FemBloc® Permanent Contraception - Confirmation Feasibility Trial

Running, not enrolling · Not applicable

Conditions studied: Contraception

In brief

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.

Key facts

Study ID

NCT04273594

Run by

Femasys Inc.

People needed

45

Starts

2020-02-27

Expected to finish

2027-04-01

Last updated by the study team

2025-01-28

Who can join

Age: 21 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• New Horizons Clinical Trials — Chandler, Arizona, United States
• Precision Trials AZ, LLC — Phoenix, Arizona, United States
• Midtown OB GYN North — Columbus, Georgia, United States
• Women's Health Advantage — Fort Wayne, Indiana, United States
• Saginaw Valley Medical Research Group — Saginaw, Michigan, United States
• University Hospitals - Cleveland Medical Center — Beachwood, Ohio, United States

Full record on ClinicalTrials.gov

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