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

Part of paid clinical trials in Lebanon, New Hampshire.

Sponsor
ECM Therapeutics, Inc.
Study ID
NCT07035925
Status
Recruiting
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Conditions

  • Fistula in Ano

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ECMT-100 — DEVICE
    Colloidal hydrogel

Study Details

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

Key Dates

Start date
Nov 24, 2025
Status verified
Dec 2025
Primary completion
Feb 24, 2027
Completion
Apr 24, 2028

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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.

Primary Outcome Measure

Adverse Events [ Time Frame: 12 months from treatment ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Dartmouth Hitchcock Medical CenterLebanonNew Hampshire03756
Madison Duclos
603-653-3607
University of Pittsburgh Medical CenterPittsburghPennsylvania15237
Kim Sainiak
[email protected]
412-647-1705

Find similar trials in Lebanon, NH

By research site
Dartmouth Hitchcock Medical Center· Lebanon, NHUniversity of Pittsburgh Medical Center· Pittsburgh, PA