[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595705":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":31,"responsibleParty":65,"collaborators":20,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":20,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":20,"enrollmentInfo":76,"targetDuration":20,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":20,"overallStatus":34,"whyStopped":20,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"ECM Therapeutics, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment","EXPERIMENTAL","ECMT-100\n\nSubjects will be followed for 12 months following last treatment with ECMT-100.\n\nSubjects are eligible for one repeat treatment as determined by the clinician\u002Finvestigator at or prior to the 6-month visit.",[13],"Device: ECMT-100",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","ECMT-100","Colloidal hydrogel",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Julie Cramer","CONTACT","330-507-0801","julie@clinicalresearchstrategies.com",{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},"Cynthia Berringer","412-638-9986","cberringer@ecmtherapeutics.com",[32,50],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Dartmouth Hitchcock Medical Center","RECRUITING","Lebanon","New Hampshire","03756","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-72.25176,43.64229,{"lat":44,"lon":43},[47],{"name":48,"role":24,"phone":49,"phoneExt":20,"email":20},"Madison Duclos","603-653-3607",{"facility":51,"status":34,"city":52,"state":53,"zip":54,"country":38,"countryCode":39,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"University of Pittsburgh Medical Center","Pittsburgh","Pennsylvania","15237",{"type":41,"coordinates":56},[57,58],-79.99589,40.44062,{"lat":58,"lon":57},[61],{"name":62,"role":24,"phone":63,"phoneExt":20,"email":64},"Kim Sainiak","412-647-1705","sainiakks@upmc.edu",{"type":66,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","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":77,"type":78},10,"ESTIMATED","INTERVENTIONAL",[81],"NA","Safety and Efficacy of ECMT-100 for the Treatment of Anorectal Fistulas",[84],"Fistula in Ano","2026-03-26",{"date":87,"type":88},"2026-03-31","ACTUAL",{"date":90,"type":88},"2025-11-24",{"date":92,"type":78},"2028-04-24",{"name":5,"class":6},2]