Actively Recruiting
Prospective Multi-Center, Single Arm Study Evaluating the Safety and Efficacy of ECMT-100 Hydrogel for Treating Anorectal Fistulas
Led by ECM Therapeutics, Inc. · Updated on 2026-03-31
10
Participants Needed
2
Research Sites
60 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of ECMT-100, a hydrogel medical device, for treating anorectal fistulas. This condition involves abnormal connections near the anus, and ECMT-100 is designed to help close these fistula tracts by adhering to soft tissue and promoting healing without causing fecal incontinence. The study is a prospective, multi-center, single-arm clinical trial sponsored by ECM Therapeutics, Inc. Participants will receive ECMT-100, which is a colloidal hydrogel made from extracellular matrix material. It is administered via catheter directly into the fistula tract after cleaning the area, with a seton (a surgical thread) placed beforehand to keep the fistula open and draining. Subjects may receive one repeat treatment if needed, determined by the clinician, with follow-up visits planned for 12 months after the last treatment. During the study, participants will attend follow-up visits to monitor safety and healing progress. Assessments include checking for adverse events, evaluating fistula closure by examining external openings, measuring changes in fecal incontinence, and assessing quality of life over a 12-month period. These evaluations aim to understand the safety profile and potential benefits of ECMT-100 as a treatment option for anorectal fistulas.
CONDITIONS
Brief 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
- Ability to provide informed consent
- Non-pregnant females
- Clinical diagnosis of one high transsphincteric anorectal fistula with one internal opening and one to two external openings, with a single seton in place
- Seton placement for a minimum of four weeks
- Willingness to participate in post-operative follow-up evaluations
You will not qualify if you...
- Inability to provide informed consent
- History of Crohn's disease or Ulcerative Colitis
- Multiple fistula tracts (more than one internal opening and/or more than two 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 causes
- Evidence of ongoing local infection or active abscess at treatment
- Chronic diseases such as congestive heart failure, liver disease, renal disease, insulin dependent diabetes, or other chronic illnesses that may interfere with study participation
- Active and unstable disease or infection anywhere in the body
- Unstable autoimmune disease
- Immunocompromised status including 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
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment with possible one repeat treatment as determined by the clinician at or prior to the 6-month visit
Participants receive the ECMT-100 hydrogel treatment administered via catheter within the fistula tract following curettage of the tract.
1 treatment visit and 1 possible repeat treatment visit
Duration - 12 months following last treatment
Participants are followed for safety and efficacy assessments including fistula closure, fecal incontinence, and quality of life.
Regular follow-up visits over 12 months
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
C
Cynthia Berringer
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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