[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594614":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":19,"locations":25,"responsibleParty":126,"collaborators":10,"id":128,"slug":10,"hasResults":129,"nctId":130,"briefTitle":131,"officialTitle":131,"acronym":10,"eligibilityCriteria":132,"healthyVolunteers":129,"sex":133,"minAge":134,"maxAge":135,"enrollmentInfo":136,"targetDuration":139,"studyType":140,"phases":10,"briefSummary":141,"conditions":142,"keywords":10,"overallStatus":28,"whyStopped":10,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},{"fullName":5,"class":6},"Signum Surgical USA Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"BioHealx",null,"Subjects will have their anal fistula treated with the BioHealx Anal Fistula Device.",[13],"Device: BioHealx",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":10},"DEVICE","Subjects will have their anal fistula treated with the BioHealx Anal Fistula Device, a bioabsorbable implant designed to securely close the fistula internal opening, preventing reinfection, while allowing for drainage through the external opening during healing.",[9],[20],{"name":21,"role":22,"phone":23,"phoneExt":10,"email":24},"Katy Feeny","CONTACT","610-860-6577","kjclinconsulting@gmail.com",[26,44,61,77,93,110],{"facility":27,"status":28,"city":29,"state":30,"zip":31,"country":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"The Colorectal Institute","RECRUITING","Fort Myers","Florida","33912","United States",{"type":34,"coordinates":35},"Point",[36,37],-81.84059,26.62168,{"lat":37,"lon":36},[40,42],{"name":41,"role":22,"phone":10,"phoneExt":10,"email":10},"J Neale, MD",{"name":41,"role":43,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"facility":45,"status":28,"city":46,"state":47,"zip":48,"country":32,"cosmosGeoPoint":49,"geoPoint":53,"contacts":54},"Hackensack University Medical Center","Hackensack","New Jersey","07601",{"type":34,"coordinates":50},[51,52],-74.04347,40.88593,{"lat":52,"lon":51},[55,59],{"name":56,"role":22,"phone":57,"phoneExt":10,"email":58},"S Taubes","551-996-4371","susan.taubes@hmhn.org",{"name":60,"role":43,"phone":10,"phoneExt":10,"email":10},"S Lee-Kong, MD",{"facility":62,"status":28,"city":63,"state":63,"zip":64,"country":32,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Weill Cornell Medicine","New York","10021",{"type":34,"coordinates":66},[67,68],-74.00597,40.71427,{"lat":68,"lon":67},[71,75],{"name":72,"role":22,"phone":73,"phoneExt":10,"email":74},"KM Muktasid","646-962-2270","kmm4010@med.cornell.edu",{"name":76,"role":43,"phone":10,"phoneExt":10,"email":10},"Lea Lowenfeld, MD, FACS, FASCRS",{"facility":78,"status":28,"city":79,"state":63,"zip":80,"country":32,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Northwell Health","Staten Island","10305",{"type":34,"coordinates":82},[83,84],-74.13986,40.56233,{"lat":84,"lon":83},[87,91],{"name":88,"role":22,"phone":89,"phoneExt":10,"email":90},"S Belotte","718-226-6398","sbelotte@northwell.edu",{"name":92,"role":43,"phone":10,"phoneExt":10,"email":10},"Poppy Addison, MD",{"facility":94,"status":28,"city":95,"state":96,"zip":97,"country":32,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"Maininle Health Lankenau","Bryn Mawr","Pennsylvania","19010",{"type":34,"coordinates":99},[100,101],-80.08672,40.30396,{"lat":101,"lon":100},[104,108],{"name":105,"role":22,"phone":106,"phoneExt":10,"email":107},"Mainline Health Lankenau","484-476-1000","HandforthK@mlhs.org",{"name":109,"role":43,"phone":10,"phoneExt":10,"email":10},"P Pearson, MD",{"facility":111,"status":28,"city":112,"state":96,"zip":113,"country":32,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"Geisinger","Danville","17822",{"type":34,"coordinates":115},[116,117],-76.61273,40.96342,{"lat":117,"lon":116},[120,124],{"name":121,"role":22,"phone":122,"phoneExt":10,"email":123},"K Rebuck","570-271-6856","krebuck@geisinger.edu",{"name":125,"role":43,"phone":10,"phoneExt":10,"email":10},"Christopher Buzas, DO",{"type":127,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","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":137,"type":138},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).",[143],"Fistula-in-ano","2026-06-02",{"date":146,"type":147},"2026-06-03","ACTUAL",{"date":149,"type":147},"2025-06-14",{"date":151,"type":138},"2026-12",{"name":5,"class":6},6]