Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-03-06 @ 3:00 AM
Study NCT ID:
NCT02592603
Status:
COMPLETED
Last Update Posted:
2017-08-04
First Post:
2015-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endocuff for Surveillance of Serrated Polyposis Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-03', 'studyFirstSubmitDate': '2015-10-29', 'studyFirstSubmitQcDate': '2015-10-29', 'lastUpdatePostDateStruct': {'date': '2017-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of serrated lesions >=5mm', 'timeFrame': 'one year', 'description': 'Number of serrated lesions \\>=5mm detected in each arm'}], 'secondaryOutcomes': [{'measure': 'Number of total polyps', 'timeFrame': 'one year', 'description': 'Number of total polyps in each arm'}, {'measure': 'Number of serrated lesions >=10mm', 'timeFrame': 'one year', 'description': 'Number of serrated lesions \\>=10mm detected in each arm'}, {'measure': 'Number of serrated lesions with displasia', 'timeFrame': 'one year', 'description': 'Number of serrated lesions with displasia in each arm'}, {'measure': 'Number of adenomas', 'timeFrame': 'one year', 'description': 'Number of adenomas in each arm'}, {'measure': 'Number of advanced adenomas', 'timeFrame': 'one year', 'description': 'Number of advanced adenomas in each arm'}, {'measure': 'Number of flat lesions', 'timeFrame': 'one year', 'description': 'Number of flat lesions in each arm'}, {'measure': 'Number of flat lesions in right colon', 'timeFrame': 'one year', 'description': 'Number of flat lesions in right colon in each arm'}, {'measure': 'Withdrawal time', 'timeFrame': '30 minutes', 'description': 'Extubation time from the cecum to scope removal from the anus, with exception of time taken for any therapeutic intervention'}, {'measure': 'Total procedure time', 'timeFrame': '30 minutes', 'description': 'Starting with endoscope insertion and withdrawal time including therapeutic interventions'}, {'measure': 'Proportion of major adverse events', 'timeFrame': 'Two weeks', 'description': 'Colonic perforation or clinically significant bleeding'}, {'measure': 'Proportion of minor adverse events', 'timeFrame': 'Two weeks', 'description': 'Superficial mucosal erosions in the colonic mucosa, abdominal pain and bloating'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Serrated lesions', 'Surveillance', 'Colorectal cancer', 'Endocuff', 'Sessile serrated adenoma', 'Colonoscopy'], 'conditions': ['Polyposis']}, 'referencesModule': {'references': [{'pmid': '26264224', 'type': 'BACKGROUND', 'citation': 'Carballal S, Rodriguez-Alcalde D, Moreira L, Hernandez L, Rodriguez L, Rodriguez-Moranta F, Gonzalo V, Bujanda L, Bessa X, Poves C, Cubiella J, Castro I, Gonzalez M, Moya E, Oquinena S, Clofent J, Quintero E, Esteban P, Pinol V, Fernandez FJ, Jover R, Cid L, Lopez-Ceron M, Cuatrecasas M, Lopez-Vicente J, Leoz ML, Rivero-Sanchez L, Castells A, Pellise M, Balaguer F; Gastrointestinal Oncology Group of the Spanish Gastroenterological Association. Colorectal cancer risk factors in patients with serrated polyposis syndrome: a large multicentre study. Gut. 2016 Nov;65(11):1829-1837. doi: 10.1136/gutjnl-2015-309647. Epub 2015 Aug 11.'}, {'pmid': '24921209', 'type': 'BACKGROUND', 'citation': 'Biecker E, Floer M, Heinecke A, Strobel P, Bohme R, Schepke M, Meister T. Novel endocuff-assisted colonoscopy significantly increases the polyp detection rate: a randomized controlled trial. J Clin Gastroenterol. 2015 May-Jun;49(5):413-8. doi: 10.1097/MCG.0000000000000166.'}, {'pmid': '25470133', 'type': 'BACKGROUND', 'citation': 'Floer M, Biecker E, Fitzlaff R, Roming H, Ameis D, Heinecke A, Kunsch S, Ellenrieder V, Strobel P, Schepke M, Meister T. Higher adenoma detection rates with endocuff-assisted colonoscopy - a randomized controlled multicenter trial. PLoS One. 2014 Dec 3;9(12):e114267. doi: 10.1371/journal.pone.0114267. eCollection 2014.'}, {'pmid': '26171436', 'type': 'BACKGROUND', 'citation': 'Sawatzki M, Meyenberger C, Marbet UA, Haarer J, Frei R. Prospective Swiss pilot study of Endocuff-assisted colonoscopy in a screening population. Endosc Int Open. 2015 Jun;3(3):E236-9. doi: 10.1055/s-0034-1391418. Epub 2015 Feb 27.'}, {'pmid': '31174224', 'type': 'DERIVED', 'citation': 'Rivero-Sanchez L, Lopez Vicente J, Hernandez Villalba L, Puig I, Arnau-Collell C, Moreno L, Diaz M, Rodriguez de Miguel C, Ocana T, Moreira L, Cuatrecasas M, Carballal S, Sanchez A, Ortiz O, Llach J, Balaguer F, Pellise M; EndoCAR group from the Spanish Gastroenterology Association and the Spanish Society of Digestive Endoscopy. Endocuff-assisted colonoscopy for surveillance of serrated polyposis syndrome: a multicenter randomized controlled trial. Endoscopy. 2019 Jul;51(7):637-645. doi: 10.1055/a-0925-4956. Epub 2019 Jun 7.'}]}, 'descriptionModule': {'briefSummary': 'Serrated Polyposis Syndrome (SPS) is a high-risk condition for colorectal cancer (CRC). SPS patients have a cumulative CRC risk of 1.9% in 5 years despite a strict endoscopic surveillance in specialized centers. Proximal serrated lesions are endoscopically challenging to detect due to their unremarkable morphology. Endocuff is a novel device comprised of a cap with a row of finger-like projections with a unique dynamic shape that help to flatten mucosal folds during withdrawal of the instrument in order to improve detection of lesions. Recent studies have reported an increase of detection rate and mean per patient of adenomas with Endocuff-assisted Colonoscopy compared with Standard Colonoscopy. The purpose of this study is to assess the usefulness of Endocuff-assisted Colonoscopy to detect serrated lesions in SPS patients undergoing surveillance compared to Standard Colonoscopy in a randomized fashion', 'detailedDescription': 'According to own data and similarly to previous published studies, patients diagnosed of Serrated Polyposis Syndrome undergoing annual surveillance after clearance of all serrated lesions ≥ 5mm, have a mean of 5 serrated lesions per patient at follow-up colonoscopies. The study was powered to establish a 25% significant increase in the mean of serrated lesions per patient in the Endocuff-assisted colonoscopy group. Accepting an alpha risk of 0.05, a beta risk of 0.2 and a loss rate of 10% in a bilateral contrast, a sample size of 124 patients (62 in each arm) are required to achieve statistic significance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Adults with diagnosis of Serrated Polyposis Syndrome undergoing surveillance colonoscopies after clearance of all lesions \\>=5mm\n\nExclusion Criteria:\n\n* Patients with known strictures\n* Partial or total colonic resection\n* Acute diverticulitis\n* Concomitant inflammatory bowel disease\n* Suspected or proven lower gastrointestinal bleeding\n* Non-correctable coagulopathy or anticoagulant/clopidogrel therapy during procedure\n* Inability to sign informed consent'}, 'identificationModule': {'nctId': 'NCT02592603', 'briefTitle': 'Endocuff for Surveillance of Serrated Polyposis Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Clinic of Barcelona'}, 'officialTitle': 'Endocuff-assisted vs. Standard Colonoscopy for Surveillance of Serrated Polyposis Syndrome: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'HCB/2015/0803'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Endocuff-assisted Colonoscopy', 'description': 'Endocuff-assisted Colonoscopy with the ARC Endocuff-vision® attached at the distal tip of the scope.', 'interventionNames': ['Device: Endocuff-assisted Colonoscopy']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Colonoscopy', 'description': 'Standard Colonoscopy without any additional device'}], 'interventions': [{'name': 'Endocuff-assisted Colonoscopy', 'type': 'DEVICE', 'otherNames': ['ECC'], 'description': 'Colonic examination with Endocuff-assisted Colonoscopy', 'armGroupLabels': ['Endocuff-assisted Colonoscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'María Pellisé. MD. PhD.', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'María Pellisé, MD. PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Clinic of Barcelona'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Clinic of Barcelona', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundacion Clinic per a la Recerca Biomédica', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD. PhD. Consultant', 'investigatorFullName': 'María Pellisé', 'investigatorAffiliation': 'Hospital Clinic of Barcelona'}}}}