Study of ECMT-100 Hydrogel Device for Treating Anorectal Fistulas in Adults Single-Group, Multi-Center Evaluation of Safety and Effectiveness

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.

Study Evaluating the Safety and Efficacy of an ECM Hydrogel for the Treatment of Anorectal Fistulas