Clinical trial NCT03067272: Pilot Bi-Lateral Tubal Occlusion Trial for Female Permanent Contraception
Official title: Pilot Bi-Lateral Tubal Occlusion Trial for Female Permanent Contraception
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Keywords: Permanent contraception
Birth control
Lead sponsor: Femasys Inc.
Sponsor class: INDUSTRY
First posted: 2017-03-01
Enrollment: 49
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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

Detailed 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.

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

Primary outcomes:
measure: Number of subjects who experience an Adverse Event divided by the number of subjects exposed to the FemBloc treatment procedure
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
measure: Number of subjects who experience an Adverse Event divided by the number of subjects exposed to the FemBloc Confirmation test
timeFrame: 5 months
measure: Number of subjects who experience an Adverse Event divided by the number of subjects exposed to the FemBloc Biopolymer
timeFrame: 5 months
Locations:
city: Lake Worth
country: United States
facility: Altus Research Inc.
state: Florida
city: New York
country: United States
facility: New York Presbyterian Hospital - Columbia University Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina, Chapel Hill
state: North Carolina
city: Chattanooga
country: United States
facility: Chattanooga Medical Research
state: Tennessee
Study officials:
affiliation: Sponsor Clinical Affairs
name: Study Director
role: STUDY_DIRECTOR
References: