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Pilot Bi-Lateral Tubal Occlusion Trial for Female Permanent Contraception

CompletedNA

Sponsor: Femasys Inc.

Conditions: Contraception

Interventions: FemBloc® Permanent Contraceptive System

Countries: United States

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

Eligibility overview

Sex: FEMALE

Age: 21 Years to 45 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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 \<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

Locations (5)

Stamford, Connecticut, United States
Miami, Florida, United States
New York, New York, United States
Chapel Hill, North Carolina, United States
Chattanooga, Tennessee, United States