Prospective Multi-Center Trial for FemBloc Permanent Birth Control
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FemBloc.
- Who it may be relevant to
- Registry conditions: Contraception. Basic parameters: 21 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
FINALE: Prospective Multi-Center Trial for FemBloc INtratubal Occlusion for TranscervicAL PErmanent Birth Control
Overview
Prospective, multi-center, international, unblinded, single-arm trial of subjects undergoing FemBloc followed by ultrasound confirmation test.
Detailed description
Prospective, multi-center, international, unblinded, single-arm trial of subjects undergoing FemBloc followed by ultrasound confirmation test.
Interventions
- Device FemBloc
Treatment for women who desire non-surgical permanent birth control by occlusion of the fallopian tubes.
Primary outcome measures
- Pregnancy Rate [Time frame: one (1) year]
Secondary outcome measures (2)
- Reliance Rate [Time frame: ninety (90) days post treatment]
- Long term Pregnancy Rate [Time frame: Five (5) years]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 8 centers
- New Horizons Clinical Trials — Chandler
- Stanford University — Palo Alto
- University of California Davis — Sacramento
- Midtown OB GYN North — Columbus
- Rosemark WomenCare Specialists — Idaho Falls
- Maimonides Medical Center — Brooklyn
- Seven Hills Women's Health Centers — Cincinnati
- University of Utah — Salt Lake City
Identifiers
NCT: NCT05977751 · CP-100-009