NCT00716404

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. 1.Better understand and quantify usage patterns including patient characteristics, adjunctive procedures, and infusion agents.
  2. 2.Collect user-interface information and overall customer satisfaction.
  3. 3.Monitor post-marketing device performance.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

4 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 15, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 16, 2008

Completed
Last Updated

February 5, 2010

Status Verified

February 1, 2010

First QC Date

July 15, 2008

Last Update Submit

February 3, 2010

Conditions

Targeted Renal Therapy

Keywords

FlowMedicaBenephitTRTPatientsComponentsBenephit Infusion SystemPlannedTo be used

Study Arms (1)

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

Interventions

Targeted Renal TherapyDEVICE

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.

Also known as: Benephit CV Infusion System, Benephit PV Infusion System, Benephit PVMini Infusion System, Benephit PVSolo Infusion System, Benephit XT Infusion System
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Scripps Clinic

La Jolla, California, 92037, United States

Location

Owensboro Heart & Vascular

Owensboro, Kentucky, 42303, United States

Location

Cardiovascular Institute of the South

Lafayette, Louisiana, 70506, United States

Location

Providence Heart & Vascular

Portland, Oregon, 97225, United States

Location

Related Links

Study Officials

  • James A Tumlin, MD

    Southeast Renal Associates

    PRINCIPAL INVESTIGATOR

  • David E Allie, MD

    Cardiovascular Institute of the South

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 15, 2008

First Posted

July 16, 2008

Study Start

April 1, 2008

Last Updated

February 5, 2010

Record last verified: 2010-02

Locations

US(4)