Post-Market Observational Study of Intra-Renal Drug Delivery (PROVIDE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00716404|
Recruitment Status : Withdrawn (FlowMedica was purchased by AngioDynamics. Study will be re-started by AngioDynamics.)
First Posted : July 16, 2008
Last Update Posted : February 5, 2010
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:
- Better understand and quantify usage patterns including patient characteristics, adjunctive procedures, and infusion agents.
- Collect user-interface information and overall customer satisfaction.
- Monitor post-marketing device performance.
|Condition or disease||Intervention/treatment|
|Targeted Renal Therapy||Device: Targeted Renal Therapy|
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Post-Market Observational Study of Intra-Renal Drug Delivery|
|Study Start Date :||April 2008|
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00716404
|United States, California|
|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|
|Principal Investigator:||James A Tumlin, MD||Southeast Renal Associates|
|Principal Investigator:||David E Allie, MD||Cardiovascular Institute of the South|