Trial Outcomes & Findings for Symphion® System In-Office Study (NCT NCT02520414)
NCT ID: NCT02520414
Last Updated: 2021-03-26
Results Overview
Absence of device related adverse events, or death.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
2 weeks
Results posted on
2021-03-26
Participant Flow
Participant milestones
| Measure |
Symphion®
Patients treated in-office with Symphion® Bipolar Hysteroscopic Tissue Resection System.
Symphion® Bipolar Hysteroscopic Tissue Resection System
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Symphion® System In-Office Study
Baseline characteristics by cohort
| Measure |
Symphion®
n=10 Participants
Patients treated in-office with Symphion® Bipolar Hysteroscopic Tissue Resection System.
Symphion® Bipolar Hysteroscopic Tissue Resection System
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
50.4 years
STANDARD_DEVIATION 5.7 • n=99 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
|
Body Mass Index
|
29.6 kg/m^2
STANDARD_DEVIATION 7.2 • n=99 Participants
|
PRIMARY outcome
Timeframe: 2 weeksAbsence of device related adverse events, or death.
Outcome measures
| Measure |
Symphion®
n=10 Participants
Patients treated in-office with Symphion® Bipolar Hysteroscopic Tissue Resection System.
Symphion® Bipolar Hysteroscopic Tissue Resection System
|
|---|---|
|
Safety Profile of the Symphion® Bipolar Hysteroscopic Tissue Resection System When Used in the Office Setting for the Removal of Intracavitary Polyps and Myomas.
Adverse Events
|
0 percentage of participants
|
|
Safety Profile of the Symphion® Bipolar Hysteroscopic Tissue Resection System When Used in the Office Setting for the Removal of Intracavitary Polyps and Myomas.
Device Malfunctions
|
0 percentage of participants
|
Adverse Events
Symphion®
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place