[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fistula\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fistula":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,49,83,110],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100641301","restoregi-study-regenerative-endoscopic-stromal-therapy-outcomes-and-risk-factor-evaluation-in-gi-fistulas-100641301",false,"NCT07661043","RESTOREGI Study: Regenerative Endoscopic Stromal Therapy: Outcomes and Risk Factor Evaluation in GI Fistulas","PROSPECTIVE RISK FACTOR ANALYSIS OF CLINICAL OUTCOMES FOLLOWING ENDOSCOPIC tSVF-em THERAPY FOR BENIGN GASTROINTESTINAL FISTULAS - RESTOREGI Study","RESTORE-GI","Inclusion Criteria:\n\n* Age ≥18 years\n* Confirmed benign gastrointestinal fistula involving the luminal gastrointestinal tract\n* Fistula accessible for endoscopic evaluation and treatment\n* Planned treatment with endoscopic tSVF-EM therapy, with or without adjunctive endoscopic therapies (argon plasma coagulation \\[APC\\], tract abrasion\u002Fcurettage, clips, over-the-scope clips \\[OTSC\\], endoscopic suturing, or stent placement)\n* Ability and willingness to provide written informed consent\n* Willingness to comply with scheduled follow-up visits and study assessments\n\nExclusion Criteria:\n\n* Perianal fistulas of any aetiology\n* Inflammatory bowel disease-associated fistulas, including fistulas related to Crohn's disease or ulcerative colitis\n* Malignancy-related fistulas\n* Fistulas requiring primary oncologic surgical management\n* Uncontrolled sepsis or undrained abscess at baseline (patients may become eligible following adequate drainage and clinical stabilisation)\n* Contraindication to adipose tissue harvest, sedation, anaesthesia, or therapeutic endoscopy\n* Pregnancy or lactation\n* Severe coagulopathy not correctable prior to intervention\n* Inability to provide informed consent\n* Anticipated inability to complete study follow-up\n* Participation in another interventional study that may influence fistula healing outcomes","ALL","18 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"NA","RESTOREGI Study Benign gastrointestinal fistulas are abnormal communications between the gastrointestinal tract and adjacent organs or the skin. Chronic fistulas are often difficult to treat because of persistent inflammation, fibrosis, impaired vascularity, and defective tissue regeneration. Endoscopic regenerative therapy using mechanically processed autologous total stromal vascular fraction-enriched microfragmented adipose tissue (tSVF-EM) has emerged as a novel therapeutic approach that may promote tissue repair through angiogenesis, immunomodulation, and regenerative signaling.\n\nAlthough early clinical experience suggests promising healing outcomes, factors predicting successful fistula closure remain poorly understood. The RESTOREGI study is a prospective, single-center observational cohort study designed to identify patient-related, fistula-related, and procedural factors associated with successful healing following endoscopic tSVF-EM therapy in benign gastrointestinal fistulas. The study will also evaluate treatment safety, time to healing, recurrence rates, and the impact of procedural variables on outcomes.",[27,28,29],"Fistula","Regenerative Medicine","Stromal Vascular Fraction",[31,32,33,34,35],"Gastrointestinal fistula","Stromal vascular fraction","Endoscopic fistula closure","Regenerative endoscopy","Mesenchymal stromal cells","NOT_YET_RECRUITING","2026-06-22",{"date":39,"type":40},"2026-06-24","ACTUAL",{"date":42,"type":21},"2026-06-15",{"date":44,"type":21},"2027-08-31",{"name":46,"class":47},"Asian Institute of Gastroenterology, India","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":57,"minAge":58,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":62,"conditions":63,"keywords":67,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":82},"100473408","effectiveness-and-acceptability-of-insertable-devices-for-obstetric-fistula-management-100473408","NCT05444504","Effectiveness and Acceptability of Insertable Devices for Obstetric Fistula Management","Effectiveness and Acceptability of Two Insertable Device Models for Non-surgical Management of Obstetric Fistula: a Randomized Crossover Trial","COPE","Inclusion criteria:\n\n* VVF confirmed by dye test and clinical exam at least 3cm from the external urethral orifice (regardless of size), adequate vaginal capacity to accommodate the cup (per physician)\n* Willing to insert and remove cup\u002Fcup+\n* Clear understanding of the study procedures\n* Willing to participate fully, not yet been repaired or previously failed surgical repair, at least 6mo post-surgery\n* If previous fistula repair, ≥3mo post-delivery\n* If recent birth, age 18+ or emancipated minor\n* Speak English or local language\n\nExclusion criteria:\n\n* Any rectovaginal fistula\n* Urinary leakage \\\u003C6ml over 6 hours\n* Women who are candidates for catheterization who could be healed without surgery will be excluded as they are \\\u003C3mo post-delivery.","FEMALE","15 Years",{"count":60,"type":21},100,[24],"The investigators propose a clinical trial and nested qualitative study to 1) quantify the effectiveness of an insertable vaginal cup to manage fistula urinary incontinence, 2) examine user and implementer acceptability, and 3) quantify fistula management cost. Two intervention models will be compared among women awaiting fistula surgery or whose surgery was unsuccessful: 1) a vaginal cup ('cup'), and 2) the cup attached via rubber tubing to a leg-secured urine collection bag ('cup+') for greater urine holding capacity.",[64,27,65,66],"Obstetric Fistula","Fistula, Urinary","Fistula, Vaginal",[68,69,27,64,66,65,70,71],"Menstrual cup","Urinary incontinence","Women's health","Quality of LIfe","RECRUITING","2025-12-18",{"date":75,"type":40},"2025-12-22",{"date":77,"type":40},"2023-04-15",{"date":79,"type":21},"2027-01-01",{"name":81,"class":47},"University of California, San Francisco",3,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":92,"phases":4,"briefSummary":93,"conditions":94,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":109},"100504755","evaluation-of-the-clinical-utility-of-endoscopic-closure-using-a-dual-action-tissue-dat-clip-100504755","NCT05852457","Evaluation of the Clinical Utility of Endoscopic Closure Using a Dual Action Tissue (DAT) Clip","Prospective Evaluation of the Clinical Utility of Endoscopic Closure Using a Dual Action Tissue (DAT) Clip","Inclusion Criteria:\n\n* Age 18 years or older.\n* Patients scheduled to undergo endoscopic procedures as part of their routine care in which endoscopic clip closure is clinically indicated:\n\nTreatment of bleeding Treatment of perforation and\u002For fistulas Tissue approximation for mucosal gaps associated with endoscopic resection (e.g., endoscopic mucosal resection, endoscopic submucosal dissection) or third space endoscopy (e.g., peroral endoscopic myotomy in the gastrointestinal tract)\n\nExclusion Criteria:\n\n* Any contraindications to performing endoscopy.\n* Participants in another research protocol that could interfere or influence the outcomes measures of the present study.",{"count":91,"type":21},250,"OBSERVATIONAL","This study is designed as a multicenter prospective data recording study to document the performance of the DAT clip as part of standard medical care of patients. No experimental interventions will be performed.",[95,96,97,98,99,27],"GI Bleeding","Perforation Colon","Perforation Bowel","Perforation Duodenal","Perforated Bowel","2025-10-07",{"date":102,"type":40},"2025-10-08",{"date":104,"type":40},"2022-08-31",{"date":106,"type":21},"2027-12",{"name":108,"class":47},"AdventHealth",2,{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":118,"enrollmentInfo":119,"targetDuration":4,"studyType":22,"phases":121,"briefSummary":122,"conditions":123,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":48},"100561243","3d-bio-structures-for-gi-post-surgical-defects-100561243","NCT06587633","3D BIO-STRUCTURES FOR G.I. POST-SURGICAL DEFECTS","3D BIO-STRUCTURES POPULATED WITH MICRO-FRAGMENTED, EMULSIFIED STROMAL TISSUE DERIVED FROM AUTOLOGOUS ADIPOSE TISSUE HARVESTING FOR THE REGENERATIVE TREATMENT OF POST-SURGICAL DEFECTS OF THE GASTROINTESTINAL TRACT","3DReG","Inclusion Criteria:\n\n* patients with CGF at any level that can be approached endoscopically and for whom the possibility of conventional conservative treatment is ruled out, or all possible conservative or surgical treatments have already been performed without benefit, or in whom the reiteration of such treatments is contraindicated, because of life-threatening, and\u002For possible complications, and\u002For disabling outcomes.\n\nExclusion Criteria:\n\n* patients who have not given informed consent to the procedure;\n* patients with entero-enteral CGF,\n* patients who have therapeutic options of other type.","100 Years",{"count":120,"type":21},15,[24],"The study is focused on evaluating the safety and efficacy of using vascular stromal tissue, derived from autologous adipose tissue, and subjected to microfragmentation and emulsification (Stromal Vascular Fraction Micro-Emulsion - tSVFem), in the treatment of chronic gastrointestinal fistulae (CGF). Tissue regeneration will be stimulated using 3D bio-printed scaffolds, enriched at implantation with mesenchymal stem cells derived from patients' adipose tissue; injection of tSVFem and scaffold placement will be performed endoscopically. The study proposes to use 3D bioprinting to create customized polymeric bioinks (gels) on supporting scaffolds that can serve as a framework for the growth and development of the patient's cells. This approach aims to promote tissue regeneration and integration, repair extensive CGF and restore the proper microbiota.\n\nA small portion of the patient's tSVFem will be injected in a bioreactor into the scaffolds and used for evaluation of the ability of the scaffolds to support cell proliferation, migration, and differentiation, as well as secretion of cytokines and growth factors and the immunological response. Also, to analyze the effect on cells and microbial species, the intestinal microbiota will be analyzed in a bioreactor under different dynamic conditions on the growth and differentiation of the MSCs contained in tsVFem, on the bio-printed scaffolds and the immunological results.",[27],"2024-09-23",{"date":126,"type":40},"2024-09-25",{"date":128,"type":21},"2024-10-01",{"date":130,"type":21},"2026-09-10",{"name":132,"class":47},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS"]