Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-25 @ 5:26 PM
Study NCT ID:
NCT00716404
Status:
WITHDRAWN
Last Update Posted:
2010-02-05
First Post:
2008-07-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Post-Market Observational Study of Intra-Renal Drug Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'whyStopped': 'FlowMedica was purchased by AngioDynamics. Study will be re-started by AngioDynamics.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'lastUpdateSubmitDate': '2010-02-03', 'studyFirstSubmitDate': '2008-07-15', 'studyFirstSubmitQcDate': '2008-07-15', 'lastUpdatePostDateStruct': {'date': '2010-02-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-16', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['FlowMedica', 'Benephit', 'TRT', 'Patients', 'Components', 'Benephit Infusion System', 'Planned', 'To be used'], 'conditions': ['Targeted Renal Therapy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.flowmedica.com', 'label': 'Sponsor Website'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective, observational, multi-center study with consecutive enrollment. Up to 1,000 patients will be enrolled. The objective of this post-marketing surveillance study is to collect clinical usage patterns of the Benephit Infusion Systems. As a result, FlowMedica will be able to:\n\n1. Better understand and quantify usage patterns including patient characteristics, adjunctive procedures, and infusion agents.\n2. Collect user-interface information and overall customer satisfaction.\n3. Monitor post-marketing device performance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hospitalized patients in whom one or more components of the Benephit Infusion System are planned to be used.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Exposure to one or more components of the Benephit Infusion System\n* Ability to give written informed consent\n\nExclusion Criteria:\n\n* Inclusion in another clinical study that may affect usage of the Benephit system'}, 'identificationModule': {'nctId': 'NCT00716404', 'acronym': 'PROVIDE', 'briefTitle': 'Post-Market Observational Study of Intra-Renal Drug Delivery', 'organization': {'class': 'INDUSTRY', 'fullName': 'FlowMedica, Inc.'}, 'officialTitle': 'Post-Market Observational Study of Intra-Renal Drug Delivery', 'orgStudyIdInfo': {'id': 'CL0015'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'All (consecutive) patients in whom one or more components of the Benephit Infusion System are planned to be used are eligible for enrollment in the study and should be offered informed consent.', 'interventionNames': ['Device: Targeted Renal Therapy']}], 'interventions': [{'name': 'Targeted Renal Therapy', 'type': 'DEVICE', 'otherNames': ['Benephit CV Infusion System', 'Benephit PV Infusion System', 'Benephit PVMini Infusion System', 'Benephit PVSolo Infusion System', 'Benephit XT Infusion System'], 'description': 'Patient diagnosis, treatment, and follow-up are left to the discretion of the participating investigator. There are no requisites as to how patients should be managed as this is intended to be an observational study. No procedures other than usage of the Benephit Infusion System per its Instructions for Use are specifically required for participation in this study.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Scripps Clinic', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '42303', 'city': 'Owensboro', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Owensboro Heart & Vascular', 'geoPoint': {'lat': 37.77422, 'lon': -87.11333}}, {'zip': '70506', 'city': 'Lafayette', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Cardiovascular Institute of the South', 'geoPoint': {'lat': 30.22409, 'lon': -92.01984}}, {'zip': '97225', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Providence Heart & Vascular', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'James A Tumlin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Southeast Renal Associates'}, {'name': 'David E Allie, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiovascular Institute of the South'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'FlowMedica, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Burt Goodson/Director, Scientific Affairs', 'oldOrganization': 'AngioDynamics, Inc.'}}}}