Study Evaluating the Safety and Efficacy of an ECM Hydrogel for the Treatment of Anorectal Fistulas
NCT ID: NCT07035925
Last Updated: 2025-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
10 participants
INTERVENTIONAL
2025-11-24
2028-04-24
Brief Summary
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Detailed Description
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ECMT-100 is a mucoadhesive hydrogel composed of ECM formulated to adhere to the gastrointestinal mucosa, fill the transsphincteric fistula tract, and promote tract closure by allowing for timely host tissue integration without fecal incontinence.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
ECMT-100
Colloidal hydrogel
Interventions
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ECMT-100
Colloidal hydrogel
Eligibility Criteria
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Inclusion Criteria
* 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 3 months
* Willingness to participate in post-operative follow-up evaluations.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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ECM Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Madison Duclos
Role: primary
Other Identifiers
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ECMT-100-1
Identifier Type: -
Identifier Source: org_study_id
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