Permanent birth control using FemBloc
FINALE: Prospective Multi-Center Trial for FemBloc INtratubal Occlusion for TranscervicAL PErmanent Birth Control
This study is testing a new method for permanent birth control called FemBloc to see how well it works and is safe for women.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 573 (estimated) |
| Ages | 21 Years to 50 Years |
| Sex | Female |
| Sponsor | Femasys Inc. Industry-sponsored |
| Locations | 8 sites (Chandler, Arizona and 7 other locations) |
| Trial ID | NCT05977751 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of FemBloc, a method for permanent birth control, through a prospective, multi-center approach. Participants will undergo the FemBloc procedure followed by an ultrasound confirmation test to ensure the procedure's success. The study is unblinded and single-arm, meaning all participants will receive the same intervention without a control group. It aims to gather data from various international sites to assess the procedure's safety and efficacy.
Who should consider this trial
Good fit: Ideal candidates are women aged 21 to 50 who are sexually active and desire permanent contraception.
Not a fit: Patients who are uncertain about their desire to end fertility or have a history of gynecologic malignancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this could provide a reliable and effective method for women seeking permanent birth control.
How similar studies have performed: Other studies on permanent birth control methods have shown success, indicating that this approach is promising and not entirely novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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. * Abnormal uterine bleeding requiring evaluation or treatment.
Where this trial is running
Chandler, Arizona and 7 other locations
- New Horizons Clinical Trials — Chandler, Arizona, United States (Recruiting)
- Stanford University — Palo Alto, California, United States (Recruiting)
- University of California Davis — Sacramento, California, United States (Recruiting)
- Midtown OB GYN North — Columbus, Georgia, United States (Recruiting)
- Rosemark WomenCare Specialists — Idaho Falls, Idaho, United States (Recruiting)
- Maimonides Medical Center — Brooklyn, New York, United States (Recruiting)
- Seven Hills Women's Health Centers — Cincinnati, Ohio, United States (Recruiting)
- University of Utah — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Study coordinator: Study Director
- Email: StudySupport@Femasys.com
- Phone: 770-500-3910 Ext. 146
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.