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H-Guard Pilot Safety Evaluation in Haemodialysis Patients

NCT06070337 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2024-03-07

No results posted yet for this study

Summary

The purpose of this research study is to find out the safety and effectiveness of a new medical device called H-Guard.

During this research study, participants will receive the standard of care haemodialysis treatment, as decided by the treating doctor. Participants will be observed during 5-6 haemodialysis treatments throughout the course of the study. The only change to the treatment process, will be the use of the medical device (H-Guard) to prime the dialysis system, before one of the treatments.

Participants will have various blood tests taken throughout the course of the study for safety and research analysis.

Conditions

  • Renal Failure
  • Renal Insufficiency
  • Renal Disease

Interventions

DEVICE

H-Guard

A novel Haemodialyser primer used for one treatment only

Sponsors & Collaborators

  • Tailored Clinical Research Solutions (TCRS)

    collaborator UNKNOWN

  • Invizius Limited

    lead INDUSTRY

Principal Investigators

  • Leonard Ebah · Manchester University NHS Foundation Trust

  • Magnus Nicolson · Invizius Limited

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-19
Primary Completion
2024-02-29
Completion
2024-02-29

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06070337 on ClinicalTrials.gov