Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2025-12-29 @ 10:31 PM
Study NCT ID:
NCT05949268
Status:
RECRUITING
Last Update Posted:
2024-12-09
First Post:
2023-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Video Capsule Endoscopy for Detection of Gastrointestinal Bleeding in the Small Bowel
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006471', 'term': 'Gastrointestinal Hemorrhage'}], 'ancestors': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2028-07-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-04', 'studyFirstSubmitDate': '2023-06-29', 'studyFirstSubmitQcDate': '2023-07-07', 'lastUpdatePostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of small bowel bleeding detected during small bowel capsule endoscopy', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Detection of bleeding during small bowel capsule endoscopy'}], 'secondaryOutcomes': [{'measure': 'Prevalence of vascular lesions as source of bleeding', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Detection of vascular lesions angiodysplasia) as source of bleeding'}, {'measure': 'Prevalence of inflammatory lesions as source of bleeding', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Detection of inflammatory lesions as source of bleeding'}, {'measure': 'Prevalence of tumor lesions as source of bleeding', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Detection of tumor lesions as source of bleeding'}, {'measure': 'Complications of small bowel capsule endoscopy', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Complications of small bowel capsule endoscopy'}, {'measure': 'Technical success of small bowel capsule endoscopy', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Technical success is defined as arrival of the capsule in the cecum'}, {'measure': 'Time between diagnostic small bowel capsule endoscopy and small bowel enteroscopy for treatment of bleeding', 'timeFrame': 'From time to the end of capsule endoscopy until beginning of small bowel enteroscopy', 'description': 'Time between diagnostic mall bowel capsule endoscopy and small bowel enteroscopy for treatment of bleeding'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Small bowel capsule endoscopy', 'gastrointestinal bleeding', 'anticaogulation'], 'conditions': ['GastroIntestinal Bleeding']}, 'referencesModule': {'references': [{'pmid': '29539652', 'type': 'BACKGROUND', 'citation': 'Rondonotti E, Spada C, Adler S, May A, Despott EJ, Koulaouzidis A, Panter S, Domagk D, Fernandez-Urien I, Rahmi G, Riccioni ME, van Hooft JE, Hassan C, Pennazio M. Small-bowel capsule endoscopy and device-assisted enteroscopy for diagnosis and treatment of small-bowel disorders: European Society of Gastrointestinal Endoscopy (ESGE) Technical Review. Endoscopy. 2018 Apr;50(4):423-446. doi: 10.1055/a-0576-0566. Epub 2018 Mar 14.'}]}, 'descriptionModule': {'briefSummary': 'Small bowel capsule endoscopy is the main diagnostic standard for small bowel bleeding. This study investigates the detection rate of small bowel bleeding in capsule endoscopy and further endoscopic treatment in a prospective and retrospective cohort.', 'detailedDescription': 'Small bowel capsule endoscopy is considered the diagnostic gold standard in the diagnosis of diseases of the small bowel. Most indications for capsule endoscopy are overt small bowel bleedings - defined as gastrointestinal bleeding after negative gastroscopy and colonoscopy - or occult iron deficiency anemia. Timing of small bowel capsule endoscopy seems to be decisive for the diagnosis of small bowel bleeding: corresponding to the actual guidelines the detection of small bowel bleeding can be up to \\> 70% if the intervention is performed within 2 days. Treatment of small bowel bleedings can be performed with small bowel enteroscopy such as balloon or motorized spiral enteroscopy. Against this background this study investigates the rate of small bowel bleeding diagnosed in capsule endoscopy. The aim of the study is to report tumorous, vascular and inflammatory findings as well as complications and cecal accessibility. One focus of the study is the time between small bowel bleeding and small bowel capsule endoscopy and small bowel enteroscopy, respectively. Endoscopic therapies and further bleeding episodes are recorded. In order to determine the improved clinical outcome after the introduction of the shortened timing for recommendation published in 2022, a retrospective cohort should be included in addition to a prospective cohort.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who present with gastrointestinal bleeding undetected in gastroscopy or colonoscopy will be included in this cohort study. In these patients bleeding in the small bowel is suspected and they are allocated to a diagnostic assessment with small bowel capsule endoscopy.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* suspicion of gastrointestinal bleeding in the small bowel undetected by gastroscopy and colonoscopy\n* informed consent\n\nExclusion Criteria:\n\n* contraindications for small bowel capsule endoscopy (e.g. stenosis)'}, 'identificationModule': {'nctId': 'NCT05949268', 'briefTitle': 'Video Capsule Endoscopy for Detection of Gastrointestinal Bleeding in the Small Bowel', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Freiburg'}, 'officialTitle': 'Video Capsule Endoscopy for Detection of Gastrointestinal Bleeding in the Jejunum', 'orgStudyIdInfo': {'id': 'Capsule endoscopy_FR'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with gastrointestinal bleeding undetected in gastroscopy and colonoscopy', 'description': 'Gastrointestinal bleeding in the small bowel.', 'interventionNames': ['Device: Small bowel capsule endoscopy']}], 'interventions': [{'name': 'Small bowel capsule endoscopy', 'type': 'DEVICE', 'description': 'Patients with gastrointestinal bleeding receive small bowel capsule endoscopy after bleeding could not be located in gastroscopy or colonoscopy.', 'armGroupLabels': ['Patients with gastrointestinal bleeding undetected in gastroscopy and colonoscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '79106', 'city': 'Freiburg im Breisgau', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Michael Schultheiss, MD', 'role': 'CONTACT', 'email': 'michael.schultheiss@uniklinik-freiburg.de', 'phone': '49761270-34010'}, {'name': 'Dominik Bettinger, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Paul-Christoph Zeisler, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Medical Center Freiburg, Department of Medicine II', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}], 'centralContacts': [{'name': 'Michael Schultheiss, MD', 'role': 'CONTACT', 'email': 'michael.schultheiss@uniklinik-freiburg.de', 'phone': '+49761/270-34010'}, {'name': 'Dominik Bettinger, MD', 'role': 'CONTACT', 'email': 'dominik.bettinger@uniklinik-freiburg.de', 'phone': '+49761/270-36870'}], 'overallOfficials': [{'name': 'Michael Schultheiss, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center Freiburg, Department of Medicine II, Freiburg, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD are shared on reasonable request to the Principal Investigator.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Freiburg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Prof. Dr. Dominik Bettinger', 'investigatorAffiliation': 'University Hospital Freiburg'}}}}