New implant aims to seal anal fistulas without repeat surgery

NCT ID NCT07021742

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

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.

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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

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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