Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2025-12-25 @ 7:08 PM
Study NCT ID:
NCT03436004
Status:
COMPLETED
Last Update Posted:
2019-08-22
First Post:
2018-01-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Colonoscopy With a Specific Device for the Detection of Adenomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D000236', 'term': 'Adenoma'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'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': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003113', 'term': 'Colonoscopy'}], 'ancestors': [{'id': 'D016099', 'term': 'Endoscopy, Gastrointestinal'}, {'id': 'D016145', 'term': 'Endoscopy, Digestive System'}, {'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Concealed assignation'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Multicenter prospective trial with medical device'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1453}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-06-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-20', 'studyFirstSubmitDate': '2018-01-26', 'studyFirstSubmitQcDate': '2018-02-15', 'lastUpdatePostDateStruct': {'date': '2019-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adenoma detection rate (ADR)', 'timeFrame': '1 day', 'description': 'Number of adenoma detected by colonoscopy'}, {'measure': 'Mean adenoma per procedure (MAP)', 'timeFrame': '1 day', 'description': 'Mean of adenoma detected by patient'}], 'secondaryOutcomes': [{'measure': 'Total number of adenomas detected by colonoscopy', 'timeFrame': '1 day'}, {'measure': 'Total number of advanced adenomas detected by colonoscopy', 'timeFrame': '1 day'}, {'measure': 'Total number of serrated lesions with or without detected dysplasia by colonoscopy', 'timeFrame': '1 day'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Colonoscopy', 'Adenoma', 'Adenoma detection rate'], 'conditions': ['Colorectal Cancer', 'Adenoma Colon']}, 'descriptionModule': {'briefSummary': 'Evaluation of colonoscopy with a specific device for the detection of adenomas: Multicenter, prospective and randomized study', 'detailedDescription': 'Given the discrepancy in the results of the published studies, the main objective of the present study would be to evaluate, through a multicentric design and with a sufficiently large sample of patients, if there are relevant differences in the ADR and in the MAP between the colonoscopy performed with a device specific (Endocuff visionTM) versus standard colonoscopy.\n\nSecondarily, the number of adenomas, the number of advanced adenomas and the number of serrated lesions in both groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll patients must be adults (≥18 years), give their consent for endoscopic exploration, for the study and meet following inclusion criteria:\n\n1. Patients with positive immunologic fecal occult blood test (IFOBT) for population screening.\n2. Patients invited to an opportunistic screening colonoscopy or included regional population screening program.\n3. Patients with a family history of CRC and indication of screening colonoscopy.\n4. Patients with follow-up colonoscopy indication by personal history of adenomas.\n\nExclusion Criteria:\n\n1. Patients with absolute contraindications for colonoscopy (suspicion of intestinal obstruction or perforation, acute diverticulitis suspected or confirmed 6 weeks before the colonoscopy, etc).\n2. Symptomatic patients with indication of diagnostic colonoscopy.\n3. Patients with a personal history of CRC.\n4. Patients with a personal history of chronic inflammatory bowel disease (IBD).\n5. Patients with a known personal history of hereditary CRC syndrome:\n\n I. No polyposis (Lynch syndrome). II. Polypic.\n6. Patients with suspected attenuated polyposis (\\> 20 adenomas) with genetic diagnosis not defined.\n7. Patients with total or partial colic resection.\n8. Complete colonoscopy with an adequate preparation (total Boston ≥6 with at least score ≥2 per segment) in a period of less than a year\n9. Pregnant or breastfeeding mothers.\n10. Patients who have expressed their wish not to participate or who do not have the ability to understand and / or sign informed consent.\n11. Patients with any serious and uncontrolled medical, psychological, psychiatric, geographic or social problem that could interfere with the participation of the patient in the study or not allow an adequate follow-up and adherence with the protocol and evaluation of the results of the study.'}, 'identificationModule': {'nctId': 'NCT03436004', 'acronym': 'ENDOCOLES', 'briefTitle': 'Evaluation of Colonoscopy With a Specific Device for the Detection of Adenomas', 'organization': {'class': 'OTHER', 'fullName': 'Puerta de Hierro University Hospital'}, 'officialTitle': 'Evaluation of Colonoscopy With a Specific Device for the Detection of Adenomas: Multicenter, Prospective and Randomized Study', 'orgStudyIdInfo': {'id': 'ENDOCOLES'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Colonoscopy with specific device with CE marking (Endocuff Vision)', 'interventionNames': ['Device: Colonoscopy with specific device (Endocuff Vision)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active Comparator', 'description': 'Colonoscopy with standard device of the center', 'interventionNames': ['Device: Colonoscopy']}], 'interventions': [{'name': 'Colonoscopy', 'type': 'DEVICE', 'description': 'Patients undergoing screening colonoscopy', 'armGroupLabels': ['Active Comparator']}, {'name': 'Colonoscopy with specific device (Endocuff Vision)', 'type': 'DEVICE', 'description': 'Patients undergoing screening colonoscopy using the Endocuff Vision device', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28222', 'city': 'Majadahonda', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Department of Gastroenterology, Hospital Universitario Puerta de Hierro - Majadahonda', 'geoPoint': {'lat': 40.47353, 'lon': -3.87182}}, {'zip': '28006', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Department of Gastroenterology, Hospital Universitario La Princesa', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28007', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Department of Gastroenterology, Hospital General Universitario Gregorio Marañón', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28034', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Department of Gastroenterology, Hospital Universitario Ramón y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Department of Gastroenterology, Hospital Clínico San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Department of Gastroenterology, Hospital Universitario 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Department of Gastroenterology, Hospital Universitario La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28922', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Department of Gastroenterology, Hospital Universitario Fundacion Alcorcon', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Alberto Herreros de Tejada, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Puerta de Hierro University Hospital'}, {'name': 'Aurora Burgos, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'La Paz University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Alberto Herreros de Tejada Echanojáuregui', 'class': 'OTHER'}, 'collaborators': [{'name': 'Spanish Clinical Research Network - SCReN', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr. Alberto Herreros de Tejada Echanojáuregui', 'investigatorAffiliation': 'Puerta de Hierro University Hospital'}}}}