Post-Market Observational Study of Intra-Renal Drug Delivery (PROVIDE)
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|