Post-Market Observational Study of Intra-Renal Drug Delivery (PROVIDE)

February 3, 2010 updated by: FlowMedica, Inc.

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • Scripps Clinic
    • Kentucky
      • Owensboro, Kentucky, United States, 42303
        • Owensboro Heart & Vascular
    • Louisiana
      • Lafayette, Louisiana, United States, 70506
        • Cardiovascular Institute of the South
    • Oregon
      • Portland, Oregon, United States, 97225
        • Providence Heart & Vascular

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hospitalized patients in whom one or more components of the Benephit Infusion System are planned to be used.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
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.
Other Names:
  • Benephit CV Infusion System
  • Benephit PV Infusion System
  • Benephit PVMini Infusion System
  • Benephit PVSolo Infusion System
  • Benephit XT Infusion System

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

FlowMedica, Inc.

Investigators

  • Principal Investigator: James A Tumlin, MD, Southeast Renal Associates
  • Principal Investigator: David E Allie, MD, Cardiovascular Institute of the South

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Study Registration Dates

First Submitted

July 15, 2008

First Submitted That Met QC Criteria

July 15, 2008

First Posted (Estimate)

July 16, 2008

Study Record Updates

Last Update Posted (Estimate)

February 5, 2010

Last Update Submitted That Met QC Criteria

February 3, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CL0015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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