Post-Market Observational Study of Intra-Renal Drug Delivery

Withdrawn

• Conditions: Targeted Renal Therapy
• Interventions: Device: Targeted Renal Therapy

• Registration Number: NCT00716404
• Lead Sponsor: FlowMedica, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-07-15
• Study First Submitted QC: 2008-07-15
• Study First Posted: 2008-07-16
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-03
• Last Update Posted: 2010-02-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 1000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Targeted Renal Therapy	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.

Trial Locations

Locations (4)

Cardiovascular Institute of the South; 🇺🇸 Lafayette, Louisiana, United States

Scripps Clinic; 🇺🇸 La Jolla, California, United States

Owensboro Heart & Vascular; 🇺🇸 Owensboro, Kentucky, United States

Providence Heart & Vascular; 🇺🇸 Portland, Oregon, United States