Post-Market Observational Study of Intra-Renal Drug Delivery

Withdrawn before enrolling

Conditions studied: Targeted Renal Therapy

In brief

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.

Key facts

Study ID

NCT00716404

Run by

FlowMedica, Inc.

People needed

1000

Starts

2008-04-01

Last updated by the study team

2010-02-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Inclusion in another clinical study that may affect usage of the Benephit system

Where it is running

• Scripps Clinic — La Jolla, California, United States
• Owensboro Heart & Vascular — Owensboro, Kentucky, United States
• Cardiovascular Institute of the South — Lafayette, Louisiana, United States
• Providence Heart & Vascular — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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