ECMT-100 ECM hydrogel to close high transsphincteric anorectal fistulas

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

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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: ECM Therapeutics, Inc. (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 2 sites (Lebanon, New Hampshire and 1 other locations)
• Trial ID: NCT07035925 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Lebanon, New Hampshire and 1 other locations

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

Study contacts

• Study coordinator: Julie Cramer

Conditions Fistula in Ano