Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-03-15 @ 1:02 PM
Study NCT ID:
NCT03645720
Status:
WITHDRAWN
Last Update Posted:
2022-08-03
First Post:
2018-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Prognosis of Graft Using Plastic Cannula in Hemodialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'difficulty in performing study', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-10-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-01', 'studyFirstSubmitDate': '2018-08-21', 'studyFirstSubmitQcDate': '2018-08-22', 'lastUpdatePostDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of pseudoaneurysm', 'timeFrame': 'Incidence of pseudoaneurysm at 6 months', 'description': 'critical puncture related complication in AVG'}], 'secondaryOutcomes': [{'measure': 'punctutre related complication', 'timeFrame': 'Monthly for 6 months.', 'description': 'hematoma, inflitration, thrombus'}, {'measure': 'Dialysis adeqaucy', 'timeFrame': 'Monthly for 6 months.', 'description': 'Kt/V by serum test in two groups'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['End Stage Renal Failure on Dialysis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the complication of the puncture related complication in AVG (arteriovenous graft) such as pseudoaneurysm and hematoma, and the dialysis adequacy using plastic cannula versus metal needle in hemodialysis patients', 'detailedDescription': '1. Ultrasonography is performed to determine the maturity of vascular access 4 weeks after AVG creation.\n2. The first puncture is performed with plastic cannula or metal needle when it is judged that the blood vessel has matured.\n3. Four skilled nurses perform vascular access puncture with plastic or metal needle\n4. Ultrasound are used to evaluate and record the complications related to the puncture in plastic or metal needle group every month.\n5. Complications and dialysis adequacy between the two groups will be evaluated after 6 months'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients receiving hemodialysis treatment using AVG\n\nExclusion Criteria:\n\n* Age under 20 years old or over 75 years old\n* Abnormal skin condition using immunosuppressants such as steroids.\n* Skin disorder\n* Metal allergy'}, 'identificationModule': {'nctId': 'NCT03645720', 'briefTitle': 'The Prognosis of Graft Using Plastic Cannula in Hemodialysis', 'organization': {'class': 'OTHER', 'fullName': 'Hallym University Medical Center'}, 'officialTitle': 'A Prospective Study of the Prognosis of Graft With Plastic Cannula in Hemodialysis', 'orgStudyIdInfo': {'id': '2018-05-030'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Metal needle gruop', 'description': 'puncture using metal needle'}, {'type': 'EXPERIMENTAL', 'label': 'plastic cannula', 'description': 'puncture using plastic cannula', 'interventionNames': ['Device: Plastic cannula']}], 'interventions': [{'name': 'Plastic cannula', 'type': 'DEVICE', 'description': 'puncture using plastic cannula', 'armGroupLabels': ['plastic cannula']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14066', 'city': 'Anyang-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Hallym University Sacred Heart Hospital', 'geoPoint': {'lat': 37.3925, 'lon': 126.92694}}], 'overallOfficials': [{'name': 'Sun Ryoung Choi, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hallym University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hallym University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'choi sun ryoung, MD', 'investigatorAffiliation': 'Hallym University Medical Center'}}}}