[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fistula-in-ano\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fistula-in-ano":54},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,39,78,101,122,150,174],{"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,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":47,"targetDuration":49,"studyType":22,"phases":4,"briefSummary":50,"conditions":51,"keywords":58,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100632912","the-impact-of-perianal-disease-on-patients-sex-life-100632912","NCT07519850","The Impact of Perianal Disease on Patient's Sex Life","The \"Hidden Morbidity\" of Perianal Disease: A Prospective Evaluation of Psychosexual Health and Body Image.","SEXTON","Inclusion Criteria:\n\n* Diagnosis of chronic perianal disease (fistula-in-ano, pCD, pilonidal).\n* Age \\>18 years.\n* Ability to understand and complete the Greek versions of the IIEF-5\u002FFSFI-6 and the study PROM.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Active malignancy (colorectal or anal cancer).\n* Major pelvic surgery in the last 3 months (unrelated to perianal disease).\n* Cognitive impairment preventing survey completion.",{"count":48,"type":20},60,"3 Months","Perianal diseases, such as perianal abcesses, anal fistulae and perianal Crohn's disease, are often associated with significant physical symptoms, including pain and chronic drainage. However, the impact of these conditions on a patient's personal life, intimacy, and body image-often referred to as \"hidden morbidity\"-is frequently overlooked in clinical practice.\n\nThe purpose of this prospective observational study is to evaluate the psychosexual burden in patients suffering from chronic perianal disease. Using validated tools (IIEF-5 for men, FSFI-6 for women) and a specialized Supplemental Patient-Reported Outcome Measure (PROM), researchers will investigate how the presence of surgical devices (such as setons), disease etiology, and clinical symptoms affect sexual function and self-esteem.\n\nThe study also aims to identify gaps in physician-patient communication regarding sexual health. By quantifying these impacts, the study seeks to promote a more holistic, patient-centered approach to the surgical management of perianal conditions.",[52,53,54,55,56,57],"Perianal Crohn Disease","Perianal Fistula","Fistula in Ano","Perianal Abscess","Pilonidal Cyst\u002FFistula","Anal Fissure and Fistula",[59,60,61,62,63,64,65,66],"fistula in ano","perianal fistula","perianal Crohn's disease","anal fissure","psychosexual life","sex life","intimacy","fistula","2026-04-02",{"date":69,"type":30},"2026-04-09",{"date":71,"type":20},"2026-03-31",{"date":73,"type":20},"2026-06-20",{"name":75,"class":76},"AHEPA University Hospital","OTHER",1,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":100},"100595705","study-evaluating-the-safety-and-efficacy-of-an-ecm-hydrogel-for-the-treatment-of-anorectal-fistulas-100595705","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.",{"count":86,"type":20},10,"INTERVENTIONAL",[89],"NA","Safety and Efficacy of ECMT-100 for the Treatment of Anorectal Fistulas",[54],"2026-03-26",{"date":71,"type":30},{"date":95,"type":30},"2025-11-24",{"date":97,"type":20},"2028-04-24",{"name":99,"class":37},"ECM Therapeutics, Inc.",2,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":16,"enrollmentInfo":108,"targetDuration":4,"studyType":87,"phases":110,"briefSummary":111,"conditions":112,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":77},"100490475","fistula-in-ano-in-infants-and-children-100490475","NCT05666609","Fistula-in-ano in Infants and Children","Fistula-in-ano in Infants and Children: Prospective, Randomized Clinical Trail on the Duration of Non-cutting Seton Placement","Inclusion Criteria:\n\n* any patient with FIA and treatment with non-cutting seton placement in our institution\n* regardless of underlying diagnoses\n* age 0-18 years\n\nExclusion Criteria:\n\n* none",{"count":109,"type":20},20,[89],"In this prospective, randomized trail, duration of non-cutting seton placement in patients with fistula-in-ano is evaluated.",[54],"2025-08-31",{"date":115,"type":30},"2025-09-08",{"date":117,"type":30},"2023-01-01",{"date":119,"type":20},"2027-12-31",{"name":121,"class":76},"Friedrich-Alexander-Universität Erlangen-Nürnberg",{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":129,"targetDuration":4,"studyType":87,"phases":131,"briefSummary":133,"conditions":134,"keywords":136,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":77},"100442286","phase-1-safety-of-allogeneic-human-umbilical-cord-mesenchymal-stem-cells-uc-mscs-to-treat-perianal-fistulas-w-crohns-disease-100442286","NCT05039411","Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) to Treat Perianal Fistulas w\u002F Crohn's Disease","A Phase I Study of the Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) for Perianal Fistulas in Patients With Crohn's Disease","Inclusion Criteria:\n\n* Adult men and women age 18 years and above.\n* Diagnosis of perianal fistulae associated with Crohn's disease refractory to medical therapy.\n* Presence of perianal fistula(s) with a maximum of 2 internal openings and a maximum of 3 external openings based on clinical assessment.\n* Fit for surgery.\n\nExclusion Criteria:\n\n* Informed consent refusal.\n* Pregnancy or breastfeeding women.\n* Current diagnosis of active cancer or remission for less than 5 years.\n* Evidence of active sepsis or significant localised infection.\n* Patients with HIV, HBV, HCV or treponema infection, whether active or latent.\n* Patients with documented allergies.\n* Patients who have received infliximab or any other biologics in the 4 weeks before the cell treatment administration.\n* Patients currently receiving, or having received within 1 month prior to enrollment into this clinical trial, any investigational drug.\n* Patients with any other co-morbidity\u002F co-pathologies which is deemed as contraindication to stem cells infusion (infection, administration of steroids).",{"count":130,"type":20},5,[132],"PHASE1","Objectives:\n\nPrimary: To demonstrate the safety of allogeneic UC-MSCs administered by injection for complex perianal fistulas in patients with Crohn's disease\n\nSecondary: To determine the efficacy of a single\u002Fmultiple allogeneic UC-MSCs injection in improving complex perianal fistula complications and (re-epithelialization of the external openings).",[135,54],"Perianal Fistula Due to Crohn's Disease",[137,138,139,140],"Perianal fistula","Crohn's Disease","Umbilical cord mesenchymal stem cells (UC-MSCs)","Allogeneic stem cells","2025-05-07",{"date":143,"type":30},"2025-05-11",{"date":145,"type":30},"2022-03-01",{"date":147,"type":20},"2026-12-31",{"name":149,"class":37},"CryoCord Sdn Bhd",{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":157,"targetDuration":4,"studyType":87,"phases":158,"briefSummary":159,"conditions":160,"keywords":162,"overallStatus":164,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":4},"100579314","autologous-stem-cells-in-the-management-of-fistulating-perianal-crohns-disease-100579314","NCT06822686","Autologous Stem Cells in the Management of Fistulating Perianal Crohn's Disease","Assessment of the Feasibility of Autologous Bone Marrow-derived Mesenchymal Stem Cells in the Management of Fistulating Perianal Crohn's Disease","Inclusion Criteria:\n\n* Diagnosed with perianal Crohn's disease\n* Medically controlled proximal disease as confirmed by endoscopy or Harvey Bradshaw Index scores of less than 7 (remission \u002F mild disease)\n* Recent MRI scan to assess fistulating perianal Crohn's\n* Non-branching fistula with no more than 1 internal opening and 2 external opening i.e. a single tract.\n* No previous definitive fistula treatment (seton excluded)\n* In the Investigator's opinion, is able and willing to comply with all trial requirements.\n* Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the trial.\n\nExclusion Criteria:\n\n* Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.\n* Participants who have participated in another research trial involving an investigational product in the past 12 weeks.\n* Ongoing perianal sepsis or anal stenosis\n* Patients with a defunctioning stoma",{"count":86,"type":20},[89],"Crohn's disease is a chronic inflammatory condition that can affect any part of the bowel which can be controlled by a combination of medical and surgical treatments but cannot be cured. A 1\u002F3 of patients have involvement of the perianal region. There are several conditions that can affect the perianal region but the most debilitating is the presence of fistulating disease. Fistulae are small tunnels that run under the skin from the inside of the anus to skin outside the anus and are associated with the inflammatory process seen with Crohn's disease. They can cause pain, infection and discharge which adversely affects the quality of life of the patient. Surgery can be used to treat the symptoms however cure is often difficult to achieve.\n\nStem cells have anti-inflammatory potential and have been shown to be a useful treatment for this condition in combination with effective medical therapy. The stem cells used in the studies need to be prepared 48 hours before use which limits their usage and this is not readily available in the UK.\n\nThe proposed study aims to assess the feasibility of using autologous stem cells prepared with a rapid preparation system at the time of surgery, within the operating room (currently in use at Oxford University Hospitals NHS Foundation Trust (OUH) within the orthopaedic department for a different indication) for fistulating anal Crohn's disease. The stem cells are derived from the patients own bone marrow. The patients undergoing surgery would be having it done for the stem cell treatment. They will then undergo 3 follow up visits and complete questionnaires at each visit alongside a clinical assessment. This study is funded by Occtopus (Colorectal charity based in Oxford).",[54,161],"Crohn Disease",[163],"Stem cell","NOT_YET_RECRUITING","2025-02-11",{"date":167,"type":30},"2025-02-12",{"date":169,"type":20},"2025-03-01",{"date":171,"type":20},"2026-05-01",{"name":173,"class":76},"Oxford University Hospitals NHS Trust",{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":181,"targetDuration":4,"studyType":87,"phases":183,"briefSummary":184,"conditions":185,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":100},"100545816","collagen-paste-vs-mucosal-advancement-flap-for-fia-100545816","NCT06386835","Collagen Paste vs Mucosal Advancement Flap for FIA","Collagen Paste Injection Compared With Mucosal Advancement Flap for the Treatment of Fistula-in-ano: Single Centre Non-inferiority Randomised Controlled Trial","Inclusion Criteria:\n\n* Clinical diagnosis of high cryptoglandular fistula-in-ano.\n* Patients must have undergone a prior EUA to characterise the nature of the fistula.\n* The fistula tract should be ≥ 2 cm in length.\n* Only a single internal fistula opening should be present at EUA, such that the fistula is suitable for treatment by insertion of a seton drain.\n* Patients must have been treated with a draining seton for a minimum period of 6 weeks prior to randomisation.\n* Patients must be aged ≥ 18 years and able to provide informed consent.\n* Fistulas must be of cryptoglandular aetiology.\n\nExclusion Criteria:\n\n* Unable\u002Funwilling to provide informed consent.\n* Contraindication to general anaesthesia or spinal anaesthesia.\n* Low trans-sphincteric fistulas.\n* Non-cryptoglandular fistulas (e.g. Crohn's disease, obstetric, irradiation, malignant, etc.).\n* Other perineal fistulas (e.g. rectovaginal fistulas, pouch-vaginal fistulas, etc.).\n* Complex disease in which more than one internal fistula opening is present and requiring concurrent insertion of more than one fistula plug.\n* Clinical evidence of active perianal sepsis. In the event that there is disagreement between clinical and radiological assessment of active sepsis\u002Fcollection, the clinical opinion will prevail.\n* Cultural or religious objection to the use of pig tissue.\n* Absolute contraindication to magnetic resonance imaging (MRI) (e.g. cardiac pacemaker).\n* Patients with recurrent anal fistulas previously treated with a fistula plug.",{"count":182,"type":20},118,[89],"The treatment for fistula-in-ano (FIA) remains a challenge to General and Colorectal Surgeons Worldwide. A variety of surgical treatments have been described for high anal fistulas, but none offers the panacea of fistula eradication with guaranteed preservation of continence. This study compares Collagen paste injection to mucosal advancement flap for the treatment of fistula-in-ano.",[25],"2024-04-24",{"date":188,"type":30},"2024-04-26",{"date":190,"type":30},"2024-01-26",{"date":192,"type":20},"2027-03-31",{"name":194,"class":76},"Chinese University of Hong Kong"]