Renal Assist Device (RAD) for Patients With Renal Insufficiency Undergoing Cardiac Surgery

NCT05990660 | Completed FDA Device

• 1 other identifier: RAD1117-01
• Study Type: interventional
• Target: 10
• Locations: 2 countries
• Sites: 3

Brief Summary

The study is a prospective, non-randomized early feasibility study intended to evaluate the safety and performance of the JuxtaFlow System (also known as the JuxtaFlow Renal Assist Device (RAD)) in participants with pre-existing renal insufficiency who are undergoing cardiac surgery.

Conditions

Renal Insufficiency; Acute Kidney Injury

Keywords

Cardiac Surgery Associated Acute Kidney Injury (CSA-AKI); Renal Compromise; Kidney Disease; Cardiopulmonary Bypass; Renal Assist Device (RAD); Cardiac Surgery

Outcome Measures

Primary Outcomes (3)

• [Safety] Adverse Events Characterization

  The characterization of all type, frequency, severity, and device-relatedness of the adverse events (AEs) associated with the placement, use, and removal of the JuxtaFlow System for the treatment of renal insufficiency in cardiac surgery patients.

  30 days

• [Efficacy] Creatinine Clearance

  The change in measured creatinine clearance occurring over the treatment period of 24 hours or less.

  24 hours

• [Efficacy] Urine Sodium Excretion

  The change in urine sodium excretion occurring over the treatment period of 24 hours or less.

  24 hours

Study Arms (1)

Treatment

EXPERIMENTAL

Device: JuxtaFlow System

Interventions

JuxtaFlow System DEVICE

Mild, controlled negative pressure introduced into the renal pelvis via JuxtaFlow catheters

Treatment

Eligibility Criteria

• Age: 22 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Candidate cardiac surgical patients
• Elective or Urgent on-pump coronary artery bypass grafting (CABG) and/or valvular surgery
• Age 22 to 85 years
• eGFR \< 60 mL/min/1.73m2
• Signed informed consent

You may not qualify if:

• End-stage renal disease (receiving hemodialysis or glomerular filtration rate \<15 ml/min/1.73m2)
• Planned off-pump surgery
• Any patients with high-grade proteinuria (i.e., urine protein concentration \> 300 mg/dL)
• Pregnancy
• Any secondary condition as determined by the investigator that would place the subject at an increased risk, or preclude the subject's full compliance with the study procedures, including injuries to the urinary organs and/or external genitals
• Current or planned treatment with an investigational drug (IND), device (IDE), or other investigational intervention within 3 months prior to or during participation in this clinical trial

Sponsors & Collaborators

• 3ive Labs: lead
• SCIRENT: collaborator

Study Sites (3)

Polsko-Amerykanskie Kliniki Serca, Centrum Kardiologii

Krakow, Bielsko-Biata, 43-316, Poland

Location

Institute for Cardiovascular Diseases "Dedinje"

Belgrade, Serbia

Location

Institute of Cardiovascular Diseases of Vojvodina

Kamenitz, Serbia

Location

MeSH Terms

Conditions

Renal Insufficiency; Acute Kidney Injury; Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Slobodan Micovic, MD

  Institute for Cardiovascular Diseases Dedinje

  PRINCIPAL INVESTIGATOR

• Milovan Petrovic, MD

  Institute of Cardiovascular Diseases of Vojvodina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: BIPASS-AKI is a single-arm, unblinded interventional study designed to assess the safety of the JuxtaFlow System.

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: August 14, 2023
• Study Start: September 28, 2023
• Primary Completion: December 28, 2023
• Study Completion: January 18, 2024
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2); PL (1)