[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Signum Surgical USA Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":39},{"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":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100594614","biohealx-anal-fistula-device-post-market-surveillance-study-100594614",false,"NCT07021742","BioHealx® Anal Fistula Device Post Market Surveillance Study","Inclusion Criteria:\n\n* Age 18 - 75 years\n* Presence of Single Continuous Anal Fistula presenting for initial curative surgery\n* Failed or Recurrent Anal Fistula Closure\n* Minimum of 6-weeks of draining seton placed prior to procedure.\n* Availability for follow-up contacts and willingness to complete the Informed Consent.\n\nExclusion Criteria:\n\n* Fistula tract shorter than 2cm\n* Complex fistula tract (branching)\n* Body Mass Index \\> 35\n* Known uncontrolled diabetes or other systemic condition associated with impaired healing\n* Known HIV-positive or immunocompromised\n* Rectal prolapse\n* Pregnancy\n* Rectal \u002F fistula malignancy\n* Crohn's disease\n* Ulcerative proctitis\n* Hidradenitis suppurativa of the anal region\n* Pilonidal sinus disease\n* Presence of hemorrhoid Involving fistula site\n* Continuous use of anti-inflammatory\n* Intersphincteric fistula in ano or fistula treatable by simple fistulotomy\n* Active infection or abscess involving fistula site\n* Known allergy to PLGA material\n* Any severe acute or uncontrolled chronic disease that according to the investigator might render the patient unsuitable for the study\n* Treatment with an investigational drug or medical device in the past 30 days","ALL","18 Years","75 Years",{"count":19,"type":20},50,"ESTIMATED","36 Months","OBSERVATIONAL","This post market surveillance study is a single arm multicenter study to demonstrate the long-term durability and effectiveness of the BioHealx Anal Fistula Device for fistula-in-ano closure (internal and external fistula openings).",[25],"Fistula-in-ano","RECRUITING","2026-06-02",{"date":29,"type":30},"2026-06-03","ACTUAL",{"date":32,"type":30},"2025-06-14",{"date":34,"type":20},"2026-12",{"name":36,"class":37},"Signum Surgical USA Inc.","INDUSTRY",6,""]