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Post-Market Observation Study of Intra-renal Drug Delivery (PROVIDE)

NCT01064895 · Status: TERMINATED · Type: OBSERVATIONAL

Last updated 2016-11-08

No results posted yet for this study

Summary

This is a prospective, observational, multi-center study with consecutive enrollment. Up to 500 patients will be enrolled. All (consecutive) adult patients in whom one or more components of the Benephit Infusion System are planned to be used at participating sites are eligible for enrollment. The objective of this post-marketing surveillance study is to collect clinical usage patterns of the Benephit Infusion Systems. As a result, AngioDynamics 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, and (3) Monitor post-marketing device performance and safety for ISO quality adherence.

Conditions

Interventions

DEVICE

Benephit catheter for Targeted Renal Therapy

Local physician-specified agent delivery to the kidneys bilaterally via the renal arteries using the Benephit infusion system.

Sponsors & Collaborators

  • Angiodynamics, Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT01064895 on ClinicalTrials.gov