[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583950":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":39,"centralContacts":43,"locations":51,"responsibleParty":124,"collaborators":127,"id":135,"slug":11,"hasResults":136,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":136,"sex":142,"minAge":143,"maxAge":144,"enrollmentInfo":145,"targetDuration":11,"studyType":148,"phases":149,"briefSummary":151,"conditions":152,"keywords":154,"overallStatus":53,"whyStopped":11,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":168},{"fullName":5,"class":6},"Esbjerg Hospital - University Hospital of Southern Denmark","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Minimally invasive diagnostic algorithm","EXPERIMENTAL",null,[13],"Diagnostic Test: Panenteric capsule endoscopy",{"label":15,"type":16,"description":17,"interventionNames":18},"Traditional work-up","ACTIVE_COMPARATOR","Colonoscopy and either MRI enterography or small bowel capsule endoscopy",[19,20,21],"Diagnostic Test: Ileocolonoscopy","Diagnostic Test: MRI enterography","Diagnostic Test: Small bowel capsule endoscopy",[23,27,31,35],{"type":24,"name":25,"description":25,"armGroupLabels":26,"otherNames":11},"DIAGNOSTIC_TEST","Panenteric capsule endoscopy",[9],{"type":24,"name":28,"description":29,"armGroupLabels":30,"otherNames":11},"Ileocolonoscopy","Endoscopic examination of the colon and terminal ileum after bowel preparation.",[15],{"type":24,"name":32,"description":33,"armGroupLabels":34,"otherNames":11},"MRI enterography","MRI of the small bowel",[15],{"type":24,"name":36,"description":37,"armGroupLabels":38,"otherNames":11},"Small bowel capsule endoscopy","Capsule endoscopy of the small bowel",[15],[40],{"name":41,"affiliation":5,"role":42},"Frederik D Thrane, MD","PRINCIPAL_INVESTIGATOR",[44,48],{"name":41,"role":45,"phone":46,"phoneExt":11,"email":47},"CONTACT","0045 79183140","Frederik.Drejer.Thrane2@rsyd.dk",{"name":49,"role":45,"phone":46,"phoneExt":11,"email":50},"Michael D Jensen, MD, PhD","Michael.Dam.Jensen@rsyd.dk",[52,67,79,94,108],{"facility":5,"status":53,"city":54,"state":11,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"RECRUITING","Esbjerg","6700","Denmark","DK",{"type":59,"coordinates":60},"Point",[61,62],8.45187,55.47028,{"lat":62,"lon":61},[65],{"name":49,"role":45,"phone":66,"phoneExt":11,"email":50},"0045 79183146",{"facility":68,"status":53,"city":69,"state":11,"zip":70,"country":56,"countryCode":57,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Odense University Hospital","Odense C","5000",{"type":59,"coordinates":72},[73,74],10.39538,55.40841,{"lat":74,"lon":73},[77],{"name":41,"role":45,"phone":78,"phoneExt":11,"email":47},"0045 65412755",{"facility":80,"status":81,"city":82,"state":11,"zip":83,"country":56,"countryCode":57,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"Odense University Hospital - Svendborg Hospital","NOT_YET_RECRUITING","Svendborg","5700",{"type":59,"coordinates":85},[86,87],10.60677,55.05982,{"lat":87,"lon":86},[90],{"name":91,"role":45,"phone":92,"phoneExt":11,"email":93},"Claus Aalykke, MD, PhD","0045 63312906","Claus.Aalykke@rsyd.dk",{"facility":95,"status":53,"city":96,"state":11,"zip":97,"country":56,"countryCode":57,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"Lillebaelt Hospital Vejle - University Hospital of Southern Denmark","Vejle","7100",{"type":59,"coordinates":99},[100,101],9.5357,55.70927,{"lat":101,"lon":100},[104],{"name":105,"role":45,"phone":106,"phoneExt":11,"email":107},"Maiken T Jørgensen, MD, PhD","0045 79406345","Maiken.T.Joergensen@rsyd.dk",{"facility":109,"status":81,"city":110,"state":11,"zip":111,"country":112,"countryCode":113,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"Skåne University Hospital","Malmö","205 02","Sweden","SE",{"type":59,"coordinates":115},[116,117],13.00073,55.60587,{"lat":117,"lon":116},[120],{"name":121,"role":45,"phone":122,"phoneExt":11,"email":123},"Gabriele W Johansson, MD, PhD","0046 40338622","Gabriele.WurmJohansson@skane.se",{"type":42,"investigatorFullName":125,"investigatorTitle":126,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Frederik Drejer Thrane","PhD Student",[128,129,131,133],{"name":68,"class":6},{"name":130,"class":6},"Svendborg Hospital",{"name":132,"class":6},"Skane University Hospital",{"name":134,"class":6},"Vejle Hospital","100583950",false,"NCT06882993","Feasibility of a Minimally Invasive Diagnostic Algorithm in Suspected Crohn's Disease","Feasibility of a Minimally Invasive Diagnostic Algorithm in Suspected Crohn's Disease - a Prospective Comparison of Pan-Enteric Capsule Endoscopy Versus Ileocolonoscopy Plus MR Enterography or Small-Bowel Capsule Endoscopy","ANDI-3","Inclusion Criteria:\n\n* Clinical suspicion of CD\\*\n* Age 18-40 years\n* Signed informed consent\n\n  \\*A clinical suspicion of CD is based on the following definition:\n* Diarrhea and\u002For abdominal pain for more than 1 month (or repeated episodes of diarrhea and\u002For abdominal pain) and either\n\n  * fecal calprotectin ≥ 200 mg\u002Fkg or\n  * fecal calprotectin ≥ 50 mg\u002Fkg plus one or more of the following findings:\n* C-reactive protein (CRP) \\> 5 mg\u002FL\n* Thrombocytosis (\\> 400 x 109\u002FL)\n* Anemia (hemoglobin \\\u003C 7.0 mmol\u002FL for women and \\\u003C 8.0 mmol\u002FL for men or a decrease \\> 0.5 mmol\u002FL compared to the usual level)\n* Prolonged fever (\\> 37.5 ◦C for more than 2 weeks)\n* Weight loss (≥ 3 kg or ≥ 5% compared to the normal body weight)\n* Perianal abscess \u002F fistula\n* Family history of inflammatory bowel disease.\n\nExclusion Criteria:\n\n* Previous intestinal resection\n* Positive serologic markers for celiac disease\n* Positive stool polymerase chain reaction for pathogenic bacteria\n* Positive stool polymerase chain reaction for intestinal parasites\n* Suspected or established acute bowel obstruction (ileus)\n* Intake of NSAIDs or acetylsalicylic acid ≤ 4 weeks before inclusion, except low-dose, prophylactic acetylsalicylic acid (≤ 150 mg per day)\n* Intake of opioid or opioid-like medications ≤ 1 week before inclusion\n* Pregnancy or lactation\n* Inability to comply with protocol requirements, e.g. for reasons including alcohol or recreational drug abuse\n* Known gastrointestinal disorder other than functional gastrointestinal disorders\n* Renal failure defined by a plasma-creatinine above the normal reference range","ALL","18 Years","40 Years",{"count":146,"type":147},165,"ESTIMATED","INTERVENTIONAL",[150],"NA","The goal of this clinical trial is to learn whether a camera pill examination of the whole bowel can be used to diagnose Crohn's disease instead of colonoscopy and a small bowel examination (either MRI or camera pill) in patients aged 18-40 years suspected of having Crohn's disease.\n\nThe main question it aims to answer is:\n\nHow many patients examined with a camera pill examination of the whole bowel will have a complete examination of the whole bowel and have a diagnosis made without need for any more examinations?\n\nResearchers will compare with patients examined with colonoscopy and a small bowel examination.\n\nParticipants will:\n\n* Be examined with either a camera pill examination of the whole bowel, or a colonoscopy and a small bowel examination\n* Have their electronic medical records checked to see if a diagnosis has been made\n* Have an interview every three months if diagnosed with an inflammatory bowel disease or after a year if no disease was found",[153],"Crohn's Disease",[155,156,157,158],"capsule endoscopy","panenteric capsule endoscopy","Crohn's disease","inflammatory bowel disease","2025-03-17",{"date":161,"type":162},"2025-03-19","ACTUAL",{"date":164,"type":162},"2025-02-26",{"date":166,"type":147},"2028-08-31",{"name":5,"class":6},5]