[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583950":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":39,"studyPopulation":39,"armGroups":46,"interventions":60,"overallOfficials":77,"centralContacts":81,"locations":89,"responsibleParty":161,"collaborators":164,"id":172,"slug":173,"hasResults":174,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":178,"eligibilityCriteria":179,"healthyVolunteers":174,"sex":180,"minAge":181,"maxAge":182,"enrollmentInfo":183,"targetDuration":39,"studyType":186,"phases":187,"briefSummary":189,"conditions":190,"keywords":192,"overallStatus":91,"whyStopped":39,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":206},{"fullName":5,"class":6},"Esbjerg Hospital - University Hospital of Southern Denmark","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":39},[9],{"measure":10,"description":11,"timeFrame":12},"Diagnostic completeness","Proportion of patients in each arm achieving a complete gastrointestinal assessment and an unambiguous diagnosis after completion of the initial diagnostic procedure(s) without need for supplementary examinations","Immediately after initial diagnostic procedure",[14,18,21,24,27,30,33,36],{"measure":15,"description":16,"timeFrame":17},"Feasibility of pan-enteric CE","Number of patients with suspected CD examined with pan-enteric CE and the number of ICs avoided","After completion of follow-up (12 months)",{"measure":19,"description":20,"timeFrame":17},"Additional examinations","Need for additional examinations in the two randomization arms",{"measure":22,"description":23,"timeFrame":17},"Safety","Number of severe adverse events",{"measure":25,"description":26,"timeFrame":17},"Time to diagnosis","Time from referral or first diagnostic procedure to final diagnosis and treatment",{"measure":28,"description":29,"timeFrame":17},"Disease classification and medical treatments","Disease classification and medical treatments in the two randomization arms",{"measure":31,"description":32,"timeFrame":12},"Patient satisfaction","Difference in Gastrointestinal Endoscopy Satisfaction Questionnaire (GESQ) score",{"measure":34,"description":35,"timeFrame":17},"Costs","Expenditure on diagnostic procedures, treatment and loss of productivity",{"measure":37,"description":38,"timeFrame":12},"Artificial intelligence","Diagnostic utility of AI algorithms in detection of gastrointestinal pathology using pan-enteric CE - sensitivity, specificity, severity, prediction and impact on clinical decision making",null,{"allocation":41,"interventionModel":42,"interventionModelDescription":39,"primaryPurpose":43,"observationalModel":39,"timePerspective":39,"maskingInfo":44},"RANDOMIZED","PARALLEL","DIAGNOSTIC",{"masking":45,"maskingDescription":39,"whoMasked":39},"NONE",[47,52],{"label":48,"type":49,"description":39,"interventionNames":50},"Minimally invasive diagnostic algorithm","EXPERIMENTAL",[51],"Diagnostic Test: Panenteric capsule endoscopy",{"label":53,"type":54,"description":55,"interventionNames":56},"Traditional work-up","ACTIVE_COMPARATOR","Colonoscopy and either MRI enterography or small bowel capsule endoscopy",[57,58,59],"Diagnostic Test: Ileocolonoscopy","Diagnostic Test: MRI enterography","Diagnostic Test: Small bowel capsule endoscopy",[61,65,69,73],{"type":62,"name":63,"description":63,"armGroupLabels":64,"otherNames":39},"DIAGNOSTIC_TEST","Panenteric capsule endoscopy",[48],{"type":62,"name":66,"description":67,"armGroupLabels":68,"otherNames":39},"Ileocolonoscopy","Endoscopic examination of the colon and terminal ileum after bowel preparation.",[53],{"type":62,"name":70,"description":71,"armGroupLabels":72,"otherNames":39},"MRI enterography","MRI of the small bowel",[53],{"type":62,"name":74,"description":75,"armGroupLabels":76,"otherNames":39},"Small bowel capsule endoscopy","Capsule endoscopy of the small bowel",[53],[78],{"name":79,"affiliation":5,"role":80},"Frederik D Thrane, MD","PRINCIPAL_INVESTIGATOR",[82,86],{"name":79,"role":83,"phone":84,"phoneExt":39,"email":85},"CONTACT","0045 79183140","Frederik.Drejer.Thrane2@rsyd.dk",{"name":87,"role":83,"phone":84,"phoneExt":39,"email":88},"Michael D Jensen, MD, PhD","Michael.Dam.Jensen@rsyd.dk",[90,105,117,131,145],{"facility":5,"status":91,"city":92,"state":39,"zip":93,"country":94,"countryCode":95,"cosmosGeoPoint":96,"geoPoint":101,"contacts":102},"RECRUITING","Esbjerg","6700","Denmark","DK",{"type":97,"coordinates":98},"Point",[99,100],8.45187,55.47028,{"lat":100,"lon":99},[103],{"name":87,"role":83,"phone":104,"phoneExt":39,"email":88},"0045 79183146",{"facility":106,"status":91,"city":107,"state":39,"zip":108,"country":94,"countryCode":95,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"Odense University Hospital","Odense C","5000",{"type":97,"coordinates":110},[111,112],10.39538,55.40841,{"lat":112,"lon":111},[115],{"name":79,"role":83,"phone":116,"phoneExt":39,"email":85},"0045 65412755",{"facility":118,"status":91,"city":119,"state":39,"zip":120,"country":94,"countryCode":95,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"Odense University Hospital - Svendborg Hospital","Svendborg","5700",{"type":97,"coordinates":122},[123,124],10.60677,55.05982,{"lat":124,"lon":123},[127],{"name":128,"role":83,"phone":129,"phoneExt":39,"email":130},"Jakob Dahlrot, MD, PhD","0045 63202000","Jakob.Dahlrot@rsyd.dk",{"facility":132,"status":91,"city":133,"state":39,"zip":134,"country":94,"countryCode":95,"cosmosGeoPoint":135,"geoPoint":139,"contacts":140},"Lillebaelt Hospital Vejle - University Hospital of Southern Denmark","Vejle","7100",{"type":97,"coordinates":136},[137,138],9.5357,55.70927,{"lat":138,"lon":137},[141],{"name":142,"role":83,"phone":143,"phoneExt":39,"email":144},"Maiken T Jørgensen, MD, PhD","0045 79406345","Maiken.T.Joergensen@rsyd.dk",{"facility":146,"status":91,"city":147,"state":39,"zip":148,"country":149,"countryCode":150,"cosmosGeoPoint":151,"geoPoint":155,"contacts":156},"Skåne University Hospital","Malmö","205 02","Sweden","SE",{"type":97,"coordinates":152},[153,154],13.00073,55.60587,{"lat":154,"lon":153},[157],{"name":158,"role":83,"phone":159,"phoneExt":39,"email":160},"Gabriele W Johansson, MD, PhD","0046 40338622","Gabriele.WurmJohansson@skane.se",{"type":80,"investigatorFullName":162,"investigatorTitle":163,"investigatorAffiliation":5,"oldNameTitle":39,"oldOrganization":39},"Frederik Drejer Thrane","PhD Student",[165,166,168,170],{"name":106,"class":6},{"name":167,"class":6},"Svendborg Hospital",{"name":169,"class":6},"Skane University Hospital",{"name":171,"class":6},"Vejle Hospital","100583950","feasibility-of-a-minimally-invasive-diagnostic-algorithm-in-suspected-crohns-disease-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":184,"type":185},165,"ESTIMATED","INTERVENTIONAL",[188],"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",[191],"Crohn's Disease",[193,194,195,196],"capsule endoscopy","panenteric capsule endoscopy","Crohn's disease","inflammatory bowel disease","2026-09-08",{"date":199,"type":200},"2026-09-09","ACTUAL",{"date":202,"type":200},"2025-02-26",{"date":204,"type":185},"2028-08-31",{"name":5,"class":6},5]