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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This study has been withdrawn prior to enrollment.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

July 15, 2008
February 3, 2010
April 2008
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Complete list of historical versions of study NCT00716404 on ClinicalTrials.gov Archive Site
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Post-Market Observational Study of Intra-Renal Drug Delivery
Post-Market Observational Study of Intra-Renal Drug Delivery

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.
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

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

Targeted Renal Therapy
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
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.
Intervention: Device: Targeted Renal Therapy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
1000
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00716404
CL0015
No
Burt Goodson/Director, Scientific Affairs, AngioDynamics, Inc.
FlowMedica, Inc.
Not Provided
Principal Investigator: James A Tumlin, MD Southeast Renal Associates
Principal Investigator: David E Allie, MD Cardiovascular Institute of the South
FlowMedica, Inc.
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP