Pilot Bi-Lateral Tubal Occlusion Trial for Female Permanent Contraception

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

Detailed Description
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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.

Official Title
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Pilot Bi-Lateral Tubal Occlusion Trial for Female Permanent Contraception

Conditions
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Contraception

Intervention / Treatment
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* Device: FemBloc® Permanent Contraceptive System


Participation Criteria
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Eligibility Criteria
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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 Complicated IUC removal on the day of FemBloc treatment (e.g. use of intracavitary instrument for removal, bleeding, excessive pain) Scheduled to undergo concomitant intrauterine procedures at the time of FemBloc treatment or planning any uterine procedure within the 3 months after treatment Known hypersensitivity to cyanoacrylate or formaldehyde Prior history of ectopic pregnancy Abnormal uterine bleeding of unknown etiology Any general health condition or systemic disease that may represent, in the Investigator's opinion, a potential increased risk associated with device use or pregnancy, or that would not allow them to complete the trial

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FemBloc® Permanent Contraceptive System<br>Treatment of women who desire permanent birth control (female sterilization) by occlusion of the fallopian tubes. | Device: FemBloc® Permanent Contraceptive System<br>* The FemBloc Permanent Contraceptive System consists of treatment with a Delivery System and Biopolymer, and a confirmation test with the FemChec® Tubal Occlusion Confirmation device as part of a sonographic hysterosalpingogram (Sono HSG).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects who experience an Adverse Event divided by the number of subjects exposed to the FemBloc treatment procedure | Evaluated up to 3 months after the FemBloc treatment procedure | 5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Permanent contraception, Birth control