Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2026-03-11 @ 1:03 AM
Study NCT ID:
NCT05419258
Status:
COMPLETED
Last Update Posted:
2024-02-13
First Post:
2022-04-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility and Evaluation Study of the UPLUG Hemodialysis Connection Device
Sponsor:
University Hospital, Caen
Organization:
Study Overview
Official Title:
Feasibility and Evaluation Study of the UPLUG Hemodialysis Connection Device
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
UPLUG-SAFE
Brief 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.
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.
Detailed Description:
The incidence and prevalence of chronic insufficiency have been growing for several years. Increasingly older patients are treated with chronic hemodialysis. The vascular access of choice remains the arteriovenous fistula and the proportion of hemodialysis patients on the permanent central venous hemodialysis catheter varies from 20 to 35% in dialysis centres. 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 inclusion period is three months. The follow-up time for each participant is 6 weeks. Patients with a tunneled permanent central venous hemodialysis catheter and performing dialysis sessions with a flow rate ≥ 300 ml/min may be included. 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.
The secondary objectives are the infectious risk, the defects of the experimental device and the hemodialysis catheter or their implementation, the satisfaction of the nursing staff and the patient, the reduction in the number of manipulations and the effective time of these manipulations.
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 inclusion period is three months. The follow-up time for each participant is 6 weeks. Patients with a tunneled permanent central venous hemodialysis catheter and performing dialysis sessions with a flow rate ≥ 300 ml/min may be included. 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.
The secondary objectives are the infectious risk, the defects of the experimental device and the hemodialysis catheter or their implementation, the satisfaction of the nursing staff and the patient, the reduction in the number of manipulations and the effective time of these manipulations.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: