FemBloc® Permanent Contraception - Confirmation Feasibility Trial

Last updated: January 24, 2025
Sponsor: Femasys Inc.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Contraception

Treatment

FemBloc

Clinical Study ID

NCT04273594
CP-100-008
  • Ages 21-45
  • Female
  • Accepts Healthy Volunteers

Study Summary

The trial objectives include evaluating the adequacy of proposed mitigations for the previous pivotal trial of the FemBloc Permanent Contraceptive System and validating the confirmation procedure by comparing FemChec (ultrasound) to fluoroscopic hysterosalpingogram (fluoro HSG) for post-occlusion in the same patient.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Female, 21 - 45 years of age desiring permanent birth control

  • Sexually active with male partner

  • Regular menstrual cycle for last 3 months or on hormonal contraceptives

Exclusion

Exclusion Criteria:

  • Uncertainty about the desire to end fertility

  • Known or suspected pregnancy

  • Prior tubal surgery, including sterilization attempt

  • Prior endometrial ablation

  • Presence, suspicion, or previous history of gynecologic malignancy

  • Abnormal uterine bleeding requiring evaluation or treatment

  • Scheduled to undergo concomitant intrauterine procedures at the time of procedure(s)

  • Allergy to shellfish, betadine or iodinated contrast

Study Design

Total Participants: 45
Treatment Group(s): 1
Primary Treatment: FemBloc
Phase:
Study Start date:
February 27, 2020
Estimated Completion Date:
April 30, 2027

Connect with a study center

  • New Horizons Clinical Trials

    Chandler, Arizona 85224
    United States

    Site Not Available

  • Precision Trials AZ, LLC

    Phoenix, Arizona 85032
    United States

    Site Not Available

  • The Stamford Hospital

    Stamford, Connecticut 06904
    United States

    Site Not Available

  • Midtown OB GYN North

    Columbus, Georgia 31909
    United States

    Site Not Available

  • Women's Health Advantage

    Fort Wayne, Indiana 46825
    United States

    Site Not Available

  • Saginaw Valley Medical Research Group

    Saginaw, Michigan 48604
    United States

    Site Not Available

  • University Hospitals - Cleveland Medical Center

    Beachwood, Ohio 44122
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.