Feasibility and Evaluation Study of the UPLUG Hemodialysis Connection Device

NCT05419258 | Completed

• 1 other identifier: 21-0265
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodialysis; Renal Insufficiency, Chronic

Keywords

medical device; connection medical device

Outcome Measures

Primary Outcomes (1)

• success in performing dialysis

  Study the feasibility of performing dialysis with the UPlug Technology in patients with a permanent tunneled central venous hemodialysis catheter with the objective of a success rate ≥ 80%.

  one month

Secondary Outcomes (5)

• Number of participants with Adverse Events [Safety and Tolerability] of the experimental device UPLUG

  one month

• experimental device integrity

  one month

• nurses' satisfaction

  one month

• patient satisfaction

  one month

• clinical performance of device

  one month

Study Arms (1)

use of the device during hemodialysis sessions

EXPERIMENTAL

use of the device during one month during hemodialysis sessions

Device: UPLUG Hemodialysis Connection Device

Interventions

UPLUG Hemodialysis Connection Device DEVICE

use of the device UPLUG during 1 month

use of the device during hemodialysis sessions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• with end-stage chronic renal failure treated by hemodialysis (2 or 3 sessions per week)
• Wearer of a right or left jugular permanent tunneled central venous hemodialysis catheter whose end has been in the superior vena cava or the right atrium for at least 1 month
• Hemodialysis catheter lock used = heparin or 4% citrate
• Expected life expectancy \> 6 months

You may not qualify if:

• Patient with a mechanical heart valve
• Patient with an arteriovenous fistula (AVF) that can be used within one month
• Kidney transplant by living donor planned in the following month
• Pregnant or breastfeeding woman
• History of infection on the hemodialysis catheter in place dating from less than 6 months
• Psychiatric or demented patient unable to obtain informed consent
• Patient already included in another protocol

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

CHU Caen Normandie

Caen, 14000, France

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: feasibility study on medical device

Study Record Dates

• First Submitted: April 29, 2022
• First Posted: June 15, 2022
• Study Start: May 6, 2022
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: February 13, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

FR (1)