FINALE: Prospective Multi-Center Trial for FemBloc INtratubal Occlusion for TranscervicAL PErmanent Birth Control
Femasys Inc.
Summary
Prospective, multi-center, international, unblinded, single-arm trial of subjects undergoing FemBloc followed by ultrasound confirmation test.
Description
Prospective, multi-center, international, unblinded, single-arm trial of subjects undergoing FemBloc followed by ultrasound confirmation test.
Eligibility
- Age range
- 21–50 years
- Sex
- Female
- Healthy volunteers
- Yes
Inclusion Criteria: * Female, 21 - 50 years of age desiring permanent birth control. * Sexually active with male partner. * Regular menstrual cycle for last 3 months or on hormonal contraceptives. Exclusion Criteria: * Uncertainty about the desire to end fertility. * Known or suspected pregnancy. * Prior tubal surgery, including sterilization attempt. * Presence, suspicion, or previous history of gynecologic malignancy. * Scheduled to undergo concomitant intrauterine procedures (i.e. endometrial ablation) at the time of either FemBloc Treatment or prior to final confirmation test. * Abnorma…
Interventions
- DeviceFemBloc
Treatment for women who desire non-surgical permanent birth control by occlusion of the fallopian tubes.
Locations (8)
- New Horizons Clinical TrialsChandler, Arizona
- Stanford UniversityPalo Alto, California
- University of California DavisSacramento, California
- Midtown OB GYN NorthColumbus, Georgia
- Rosemark WomenCare SpecialistsIdaho Falls, Idaho
- Maimonides Medical CenterBrooklyn, New York