Pilot Bi-Lateral Tubal Occlusion Trial for Female Permanent Contraception

Contraception Clinical Trial

— BLOC  

Official title:

Pilot Bi-Lateral Tubal Occlusion Trial for Female Permanent Contraception

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03067272
• Other study ID #: CP-100-006
• Status: Completed
• Phase: N/A
• Start date: March 15, 2017
• Est. completion date: March 14, 2023

Study information

• Verified date: February 2023
• Source: Femasys Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: March 14, 2023
• Est. primary completion date: February 27, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception

Intervention

Device:
• FemBloc® Permanent Contraceptive System
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).

Locations

Country	Name	City	State
United States	University of North Carolina, Chapel Hill	Chapel Hill	North Carolina
United States	Chattanooga Medical Research	Chattanooga	Tennessee
United States	Altus Research Inc.	Lake Worth	Florida
United States	New York Presbyterian Hospital - Columbia University Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Femasys Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of subjects who experience an Adverse Event divided by the number of subjects exposed to the FemBloc Confirmation test	Evaluated at 3 months after the FemBloc treatment procedure	5 months
Other	Number of subjects who experience an Adverse Event divided by the number of subjects exposed to the FemBloc Biopolymer	Evaluated up to 3 months after the FemBloc treatment procedure	5 months
Primary	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