[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"ECM Therapeutics, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":40},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100595705","study-evaluating-the-safety-and-efficacy-of-an-ecm-hydrogel-for-the-treatment-of-anorectal-fistulas-100595705",false,"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","Inclusion Criteria:\n\n* Male and female subjects at least 18 years of age.\n* Provide informed consent\n* Non-pregnant females\n* Clinical diagnosis of 1 high transsphincteric anorectal fistula, with 1 internal opening and 1-2 external openings, with a single seton in place.\n* Seton placement for a minimum of four (4) weeks\n* Willingness to participate in post-operative follow-up evaluations.\n\nExclusion Criteria:\n\n* Inability to provide informed consent.\n* Medical history of Crohn's disease\u002FUlcerative Colitis.\n* Subjects with multiple fistula tracts (defined as \\>1 internal opening and\u002For \\>2 external openings), secondary tracts, horseshoe fistulas, J-pouch fistulas, superficial fistulas, ano\u002Frecto-vaginal fistulas or rectourethral fistulas.\n* Previous fistulotomy\u002Ffistulectomy at the target treatment site (a history of these procedures at other locations is not exclusionary).\n* Fistula of traumatic origin including obstetric.\n* Evidence of ongoing local infection.\n* Evidence of active abscess at the time of treatment.\n* Chronic disease such as congestive heart failure, liver disease, renal disease, insulin dependent diabetes (as determined by A1C reading from past 6-12 months), or any chronic illness that may interfere with participation in this study.\n* Active and unstable disease state or infection anywhere in the body per Investigator's evaluation and determination.\n* Autoimmune disease that is not stable.\n* Subjects who are immunocompromised such as known human immunodeficiency virus (HIV) or currently receiving chemotherapy or radiation therapy.\n* Ongoing use of antiplatelet drugs. Subjects may be included in the study if antiplatelet drugs have been stopped for 5 to 7 days prior to surgery.\n* Known coagulopathy (demonstrated by stated or medical record history of diagnosis)\n* Pregnancy\n* Previous history of radiation therapy in the area of the fistula.\n* History of collagen disease.\n* Known allergy to porcine products.\n* Religious objection to use of porcine products.","ALL","18 Years",{"count":19,"type":20},10,"ESTIMATED","INTERVENTIONAL",[23],"NA","Safety and Efficacy of ECMT-100 for the Treatment of Anorectal Fistulas",[26],"Fistula in Ano","RECRUITING","2026-03-26",{"date":30,"type":31},"2026-03-31","ACTUAL",{"date":33,"type":31},"2025-11-24",{"date":35,"type":20},"2028-04-24",{"name":37,"class":38},"ECM Therapeutics, Inc.","INDUSTRY",2,""]