Trials / Completed
CompletedNCT05888376
A Post-Market Clinical Performance and Safety Evaluation of GamCath HighFlow Dolphin Protect Catheter
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 76 (actual)
- Sponsor
- Vantive Health LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2023-12-07
- Primary completion
- 2024-04-30
- Completion
- 2024-04-30
- First posted
- 2023-06-05
- Last updated
- 2025-03-13
Locations
2 sites across 1 country: Poland
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05888376. Inclusion in this directory is not an endorsement.