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Post-Market Observational Study of Intra-Renal Drug Delivery (PROVIDE)

This study has been withdrawn prior to enrollment.
(FlowMedica was purchased by AngioDynamics. Study will be re-started by AngioDynamics.)
Sponsor:
Information provided by:
FlowMedica, Inc.
ClinicalTrials.gov Identifier:
NCT00716404
First received: July 15, 2008
Last updated: February 3, 2010
Last verified: February 2010
History of Changes
  Purpose

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:

  1. Better understand and quantify usage patterns including patient characteristics, adjunctive procedures, and infusion agents.
  2. Collect user-interface information and overall customer satisfaction.
  3. Monitor post-marketing device performance.

Condition Intervention
Targeted Renal Therapy
 Device: Targeted Renal Therapy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Post-Market Observational Study of Intra-Renal Drug Delivery

Further study details as provided by FlowMedica, Inc.:

Estimated Enrollment: 1000
Study Start Date: April 2008
Groups/Cohorts Assigned Interventions
1
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.
 Device: Targeted Renal Therapy
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.
Other Names:
  • Benephit CV Infusion System
  • Benephit PV Infusion System
  • Benephit PVMini Infusion System
  • Benephit PVSolo Infusion System
  • Benephit XT Infusion System

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Hospitalized patients in whom one or more components of the Benephit Infusion System are planned to be used.

Criteria

Inclusion Criteria:

  • Exposure to one or more components of the Benephit Infusion System
  • Ability to give written informed consent

Exclusion Criteria:

  • Inclusion in another clinical study that may affect usage of the Benephit system
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00716404

Locations
United States, California
Scripps Clinic
La Jolla, California, United States, 92037
United States, Kentucky
Owensboro Heart & Vascular
Owensboro, Kentucky, United States, 42303
United States, Louisiana
Cardiovascular Institute of the South
Lafayette, Louisiana, United States, 70506
United States, Oregon
Providence Heart & Vascular
Portland, Oregon, United States, 97225
Sponsors and Collaborators
FlowMedica, Inc.
Investigators
Principal Investigator: James A Tumlin, MD Southeast Renal Associates
Principal Investigator: David E Allie, MD Cardiovascular Institute of the South
  More Information

Additional Information:
Sponsor Website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Burt Goodson/Director, Scientific Affairs, AngioDynamics, Inc.
ClinicalTrials.gov Identifier: NCT00716404     History of Changes
Other Study ID Numbers: CL0015
Study First Received: July 15, 2008
Last Updated: February 3, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by FlowMedica, Inc.:
FlowMedica
Benephit
TRT
Patients
 Components
Benephit Infusion System
Planned
To be used

Additional relevant MeSH terms:
Renal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013