Pilot Bi-Lateral Tubal Occlusion Trial for Female Permanent Contraception (BLOC)

Femasys

Status

Completed

Conditions

Contraception

Treatments

Device: FemBloc® Permanent Contraceptive System

Study type

Interventional

Funder types

Industry

Identifiers

NCT03067272

CP-100-006

Details and patient eligibility

About

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

Full 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.

Enrollment

49 patients

Sex

Female

Ages

21 to 45 years old

Volunteers

Accepts Healthy Volunteers

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