Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2026-01-01 @ 3:39 AM
Study NCT ID:
NCT06882993
Status:
RECRUITING
Last Update Posted:
2025-03-19
First Post:
2025-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of a Minimally Invasive Diagnostic Algorithm in Suspected Crohn's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004724', 'term': 'Endoscopy'}], 'ancestors': [{'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-11-08', 'size': 1117376, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-11-13T09:14', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 165}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2028-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-17', 'studyFirstSubmitDate': '2025-02-26', 'studyFirstSubmitQcDate': '2025-03-17', 'lastUpdatePostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic completeness', 'timeFrame': 'Immediately after initial diagnostic procedure', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Feasibility of pan-enteric CE', 'timeFrame': 'After completion of follow-up (12 months)', 'description': 'Number of patients with suspected CD examined with pan-enteric CE and the number of ICs avoided'}, {'measure': 'Additional examinations', 'timeFrame': 'After completion of follow-up (12 months)', 'description': 'Need for additional examinations in the two randomization arms'}, {'measure': 'Safety', 'timeFrame': 'After completion of follow-up (12 months)', 'description': 'Number of severe adverse events'}, {'measure': 'Time to diagnosis', 'timeFrame': 'After completion of follow-up (12 months)', 'description': 'Time from referral or first diagnostic procedure to final diagnosis and treatment'}, {'measure': 'Disease classification and medical treatments', 'timeFrame': 'After completion of follow-up (12 months)', 'description': 'Disease classification and medical treatments in the two randomization arms'}, {'measure': 'Patient satisfaction', 'timeFrame': 'Immediately after initial diagnostic procedure', 'description': 'Difference in Gastrointestinal Endoscopy Satisfaction Questionnaire (GESQ) score'}, {'measure': 'Costs', 'timeFrame': 'After completion of follow-up (12 months)', 'description': 'Expenditure on diagnostic procedures, treatment and loss of productivity'}, {'measure': 'Artificial intelligence', 'timeFrame': 'Immediately after initial diagnostic procedure', 'description': 'Diagnostic utility of AI algorithms in detection of gastrointestinal pathology using pan-enteric CE - sensitivity, specificity, severity, prediction and impact on clinical decision making'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['capsule endoscopy', 'panenteric capsule endoscopy', 'Crohn&#39;s disease', 'inflammatory bowel disease'], 'conditions': ["Crohn's Disease"]}, 'descriptionModule': {'briefSummary': "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"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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/or abdominal pain for more than 1 month (or repeated episodes of diarrhea and/or abdominal pain) and either\n\n * fecal calprotectin ≥ 200 mg/kg or\n * fecal calprotectin ≥ 50 mg/kg plus one or more of the following findings:\n* C-reactive protein (CRP) \\> 5 mg/L\n* Thrombocytosis (\\> 400 x 109/L)\n* Anemia (hemoglobin \\< 7.0 mmol/L for women and \\< 8.0 mmol/L for men or a decrease \\> 0.5 mmol/L 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 / 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'}, 'identificationModule': {'nctId': 'NCT06882993', 'acronym': 'ANDI-3', 'briefTitle': "Feasibility of a Minimally Invasive Diagnostic Algorithm in Suspected Crohn's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Esbjerg Hospital - University Hospital of Southern Denmark'}, 'officialTitle': "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", 'orgStudyIdInfo': {'id': '24/50881'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Minimally invasive diagnostic algorithm', 'interventionNames': ['Diagnostic Test: Panenteric capsule endoscopy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional work-up', 'description': 'Colonoscopy and either MRI enterography or small bowel capsule endoscopy', 'interventionNames': ['Diagnostic Test: Ileocolonoscopy', 'Diagnostic Test: MRI enterography', 'Diagnostic Test: Small bowel capsule endoscopy']}], 'interventions': [{'name': 'Panenteric capsule endoscopy', 'type': 'DIAGNOSTIC_TEST', 'description': 'Panenteric capsule endoscopy', 'armGroupLabels': ['Minimally invasive diagnostic algorithm']}, {'name': 'Ileocolonoscopy', 'type': 'DIAGNOSTIC_TEST', 'description': 'Endoscopic examination of the colon and terminal ileum after bowel preparation.', 'armGroupLabels': ['Traditional work-up']}, {'name': 'MRI enterography', 'type': 'DIAGNOSTIC_TEST', 'description': 'MRI of the small bowel', 'armGroupLabels': ['Traditional work-up']}, {'name': 'Small bowel capsule endoscopy', 'type': 'DIAGNOSTIC_TEST', 'description': 'Capsule endoscopy of the small bowel', 'armGroupLabels': ['Traditional work-up']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6700', 'city': 'Esbjerg', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Michael D Jensen, MD, PhD', 'role': 'CONTACT', 'email': 'Michael.Dam.Jensen@rsyd.dk', 'phone': '0045 79183146'}], 'facility': 'Esbjerg Hospital - University Hospital of Southern Denmark', 'geoPoint': {'lat': 55.47028, 'lon': 8.45187}}, {'zip': '5000', 'city': 'Odense C', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Frederik D Thrane, MD', 'role': 'CONTACT', 'email': 'Frederik.Drejer.Thrane2@rsyd.dk', 'phone': '0045 65412755'}], 'facility': 'Odense University Hospital', 'geoPoint': {'lat': 55.40841, 'lon': 10.39538}}, {'zip': '5700', 'city': 'Svendborg', 'status': 'NOT_YET_RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Claus Aalykke, MD, PhD', 'role': 'CONTACT', 'email': 'Claus.Aalykke@rsyd.dk', 'phone': '0045 63312906'}], 'facility': 'Odense University Hospital - Svendborg Hospital', 'geoPoint': {'lat': 55.05982, 'lon': 10.60677}}, {'zip': '7100', 'city': 'Vejle', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Maiken T Jørgensen, MD, PhD', 'role': 'CONTACT', 'email': 'Maiken.T.Joergensen@rsyd.dk', 'phone': '0045 79406345'}], 'facility': 'Lillebaelt Hospital Vejle - University Hospital of Southern Denmark', 'geoPoint': {'lat': 55.70927, 'lon': 9.5357}}, {'zip': '205 02', 'city': 'Malmo', 'status': 'NOT_YET_RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Gabriele W Johansson, MD, PhD', 'role': 'CONTACT', 'email': 'Gabriele.WurmJohansson@skane.se', 'phone': '0046 40338622'}], 'facility': 'Skåne University Hospital', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}], 'centralContacts': [{'name': 'Frederik D Thrane, MD', 'role': 'CONTACT', 'email': 'Frederik.Drejer.Thrane2@rsyd.dk', 'phone': '0045 79183140'}, {'name': 'Michael D Jensen, MD, PhD', 'role': 'CONTACT', 'email': 'Michael.Dam.Jensen@rsyd.dk', 'phone': '0045 79183140'}], 'overallOfficials': [{'name': 'Frederik D Thrane, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Esbjerg Hospital - University Hospital of Southern Denmark'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Esbjerg Hospital - University Hospital of Southern Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Odense University Hospital', 'class': 'OTHER'}, {'name': 'Svendborg Hospital', 'class': 'OTHER'}, {'name': 'Skane University Hospital', 'class': 'OTHER'}, {'name': 'Vejle Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD Student', 'investigatorFullName': 'Frederik Drejer Thrane', 'investigatorAffiliation': 'Esbjerg Hospital - University Hospital of Southern Denmark'}}}}