Feasibility and Evaluation Study of the UPLUG Hemodialysis Connection Device
NCT05419258 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2024-02-13
Summary
The new Uplug° technology, interface between the end of the hemodialysis catheter and the dialysis circuit, makes it possible to limit direct access to the hemodialysis catheter during connections and disconnections.
Aim:
The investigators propose a feasibility study, in order to study the new Uplug° technology in real conditions of use.
Material and methods:
This study aim to include 15 hemodialysis patients in a center on a tunneled permanent central venous hemodialysis catheter. The Uplug° technology will be placed at the end of each patient's hemodialysis catheter for a period of one month.
Hypothesis tested:
The main endpoint is the proportion of hemodialysis sessions performed successfully with this technology, respecting the usual dialysis prescription.
Conditions
- Hemodialysis
- Renal Insufficiency, Chronic
Interventions
- DEVICE
-
UPLUG Hemodialysis Connection Device
use of the device UPLUG during 1 month
Sponsors & Collaborators
-
University Hospital, Caen
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- DEVICE_FEASIBILITY
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-05-06
- Primary Completion
- 2023-10-30
- Completion
- 2023-10-30
Countries
- France
Study Locations
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