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New implant aims to seal anal fistulas without repeat surgery

NCT ID NCT07021742

Disease control Sponsor: Signum Surgical USA Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a device called BioHealx, a bioabsorbable implant that is placed in the anal fistula to close the internal opening and allow healing. Researchers will enroll 50 adults with a single anal fistula that has failed previous treatment. The goal is to see if the device can successfully close the fistula and prevent it from coming back over the long term.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BioHealx Anal Fistula Device (bioabsorbable implant)
What this could lead to
If successful, this device could offer a reliable, minimally invasive way to close anal fistulas and reduce the need for repeat surgeries.
What could go wrong
This is a small, single-arm study (50 people) without a comparison group, so results may not apply to everyone. The device may fail to close the fistula or the fistula could come back.

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.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

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.

Who is studied

Patients presenting for treatment of mature, cryptogenic, transsphincteric, non-branching fistulas in ano via tissue apposition.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Age 18 - 75 years * Presence of Single Continuous Anal Fistula presenting for initial curative surgery * Failed or Recurrent Anal Fistula Closure * Minimum of 6-weeks of draining seton placed prior to procedure. * Availability for follow-up contacts and willingness to complete the Informed Consent. Exclusion Criteria: * Fistula tract shorter than 2cm * Complex fistula tract (branching) * Body Mass Index \> 35 * Known uncontrolled diabetes or other systemic condition associated with impaired healing * Known HIV-positive or immunocompromised * Rectal prolapse * Pregnancy * Rectal / fistula malignancy * Crohn's disease * Ulcerative proctitis * Hidradenitis suppurativa of the anal region * Pilonidal sinus disease * Presence of hemorrhoid Involving fistula site * Continuous use of anti-inflammatory * Intersphincteric fistula in ano or fistula treatable by simple fistulotomy * Active infection or abscess involving fistula site * Known allergy to PLGA material * Any severe acute or uncontrolled chronic disease that according to the investigator might render the patient unsuitable for the study * Treatment with an investigational drug or medical device in the past 30 days

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Conditions

The condition(s) this trial relates to.

anal fistula

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fistula in ano

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Geisinger

    RECRUITING

    Danville, Pennsylvania, 17822, United States

  • Hackensack University Medical Center

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Maininle Health Lankenau

    RECRUITING

    Bryn Mawr, Pennsylvania, 19010, United States

  • Northwell Health

    RECRUITING

    Staten Island, New York, 10305, United States

  • The Colorectal Institute

    RECRUITING

    Fort Myers, Florida, 33912, United States

  • Weill Cornell Medicine

    RECRUITING

    New York, New York, 10021, United States

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