Study Evaluating the Safety and Efficacy of an ECM Hydrogel for the Treatment of Anorectal Fistulas
Prospective Multi-Center, Single Arm, Study Evaluating the Safety and Efficacy of an ECM Hydrogel for the Treatment of Anorectal Fistulas
1 other identifier
interventional
10
1 country
2
Brief Summary
Safety and Efficacy of ECMT-100 for the Treatment of Anorectal Fistulas
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2025
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2025
CompletedFirst Posted
Study publicly available on registry
June 25, 2025
CompletedStudy Start
First participant enrolled
November 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 24, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 24, 2028
March 31, 2026
December 1, 2025
1.3 years
May 13, 2025
March 26, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse Events
Number of Adverse Events
12 months from treatment
Secondary Outcomes (3)
Percentage of Subjects in whom external openings of the fistula have closed
12 months from treatment
Changes in Fecal Incontinence
12 months from treatment
Changes in Quality of Life
12 months from treatment
Study Arms (1)
Treatment
EXPERIMENTALECMT-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
Eligibility Criteria
You may qualify if:
- 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 may not qualify if:
- 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.
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15237, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2025
First Posted
June 25, 2025
Study Start
November 24, 2025
Primary Completion (Estimated)
February 24, 2027
Study Completion (Estimated)
April 24, 2028
Last Updated
March 31, 2026
Record last verified: 2025-12