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

November 7, 2016 updated by: Angiodynamics, Inc.
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Acute kidney injury, or AKI, is a rapid decline in renal function characterized by a decrease in urine output and/or an increase in serum creatinine (Cr), and is associated with worsened clinical outcomes and increased healthcare costs. AKI may be caused by numerous factors including interruptions or perturbations of renal blood flow or toxins, and often these factors are extra-renal in origin. AKI diagnoses in hospitalized patients are over one million per year and are projected to continue to grow, due largely to the aging population and increasing numbers of medical and invasive procedures performed on the elderly and the ever-increasing prevalence of diabetes mellitus and its medical complications, as well as increasing awareness within the medical community.

Treatment options for established acute kidney injury are limited and consist mainly of fluid and electrolyte balance (diuretics and/or IV fluids) supportive care up until the point that dialysis or other renal replacement therapy (RRT) is required. Despite the advent of newer drugs, more sophisticated RRT equipment, and increased awareness of the problem, little has changed relative to patient outcomes, which remain poor. Similarly, limited options exist in patients with known risk factors for AKI to prevent its development due to iatrogenic causes (e.g., major surgery, exposure to contrast media).

Targeted Renal Therapy allows for direct delivery of therapeutically relevant doses of various pharmacological agents directly to the renal bed, potentially reducing dose limiting side effects of traditional IV therapy. With Targeted Renal Therapy, or TRT, the kidney can metabolize, conjugate, and/or clear a substantial portion of many agents immediately (known as the "renal first-pass" effect), reducing the amount that is returned to the systemic circulation via the renal veins, thus potentially reducing untoward side effects. While the existence of a renal first-pass effect has been hypothesized in the medical literature for some time, it has not been possible to take clinical advantage of this important physiological function prior to the advent of AngioDynamics' TRT. Thus, TRT has the potential to offer an additional preventative or treatment opportunity in those patients at risk for AKI, or with established AKI, respectively.

Study Type

Observational

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
    • Florida
      • Miami, Florida, United States, 33176
        • Baptist Cardiac & Vascular Institute
      • Miramar, Florida, United States, 33025
        • HealthwoRx South Florida Research Solutions
    • Idaho
      • Blackfoot, Idaho, United States, 83221
        • Bingham Memorial Hospital
    • Indiana
      • Munster, Indiana, United States, 46321
        • Cardiology Associates of NW Indiana
    • Iowa
      • Davenport, Iowa, United States, 52803
        • Midwest Cardiovascular Research Foundation
    • Kentucky
      • Ashland, Kentucky, United States, 41101
        • King's Daughters Medical Center
      • Bowling Green, Kentucky, United States, 42101
        • Graves Gilbert Clinic
      • Bowling Green, Kentucky, United States, 42101
        • Western Kentucky Heart And Lung
      • Bowling Green, Kentucky, United States, 42101
        • Sahetya Medical Institute
    • Maryland
      • Baltimore, Maryland, United States, 42101
        • University of Maryland Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48236
        • St. John Hospital & Medical Center
    • Missouri
      • St. Charles, Missouri, United States, 63301
        • St. Joseph Health Center
    • Pennsylvania
      • Chambersburg, Pennsylvania, United States, 17201
        • Chambersburg Hospital
    • Utah
      • Layton, Utah, United States, 84041
        • Utah Cardiology PC
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University Medical Center

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

For use in patients undergoing medical, interventional, or surgical procedures, where the procedure carries an elevated risk of iatrogenic acute kidney injury for the patient. Also indicated in patients who have demonstrated symptoms of acute kidney injury, and in whom arterial catheterization with the Benephit infusion systems is feasible.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Active Cohort
Patients receiving the Benephit device and targeted renal therapy.
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.
Other Names:
  • Benephit CV,PV,XT Infusion Systems(K033569,K050205,K082163)

Collaborators and Investigators

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

Sponsor

Angiodynamics, Inc.

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

February 1, 2010

Primary Completion (ACTUAL)

December 1, 2011

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

February 5, 2010

First Submitted That Met QC Criteria

February 5, 2010

First Posted (ESTIMATE)

February 9, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

November 8, 2016

Last Update Submitted That Met QC Criteria

November 7, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-CL0015 Revision C

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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