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Aortix Therapy for Perioperative Reduction of Kidney Injury

NCT04999163 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-11-12

Study results available
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Summary

The study is a prospective, non-randomized feasibility study to evaluate the safety and performance of providing support with the Aortix System to patients at heightened risk of acute kidney injury (AKI) undergoing cardiovascular surgery.

Conditions

Interventions

DEVICE

Aortix System

Aortix is indicated as a partial circulatory support device to increase renal perfusion and reduce the incidence of acute kidney injury (AKI) in patients undergoing cardiac surgery who are at heightened risk of developing AKI.

Sponsors & Collaborators

  • Procyrion Australia Pty Ltd

    collaborator INDUSTRY

  • Procyrion

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-17
Primary Completion
2023-08-22
Completion
2023-08-22
FDA Device
Yes

Countries

  • Australia

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 NCT04999163 on ClinicalTrials.gov