Prospective Multi-Center, Single Arm, Study Evaluating the Safety and Efficacy of an ECM Hydrogel for the Treatment of Anorectal Fistulas
ECM Therapeutics, Inc.
Summary
Safety and Efficacy of ECMT-100 for the Treatment of Anorectal Fistulas
Description
ECMT-100 is a colloidal hydrogel derived from extracellular matrix (ECM), formulated to adhere to sub-epithelial soft tissue and allow for filling of anorectal fistulas to reinforce and promote fistula tract closure. ECMT-100 is a medical device and should be administered via catheter within the fistula tract following curettage of the tract, with draining setons used preoperatively. 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 integ…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 exte…
Interventions
- DeviceECMT-100
Colloidal hydrogel
Locations (2)
- Dartmouth Hitchcock Medical CenterLebanon, New Hampshire
- University of Pittsburgh Medical CenterPittsburgh, Pennsylvania