[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"perianal-crohns-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:perianal-crohns-disease":73},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":5},"100641957","regenerative-endoscopy-in-refractory-perianal-crohns-disease-100641957",false,"NCT07652632","Regenerative Endoscopy in Refractory Perianal Crohn's Disease","Autologous Mechanical tSVF Injection in Refractory Perianal Fistulizing Crohn's Disease: A Single Arm Pilot Feasibility Study","REPAIR-pCD","Inclusion Criteria:\n\n* Age 18-65 years\n* Crohn's disease with complex perianal fistula (≥1 secondary tract or internal opening involvement)\n* Refractory to ≥1 biologic and\u002For ≥1 prior sphincter sparing procedure\n* No abscess on screening MRI\n* Mild or no proctitis on endoscopic assessment\n* CDAI \\\u003C220\n* Stable IBD therapy ≥8 weeks\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Rectovaginal fistula\n* Severe active proctitis requiring urgent escalation\n* Malignancy in tract or pelvic region\n* Pregnancy or lactation\n* ASA IV status or bleeding disorder\n* MRI contraindications","ALL","18 Years","65 Years",{"count":21,"type":22},50,"ESTIMATED","INTERVENTIONAL",[25],"NA","Perianal fistulizing Crohn's disease (pCD) represents a severe phenotype of Crohn's disease, affecting approximately 20-30% of patients and resulting in chronic drainage, recurrent sepsis, impaired continence, and reduced quality of life. Despite optimization of biologics, antibiotics, and surgical drainage, durable healing remains difficult to achieve. Conventional surgical approaches such as curettage or seton management alone yield modest remission rates, and repeated procedures may compromise sphincter integrity.\n\nAutologous mechanically processed tissue stromal vascular fraction (tSVF) is derived from adipose tissue using non enzymatic methods and can be prepared and reinjected during the same operative session. Unlike culture-expanded or enzymatically isolated cell products, mechanical tSVF retains a native adipose micro architecture containing stromal cells, perivascular elements, endothelial progenitors, extracellular matrix components, and bioactive cytokines. This heterogeneous microenvironment is hypothesized to exert immunomodulatory, pro angiogenic, and regenerative effects that may enhance tract healing while preserving sphincter function.\n\nMechanical processing avoids enzymatic digestion, cell expansion, and complex laboratory infrastructure, making it potentially more feasible and cost effective in real world settings. However, high quality prospective data evaluating mechanically processed autologous tSVF specifically in refractory complex pCD remain limited, and feasibility data are required before undertaking a large randomized trial.\n\nThis single arm pilot feasibility study is therefore designed to evaluate procedural feasibility, safety, and preliminary signals of clinical and radiological healing following mechanical tSVF injection in refractory complex perianal Crohn's disease. The results will inform design parameters, outcome variability, and sample size estimation for a future definitive multicenter trial.",[28,29],"Crohn Disease (CD)","Perianal Crohns Disease",[31,32],"tSVF","REPAIR-CD","RECRUITING","2026-06-11",{"date":36,"type":37},"2026-06-17","ACTUAL",{"date":39,"type":37},"2026-04-20",{"date":41,"type":22},"2028-03",{"name":43,"class":44},"Asian Institute of Gastroenterology, India","OTHER",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100561244","virtual-technology-to-improve-the-management-of-perianal-crohn39s-vamp---prospective-100561244","NCT06587646","VirtuAl Technology to Improve the Management of Perianal Crohn's (VAMP) - PROSPECTIVE","A Feasibility Study to Assess a "Virtual" (vEUA) Technology to Improve the Management of Perianal Crohn's Disease","VAMP-PROSPECT","Inclusion Criteria:\n\n* Ability to give informed consent\n* Active perianal Crohn's disease as defined by clinical assessment with fistula or abscess formation\n* A clinical decision has been taken that surgery is required for perianal disease\n* Ages of 18-75\n\nExclusion Criteria:\n\n* Inability to consent\n* history of Proctectomy,\n* absence of a diagnosis of Crohn's disease,\n* perianal fistulising disease not secondary to Crohn's disease,\n* Rectovaginal fistulas\n* Malignant disease\n* Significant cardiovascular or respiratory disease\n* Neurological or cognitive impairment\n* Significant physical disability\n* Significant hepatic disease or renal failure\n* Subjects currently (or in the last three months) participating in another research project\n* Pregnancy or breastfeeding\n* If MRI is contraindicated (e.g. pacemaker).\n* under 18 years old or over 75 years old","75 Years",{"count":55,"type":22},30,[25],"Crohn's is an inflammatory condition that can affect any part of the gut. Over half a million people in the UK live with Crohn's disease and about a quarter will develop a fistula near their back passage. A fistula is an abnormal connection between two surfaces of the body. These can be hard to treat causing pain and infection. Surgery is required to control infection and in extreme cases this can lead to incontinence or even formation of a stoma, when the bowel is brought to the skin and waste goes into a bag on the tummy wall.\n\nPatients with perianal Crohn's are usually referred to a surgeon by their medical team and subsequently undergo a MRI scan and an examination under anaesthesia (EUA) where abscesses (regions of fluid build-up) will be drained and a seton (plastic sling or suture) inserted through the fistula, or the fistula opened to the skin if this will not affect continence. They are then started on specialist medication by the gastroenterologists (gut doctors).\n\nAbscesses or fistulas can be difficult to identify during EUA, leading to ongoing infection and repeat procedures. This causes additional scarring and delays the medical treatment that can allow fistulas to heal. Multiple or incorrectly performed operations can also damage the muscles that help hold stool in the back passage, leading to incontinence.\n\nWe believe that improving how information is communicated between radiology (who report scans) and surgeons will improve their ability to identify and manage all fistulas and collections at operation. Here is a typical MRI report given to the surgeon by the radiologist:\n\n\\'There is a low intersphincteric fistula with predicted internal opening in the lower half of the anal canal at dentate line level between 5-6 o'clock that passes in the intersphincteric plane to the anal verge between 5-6 o\\'clock.\\'\n\nThis protocol was developed in an era when written communication was really the only way to convey information between specialists. Jargon aside, surgeons face significant difficulty interpreting such written descriptions of a complex 3D structure and using it as a surgical guide. Indeed, a major complaint from surgeons is how difficult it is to get real value from these preoperative MRIs, which cost time and money.\n\nWith advances in digital technology, we believe this system can be vastly improved.\n\nMotilent (a UK SME specialising in technology to improve the management of Crohn\\'s Disease) has developed a sophisticated visualisation tool to provide a 3D model of the fistula and surrounding structures, we call this tool Virtual EUA (vEUA), allowing the surgeon to better understand the anatomy of the problem in conjunction with radiology.\n\nWe are aiming to establish whether vEUA changes the behaviour of colorectal surgeons, increasing confidence in identifying and dealing with fistulas, which will reduce the number of surgical procedures required and improve the quality of care, resulting in a cost saving for the hospital and a much-needed step towards more effective management of perianal Crohn\\'s.\n\nAny patient taking part in the trial will be randomly allocated to have the 3D model utilised in their care or standard care. We will use pre- and post-surgical patient questionnaires, surgical questionnaires and MRI imaging to establish if vEUA is safe and effective in improving the care of patients with perianal Crohn\\'s.",[29],[60,61,62],"Perianal Crohn's Disease","3D imaging","MRI","2026-01-20",{"date":65,"type":37},"2026-01-21",{"date":67,"type":37},"2024-07-23",{"date":69,"type":22},"2026-09-07",{"name":71,"class":44},"Nottingham University Hospitals NHS Trust",1,"Perianal Crohn's Disease"]