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

NCT05990660 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-01-23

No results posted yet for this study

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

Interventions

DEVICE

JuxtaFlow System

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

Sponsors & Collaborators

  • SCIRENT

    collaborator UNKNOWN

  • 3ive Labs

    lead INDUSTRY

Principal Investigators

  • Slobodan Micovic, MD · Institute for Cardiovascular Diseases Dedinje

  • Milovan Petrovic, MD · Institute of Cardiovascular Diseases of Vojvodina

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-28
Primary Completion
2023-12-28
Completion
2024-01-18
FDA Device
Yes

Countries

  • Poland
  • Serbia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05990660 on ClinicalTrials.gov