Trial Outcomes & Findings for Safety & Efficacy Study of the Adiana System for Women Who Desire Permanent Birth Control (Sterilization) (NCT NCT00737061)
NCT ID: NCT00737061
Last Updated: 2017-09-08
Results Overview
Pregnancy rate is defined as the cumulative percentage of pregnancies occuring within the time frame. The primary endpoint for this study is the pregnancy prevention rate after one year of reliance on the Adiana System for pregnancy prevention. The pregnancy rate was evaluated for all participants who underwent successful bilateral treatment and who had demonstrated tubal occlusion by hysterosalpingogram (HSG) at the end of the Waiting Period.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
770 participants
Primary outcome timeframe
1 year
Results posted on
2017-09-08
Participant Flow
Subjects were enrolled in the trial from 16 investigative sites between November 13, 2002 and April 28, 2005. Fourteen sites were located in the US and two were international sites.
770 subjects were enrolled: 75 withdrew consent and 50 were excluded for pathology/procedural criteria. All subjects were enrolled on an intent to treat (ITT) basis. The ITT population included all patients who were enrolled in the study and had device placement attempted. 645 subjects had treatment attempted. No comparative assessment was made.
Participant milestones
| Measure |
Adiana Permanent Contraception System
Implantation of silicone matrix in fallopian tubes
|
|---|---|
|
Waiting Period
STARTED
|
645
|
|
Waiting Period
COMPLETED
|
570
|
|
Waiting Period
NOT COMPLETED
|
75
|
|
1 Year Wearing Period
STARTED
|
570
|
|
1 Year Wearing Period
COMPLETED
|
553
|
|
1 Year Wearing Period
NOT COMPLETED
|
17
|
Reasons for withdrawal
| Measure |
Adiana Permanent Contraception System
Implantation of silicone matrix in fallopian tubes
|
|---|---|
|
Waiting Period
Lost to Follow-up
|
6
|
|
Waiting Period
Withdrawal by Subject
|
1
|
|
Waiting Period
Bilateral placement failure
|
34
|
|
Waiting Period
Deemed patent following HSG
|
26
|
|
Waiting Period
Alternative contraception failure
|
3
|
|
Waiting Period
Elected surgical tubal ligation
|
5
|
|
1 Year Wearing Period
Lost to Follow-up
|
11
|
|
1 Year Wearing Period
Withdrawal by Subject
|
2
|
|
1 Year Wearing Period
Discontinued reilance
|
3
|
|
1 Year Wearing Period
Terminated for protocol non-compliance
|
1
|
Baseline Characteristics
Safety & Efficacy Study of the Adiana System for Women Who Desire Permanent Birth Control (Sterilization)
Baseline characteristics by cohort
| Measure |
Adiana Permanent Contraception System
n=645 Participants
Implantation of silicone matrix in fallopian tubes
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
645 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
All Participants
|
31.5 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
645 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: 645 participants had treatment attempted; Intent to Treat population. Of these 645, 570 were able to rely on the device and are used to evaluate the pregnancy prevention rate for the 1-year endpoint. During the 1-year follow-up period, there were 6 pregnancies, of which 3 were attributable to physician error, i.e., misinterpretation of HSG results.
Pregnancy rate is defined as the cumulative percentage of pregnancies occuring within the time frame. The primary endpoint for this study is the pregnancy prevention rate after one year of reliance on the Adiana System for pregnancy prevention. The pregnancy rate was evaluated for all participants who underwent successful bilateral treatment and who had demonstrated tubal occlusion by hysterosalpingogram (HSG) at the end of the Waiting Period.
Outcome measures
| Measure |
Adiana Permanent Contraception System
n=570 Participants
Implantation of silicone matrix in fallopian tubes
|
|---|---|
|
1 Year Pregnancy Rate
|
1.1 percentage of participants
|
SECONDARY outcome
Timeframe: After First Treatment AttemptPopulation: Device placement rate reported on a per participant basis for 645 intent to treat participants. Successful bilateral placement of the matrices was achieved in 604/645 participants after the first procedure.
Defined as successful bilateral tubal access followed by successful bilateral RF treatment and matrix placement.
Outcome measures
| Measure |
Adiana Permanent Contraception System
n=645 Participants
Implantation of silicone matrix in fallopian tubes
|
|---|---|
|
Device Placement Rate
|
93.6 percentage of participants
|
SECONDARY outcome
Timeframe: Including Second Treatment AttemptPopulation: Device placement rate reported on a per participant basis for 645 intent to treat participants. Successful bilateral placement of the matrices was achieved in 611/645 participants after 7 participants underwent a successful second attempt.
Defined as successful bilateral tubal access followed by successful bilateral RF treatment and matrix placement.
Outcome measures
| Measure |
Adiana Permanent Contraception System
n=645 Participants
Implantation of silicone matrix in fallopian tubes
|
|---|---|
|
Device Placement Rate
|
94.7 percentage of participants
|
SECONDARY outcome
Timeframe: 48 hoursPopulation: Intent to treat population; no imputations for missing data. Minimum satisfaction reported as 605/625 participants.
Determined by verbal questions up to 48 hours post placement. Endpoint reported represents minimum percentage of participants reporting somewhat satisfied, satisfied or very satisfied.
Outcome measures
| Measure |
Adiana Permanent Contraception System
n=625 Participants
Implantation of silicone matrix in fallopian tubes
|
|---|---|
|
Patient Satisfaction With Placement Procedure
|
96.8 percentage of participants
|
SECONDARY outcome
Timeframe: Waiting Period (1-Month, 2-Months, 3-Months)Population: Intent to treat population; no imputations for missing data. Minimum satisfaction reported at 2-Months as 587/613 participants.
Determined by verbal questions during periodic follow-up contacts. Endpoint reported represents minimum percentage of subjects reporting somewhat satisfied, satisfied or very satisfied.
Outcome measures
| Measure |
Adiana Permanent Contraception System
n=613 Participants
Implantation of silicone matrix in fallopian tubes
|
|---|---|
|
Patient Satisfaction With Device Wearing
|
95.8 percentage of participants
|
SECONDARY outcome
Timeframe: Wearing Period (3-Months, 6-Months, 9-Months, 12-Months)Population: Per protocol population; no imputations for missing data. Minimum satisfaction reported at 12-Months as 528/531 participants.
Determined by verbal questions during periodic follow-up contacts. Endpoint reported represents minimum percentage of subjects reporting somewhat satisfied, satisfied or very satisfied.
Outcome measures
| Measure |
Adiana Permanent Contraception System
n=531 Participants
Implantation of silicone matrix in fallopian tubes
|
|---|---|
|
Patient Satisfaction With Device Wearing
|
99.4 percentage of participants
|
SECONDARY outcome
Timeframe: Post-ProcedurePopulation: Intent to treat population; no imputations for missing data. Minimum comfort reported as 504/629 participants.
Determined by verbal questions two hours following procedure or at discharge from facility, whichever came first. Endpoint reported represents minimum percentage of participants reporting any discomfort or pain experienced during the procedure as the same as or less than they expected.
Outcome measures
| Measure |
Adiana Permanent Contraception System
n=629 Participants
Implantation of silicone matrix in fallopian tubes
|
|---|---|
|
Patient Comfort With Placement Procedure
|
80.1 percentage of participants
|
SECONDARY outcome
Timeframe: 48 hoursPopulation: Intent to treat population; no imputations for missing data. Minimum comfort reported as 578/632 participants.
Determined by verbal questions up to 48 hours post placement. Endpoint reported represents minimum percentage of participants reporting any discomfort or pain experienced in first 48 hours following procedure as the same as they expected, less than they expected or no pain.
Outcome measures
| Measure |
Adiana Permanent Contraception System
n=632 Participants
Implantation of silicone matrix in fallopian tubes
|
|---|---|
|
Patient Comfort With Placement Procedure
|
91.5 percentage of participants
|
SECONDARY outcome
Timeframe: Waiting Period (1-Month, 2-Months, 3-Months)Population: Intent to treat population; no imputations for missing data. Minimum comfort reported at 1-Month as 604/608 participants.
Determined by verbal questions during periodic follow-up contacts. Endpoint represents minimum percentage of subjects reporting good, very good or excellent comfort.
Outcome measures
| Measure |
Adiana Permanent Contraception System
n=608 Participants
Implantation of silicone matrix in fallopian tubes
|
|---|---|
|
Patient Comfort With Device Wearing
|
99.3 percentage of participants
|
SECONDARY outcome
Timeframe: Wearing Period (3-Months, 6-Months, 9-Months, 12-Months)Population: Per protocol population; no imputations for missing data. Minimum comfort reported at 12-Months as 530/532 participants.
Determined by verbal questions during periodic follow-up contacts. Endpoint represents minimum percentage of subjects reporting good, very good or excellent comfort.
Outcome measures
| Measure |
Adiana Permanent Contraception System
n=532 Participants
Implantation of silicone matrix in fallopian tubes
|
|---|---|
|
Patient Comfort With Device Wearing
|
99.6 percentage of participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Population includes all participants able to rely on Adiana (n=570). This analysis is cumulative and based on survival analysis methodology. Thus, participants only followed for 2 years, for example, would still be included in this cumulative analysis. In total, 481 participants were available with 3 years of follow-up at the time of analysis.
Pregnancy rate is defined as the cumulative percentage of pregnancies occuring within the time frame. The pregnancy rate was evaluated for all participants who underwent successful bilateral treatment and who had demonstrated tubal occlusion by hysterosalpingogram (HSG) at the end of the Waiting Period who have been followed for up to 3 years.
Outcome measures
| Measure |
Adiana Permanent Contraception System
n=570 Participants
Implantation of silicone matrix in fallopian tubes
|
|---|---|
|
3 Year Pregnancy Rate
|
1.6 percentage of participants
|
Adverse Events
Adiana Permanent Contraception System
Serious events: 60 serious events
Other events: 642 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adiana Permanent Contraception System
n=645 participants at risk
Implantation of silicone matrix in fallopian tubes
|
|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.16%
1/645 • Number of events 1 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Cardiac disorders
Arrhythmia
|
0.16%
1/645 • Number of events 1 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Cardiac disorders
Palpitations
|
0.16%
1/645 • Number of events 1 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Cardiac disorders
Tachycardia
|
0.16%
1/645 • Number of events 1 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Endocrine disorders
Basedow's disease
|
0.16%
1/645 • Number of events 1 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Eye disorders
Keratoconjunctivitis sicca
|
0.16%
1/645 • Number of events 1 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.16%
1/645 • Number of events 1 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.16%
1/645 • Number of events 1 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Infections and infestations
Breast abscess
|
0.16%
1/645 • Number of events 1 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Infections and infestations
Enterocolitis infectious
|
0.16%
1/645 • Number of events 1 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Infections and infestations
Pneumonia
|
0.47%
3/645 • Number of events 3 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Infections and infestations
Sepsis
|
0.16%
1/645 • Number of events 1 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Infections and infestations
Urinary tract infection
|
0.16%
1/645 • Number of events 1 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.16%
1/645 • Number of events 1 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.16%
1/645 • Number of events 1 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.16%
1/645 • Number of events 1 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Injury, poisoning and procedural complications
Nerve injury
|
0.16%
1/645 • Number of events 1 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Injury, poisoning and procedural complications
Pain trauma activated
|
0.16%
1/645 • Number of events 1 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.16%
1/645 • Number of events 1 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.16%
1/645 • Number of events 1 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.16%
1/645 • Number of events 1 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.16%
1/645 • Number of events 1 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.16%
1/645 • Number of events 1 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
0.31%
2/645 • Number of events 2 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of spinal cord
|
0.16%
1/645 • Number of events 1 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.16%
1/645 • Number of events 1 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.16%
1/645 • Number of events 1 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.16%
1/645 • Number of events 1 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma stage unspecified
|
0.16%
1/645 • Number of events 1 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid gland cancer
|
0.16%
1/645 • Number of events 1 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.62%
4/645 • Number of events 4 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Nervous system disorders
Monoplegia
|
0.16%
1/645 • Number of events 1 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Nervous system disorders
Multiple sclerosis
|
0.31%
2/645 • Number of events 2 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.31%
2/645 • Number of events 2 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Psychiatric disorders
Bipolar disorder
|
0.31%
2/645 • Number of events 2 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Psychiatric disorders
Depression
|
0.16%
1/645 • Number of events 1 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Psychiatric disorders
Suicidal ideation
|
0.16%
1/645 • Number of events 1 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.31%
2/645 • Number of events 2 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Renal and urinary disorders
Renal pain
|
0.16%
1/645 • Number of events 1 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Reproductive system and breast disorders
Adenomyosis
|
0.31%
2/645 • Number of events 2 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.16%
1/645 • Number of events 1 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Reproductive system and breast disorders
Dysfunctional uterine bleeding
|
0.31%
2/645 • Number of events 2 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.16%
1/645 • Number of events 1 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.31%
2/645 • Number of events 2 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.31%
2/645 • Number of events 2 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.47%
3/645 • Number of events 3 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.31%
2/645 • Number of events 2 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.16%
1/645 • Number of events 1 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.16%
1/645 • Number of events 1 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Surgical and medical procedures
Gastric bypass
|
0.47%
3/645 • Number of events 3 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Surgical and medical procedures
Hernia hiatus repair
|
0.16%
1/645 • Number of events 1 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Surgical and medical procedures
Hysterectomy
|
0.16%
1/645 • Number of events 1 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Surgical and medical procedures
Mastectomy
|
0.16%
1/645 • Number of events 1 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Surgical and medical procedures
Surgery
|
0.47%
3/645 • Number of events 3 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
Other adverse events
| Measure |
Adiana Permanent Contraception System
n=645 participants at risk
Implantation of silicone matrix in fallopian tubes
|
|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
8.5%
55/645 • Number of events 76 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.9%
51/645 • Number of events 82 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.4%
35/645 • Number of events 40 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Gastrointestinal disorders
Nausea
|
30.9%
199/645 • Number of events 270 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
11.5%
74/645 • Number of events 89 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Immune system disorders
Hypersensitivity
|
6.8%
44/645 • Number of events 118 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Infections and infestations
Influenza
|
12.1%
78/645 • Number of events 90 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Infections and infestations
Nasopharyngitis
|
14.0%
90/645 • Number of events 115 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Infections and infestations
Sinusitis
|
9.1%
59/645 • Number of events 73 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.9%
38/645 • Number of events 44 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Infections and infestations
Urinary tract infection
|
10.1%
65/645 • Number of events 78 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Infections and infestations
Vaginal mycosis
|
6.7%
43/645 • Number of events 58 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
5.3%
34/645 • Number of events 36 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Injury, poisoning and procedural complications
Post procedural pain
|
14.1%
91/645 • Number of events 118 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
18.0%
116/645 • Number of events 178 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
59.7%
385/645 • Number of events 1139 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
75.2%
485/645 • Number of events 895 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.3%
47/645 • Number of events 76 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.2%
40/645 • Number of events 61 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Nervous system disorders
Headache
|
66.4%
428/645 • Number of events 2006 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Nervous system disorders
Migraine
|
10.9%
70/645 • Number of events 241 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Nervous system disorders
Sinus headache
|
6.5%
42/645 • Number of events 83 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Psychiatric disorders
Depression
|
9.1%
59/645 • Number of events 62 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Psychiatric disorders
Insomnia
|
5.6%
36/645 • Number of events 49 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Renal and urinary disorders
Dysuria
|
11.6%
75/645 • Number of events 83 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Reproductive system and breast disorders
Amenorrhoea
|
5.6%
36/645 • Number of events 51 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
80.6%
520/645 • Number of events 2860 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Reproductive system and breast disorders
Dyspareunia
|
15.7%
101/645 • Number of events 186 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Reproductive system and breast disorders
Menorrhagia
|
22.6%
146/645 • Number of events 269 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
8.1%
52/645 • Number of events 66 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
88.8%
573/645 • Number of events 1149 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Reproductive system and breast disorders
Muscle cramp
|
11.2%
72/645 • Number of events 76 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Reproductive system and breast disorders
Pelvic pain
|
53.6%
346/645 • Number of events 924 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Reproductive system and breast disorders
Polymenorrhoea
|
5.1%
33/645 • Number of events 42 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Reproductive system and breast disorders
Post procedural haemorrhage
|
29.1%
188/645 • Number of events 208 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
44.0%
284/645 • Number of events 738 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
39.5%
255/645 • Number of events 515 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
5.9%
38/645 • Number of events 44 • Post-procedure, 48-Hours, 1-Week, 1-Month, 2-Months, 3-Months (Waiting Period), 3-Months (Wearing Period), participant diary through the 3-Month Wearing Period, 6-Months, 9-Months, 12-Months, 18-Months, 24-Months, 36-Months.
Questions were asked through the 12-Month visit to assess subjects' presence or absence of post-operative discomfort. Subjects completed a participant diary detailing menstrual and sexual activity, and any symptoms, through the 3-Month Wearing Period. Follow-up visits included an assessment of subjects' potential adverse events.
|
Additional Information
Edward Evantash, MD, Medical Director, Vice President Medical Affairs
Hologic, Inc.
Phone: 508-263-8475
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee All publications must be submitted for review and approval at least (30) days before the date on which it is to be submitted. No publication of data wil be permitted prior to the submission and publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER