Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-02-25 @ 5:43 PM
Study NCT ID:
NCT00579202
Status:
COMPLETED
Last Update Posted:
2025-03-11
First Post:
2007-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ease of Use Study for the Gambro Polyflux HD-C4 Small Dialyzer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-06', 'studyFirstSubmitDate': '2007-12-19', 'studyFirstSubmitQcDate': '2007-12-19', 'lastUpdatePostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-12-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'For each dialyzer, the perceived ease of priming.', 'timeFrame': 'During priming of each dialyzer'}], 'secondaryOutcomes': [{'measure': 'Visual assessment of residual blood in the dialyzer after rinse-back and if dialyzer clotted during treatment.', 'timeFrame': 'At the completion of each treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dialyzer'], 'conditions': ['Hemodialysis']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to study the ease of use of the Polyflux HD-C4 Small dialyzer under conditions of routine clinical use for hemodialysis', 'detailedDescription': "Market evaluation protocol.\n\nThis ease of use study involves the use of FDA 510(k) cleared hemodialyzers and will have no impact on the patient's routine dialysis therapy. This study is strictly aimed at obtaining feedback from the nursing and technical staff regarding the use of the Polyflux HD-C4 Small dialyzer. The dialysis nursing staff will complete ease of use assessments following routine dialysis therapy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The dialysis nursing staff will complete ease of use assessments following routine dialysis therapy of adult (≥ 18 years of age) patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* n/a routine dialysis patients\n\nExclusion Criteria:\n\n* n/a routine dialysis patients'}, 'identificationModule': {'nctId': 'NCT00579202', 'briefTitle': 'Ease of Use Study for the Gambro Polyflux HD-C4 Small Dialyzer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vantive Health LLC'}, 'officialTitle': 'The Gambro Polyflux HD-C4 Small Ease of Use Study', 'orgStudyIdInfo': {'id': '07-0002'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Gambro HD-C4 Small Dialyzer', 'type': 'DEVICE', 'description': "Involves the use of FDA 510(k) cleared hemodialyzers and will have no impact on the patient's routine dialysis therapy."}]}, 'contactsLocationsModule': {'locations': [{'zip': '20706', 'city': 'Lanham', 'state': 'Maryland', 'country': 'United States', 'facility': 'Advanced Dialysis Center', 'geoPoint': {'lat': 38.96875, 'lon': -76.8634}}], 'overallOfficials': [{'name': 'Rana Irmindra, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Advanced Dialysis Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vantive Health LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Gambro Renal Products, Inc.', 'class': 'INDUSTRY'}, {'name': 'Baxter Healthcare Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}