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NCT05977751NARecruitingAccepts Healthy Volunteers

Prospective Multi-Center Trial for FemBloc Permanent Birth Control

Femasys Inc.

Start Date

10/31/2023

Completion Date

6/1/2031

Summary

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.

Eligibility Criteria

Age Range: 21 years to 50 years

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.

Interventions

DEVICE

FemBloc

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Conditions

Contraception

Locations

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