Prospective Multi-Center Trial for FemBloc Permanent Birth Control (FINALE)

March 1, 2026 updated by: Femasys Inc.

FINALE: Prospective Multi-Center Trial for FemBloc INtratubal Occlusion for TranscervicAL PErmanent Birth Control

Prospective, multi-center, international, unblinded, single-arm trial of subjects undergoing FemBloc followed by ultrasound confirmation test.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Prospective, multi-center, international, unblinded, single-arm trial of subjects undergoing FemBloc followed by ultrasound confirmation test.

Study Type

Interventional

Enrollment (Estimated)

573

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Recruiting
        • New Horizons Clinical Trials
        • Contact:
          • Research Coordinator
          • Phone Number: 480-8496-2236
    • California
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford University
        • Contact:
          • Research Coordinator
          • Phone Number: (650) 497-5175
      • Sacramento, California, United States, 95817
        • Recruiting
        • University of California Davis
        • Contact:
          • Research Coordinator
          • Phone Number: 916-734-6846
    • Georgia
      • Columbus, Georgia, United States, 31909
        • Recruiting
        • Midtown OB GYN North
        • Contact:
          • Research Coordinator
          • Phone Number: 7063202547
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Recruiting
        • Rosemark WomenCare Specialists
        • Contact:
          • Research Coordinator
          • Phone Number: 208-557-2924
    • New York
      • Brooklyn, New York, United States, 11219-2919
        • Recruiting
        • Maimonides Medical Center
        • Contact:
          • Research Coordinator
          • Phone Number: 718-283-7962
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Recruiting
        • Seven Hills Women's Health Centers
        • Contact:
          • Research Coordinator
          • Phone Number: 5132903221
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • Recruiting
        • University of Utah
        • Contact:
          • Research Coordinator
          • Phone Number: 801-231-2774

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FemBloc
Investigational device and procedure
Device: FemBloc
Treatment for women who desire non-surgical permanent birth control by occlusion of the fallopian tubes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy Rate
Time Frame: one (1) year
Number of subjects who were told to rely on FemBloc for birth control and became pregnant through one (1) year.
one (1) year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reliance Rate
Time Frame: ninety (90) days post treatment
Number of subjects who were told to rely on FemBloc.
ninety (90) days post treatment
Long term Pregnancy Rate
Time Frame: Five (5) years
Number of subjects who were told to rely on FemBloc for birth control that became pregnant after one (1) year through 2-, 3-, 4-, and 5-years.
Five (5) years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Femasys Inc.

Investigators

  • Study Director: Study Sponsor, Medical Affairs and Clinical Development

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2023

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

June 1, 2031

Study Registration Dates

First Submitted

July 27, 2023

First Submitted That Met QC Criteria

August 3, 2023

First Posted (Actual)

August 4, 2023

Study Record Updates

Last Update Posted (Actual)

March 3, 2026

Last Update Submitted That Met QC Criteria

March 1, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CP-100-009

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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