Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2026-02-25 @ 5:33 PM
Study NCT ID:
NCT03219918
Status:
TERMINATED
Last Update Posted:
2019-04-11
First Post:
2017-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adenoma Detection Rate in Colonoscopy Performed With EndoRings
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D056587', 'term': 'Cryopyrin-Associated Periodic Syndromes'}], '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': 'D056660', 'term': 'Hereditary Autoinflammatory Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D000094482', 'term': 'Chronic Inducible Urticaria'}, {'id': 'D000080223', 'term': 'Chronic Urticaria'}, {'id': 'D014581', 'term': 'Urticaria'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D000096703', 'term': 'Cold Urticaria'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'It is partially blinded in the way that the endoscopist knows whether the procedure is performed with or without the EndoRings but neither patient, pathologist nor investigators will have this information, which is only to be revealed to the investigators at the end of data processing.'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study is a single-centre prospective randomised clinical trial. Patients are included if they meet the specified inclusion criteria and accept to take part in the study after proper oral and written information (see patient information below).\n\nSpecimens i.e. removed adenomas and biopsies of suspected malignancies are analysed by pathologists according to standard procedure. The pathologist will not know the nature of specimen collection (colonoscopy with or without EndoRings). The specimens are not saved for any other study related activities.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97}}, 'statusModule': {'whyStopped': 'Practically difficult to inroll the number of patients anticipated', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-06-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-06-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-09', 'studyFirstSubmitDate': '2017-06-13', 'studyFirstSubmitQcDate': '2017-07-13', 'lastUpdatePostDateStruct': {'date': '2019-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adenoma detection rate', 'timeFrame': 'maximum 60 minutes', 'description': 'Number of colorectal adenomas/neoplasms/carcinomas found in colonoscopy'}], 'secondaryOutcomes': [{'measure': 'Completion time', 'timeFrame': 'maximum 60 minutes', 'description': 'Overall colonoscopy duration'}, {'measure': 'Completion rate', 'timeFrame': 'maximum 60 minutes', 'description': 'Colonoscopy completion (intubation to coecum)'}, {'measure': 'Malignancy detection', 'timeFrame': 'maximum 60 minutes', 'description': 'Number of colorectal malignancies found in colonoscopy'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Colorectal adenoma', 'Colonoscopy', 'Caps', 'Adenoma detection rate'], 'conditions': ['Colorectal Adenoma', 'Colorectal Neoplasms']}, 'descriptionModule': {'briefSummary': 'The study is designed to examine whether colonoscopy using an EndoRings cap has a higher adenoma detection rate than conventional colonoscopy. Secondary end-points is to compare completion rate, completion time, complication rate and detection of malignancies. Half of the patients will be randomised to colonoscopy using cap and the other half to no cap.', 'detailedDescription': 'Colonoscopy is recognised as the standard method for finding and removing colorectal adenomas, which are precursors of most colorectal cancers. It has been shown that there is a direct correlation between adenoma detection rate and the risk of developing colorectal cancer subsequently. However, patients undergoing colonoscopy are still at risk of developing colorectal cancer, mainly because precursor lesions are missed during the procedure. This may be due to insufficient bowel preparation, difficulties in visualising flat lesions or the location of lesions behind haustral folds.\n\nImproving the ADR can be achieved by different means; better training of endoscopists, improved bowel preparation, optimal sedation and medico technical developments. The technical improvements have mainly been in the optimising of image and improved scope thickness and flexibility, including devices that improve visualisation by increasing the exposed colonic surface . One of these new inventions is the EndoRings II Distal Attachment.\n\nAccording to the Danish Colorectal Cancer Screening Database, the ADR of standard screening colonoscopy is between 34 and 67 % with a national average of 49 % of patients with detected adenomas. Due to the known adenoma miss rate in standard screening colonoscopies, it is important to increase the ADR on average as well as finding ways to improve ADR for centres with a lower than average ADR.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients meeting all the below listed criteria are eligible for inclusion in the trial:\n\n1. Age between 50 - 74 years (age range of screening population)\n2. Positive HemoCult home test from the Danish Colorectal Cancer Screening Programme\n3. Ability to give informed consent to participation in the trial.\n\nExclusion Criteria:\n\nPatients meeting one or more of the below listed criteria will be excluded from the trial:\n\n1. History of colorectal cancer\n2. History of Inflammatory Bowel Disease\n3. Part of other control programme (e.g. HNPCC or adenoma control)\n4. ASA =/\\> 4 and/or necessity of general anaesthesia\n5. Former surgery with removal of a part of the colon on either benign or malignant background'}, 'identificationModule': {'nctId': 'NCT03219918', 'briefTitle': 'Adenoma Detection Rate in Colonoscopy Performed With EndoRings', 'organization': {'class': 'OTHER', 'fullName': 'Zealand University Hospital'}, 'officialTitle': 'Adenoma Detection Rate in Colonoscopy Performed With EndoRings - a Single-centre Prospective Randomised Clinical Trial', 'orgStudyIdInfo': {'id': 'ZUH-KØGE-KIR1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'With EndoRings', 'description': 'Colonoscopy is performed with the use of the cap-device EndoRings II Distal Attachment to be attached to the tip of the colonoscope', 'interventionNames': ['Device: EndoRings II Distal Attachment']}, {'type': 'NO_INTERVENTION', 'label': 'NO EndoRings', 'description': 'Colonoscopy is performed conventionally without any caps'}], 'interventions': [{'name': 'EndoRings II Distal Attachment', 'type': 'DEVICE', 'description': 'Colonoscopy cap', 'armGroupLabels': ['With EndoRings']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4600', 'city': 'Køge', 'country': 'Denmark', 'facility': 'Zealand University Hospital Køge, Department of Surgery', 'geoPoint': {'lat': 55.45802, 'lon': 12.18214}}], 'overallOfficials': [{'name': 'Line E Line, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zealand University Hospital Køge'}, {'name': 'Ismayil Gögenur, Prof, DMSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Zealand University Hospital Køge'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zealand University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}