouch System: The investigational treatment (endometrial ablation) will be performed utilizing the Minitouch System
|
|---|---|
|
Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities
Month 12 · Slightly
|
4 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities
Month 12 · Moderately
|
1 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities
Baseline · Not at all
|
7 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities
Baseline · Slightly
|
20 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities
Baseline · Moderately
|
30 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities
Baseline · Quite a bit
|
36 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities
Baseline · Extremely
|
21 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities
Month 6 · Not at all
|
107 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities
Month 6 · Slightly
|
6 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities
Month 6 · Moderately
|
1 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities
Month 6 · Quite a bit
|
0 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities
Month 6 · Extremely
|
0 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities
Month 12 · Not at all
|
108 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities
Month 12 · Quite a bit
|
1 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities
Month 12 · Extremely
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and Month 24 post-procedurePopulation: The Per Protocol (PP) Analysis Cohort is comprised of all Intent-to-Treat (ITT) subjects who are treatable, completed the ablation procedure, and attended the 12-month follow-up visit.
Change in quality of life as measured by Menorrhagia Impact Questionnaire (MIQ 4): Subjects were asked if they had any limitations in social or leisure activities based on the following categories: not at all, slightly, moderately, quite a bit, extremely
Outcome measures
| Measure |
Single-Arm, Open-Label Treatment With the Minitouch System
n=112 Participants
Eligible participants will undergo a single treatment (endometrial ablation) with the Minitouch System
Minitouch System: The investigational treatment (endometrial ablation) will be performed utilizing the Minitouch System
|
|---|---|
|
Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities
Baseline · Extremely
|
21 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities
Month 24 · Not at all
|
101 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities
Month 24 · Slightly
|
7 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities
Month 24 · Moderately
|
2 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities
Month 24 · Extremely
|
1 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities
Baseline · Not at all
|
7 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities
Baseline · Slightly
|
20 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities
Baseline · Moderately
|
28 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities
Baseline · Quite a bit
|
36 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities
Month 24 · Quite a bit
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline and Month 36 post-procedurePopulation: The Per Protocol (PP) Analysis Cohort is comprised of all Intent-to-Treat (ITT) subjects who are treatable, completed the ablation procedure, and attended the 12-month follow-up visit.
Change in quality of life as measured by Menorrhagia Impact Questionnaire (MIQ 4): Subjects were asked if they had any limitations in social or leisure activities based on the following categories: not at all, slightly, moderately, quite a bit, extremely
Outcome measures
| Measure |
Single-Arm, Open-Label Treatment With the Minitouch System
n=107 Participants
Eligible participants will undergo a single treatment (endometrial ablation) with the Minitouch System
Minitouch System: The investigational treatment (endometrial ablation) will be performed utilizing the Minitouch System
|
|---|---|
|
Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities
Baseline · Not at all
|
6 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities
Baseline · Slightly
|
19 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities
Baseline · Quite a bit
|
36 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities
Baseline · Extremely
|
20 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities
Baseline · Moderately
|
26 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities
Month 36 · Not at all
|
102 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities
Month 36 · Slightly
|
3 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities
Month 36 · Moderately
|
1 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities
Month 36 · Quite a bit
|
1 Participants
|
|
Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities
Month 36 · Extremely
|
0 Participants
|
SECONDARY outcome
Timeframe: Day of Procedure (during the procedure)Population: The Per Protocol (PP) Analysis Cohort is comprised of all Intent-to-Treat (ITT) subjects who are treatable, completed the ablation procedure, and attended the 12-month follow-up visit.
Secondary Outcome Measure - Use of Cervical Dilator (Yes / No) Time frame: the need for using a cervical dilator is assessed on day of procedure, during the procedure
Outcome measures
| Measure |
Single-Arm, Open-Label Treatment With the Minitouch System
n=114 Participants
Eligible participants will undergo a single treatment (endometrial ablation) with the Minitouch System
Minitouch System: The investigational treatment (endometrial ablation) will be performed utilizing the Minitouch System
|
|---|---|
|
Procedure Details: Number of Trial Participants in Which a Cervical Dilator Was Used
Yes - cervical dilator used
|
9 Participants
|
|
Procedure Details: Number of Trial Participants in Which a Cervical Dilator Was Used
No - cervical dilator not used
|
105 Participants
|
SECONDARY outcome
Timeframe: Day of Procedure (prior to the procedure)Population: The Per Protocol (PP) Analysis Cohort is comprised of all Intent-to-Treat (ITT) subjects who are treatable, completed the ablation procedure, and attended the 12-month follow-up visit.
Secondary Outcome Measure - Setting in which the Minitouch Procedure took place Time frame: the type of setting is assessed on day of procedure, prior to the procedure
Outcome measures
| Measure |
Single-Arm, Open-Label Treatment With the Minitouch System
n=114 Participants
Eligible participants will undergo a single treatment (endometrial ablation) with the Minitouch System
Minitouch System: The investigational treatment (endometrial ablation) will be performed utilizing the Minitouch System
|
|---|---|
|
Procedure Details: Type of Setting in Which the Procedure Took Place
Physician's office
|
114 Participants
|
|
Procedure Details: Type of Setting in Which the Procedure Took Place
Outpatient clinic/facility (surgery center)
|
0 Participants
|
|
Procedure Details: Type of Setting in Which the Procedure Took Place
Affiliated hospital
|
0 Participants
|
SECONDARY outcome
Timeframe: Pre-Procedure (on day of, prior to procedure), Discharge (post-procedure, prior to discharge) and 24-hours post-procedurePopulation: The Per Protocol (PP) Analysis Cohort is comprised of all Intent-to-Treat (ITT) subjects who are treatable, completed the ablation procedure, and attended the 12-month follow-up visit.
Procedure-related pain score using the Numerical Rating Scale (NRS) (scale of minimum 0 to maximum 10, where 0 = no pain, 5 = moderate pain, 10 = worst pain). A higher score indicates a worse outcome. Timepoints: Pre-procedure (on the day of, prior to the procedure) Discharge (post-procedure, prior to discharge) 24-hours post-procedure (18-48 hours post-procedure)
Outcome measures
| Measure |
Single-Arm, Open-Label Treatment With the Minitouch System
n=114 Participants
Eligible participants will undergo a single treatment (endometrial ablation) with the Minitouch System
Minitouch System: The investigational treatment (endometrial ablation) will be performed utilizing the Minitouch System
|
|---|---|
|
Procedure-related Pain Score
Pre-procedure (on the day of, prior to the procedure
|
0.6 score on a scale
Standard Deviation 1.5
|
|
Procedure-related Pain Score
Discharge (post-procedure, prior to discharge)
|
2.6 score on a scale
Standard Deviation 2.4
|
|
Procedure-related Pain Score
24-hours post-procedure (18-48 hours post-procedure)
|
1.2 score on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Day of Procedure (post-procedure, prior to discharge)Population: The Per Protocol (PP) Analysis Cohort is comprised of all Intent-to-Treat (ITT) subjects who are treatable, completed the ablation procedure, and attended the 12-month follow-up visit.
Secondary Outcome Measure - Total Procedure Recovery Time Time frame: assessed on the day of procedure/post-procedure, prior to discharge
Outcome measures
| Measure |
Single-Arm, Open-Label Treatment With the Minitouch System
n=114 Participants
Eligible participants will undergo a single treatment (endometrial ablation) with the Minitouch System
Minitouch System: The investigational treatment (endometrial ablation) will be performed utilizing the Minitouch System
|
|---|---|
|
Procedure Details: Recovery Time
|
20.8 minutes
Standard Deviation 22.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 36 post-procedureCount of subject self-report of pregnancy at Month 36 to satisfy the post-approval study (PAS) reporting requirements
Outcome measures
| Measure |
Single-Arm, Open-Label Treatment With the Minitouch System
n=107 Participants
Eligible participants will undergo a single treatment (endometrial ablation) with the Minitouch System
Minitouch System: The investigational treatment (endometrial ablation) will be performed utilizing the Minitouch System
|
|---|---|
|
Additonal Measure - Subject Self-Report of Pregnancy
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 36 post-procedureCount of subject contraception menthods reported at Month 36 to satisfy the post-approval study (PAS) reporting requirements; subjects could report more than one method of contraception so numbers may be greater than the total of subjects
Outcome measures
| Measure |
Single-Arm, Open-Label Treatment With the Minitouch System
n=107 Participants
Eligible participants will undergo a single treatment (endometrial ablation) with the Minitouch System
Minitouch System: The investigational treatment (endometrial ablation) will be performed utilizing the Minitouch System
|
|---|---|
|
Additonal Measure - Contraception Status at Month 36
Tubal sterilization
|
30 participants
|
|
Additonal Measure - Contraception Status at Month 36
Hormonal method (includes pills, injections, rings, implants)
|
4 participants
|
|
Additonal Measure - Contraception Status at Month 36
Abstinence
|
5 participants
|
|
Additonal Measure - Contraception Status at Month 36
Condom
|
21 participants
|
|
Additonal Measure - Contraception Status at Month 36
Partner's vasectomy
|
48 participants
|
|
Additonal Measure - Contraception Status at Month 36
Intrauterine devices
|
2 participants
|
|
Additonal Measure - Contraception Status at Month 36
Other (includes no method of contraception)
|
4 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 24 and Month 36 post-procedureCount of number of subjects that reported gynecologic adverse events through Month 24 and Month 36;
Outcome measures
| Measure |
Single-Arm, Open-Label Treatment With the Minitouch System
n=114 Participants
Eligible participants will undergo a single treatment (endometrial ablation) with the Minitouch System
Minitouch System: The investigational treatment (endometrial ablation) will be performed utilizing the Minitouch System
|
|---|---|
|
Additonal Measure - Gynecologic Adverse Events
>Month 12 to Month 24: Bacterial vaginosis
|
1 Participants
|
|
Additonal Measure - Gynecologic Adverse Events
>Month 12 to Month 24: Stress urinary incontinence
|
1 Participants
|
|
Additonal Measure - Gynecologic Adverse Events
>Month 12 to Month 24: Ureterolithiasis
|
1 Participants
|
|
Additonal Measure - Gynecologic Adverse Events
>Month 12 to Month 24: Urinary incontinence
|
1 Participants
|
|
Additonal Measure - Gynecologic Adverse Events
>Month 12 to Month 24: Coital bleeding
|
1 Participants
|
|
Additonal Measure - Gynecologic Adverse Events
>Month 12 to Month 24: Menopausal symptoms
|
1 Participants
|
|
Additonal Measure - Gynecologic Adverse Events
>Month 12 to Month 24: Ovarian cyst
|
1 Participants
|
|
Additonal Measure - Gynecologic Adverse Events
>Month 12 to Month 24: Uterine hemorrage
|
1 Participants
|
|
Additonal Measure - Gynecologic Adverse Events
>Month 24 to Month 36: Bacterial vaginosis
|
1 Participants
|
|
Additonal Measure - Gynecologic Adverse Events
>Month 24 to Month 36: Urinary tract infection
|
1 Participants
|
|
Additonal Measure - Gynecologic Adverse Events
>Month 24 to Month 36: Dysuria
|
1 Participants
|
|
Additonal Measure - Gynecologic Adverse Events
>Month 12 to Month 24: Urinary tract infection
|
4 Participants
|
|
Additonal Measure - Gynecologic Adverse Events
>Month 12 to Month 24: Bladder pain
|
1 Participants
|
|
Additonal Measure - Gynecologic Adverse Events
>Month 12 to Month 24: Renal colic
|
1 Participants
|
|
Additonal Measure - Gynecologic Adverse Events
>Month 12 to Month 24: Renal mass
|
1 Participants
|
|
Additonal Measure - Gynecologic Adverse Events
>Month 12 to Month 24: Anxiety
|
1 Participants
|
|
Additonal Measure - Gynecologic Adverse Events
>Month 24 to Month 36: Dysmenorrhea
|
2 Participants
|
|
Additonal Measure - Gynecologic Adverse Events
>Month 24 to Month 36: Ovarian cyst
|
1 Participants
|
Adverse Events
Single-Arm, Open-Label Treatment With the Minitouch System
Serious events: 3 serious events
Other events: 109 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Single-Arm, Open-Label Treatment With the Minitouch System
n=114 participants at risk
Eligible participants will undergo a single treatment (endometrial ablation) with the Minitouch System
Minitouch System: The investigational treatment (endometrial ablation) will be performed utilizing the Minitouch System
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Nervous system disorders
Syncope
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
Other adverse events
| Measure |
Single-Arm, Open-Label Treatment With the Minitouch System
n=114 participants at risk
Eligible participants will undergo a single treatment (endometrial ablation) with the Minitouch System
Minitouch System: The investigational treatment (endometrial ablation) will be performed utilizing the Minitouch System
|
|---|---|
|
Cardiac disorders
Postural orthostatic tachycardia syndrome (POTS)
|
1.8%
2/114 • Number of events 2 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Cardiac disorders
Tachycardia
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Ear and labyrinth disorders
Ear pain
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Ear and labyrinth disorders
Eustachian tube disorder
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Endocrine disorders
Hypothyroidism
|
1.8%
2/114 • Number of events 2 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Eye disorders
Blindness
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Gastrointestinal disorders
Abdominal distension
|
2.6%
3/114 • Number of events 3 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.6%
3/114 • Number of events 3 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Gastrointestinal disorders
Gastritis
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Gastrointestinal disorders
Hemorrhoids
|
1.8%
2/114 • Number of events 2 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Gastrointestinal disorders
Nausea
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Gastrointestinal disorders
Procedural nausea
|
6.1%
7/114 • Number of events 8 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
2/114 • Number of events 2 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
General disorders
Chest pain
|
1.8%
2/114 • Number of events 2 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
General disorders
Chills
|
1.8%
2/114 • Number of events 2 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Immune system disorders
Hypensensitivity
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Infections and infestations
Bronchitis
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Infections and infestations
COVID-19
|
28.9%
33/114 • Number of events 33 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Infections and infestations
Cellulitis
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Infections and infestations
Cholera
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Infections and infestations
Ear infection
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Infections and infestations
Fungal infection
|
1.8%
2/114 • Number of events 2 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Infections and infestations
Herpes zoster
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Infections and infestations
Onychomycosis
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Infections and infestations
Pharyngitis streptoccal
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Infections and infestations
Sialoadenitis
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Infections and infestations
Sinusitis
|
1.8%
2/114 • Number of events 2 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.8%
2/114 • Number of events 2 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Infections and infestations
Urinary tract infection
|
5.3%
6/114 • Number of events 7 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Infections and infestations
Vaginal infection
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Injury, poisoning and procedural complications
Arthropod sling
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Injury, poisoning and procedural complications
Exposure to toxic agent
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Injury, poisoning and procedural complications
Fall
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
2.6%
3/114 • Number of events 4 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
1.8%
2/114 • Number of events 2 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Investigations
Blood testosterone decreased
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Investigations
Mammogram abnormal
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Investigations
SARS-CoV-2 test positive
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Investigations
Weight increased
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Metabolism and nutrition disorders
Glucose intolerance impaired
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Metabolism and nutrition disorders
Insulin resistance
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.8%
2/114 • Number of events 2 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Nervous system disorders
Dizziness
|
2.6%
3/114 • Number of events 3 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Nervous system disorders
Headache
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Nervous system disorders
Migraine
|
1.8%
2/114 • Number of events 2 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Nervous system disorders
Neuralgia
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Nervous system disorders
Restless leg syndrome
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Nervous system disorders
Somnolence
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Product Issues
Device dislocation
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Psychiatric disorders
Adjustment disorder with depressed mood
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Psychiatric disorders
Anxiety
|
6.1%
7/114 • Number of events 7 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Psychiatric disorders
Attention deficit hyperactivity disorder
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Psychiatric disorders
Depression
|
3.5%
4/114 • Number of events 4 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Psychiatric disorders
Insomnia
|
1.8%
2/114 • Number of events 2 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Psychiatric disorders
Panic attack
|
1.8%
2/114 • Number of events 2 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Psychiatric disorders
Stress
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Renal and urinary disorders
Bladder pain
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Renal and urinary disorders
Dysuria
|
1.8%
2/114 • Number of events 2 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Renal and urinary disorders
Pollakiuria
|
1.8%
2/114 • Number of events 2 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Renal and urinary disorders
Renal colic
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Renal and urinary disorders
Renal mass
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Reproductive system and breast disorders
Breast mass
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Reproductive system and breast disorders
Breast pain
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Reproductive system and breast disorders
Coital bleeding
|
1.8%
2/114 • Number of events 2 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.88%
1/114 • Number of events 2 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Reproductive system and breast disorders
Dyspareunia
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Reproductive system and breast disorders
Endometriosis
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
1.8%
2/114 • Number of events 2 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Reproductive system and breast disorders
Pelvic pain
|
2.6%
3/114 • Number of events 3 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Reproductive system and breast disorders
Stress urinary incontinence
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Reproductive system and breast disorders
Uterine pain
|
1.8%
2/114 • Number of events 2 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Reproductive system and breast disorders
Uterine spasm
|
43.9%
50/114 • Number of events 50 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
3.5%
4/114 • Number of events 4 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Reproductive system and breast disorders
Vaginal odour
|
1.8%
2/114 • Number of events 2 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.8%
2/114 • Number of events 2 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Skin and subcutaneous tissue disorders
Autoimmune dermatitis
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Social circumstances
Menopause
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Surgical and medical procedures
Medical device change
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Vascular disorders
Hot flush
|
1.8%
2/114 • Number of events 2 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Vascular disorders
Hypertension
|
1.8%
2/114 • Number of events 2 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Infections and infestations
Bacterial vaginosis
|
5.3%
6/114 • Number of events 6 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Injury, poisoning and procedural complications
Abdominal pain
|
1.8%
2/114 • Number of events 2 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
4.4%
5/114 • Number of events 5 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Nervous system disorders
Near syncope (vasovagal response)
|
0.88%
1/114 • Number of events 1 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
|
Nervous system disorders
Syncope
|
1.8%
2/114 • Number of events 2 • Month 36 post-procedure
The protocol defines an adverse event (AE) as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the medical device. This includes any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medical device, whether or not related to the medical device. Therefore, all adverse events regardless of causality are reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place