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COMPLETEDNA

Pilot Bi-Lateral Tubal Occlusion Trial for Female Permanent Contraception

NCT03067272•Femasys Inc.

Summary

Prospective, multi-center, pilot study evaluating the safety of the FemBloc® Permanent Contraceptive System for female sterilization in preventing pregnancy.

Detailed Description

Prospective, multi-center, pilot study of subjects undergoing the FemBloc Permanent Contraceptive System procedure conducted at 5 sites in the U.S. following 49 subjects total. The objective of the trial is to evaluate the safety of the FemBloc Permanent Contraceptive System for female sterilization in preventing pregnancy through the 3-month confirmation test visit. Femasys also intends to continue follow-up of pilot subjects for safety a total duration of approximately 68 months after the FemBloc treatment procedure.

Eligibility

Age

21 - 45 years

Sex

FEMALE

Healthy Volunteers

Yes

Inclusion Criteria

•Female, 21 - 45 years of age desiring permanent birth control
•Agreement to use temporary birth control (excluding IUC) until documented occlusion
•Sexually active (minimum of 4 coital acts per month) with male partner who is not known or suspected to be sterile
•At low risk for sexually transmitted infection and / or monogamous
•Reasonably certain subject is not pregnant at time of screening and procedure visits
•Willing to accept the risk of pregnancy while relying solely on FemBloc for contraception
•Signs informed consent agreeing to the protocol requirements and is able to meet the trial schedule

Exclusion Criteria

•Uncertainty about the desire to end fertility
•Suspected or confirmed pregnancy
•Prior tubal surgery
•Uterine anomaly such as unicornuate, bicornuate, arcuate, septate, and didelphic
•Known endometrial or myometrial conditions (e.g. submucous leiomyoma) or uterine position (e.g. retroflexion or anteflexion) that would interfere with insertion tube midline fundal placement, access to uterine cornua, or lateral deployment of the catheters
•Any condition which may prohibit proper visualization of the cervix or not allow the uterus to be appropriately instrumented
•Active or untreated pelvic infection
•Presence or suspicion of gynecologic malignancy
•Any condition or medical treatment (e.g. systemic corticosteroids or chemotherapy) that compromises immune system
•Post-partum or pregnancy termination \<6 weeks of scheduled procedure
+6 more criteria

Locations (4)

Altus Research Inc.

Lake Worth, Florida, United States

New York Presbyterian Hospital - Columbia University Medical Center

New York, New York, United States

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, United States

Chattanooga Medical Research

Chattanooga, Tennessee, United States

Key Dates

Start Date

March 15, 2017

Primary Completion Date

February 27, 2018

Completion Date

March 14, 2023

Last Updated

May 9, 2023

Enrollment

ACTUAL participants

Conditions

Contraception

Interventions

FemBloc® Permanent Contraceptive System

DEVICE

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NCT06345586

Contraception

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RECRUITINGNA

Effect of Different Sex Hormone Profiles for the Response to Physical Training

NCT07115849

EumenorrheaIntrauterine Devices, Medicated+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 9, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Pilot Bi-Lateral Tubal Occlusion Trial for Female Permanent Contraception

Inclusion Criteria

Exclusion Criteria

Drospirenone Only Pills and Cervical Mucus Changes: A Pre- and Post-Bariatric Surgery Study

Effect of Different Sex Hormone Profiles for the Response to Physical Training

Study to Evaluate Contraceptive Efficacy and Safety of a Progestin Only Patch in Women of Childbearing Potential

Investigating Ovulation Inhibition for Use as a Contraceptive

Improving Shared Decision-Making in Menstrual Management and Contraception for Adolescents and Young Adults

Oral Contraceptive Pill (OCP) Pharmacogenomics