Can a polymer block tubes without surgery? a trial investigates
NCT ID NCT03067272
First seen Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time
Summary
This pilot trial tests a device called FemBloc that aims to provide permanent birth control by blocking the fallopian tubes without surgery. Women aged 21 to 45 who want permanent contraception receive the treatment, which involves delivering a polymer into the tubes and then using a confirmation test to check blockage. The study focuses on safety, tracking any side effects for up to five years, while participants use temporary birth control until blockage is confirmed.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- FemBloc Permanent Contraceptive System, a device that delivers a polymer to block the fallopian tubes, plus a confirmation test
- What this could lead to
- If it works, this could offer women a non-surgical, permanent birth control option that avoids incisions and may be reversible.
- What could go wrong
- This is a small pilot study focused on safety, so effectiveness is not yet proven. Risks include incomplete blockage, device-related side effects, and the possibility of pregnancy.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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49 people
The number who actually took part.
- Started
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Mar 2017
- Finished
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Mar 2023
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 to 45 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Chattanooga Medical Research
Chattanooga, Tennessee, 37404, United States
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New York Presbyterian Hospital - Columbia University Medical Center
New York, New York, 10032, United States
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QPS Miami Research Associates
Miami, Florida, 33143, United States
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The Stamford Hospital
Stamford, Connecticut, 06904, United States
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University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27599, United States
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