Pilot Bi-Lateral Tubal Occlusion Trial for Female Permanent Contraception (NCT03067272) | Clinical Trial Compass
CompletedNot Applicable
Pilot Bi-Lateral Tubal Occlusion Trial for Female Permanent Contraception
United States49 participantsStarted 2017-03-15
Plain-language summary
Prospective, multi-center, pilot study evaluating the safety of the FemBloc® Permanent Contraceptive System for female sterilization in preventing pregnancy.
Who can participate
Age range21 Years – 45 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Number of subjects who experience an Adverse Event divided by the number of subjects exposed to the FemBloc treatment procedure