[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594614":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":19,"locations":25,"responsibleParty":127,"collaborators":10,"id":129,"slug":130,"hasResults":131,"nctId":132,"briefTitle":133,"officialTitle":133,"acronym":10,"eligibilityCriteria":134,"healthyVolunteers":131,"sex":135,"minAge":136,"maxAge":137,"enrollmentInfo":138,"targetDuration":141,"studyType":142,"phases":10,"briefSummary":143,"conditions":144,"keywords":10,"overallStatus":28,"whyStopped":10,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":155},{"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",[26,45,62,78,94,111],{"facility":27,"status":28,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"The Colorectal Institute","RECRUITING","Fort Myers","Florida","33912","United States","US",{"type":35,"coordinates":36},"Point",[37,38],-81.84059,26.62168,{"lat":38,"lon":37},[41,43],{"name":42,"role":22,"phone":10,"phoneExt":10,"email":10},"J Neale, MD",{"name":42,"role":44,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"facility":46,"status":28,"city":47,"state":48,"zip":49,"country":32,"countryCode":33,"cosmosGeoPoint":50,"geoPoint":54,"contacts":55},"Hackensack University Medical Center","Hackensack","New Jersey","07601",{"type":35,"coordinates":51},[52,53],-74.04347,40.88593,{"lat":53,"lon":52},[56,60],{"name":57,"role":22,"phone":58,"phoneExt":10,"email":59},"S Taubes","551-996-4371","susan.taubes@hmhn.org",{"name":61,"role":44,"phone":10,"phoneExt":10,"email":10},"S Lee-Kong, MD",{"facility":63,"status":28,"city":64,"state":64,"zip":65,"country":32,"countryCode":33,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"Weill Cornell Medicine","New York","10021",{"type":35,"coordinates":67},[68,69],-74.00597,40.71427,{"lat":69,"lon":68},[72,76],{"name":73,"role":22,"phone":74,"phoneExt":10,"email":75},"KM Muktasid","646-962-2270","kmm4010@med.cornell.edu",{"name":77,"role":44,"phone":10,"phoneExt":10,"email":10},"Lea Lowenfeld, MD, FACS, FASCRS",{"facility":79,"status":28,"city":80,"state":64,"zip":81,"country":32,"countryCode":33,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Northwell Health","Staten Island","10305",{"type":35,"coordinates":83},[84,85],-74.13986,40.56233,{"lat":85,"lon":84},[88,92],{"name":89,"role":22,"phone":90,"phoneExt":10,"email":91},"S Belotte","718-226-6398","sbelotte@northwell.edu",{"name":93,"role":44,"phone":10,"phoneExt":10,"email":10},"Poppy Addison, MD",{"facility":95,"status":28,"city":96,"state":97,"zip":98,"country":32,"countryCode":33,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"Maininle Health Lankenau","Bryn Mawr","Pennsylvania","19010",{"type":35,"coordinates":100},[101,102],-80.08672,40.30396,{"lat":102,"lon":101},[105,109],{"name":106,"role":22,"phone":107,"phoneExt":10,"email":108},"Mainline Health Lankenau","484-476-1000","HandforthK@mlhs.org",{"name":110,"role":44,"phone":10,"phoneExt":10,"email":10},"P Pearson, MD",{"facility":112,"status":28,"city":113,"state":97,"zip":114,"country":32,"countryCode":33,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"Geisinger","Danville","17822",{"type":35,"coordinates":116},[117,118],-76.61273,40.96342,{"lat":118,"lon":117},[121,125],{"name":122,"role":22,"phone":123,"phoneExt":10,"email":124},"K Rebuck","570-271-6856","krebuck@geisinger.edu",{"name":126,"role":44,"phone":10,"phoneExt":10,"email":10},"Christopher Buzas, DO",{"type":128,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","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":139,"type":140},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).",[145],"Fistula-in-ano","2026-06-02",{"date":148,"type":149},"2026-06-03","ACTUAL",{"date":151,"type":149},"2025-06-14",{"date":153,"type":140},"2026-12",{"name":5,"class":6},6]