Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2026-01-09 @ 12:38 PM
Study NCT ID:
NCT06219395
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-23
First Post:
2024-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Capsule Endoscopy in Iron Deficiency Anaemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018798', 'term': 'Anemia, Iron-Deficiency'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}], 'ancestors': [{'id': 'D000747', 'term': 'Anemia, Hypochromic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000090463', 'term': 'Iron Deficiencies'}, {'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-12', 'studyFirstSubmitDate': '2024-01-12', 'studyFirstSubmitQcDate': '2024-01-12', 'lastUpdatePostDateStruct': {'date': '2024-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic yield', 'timeFrame': '90 minutes', 'description': 'Mucosal lesions detected'}], 'secondaryOutcomes': [{'measure': 'Small bowel lesions', 'timeFrame': '90 minutes', 'description': 'Number of lesions detected in the small bowel'}, {'measure': 'Complete examination', 'timeFrame': '90 minutes', 'description': 'Proportion of complete examinations'}, {'measure': 'Bowel preparation', 'timeFrame': '90 minute', 'description': 'Proportion of satisfactory bowel preparation'}, {'measure': 'Adequate examinations', 'timeFrame': '90 minutes', 'description': 'Proportion of adequate examinations defined as both satisfactory bowel preparation and complete examination'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Iron Deficiency Anemia', 'Bowel Cancer']}, 'descriptionModule': {'briefSummary': 'This project aim to investigate whether wireless capsule endoscopy(WCE) has a similar diagnostic yield as conventional endoscopy in detecting the cause of iron deficiency anemia (IDA)', 'detailedDescription': 'IDA is common and 90-95% of cases are caused by bleeding from ulcers, tumours or vascular malformations in the oesophagus, stomach, duodenum, small intestine or the large bowel.Bleeding from more than one localisation is common.\n\nInternational guidelines recommend bidirectional endoscopy(gastro- and colonoscopy) to detect and treat the source of bleeding.\n\nOur hypothesis is that WCE is non-inferior to the combination of gastroscopy and colonoscopy in locating GI-bleeding and that complete examinations will be achieved in ≥90% of the examinations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Persons with Iron Deficiency Anaemia referred for endoscopic diagnostic work-up', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Referred to flexible endoscopy for a verified Iron Deficiency Anaemia\n\nExclusion Criteria:\n\n* Unwillingness to participate\n* Not able to provide informed consent\n* Not understanding the instructions\n* Severe cardio-vascular disease New York Heart Association III-IV\n* Symptoms of bowel obstruction/previous bowel obstruction\n* Bowel surgery except for end to end anastomosis in the colon\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT06219395', 'acronym': 'WCE-IDA', 'briefTitle': 'Capsule Endoscopy in Iron Deficiency Anaemia', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Vastra Gotaland Region'}, 'officialTitle': 'Diagnostic Yield of Video Capsule Endoscopy for Iron Deficiency Anaemia', 'orgStudyIdInfo': {'id': '281233'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Iron deficiency anaemia', 'description': 'Persons 18-85 years with Iron deficiency anaemia referred for gastroscopy and colonoscopy', 'interventionNames': ['Procedure: Endoscopy']}], 'interventions': [{'name': 'Endoscopy', 'type': 'PROCEDURE', 'description': 'Patients will be examined with gastroscopy, colonoscopy and WCE and the diagnostic yield of combined gastroscopy/colonoscopy will be compared to WCE', 'armGroupLabels': ['Iron deficiency anaemia']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gothenburg', 'country': 'Sweden', 'contacts': [{'name': 'Thomas de Lange, PhD', 'role': 'CONTACT'}], 'facility': 'Sahlgrenska University Hospital', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}], 'centralContacts': [{'name': 'Thomas de Lange, PhD', 'role': 'CONTACT', 'email': 'thomas.de.lange@vgregion.se', 'phone': '+46702794054'}, {'name': 'Nikolaos Papachrysos, PhD', 'role': 'CONTACT', 'email': 'nikolaos.papachrysos@vgregion.se'}], 'overallOfficials': [{'name': 'Thomas de Lange, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sahlgrenska University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vastra Gotaland Region', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}