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Completed NCT03067272

Pilot Bi-Lateral Tubal Occlusion Trial for Female Permanent Contraception

Conditions: Contraception

Sex: Female
Ages: 21 Years – 45 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 49
Sponsor: Femasys Inc.

Location: The Stamford Hospital Stamford Connecticut

Summary

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

Eligibility Criteria

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 \

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT03067272). StuddyBuddy aggregates publicly available trial information.