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

Stopped early

Conditions studied: Acute Kidney Injury, Acute Renal Failure, Renal Failure Chronic Contrast Induced, Chronic Kidney Disease

In brief

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.

Key facts

Study ID

NCT01064895

Run by

Angiodynamics, Inc.

Starts

2010-02-01

Expected to finish

2011-12-01

Last updated by the study team

2016-11-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Physician-determined need for Benephit device/Targeted Renal Therapy
• Age >=18 years
• Ability to provide written informed consent

You may not qualify if…

• Patients who are participating in another IRB approved research study that precludes simultaneous enrollment

Where it is running

• Baptist Cardiac & Vascular Institute — Miami, Florida, United States
• HealthwoRx South Florida Research Solutions — Miramar, Florida, United States
• Bingham Memorial Hospital — Blackfoot, Idaho, United States
• Cardiology Associates of NW Indiana — Munster, Indiana, United States
• Midwest Cardiovascular Research Foundation — Davenport, Iowa, United States
• King's Daughters Medical Center — Ashland, Kentucky, United States
• Graves Gilbert Clinic — Bowling Green, Kentucky, United States
• Sahetya Medical Institute — Bowling Green, Kentucky, United States
• Western Kentucky Heart and Lung — Bowling Green, Kentucky, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• St. John Hospital & Medical Center — Detroit, Michigan, United States
• St. Joseph Health Center — Saint Charles, Missouri, United States
• Chambersburg Hospital — Chambersburg, Pennsylvania, United States
• Utah Cardiology PC — Layton, Utah, United States
• Virginia Commonwealth University Medical Center — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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