[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cryptoglandular-perianal-fistula\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cryptoglandular-perianal-fistula":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,74],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100654929","loose-seton-prior-to-surgery-for-single-tract-cryptoglandular-fistula-vs-no-seton-100654929",false,"NCT07807319","Loose Seton Prior to Surgery for Single-tract Cryptoglandular Fistula vs no Seton","Loose Seton Prior to Surgery for Single-tract Cryptoglandular Fistula vs no Seton: a Multicenter Randomised Study","SETON","Inclusion Criteria:\n\n* Age 18 years or older\n* Single-tract non-purulent mid-high or high cryptoglandular anal fistula\n* Eligible for sphincter-preserving surgical treatment\n* Able to complete Dutch-language questionnaires sent by email\n* Written informed consent provided\n\nExclusion Criteria:\n\n* Anorectal abscess\n* Multiple or complex anorectal fistulas\n* Inflammatory bowel disease or clinical suspicion requiring further investigation\n* History of anorectal malignancy\n* Use of immunosuppressive medication at the time of surgery\n* History of pelvic radiation\n* Pregnancy or lactation",true,"ALL","18 Years",{"count":21,"type":22},277,"ESTIMATED","INTERVENTIONAL",[25],"NA","Cryptoglandular anal fistulas can cause pain, discharge, recurrent infection, and a prolonged treatment course. In current practice, patients with a single-tract mid-high or high cryptoglandular anal fistula often first undergo placement of a loose seton before definitive sphincter-preserving surgery. Although this staged approach is widely used, high-quality evidence showing that preoperative seton placement improves healing or other patient outcomes is limited.\n\nThe SETON trial is a multicenter, randomized, controlled non-inferiority trial that compares two accepted treatment strategies: loose seton placement for approximately 8 weeks followed by definitive sphincter-preserving surgery versus direct sphincter-preserving surgery without prior seton placement. The study aims to determine whether omitting routine seton placement is not inferior in terms of fistula closure 26 weeks after the final surgical intervention.\n\nSecondary outcomes include recurrence, postoperative complications, re-interventions, pain, continence, fistula-related quality of life, generic quality of life, return to work, and healthcare and societal costs. The results of this trial may help determine whether a routinely used treatment step can be safely omitted, potentially reducing treatment burden, shortening the treatment pathway, and lowering costs.",[28],"Cryptoglandular Perianal Fistula","RECRUITING","2026-09-01",{"date":32,"type":33},"2026-09-08","ACTUAL",{"date":35,"type":33},"2026-01-01",{"date":37,"type":22},"2029-01-01",{"name":39,"class":40},"Proctos Kliniek","OTHER",2,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100654004","a-study-comparing-transperineal-ultrasound-magnetic-resonance-imaging-endoscopic-ultrasound-and-examination-under-anesthesia-to-detect-and-classify-perianal-fistulas-in-patients-with-crohns-disease-or-fistulas-of-unknown-cause-100654004","NCT07794410","A Study Comparing Transperineal Ultrasound, Magnetic Resonance Imaging, Endoscopic Ultrasound, and Examination Under Anesthesia to Detect and Classify Perianal Fistulas in Patients With Crohn's Disease or Fistulas of Unknown Cause","A Quadrimodal Comparison of Transperineal Ultrasound and Magnetic Resonance Imaging-based Sonographic Investigation With Integrated Testing Using Endoscopic Ultrasound and Examination Under Anesthesia for the Assessment of Perianal Fistulas in Patients With Crohn's Disease and Fistulas of Cryptogenic Origin (TRANSIT-CD Study)","TRANSIT CD","Inclusion Criteria:\n\n* Adults between 18 and 75 years of age\n* Clinical suspicion or diagnosis of perianal fistula\n* Fistula etiology can be Crohn's disease or cryptogenic\u002Ftubercular (non-Crohn's)\n* Ability to undergo all four imaging procedures (TPUS, MRI, EUS, and EUA) within a 10-day period\n* Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* Known or suspected anorectal malignancy\n* Pregnancy or breastfeeding\n* Contraindications to any of the imaging procedures:\n* MRI (e.g., presence of metal implants or claustrophobia)\n* EUS (e.g., severe anal stenosis or intolerance to procedure)\n* Anesthesia required for EUA (e.g., significant cardiopulmonary disease)\n* Prior surgery or seton placement at the index fistula site\n* Incomplete or failed imaging in any one of the modalities\n* Inability to provide informed consent","75 Years",{"count":52,"type":22},50,[25],"The goal of this study is to learn how well different imaging tests detect and describe perianal fistulas in adults with Crohn's disease or fistulas with no known cause (cryptogenic). Perianal fistulas are painful tunnels that form near the anus and can lead to discharge, swelling, or infection. The main questions this study aims to answer are:\n\nHow accurate is transperineal ultrasound (TPUS) compared to magnetic resonance imaging (MRI) in finding fistulas? How well do these tests identify key features like internal openings and abscesses? Do the test results help doctors make better treatment decisions?\n\nResearchers will compare TPUS and MRI to two other imaging methods:\n\nEndoscopic ultrasound (EUS), which uses a small camera and ultrasound inside the rectum Examination under anesthesia (EUA), in which a surgeon checks the area while the participant is asleep\n\nAll participants will:\n\nBe adults between the ages of 18 and 75 Have a suspected or confirmed perianal fistula Be able to complete all four tests-TPUS, MRI, EUS, and EUA-within 10 days Participants will not receive any experimental treatments. The tests are part of routine care and will be done using advanced equipment by expert doctors. Each test result will be used to compare how accurate and useful the test is in real-life diagnosis and treatment planning.\n\nThis study may help make fistula diagnosis faster, safer, and more affordable-especially in settings where access to MRI or surgery is limited. It may also support the use of TPUS as a first step in evaluating perianal fistulas in people with Crohn's disease.",[56,28],"Crohn Disease (CD)",[58,59,60,61,62,63],"fistula","crohn disease","transperineal ultrasound","magnetic resonance imaging","endoscopic ultrasound","examination under anaesthesia","2026-08-27",{"date":66,"type":33},"2026-08-31",{"date":68,"type":33},"2025-07-25",{"date":70,"type":22},"2027-04-30",{"name":72,"class":40},"Asian Institute of Gastroenterology, India",1,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":23,"phases":83,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":73},"100635780","phase-2-e-cel-uvec-cell-injection-treatment-of-perianal-fistulas-100635780","NCT07557134","E-CEL UVEC Cell Injection Treatment of Perianal Fistulas","A Multi-center, Randomized, No Treatment, Concurrent Controlled Study of E-CEL UVEC CELLS for the Treatment of Perianal Fistula","Inclusion Criteria:\n\n1. Age 18 or older\n2. Willing and able to provide informed consent and medically eligible\n3. Diagnosed with perianal fistula per the following criteria:\n\n   1. Diagnosis documented by physical\u002Fclinical examination and imaging specifically performed to assess the number and course of the perianal fistula tract---i.e., magnetic resonance imaging (MRI) and\u002For ultrasound\n   2. Single tract without residual abscess cavity\n   3. Low transsphincteric and intersphincteric fistulas that cross less than 30% of the external sphincter\n\n   i. Fistula internal opening width ≤ 3 mm. d. Maximum tract length of 10 cm e. Consistent with cryptoglandular origin f. Fistula-related pain of NRS \\\u003C 3 (NRS 0-10) g. Absence of history of Crohn's disease, ulcerative colitis or other inflammatory bowel diseases\n4. For female patients of childbearing potential:\n\n   1. A negative serum or urine pregnancy test at screening is required prior to enrollment\n   2. Patient must be willing to use a highly effective method of contraception from the start of the screening period until at least 3 months after completion of last treatment\n5. For male patients who can father a child and are having intercourse with females of childbearing potential who are not using adequate contraception:\n\n   1. Patient must be willing to use a recommended method of contraception and refrain from sperm donation from the start of screening period until for at least 3 months after completion of the last treatment\n\nExclusion Criteria:\n\n1. Concomitant rectovaginal fistulas\n2. Patients with an active abscess or suspicion of an active, untreated microabscess\n3. Presence of signs and symptoms suggestive or suspicious of an acute active infection or flare-up.\n4. Fistula-related pain measured as NRS ≥ 3 (NRS Scale 0-10) in the last 7 days.\n\n   • If the subject is eligible except for this exclusion criteria of fistula-related pain, then it is recommended that a loose seton be placed to reduce the fistula pain. In this particular situation, once the fistula-related pain is ≤ 2 on NRS (preferably 0 or 1), then the subject may be enrolled and the loose seton removed just prior to the 1st treatment with the investigational product.\n5. Presence of rectal and\u002For anal stenosis\n6. Presence of setons unless removed prior to the treatment\n7. Patients with known bleeding disorders.\n8. Patients with known risk factors for thrombus formation.\n9. Patients with overlying wound and skin infections.\n10. Patients with ongoing systemic steroid treatment or treated with steroids within the last 4 weeks prior to treatment\n11. Renal impairment defined by creatinine clearance below 90 mL\u002Fmin calculated using Cockcroft-Gault formula or by serum creatinine ≥ 1.5 x upper limit of normality (ULN)\n12. Hepatic impairment defined by both of the following laboratory ranges:\n\n    * Total bilirubin ≥ 1.5 x ULN unless benign congenital hyperbilirubinemia.\n    * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≥ 2.5 x ULN\n13. Known history of untreated alcohol or other addictive substance abuse in the 6 months prior to enrollment\n14. Active malignant tumor (tumors must be in complete remission for ≥ 6 months with completion of maintenance chemotherapy and\u002For radiation cycles), at least 6 months prior to first treatment\n15. Current recent history of abnormal, severe, progressive, uncontrolled hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, psychiatric, or cerebral diseases\n16. Congenital immunodeficiencies\n17. Major surgery or severe trauma within the previous 3 months\n18. Patients who are candidates for solid organ transplantation or who may have a high likelihood of needing a solid organ transplant (e.g., progressive heart failure)\n19. Female patients who are pregnant or breastfeeding or planning to become pregnant or breastfeed during the treatment regimen with investigational product (Arm A: 0-12 weeks; Arm B (with crossover): 0-24 weeks).\n20. Patients who have known hypersensitivity or documented allergy to dimethyl sulfoxide (DMSO)\n21. Patients who do not wish to or cannot comply with study procedures, including completion of all scheduled study visits and treatments\n22. Patients currently receiving, or having received any investigational drug within 6 months prior to E-CEL UVEC cell therapy",{"count":82,"type":22},78,[84],"PHASE2","The purpose of this study is to determine if experimental therapy (E-CEL UVEC Cells), a very minimally invasive procedure, can treat patients with perianal fistulas.",[28],"NOT_YET_RECRUITING","2026-04-23",{"date":90,"type":33},"2026-04-29",{"date":92,"type":22},"2027-05",{"date":94,"type":22},"2029-12",{"name":96,"class":97},"Angiocrine Bioscience","INDUSTRY"]