Safety and Efficacy of ECMT-100 for the Treatment of Anorectal Fistulas
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.
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).
Single group
ECMT-100
DeviceColloidal hydrogel
Adverse Events
Number of Adverse Events
Percentage of Subjects in whom external openings of the fistula have closed
Physical exam to confirm closure and absence of discharge
Changes in Fecal Incontinence
Wexner Score - Cleveland Clinic Fecal Incontinence Score; changes from baseline
Changes in Quality of Life
Medical Outcomes Study Questionnaire Short Form 36; changes from baseline
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