Prospective Multi-Center Trial for FemBloc Permanent Birth Control
FINALE
FINALE: Prospective Multi-Center Trial for FemBloc INtratubal Occlusion for TranscervicAL PErmanent Birth Control
1 other identifier
interventional
573
1 country
8
Brief Summary
Prospective, multi-center, international, unblinded, single-arm trial of subjects undergoing FemBloc followed by ultrasound confirmation test.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2023
Longer than P75 for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 27, 2023
CompletedFirst Posted
Study publicly available on registry
August 4, 2023
CompletedStudy Start
First participant enrolled
October 31, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2031
March 3, 2026
March 1, 2026
6.1 years
July 27, 2023
March 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pregnancy Rate
Number of subjects who were told to rely on FemBloc for birth control and became pregnant through one (1) year.
one (1) year
Secondary Outcomes (2)
Reliance Rate
ninety (90) days post treatment
Long term Pregnancy Rate
Five (5) years
Study Arms (1)
FemBloc
EXPERIMENTALInvestigational device and procedure
Interventions
Treatment for women who desire non-surgical permanent birth control by occlusion of the fallopian tubes.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Femasys Inc.lead
Study Sites (8)
New Horizons Clinical Trials
Chandler, Arizona, 85224, United States
Stanford University
Palo Alto, California, 94304, United States
University of California Davis
Sacramento, California, 95817, United States
Midtown OB GYN North
Columbus, Georgia, 31909, United States
Rosemark WomenCare Specialists
Idaho Falls, Idaho, 83404, United States
Maimonides Medical Center
Brooklyn, New York, 11219-2919, United States
Seven Hills Women's Health Centers
Cincinnati, Ohio, 45242, United States
University of Utah
Salt Lake City, Utah, 84108, United States
Related Links
Study Officials
- STUDY DIRECTOR
Study Sponsor
Medical Affairs and Clinical Development
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 27, 2023
First Posted
August 4, 2023
Study Start
October 31, 2023
Primary Completion (Estimated)
December 1, 2029
Study Completion (Estimated)
June 1, 2031
Last Updated
March 3, 2026
Record last verified: 2026-03