Ignite Creation Date:
2025-12-24 @ 6:54 PM
Ignite Modification Date:
2026-02-25 @ 10:03 PM
Study NCT ID:
NCT03856957
Status:
COMPLETED
Last Update Posted:
2021-02-16
First Post:
2019-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serrated Lesions Detection With Endocuff-assisted Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 257}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-14', 'studyFirstSubmitDate': '2019-02-26', 'studyFirstSubmitQcDate': '2019-02-26', 'lastUpdatePostDateStruct': {'date': '2021-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average number of serrated lesions ≥ 10 mm detected per colonoscopy', 'timeFrame': 'immediate', 'description': 'Average number of serrated lesions ≥ 10 mm detected per colonoscopy'}], 'secondaryOutcomes': [{'measure': 'Serrated lesions detection rate', 'timeFrame': 'immediate', 'description': 'Number of patients with at least one serrated lesion/total number of participants'}, {'measure': 'Average number of serrated lesions < 10 mm detected per colonoscopy', 'timeFrame': 'immediate', 'description': 'Average number of serrated lesions \\< 10 mm detected per colonoscopy'}, {'measure': 'Average number of adenomas detected per colonoscopy', 'timeFrame': 'immediate', 'description': 'Average number of adenomas detected per colonoscopy'}, {'measure': 'Adenoma detection rate', 'timeFrame': 'immediate', 'description': 'Number of patients with at least one adenoma/total number of participants'}, {'measure': 'Adenocarcinoma detection rate', 'timeFrame': 'immediate', 'description': 'Number of patients with at least one adenocarcinoma/total number of participants'}, {'measure': 'Cecal intubation rate', 'timeFrame': 'immediate', 'description': 'Proportion of colonoscopies with cecal intubation x100'}, {'measure': 'Cecal incubation time', 'timeFrame': 'immediate', 'description': 'time from the rectum to cecum in minutes'}, {'measure': 'Withdrawal time', 'timeFrame': 'immediate', 'description': 'time from the cecum to the rectum in minutes'}, {'measure': 'Incidence of procedure related adverse events', 'timeFrame': 'immediate', 'description': 'Number of adverse events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Serrated Lesion', 'Endocuff', 'Detection'], 'conditions': ['Serrated Lesion', 'Adenoma', 'Colorectal Cancer']}, 'descriptionModule': {'briefSummary': "Colorectal cancer (CRC) is a leading cause of morbidity and mortality worldwide, especially in Western countries. CRC is currently considered a preventable disease and screening has been endorsed by several societies, since it has been shown that screening and surveillance are effective in reducing both CRC incidence and mortality. However, recently, concern has risen regarding colonoscopy effectiveness, especially in the right colon. The most accepted explanation for this effectiveness variability is attributed to sessile serrated lesions (SSL), which are more frequent in the proximal colon, more difficult to detect because of their flat morphology and associated with interval CRC, which is the occurrence of CRC after screening colonoscopy and before the next scheduled procedure. Several techniques are emerging to increase the sensitivity of colonoscopy for pre-cancerous lesions, especially adenomas. Recently an endoscopic cap, the Endocuff, was developed to improve adenoma detection. Several studies demonstrated improved adenoma detection with Endocuff-assisted colonoscopy when compared with conventional colonoscopy. Still, the available data for its' role in detecting SSL is very limited. The aim of this randomized controlled trial is to evaluate the effectiveness of Endocuff-assisted colonoscopy in detection of colorectal SSL."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Outpatients undergoing elective colonoscopies\n\nExclusion Criteria:\n\n* Known polyposis syndromes\n* Personal colorectal cancer history\n* Previous colorectal surgery\n* Severe diverticulosis\n* Colonic stricture\n* Inflammatory bowel disease\n* Primary sclerosing cholangitis\n* Pregnancy and breastfeeding'}, 'identificationModule': {'nctId': 'NCT03856957', 'briefTitle': 'Serrated Lesions Detection With Endocuff-assisted Colonoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Beatriz Ângelo'}, 'officialTitle': 'Serrated Lesions Detection With Endocuff-assisted Colonoscopy - A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '0304'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Endocuff colonoscopy', 'description': 'Colonoscopy performed with Endocuff', 'interventionNames': ['Device: Endocuff colonoscopy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Conventional colonoscopy', 'description': 'Colonoscopy performed without any device', 'interventionNames': ['Device: control']}], 'interventions': [{'name': 'Endocuff colonoscopy', 'type': 'DEVICE', 'description': 'Colonoscopy performed with Endocuff for mucosal inspection and interventions (eg. polypectomy).', 'armGroupLabels': ['Endocuff colonoscopy']}, {'name': 'control', 'type': 'DEVICE', 'description': 'colonoscopy without endocuff', 'armGroupLabels': ['Conventional colonoscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2674-514', 'city': 'Lisbon', 'state': 'Loures', 'country': 'Portugal', 'facility': 'Hospital Beatriz Ângelo', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Beatriz Ângelo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Alexandre Ferreira', 'investigatorAffiliation': 'Hospital Beatriz Ângelo'}}}}