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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Angiodynamics, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Angiodynamics, Inc.
ClinicalTrials.gov Identifier:
NCT01064895
First received: February 5, 2010
Last updated: September 26, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention
Acute Kidney Injury
Acute Renal Failure
Renal Failure Chronic Contrast Induced
Chronic Kidney Disease
Device: Benephit catheter for Targeted Renal Therapy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Post-Market Observation Study of Intra-renal Drug Delivery (PROVIDE)

Resource links provided by NLM:


Further study details as provided by Angiodynamics, Inc.:

Estimated Enrollment: 500
Study Start Date: February 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: Benephit CV,PV,XT Infusion Systems(K033569,K050205,K082163)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01064895

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

No publications provided

Responsible Party: Angiodynamics, Inc.
ClinicalTrials.gov Identifier: NCT01064895     History of Changes
Other Study ID Numbers: 2008-CL0015 Revision C
Study First Received: February 5, 2010
Last Updated: September 26, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Angiodynamics, Inc.:
Benephit
Acute Kidney Injury
Acute Renal Failure
Contrast Induced Nephropathy
Chronic Kidney Disease

Additional relevant MeSH terms:
Kidney Diseases
Acute Kidney Injury
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Wounds and Injuries
Urologic Diseases
Renal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014