Actively Recruiting
Study Evaluating the Safety and Efficacy of an ECM Hydrogel for the Treatment of Anorectal Fistulas
Led by ECM Therapeutics, Inc. · Updated on 2026-03-31
10
Participants Needed
2
Research Sites
126 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Safety and Efficacy of ECMT-100 for the Treatment of Anorectal Fistulas
CONDITIONS
Official Title
Study Evaluating the Safety and Efficacy of an ECM Hydrogel for the Treatment of Anorectal Fistulas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- Inability to provide informed consent.
- Medical history of Crohn's disease or Ulcerative Colitis.
- Subjects with multiple fistula tracts (>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 or fistulectomy at the target treatment site.
- Fistula of traumatic origin including obstetric.
- Evidence of ongoing local infection.
- Evidence of active abscess at the time of treatment.
- Chronic diseases such as congestive heart failure, liver disease, renal disease, insulin dependent diabetes, or any chronic illness that may interfere with participation.
- Active and unstable disease or infection anywhere in the body.
- Autoimmune disease that is not stable.
- Immunocompromised status such as known HIV or current chemotherapy or radiation therapy.
- Ongoing use of antiplatelet drugs unless stopped 5 to 7 days prior to surgery.
- Known coagulopathy.
- Pregnancy.
- Previous radiation therapy in the fistula area.
- History of collagen disease.
- Known allergy to porcine products.
- Religious objection to use of porcine products.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
2
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15237
Actively Recruiting
Research Team
J
Julie Cramer
CONTACT
C
Cynthia Berringer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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