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

NCT01064895 | Terminated

• 1 other identifier: 2008-CL0015 Revision C
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 15

Brief 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

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

Keywords

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

Study Arms (1)

Active Cohort

Patients receiving the Benephit device and targeted renal therapy.

Device: Benephit catheter for Targeted Renal Therapy

Interventions

Benephit catheter for Targeted Renal Therapy DEVICE

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

Also known as: Benephit CV,PV,XT Infusion Systems(K033569,K050205,K082163)

Active Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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

Sponsors & Collaborators

• Angiodynamics, Inc.: lead

Study Sites (15)

Baptist Cardiac & Vascular Institute

Miami, Florida, 33176, United States

Location

HealthwoRx South Florida Research Solutions

Miramar, Florida, 33025, United States

Location

Bingham Memorial Hospital

Blackfoot, Idaho, 83221, United States

Location

Cardiology Associates of NW Indiana

Munster, Indiana, 46321, United States

Location

Midwest Cardiovascular Research Foundation

Davenport, Iowa, 52803, United States

Location

King's Daughters Medical Center

Ashland, Kentucky, 41101, United States

Location

Graves Gilbert Clinic

Bowling Green, Kentucky, 42101, United States

Location

Sahetya Medical Institute

Bowling Green, Kentucky, 42101, United States

Location

Western Kentucky Heart and Lung

Bowling Green, Kentucky, 42101, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 42101, United States

Location

St. John Hospital & Medical Center

Detroit, Michigan, 48236, United States

Location

St. Joseph Health Center

Saint Charles, Missouri, 63301, United States

Location

Chambersburg Hospital

Chambersburg, Pennsylvania, 17201, United States

Location

Utah Cardiology PC

Layton, Utah, 84041, United States

Location

Virginia Commonwealth University Medical Center

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2010
• First Posted: February 9, 2010
• Study Start: February 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: November 8, 2016

Record last verified: 2016-11

Locations

US (15)