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Safety and Performance Trial of DIALIVE Liver Dialysis Device in Acute On Chronic Liver Failure Patients

NCT03065699 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-06-01

No results posted yet for this study

Summary

The First-In-Man study is a multi-centre, randomised, controlled, study to generate data for the evaluation of safety and performance of DIALIVE Liver Dialysis Device in 24 evaluable patients with Acute on Chronic Liver Failure (ACLF) versus standard of care (SOC).

Conditions

  • Acute on Chronic Liver Failure

Interventions

DEVICE

DIALIVE Liver Dialysis Device

ACLF patients will receive dialysis treatment for 8-12 hrs/day and on three to five consecutive days over a 10-day time period. Dialysis treatment is performed by using the DIALIVE device provided by YAQRIT Ltd.

Sponsors & Collaborators

  • European Foundation for Chronic Liver Failure

    collaborator UNKNOWN

  • University College, London

    collaborator OTHER

  • Fakkel bvba

    collaborator INDUSTRY

  • Yaqrit Ltd

    lead INDUSTRY

Principal Investigators

  • Banwari Agarwal, Dr · Royal Free Hospital London NHS

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
81 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-09
Primary Completion
2019-12-31
Completion
2020-01-15

Countries

  • Austria
  • Belgium
  • Denmark
  • France
  • Germany
  • Romania
  • Spain
  • 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 NCT03065699 on ClinicalTrials.gov