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Post-Market Observational Study of Intra-Renal Drug Delivery

NCT00716404 · Status: WITHDRAWN · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2010-02-05

No results posted yet for this study

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.

Conditions

  • Targeted Renal Therapy

Interventions

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.

Sponsors & Collaborators

  • FlowMedica, Inc.

    lead INDUSTRY

Principal Investigators

  • James A Tumlin, MD · Southeast Renal Associates

  • David E Allie, MD · Cardiovascular Institute of the South

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00716404 on ClinicalTrials.gov