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

Completed

• Conditions: Acute Renal Failure; AKI - Acute Kidney Injury; CKD; ESRD
• Interventions: Device: Vascular access catheter to support dialysis or CRRT

• Registration Number: NCT05888376
• Lead Sponsor: Vantive Health LLC

Brief 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.

Study Timeline

• Study First Submitted: 2023-05-15
• Study First Submitted QC: 2023-06-02
• Study First Posted: 2023-06-05
• Study Start: 2023-12-07
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Consecutive CKD including ESRD treatments	Vascular access catheter to support dialysis or CRRT	Consecutive retrospective treatments across all sites with a diagnosis of CKD, including ESRD
Consecutive acute/chronic kidney disease treatments	Vascular access catheter to support dialysis or CRRT	Consecutive retrospective treatments across all sites with acute or chronic disease (excluding cases previously identified)
Consecutive treatments with minimum hospital stay of 20 days	Vascular access catheter to support dialysis or CRRT	Consecutive retrospective treatments across all sites with a minimum hospital stay of days (excluding cases previously identified; may be acute or chronic disease)

Primary Outcome Measures

Name	Time	Method
Reason(s) for Catheter Removal	Within 72 hours of catheter removal or patient transfer or discharge or death, whichever occurs first, assessed up to 12 weeks	Collect additional real-world use data describing the reason(s) for GamCath HighFlow Dolphin Protect Catheter removal to support PMCF ongoing product safety performance
Catheter Survival	From date of catheter insertion until the date of catheter removal or patient transfer or discharge or death, whichever occurs first, assessed up to 12 weeks	Confirm catheter lifetime related to GamCath HighFlow Dolphin Protect Catheter duration of use to support PMCF ongoing performance data

Secondary Outcome Measures

Name	Time	Method
Adverse Events	From date of catheter insertion until the date of catheter removal or patient transfer or discharge or death, whichever occurs first, assessed up to 12 weeks	Collect real-world use data describing adverse events potentially related to the study catheter or catheter insertion/removal procedures

Trial Locations

Locations (2)

Independent Public Hospital No. 4, Lublin; 🇵🇱 Lublin, Poland

Independent Public Health Care Unit, Łęczna; 🇵🇱 Łęczna, Poland