Post-Market Observational Study of Intra-Renal Drug Delivery

Targeted Renal Therapy Clinical Trial

— PROVIDE  

Official title:

Post-Market Observational Study of Intra-Renal Drug Delivery

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00716404
• Other study ID #: CL0015
• Status: Withdrawn
• Phase: N/A
• First received: July 15, 2008
• Last updated: February 3, 2010
• Start date: April 2008

Study information

• Verified date: February 2010
• Source: FlowMedica, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 1000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Targeted Renal Therapy

Intervention

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.

Locations

Country	Name	City	State
United States	Scripps Clinic	La Jolla	California
United States	Cardiovascular Institute of the South	Lafayette	Louisiana
United States	Owensboro Heart & Vascular	Owensboro	Kentucky
United States	Providence Heart & Vascular	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
FlowMedica, Inc.

Country where clinical trial is conducted

United States, 

External Links

•   Sponsor Website