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

NCT ID: NCT01064895

Last Updated: 2016-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-28

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acute Kidney Injury Acute Renal Failure Renal Failure Chronic Contrast Induced Chronic Kidney Disease

Keywords

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Benephit Acute Kidney Injury Acute Renal Failure Contrast Induced Nephropathy Chronic Kidney Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Active Cohort

Patients receiving the Benephit device and targeted renal therapy.

Benephit catheter for Targeted Renal Therapy

Intervention Type DEVICE

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

Interventions

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Benephit catheter for Targeted Renal Therapy

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

Intervention Type DEVICE

Other Intervention Names

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Benephit CV,PV,XT Infusion Systems(K033569,K050205,K082163)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Angiodynamics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Baptist Cardiac & Vascular Institute

Miami, Florida, United States

Site Status

HealthwoRx South Florida Research Solutions

Miramar, Florida, United States

Site Status

Bingham Memorial Hospital

Blackfoot, Idaho, United States

Site Status

Cardiology Associates of NW Indiana

Munster, Indiana, United States

Site Status

Midwest Cardiovascular Research Foundation

Davenport, Iowa, United States

Site Status

King's Daughters Medical Center

Ashland, Kentucky, United States

Site Status

Graves Gilbert Clinic

Bowling Green, Kentucky, United States

Site Status

Sahetya Medical Institute

Bowling Green, Kentucky, United States

Site Status

Western Kentucky Heart and Lung

Bowling Green, Kentucky, United States

Site Status

University of Maryland Medical Center

Baltimore, Maryland, United States

Site Status

St. John Hospital & Medical Center

Detroit, Michigan, United States

Site Status

St. Joseph Health Center

Saint Charles, Missouri, United States

Site Status

Chambersburg Hospital

Chambersburg, Pennsylvania, United States

Site Status

Utah Cardiology PC

Layton, Utah, United States

Site Status

Virginia Commonwealth University Medical Center

Richmond, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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2008-CL0015 Revision C

Identifier Type: -

Identifier Source: org_study_id