NCT07035925

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: ECM Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Safety and Efficacy of ECMT-100 for the Treatment of Anorectal Fistulas

Detailed 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 integration without fecal incontinence.

Conditions

• Fistula in Ano

Interventions

Type	Name	Description
DEVICE	ECMT-100	Colloidal hydrogel

Timeline

• Start date: 2025-11-24
• Primary completion: 2027-02-24
• Completion: 2028-04-24
• First posted: 2025-06-25
• Last updated: 2026-03-31

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study