Recruiting

ECMT-100

Sponsor:

ECM Therapeutics, Inc.

Code:

NCT07035925

Conditions

Fistula in Ano

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ECMT-100

Study Details

Brief summary:

Safety and Efficacy of ECMT-100 for the Treatment of Anorectal Fistulas

Conditions

Fistula in Ano

Study ID

NCT07035925

Start date

Nov 24, 2025

Status verified date

Dec, 2025

Completion date

Apr 24, 2028

Anticipated

Primary completion date

Feb 24, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment

ECMT-100

Subjects will be followed for 12 months following last treatment with ECMT-100.

Subjects are eligible for one repeat treatment as determined by the clinician/investigator at or prior to the 6-month visit.

Interventions

ECMT-100

Colloidal hydrogel

Primary outcome measure

  • Adverse Events [ Time Frame: 12 months from treatment ]

Central Contacts and Locations

Central contacts

Julie Cramer

330-507-0801julie@clinicalresearchstrategies.com

Cynthia Berringer

412-638-9986cberringer@ecmtherapeutics.com

Locations

Dartmouth Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03756

Contacts

Madison Duclos

603-653-3607

University of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15237

Contacts

Kim Sainiak

412-647-1705sainiakks@upmc.edu

More Information

Sponsor

ECM Therapeutics, Inc.

Last update posted

Mar 31, 2026

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by ECM Therapeutics, Inc. on 2026-03-31.