NCT07035925 Study Evaluating the Safety and Efficacy of an ECM Hydrogel for the Treatment of Anorectal Fistulas
| NCT ID | NCT07035925 |
| Status | Recruiting |
| Phase | — |
| Sponsor | ECM Therapeutics, Inc. |
| Condition | Fistula in Ano |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-11-24 |
| Primary Completion | 2027-02-24 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2025-11-24 with a primary completion date of 2027-02-24.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Safety and Efficacy of ECMT-100 for the Treatment of Anorectal Fistulas
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07035925 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Fistula in Ano. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07035925 currently recruiting?
Yes, NCT07035925 is actively recruiting participants. Contact the research team at julie@clinicalresearchstrategies.com for enrollment information.
Where is the NCT07035925 trial being conducted?
This trial is being conducted at Lebanon, United States, Pittsburgh, United States.
Who is sponsoring the NCT07035925 clinical trial?
NCT07035925 is sponsored by ECM Therapeutics, Inc.. The trial plans to enroll 10 participants.