Pilot Bi-Lateral Tubal Occlusion Trial for Female Permanent Contraception (BLOC)
September 3, 2026 updated by: Femasys Inc.
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
Intervention / Treatment
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 study was to evaluate the safety of the FemBloc Permanent Contraceptive System for female sterilization in preventing pregnancy.
Femasys continued 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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Connecticut
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Stamford, Connecticut, United States, 06904
- The Stamford Hospital
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Florida
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Miami, Florida, United States, 33143
- QPS Miami Research Associates
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New York
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New York, New York, United States, 10032
- New York Presbyterian Hospital - Columbia University Medical Center
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- University of North Carolina, Chapel Hill
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Tennessee
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Chattanooga, Tennessee, United States, 37404
- Chattanooga Medical Research
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
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.
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The FemBloc Permanent Contraceptive System consists of treatment with a Delivery System and Blended Polymer, and a confirmation test with the FemChec® Tubal Occlusion Confirmation device as part of a sonographic hysterosalpingogram (Sono HSG).
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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 System (Blended Polymer Treatment and Confirmation Test)
Time Frame: 3 months (pilot study safety endpoint and then through 5 years)
|
Number of subjects who experience an Adverse Event divided by the number of subjects exposed to the FemBloc System.
Evaluated up to 3 months after the FemBloc Treatment and Confirmation Test (device and/or procedure related AEs) and then through 5 years.
|
3 months (pilot study safety endpoint and then through 5 years)
|
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 Confirmation Test
Time Frame: 3 months (pilot study safety endpoint and then through 5 years)
|
Number of subjects who experience an Adverse Event evaluated at 3 months after the FemBloc treatment procedure exposed to the Confirmation test (device and/or procedure related AEs) and then through 5 years.
|
3 months (pilot study safety endpoint and then through 5 years)
|
|
Number of Subjects Who Experience an Adverse Event Divided by the Number of Subjects Exposed to the FemBloc Blended Polymer Treatment
Time Frame: 3 months (pilot study safety endpoint and then through 5 years)
|
Evaluated up to 3 months after the FemBloc treatment procedure (device and/or procedure related AEs) and then through 5 years
|
3 months (pilot study safety endpoint and then through 5 years)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Study Director, Sponsor Clinical Affairs
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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)
September 8, 2026
Last Update Submitted That Met QC Criteria
September 3, 2026
Last Verified
September 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.