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A Post-Market Clinical Performance and Safety Evaluation of GamCath HighFlow Dolphin Protect Catheter

NCT05888376 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 76

Last updated 2025-03-13

No results posted yet for this study

Summary

The goal of this retrospective chart review is to obtain clinical safety and performance data for the GamCath HighFlow Dolphin Protect Catheter in patients with acute kidney injury, acute renal failure, or chronic kidney disease.

The main questions to answer are:

1. Duration of catheter use (survival)
2. Reason(s) for catheter removal

Conditions

  • AKI - Acute Kidney Injury
  • Acute Renal Failure
  • CKD
  • ESRD

Interventions

DEVICE

Vascular access catheter to support dialysis or CRRT

A specialised vascular access catheter to support bi-directional blood flow at high rates to allow extracorporeal removal of toxins by dialysis or CRRT

Sponsors & Collaborators

  • Baxter Healthcare Corporation

    collaborator INDUSTRY

  • Vantive Health LLC

    lead INDUSTRY

Principal Investigators

  • Wojciech Dąbrowski, Prof MD PhD · Independent Public Clinical Hospital No. 4, Lublin

  • Marek Winiarz, MD · Independent Public Health Care Unit, Łęczna

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-07
Primary Completion
2024-04-30
Completion
2024-04-30
FDA Device
Yes

Countries

  • Poland

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 NCT05888376 on ClinicalTrials.gov