Can a polymer block tubes without surgery? a trial investigates

NCT ID NCT03067272

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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

49 people

The number who actually took part.

Started

Mar 2017

Finished

Mar 2023

Lead sponsor

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

21 to 45 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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

  • Chattanooga Medical Research

    Chattanooga, Tennessee, 37404, United States

  • New York Presbyterian Hospital - Columbia University Medical Center

    New York, New York, 10032, United States

  • QPS Miami Research Associates

    Miami, Florida, 33143, United States

  • The Stamford Hospital

    Stamford, Connecticut, 06904, United States

  • University of North Carolina, Chapel Hill

    Chapel Hill, North Carolina, 27599, United States

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