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A Post-Market Clinical Performance and Safety Evaluation of GamCath HighFlow Dolphin Protect Catheter | Clinical Trials | Clareo Health

COMPLETED

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

NCT05888376•Vantive Health LLC

View on ClinicalTrials.gov

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

Detailed 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 purification using GamCath HighFlow Dolphin Protect Catheter inserted by a physician in the subclavian, jugular, or femoral veins.

Exclusion Criteria

•Patients who required the GamCath HighFlow Dolphin Protect Catheter for any indication other than extracorporeal blood purification.
•Patients who had a local infection at the vascular access site prior to catheter insertion.
•Patients who required surgical intervention (e.g., cutdown procedure) for GamCath HighFlow 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 endpoint analyses.

Locations (2)

Independent Public Hospital No. 4, Lublin

Lublin, Poland

Independent Public Health Care Unit, Łęczna

Łęczna, Poland

Key Dates

Start Date

December 7, 2023

Primary Completion Date

April 30, 2024

Completion Date

April 30, 2024

Last Updated

March 13, 2025

Enrollment

ACTUAL participants

Conditions

AKI - Acute Kidney InjuryAcute Renal FailureCKDESRD

Interventions

Vascular access catheter to support dialysis or CRRT

DEVICE

Outpatient Recovery From Acute Kidney Injury Requiring Dialysis - 2

NCT07106151

AKIAKI - Acute Kidney Injury+1 more

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RECRUITING

Contrast-enhanced Ultrasound and Super-resolution Imaging Predict Renal Function Outcome After Nephrectomy

NCT07294859

NephrectomyRenal Cell Cancer+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 13, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Outpatient Recovery From Acute Kidney Injury Requiring Dialysis - 2

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