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Clinical trial Recruiting at 2 sites Interventional Ages 18 and up

ECMT-100 ECM hydrogel to close high transsphincteric anorectal fistulas

Official title: Prospective Multi-Center, Single Arm, Study Evaluating the Safety and Efficacy of an ECM Hydrogel for the Treatment of Anorectal Fistulas

Run by ECM Therapeutics, Inc. · NCT07035925 · Data updated 2026-11-12

This trial tests a mucoadhesive ECM hydrogel (ECMT-100) placed into the fistula tract to try to close high transsphincteric anorectal fistulas in adults who have had a seton in place.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment10 (estimated)
SponsorECM Therapeutics, Inc.
Industry-sponsored
Drugs / interventionschemotherapy, radiation
Locations2 sites (Lebanon, New Hampshire and 1 other locations)
StatusRecruiting
StartedNovember 24, 2025
Main results expectedFebruary 24, 2027
Study endsApril 24, 2028
Registry record updatedMarch 31, 2026
Trial IDNCT07035925 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (≥18) with a single high transsphincteric anorectal fistula with one internal opening and one or two external openings, who have had a seton in place for at least four weeks and do not have inflammatory bowel disease, are the ideal candidates.

Probably not a fit

Patients with Crohn's disease or ulcerative colitis, multiple or complex fistulas (including >1 internal opening, >2 external openings, secondary tracts, horseshoe, rectovaginal, or rectourethral fistulas), traumatic fistulas, active local infection, or prior fistulotomy/fistulectomy at the target site are unlikely to benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

ECMT-100 is a colloidal extracellular matrix (ECM) hydrogel formulated to adhere to gastrointestinal mucosa and fill the transsphincteric fistula tract to promote host tissue integration and tract closure. The device is delivered via catheter into the curetted fistula tract after preoperative seton placement, with the goal of reinforcing the tract without causing fecal incontinence. The trial enrolls adults with a single high transsphincteric fistula (one internal opening, one to two external openings) and excludes patients with Crohn's disease, multiple or complex fistulas, active local infection, or prior surgery at the target site. Outcomes focus on safety and whether the hydrogel leads to fistula closure compared with standard expectations for this patient population.

Why it matters

Potential benefit: If successful, ECMT-100 could close fistula tracts while preserving continence and reducing the need for more invasive surgery.

How similar studies have gone: Biologic plugs and matrix-based materials have been tried for anal fistulas with mixed results—some benefit reported for simple fistulas but overall variable closure rates—so this approach has precedent but is not uniformly proven.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Male and female subjects at least 18 years of age.
* Provide informed consent
* Non-pregnant females
* Clinical diagnosis of 1 high transsphincteric anorectal fistula, with 1 internal opening and 1-2 external openings, with a single seton in place.
* Seton placement for a minimum of four (4) weeks
* Willingness to participate in post-operative follow-up evaluations.

Exclusion Criteria:

* Inability to provide informed consent.
* Medical history of Crohn's disease/Ulcerative Colitis.
* Subjects with multiple fistula tracts (defined as \>1 internal opening and/or \>2 external openings), secondary tracts, horseshoe fistulas, J-pouch fistulas, superficial fistulas, ano/recto-vaginal fistulas or rectourethral fistulas.
* Previous fistulotomy/fistulectomy at the target treatment site (a history of these procedures at other locations is not exclusionary).
* Fistula of traumatic origin including obstetric.
* Evidence of ongoing local infection.
* Evidence of active abscess at the time of treatment.
* Chronic disease such as congestive heart failure, liver disease, renal disease, insulin dependent diabetes (as determined by A1C reading from past 6-12 months), or any chronic illness that may interfere with participation in this study.
* Active and unstable disease state or infection anywhere in the body per Investigator's evaluation and determination.
* Autoimmune disease that is not stable.
* Subjects who are immunocompromised such as known human immunodeficiency virus (HIV) or currently receiving chemotherapy or radiation therapy.
* Ongoing use of antiplatelet drugs. Subjects may be included in the study if antiplatelet drugs have been stopped for 5 to 7 days prior to surgery.
* Known coagulopathy (demonstrated by stated or medical record history of diagnosis)
* Pregnancy
* Previous history of radiation therapy in the area of the fistula.
* History of collagen disease.
* Known allergy to porcine products.
* Religious objection to use of porcine products.

Where it's running

  • Dartmouth Hitchcock Medical Center
    Lebanon, New Hampshire, United States     Recruiting
  • University of Pittsburgh Medical Center
    Pittsburgh, Pennsylvania, United States     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.