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).