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

Last updated: March 11, 2025
Sponsor: Vantive Health LLC
Overall Status: Completed

Phase

N/A

Condition

Renal Failure

Kidney Disease

Kidney Failure

Treatment

Vascular access catheter to support dialysis or CRRT

Clinical Study ID

NCT05888376
BXU565389
  • Ages > 18
  • All Genders

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients ≥ 18 years of age at the time of catheter insertion.

  • Patients diagnosed with AKI, ARF, and/or CKD (including end-stage renal disease [ESRD]).

  • Patients who required vascular access to perform extracorporeal blood purificationusing GamCath HighFlow Dolphin Protect Catheter inserted by a physician in thesubclavian, jugular, or femoral veins.

Exclusion

Exclusion Criteria:

  • Patients who required the GamCath HighFlow Dolphin Protect Catheter for anyindication other than extracorporeal blood purification.

  • Patients who had a local infection at the vascular access site prior to catheterinsertion.

  • Patients who required surgical intervention (e.g., cutdown procedure) for GamCathHighFlow Dolphin Protect Catheter placement.

  • Patients who had a prior catheter in place at the same vascular access site (i.e.,R/L jugular vein, R/L femoral vein, R/L subclavian vein) within the last 7 days.

  • Patients who do not have complete patient records to support the primary endpointanalyses.

Study Design

Total Participants: 76
Treatment Group(s): 1
Primary Treatment: Vascular access catheter to support dialysis or CRRT
Phase:
Study Start date:
December 07, 2023
Estimated Completion Date:
April 30, 2024

Study Description

The objective of this retrospective chart review is to obtain clinical safety and performance data for the GamCath HighFlow Dolphin Protect Catheter related to the duration of use (catheter survival) throughout its lifetime.

Connect with a study center

  • Independent Public Hospital No. 4, Lublin

    Lublin, 20-954
    Poland

    Site Not Available

  • Independent Public Health Care Unit, Łęczna

    Łęczna, 21-010
    Poland

    Site Not Available

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