Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-01-11 @ 3:50 PM
Study NCT ID:
NCT03279705
Status:
COMPLETED
Last Update Posted:
2019-10-29
First Post:
2017-08-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The efficacy of the Integrated Water Jet Channel Colonoscopy in Water Exchange Method
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003108', 'term': 'Colonic Diseases'}], 'ancestors': [{'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'These codes were contained in pre-arranged opaque envelopes, which were opened immediately before insertion of the colonoscope.'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A total of 120 patients were allocated into one of two groups by computerized randomization. In group A (Two-channel group), clear water was infused through the water jet channel and dirty water was sucked form the accessy channel. In group B (One-channel group), water exchange was done by using the accessory channel for both infusing and suctioning of water.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-25', 'studyFirstSubmitDate': '2017-08-24', 'studyFirstSubmitQcDate': '2017-09-10', 'lastUpdatePostDateStruct': {'date': '2019-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cecal insertion time', 'timeFrame': '2 hours', 'description': 'Cecal insertion time was defined as the time from insertion into the rectum to the time when the colonoscope tip passed to a point proximal to the ileocecal valve so that the base of cecum was visible.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['water exchange', 'water jet channel colonoscopy', 'colonoscopy', 'cecal insertion time', 'adenoma detection rate'], 'conditions': ['Colonoscopy', 'Colon Disease']}, 'referencesModule': {'references': [{'pmid': '32203986', 'type': 'DERIVED', 'citation': 'Tseng CW, Koo M, Hsieh YH. Cecal intubation time between the use of one-channel and two-channel water exchange colonoscopy: A randomized controlled trial. J Gastroenterol Hepatol. 2020 Sep;35(9):1562-1569. doi: 10.1111/jgh.15043. Epub 2020 Apr 6.'}]}, 'descriptionModule': {'briefSummary': 'This prospective randomized controlled trial compared integrated water jet channel colonoscopy with traditional accessory channel colonoscopy in cecal insertion time among patients undergoing WE method colonoscopy.', 'detailedDescription': 'When the WE method colonoscopy were done with the accessory channel for both infusing and suctioning of water. The water had to be suctioned or infused alternatively and increaed the insertion time.\n\nWith the new designed endoscopy that integrated a separate water jet channel for infusing water, infusing and suctioning of water can be done at the same time. Besides, water jet pumping system could provide a powerful jet to help us open the collapse lumen and keep an appropriate distance between the mucosa and the lens, thus preventing loss of visualization. It will help the colonoscopist to find the way during insertion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Underwent fully sedative colonoscopy with WE method in the outpatient department\n\nExclusion Criteria:\n\n* Age \\< 18 years old or \\> 80 years old\n* Without standard colon preparation\n* Allergy to meperidine or propofol\n* With a history of partial colectomy\n* Refusal to provide written informed consent.'}, 'identificationModule': {'nctId': 'NCT03279705', 'briefTitle': 'The efficacy of the Integrated Water Jet Channel Colonoscopy in Water Exchange Method', 'organization': {'class': 'OTHER', 'fullName': 'Dalin Tzu Chi General Hospital'}, 'officialTitle': 'Division of Gastroenterology, Department of Internal Medicine, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Chiayi, Taiwan', 'orgStudyIdInfo': {'id': 'DalinTCGH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Two-channel group', 'description': 'The colonoscopy was done with the new designed colonoscopy that integrated a separate water jet channel for infusing water. The dirty water was removed through other accessory channel.', 'interventionNames': ['Device: Water jet channel', 'Device: Accessory channel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'One-channel group', 'description': 'The colonoscopy was done with the traditional colonoscopy. Water exchange was done by using the accessory channel for both infusing and suctioning of water.', 'interventionNames': ['Device: Accessory channel']}], 'interventions': [{'name': 'Water jet channel', 'type': 'DEVICE', 'description': 'The separate water jet channel was used for infusing water.', 'armGroupLabels': ['Two-channel group']}, {'name': 'Accessory channel', 'type': 'DEVICE', 'description': 'The accessory channel was used for infusing and/or suctioning water', 'armGroupLabels': ['One-channel group', 'Two-channel group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '62247', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Yu-Hsi Hsieh', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chih-wei Tseng', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Division of Gastroenterology, Department of Internal Medicine', 'investigatorFullName': 'Chih-wei Tseng', 'investigatorAffiliation': 'Dalin Tzu Chi General Hospital'}}}}