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

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

Study Overview

• Status: Completed
• Conditions: Contraception
• Intervention / Treatment: Device: FemBloc® Permanent Contraceptive System

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.

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Lake Worth, Florida, United States, 33461
      • Altus Research Inc.
  • New York
    • New York, New York, United States, 10032
      • New York Presbyterian Hospital - Columbia University Medical Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina, Chapel Hill
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Chattanooga Medical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FemBloc® Permanent Contraceptive System; Treatment of women who desire permanent birth control (female sterilization) by occlusion of the fallopian tubes.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Femasys Inc.
• Investigators: Study Director: Study Director, Sponsor Clinical Affairs

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2017
• Primary Completion (Actual): February 27, 2018
• Study Completion (Actual): March 14, 2023

Study Registration Dates

• First Submitted: February 17, 2017
• First Submitted That Met QC Criteria: February 24, 2017
• First Posted (Actual): March 1, 2017

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 5, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Birth control; Permanent contraception
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Contraceptive Agents
• Other Study ID Numbers: CP-100-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes