Feasibility Pilot Study to Evaluate the Safety and Performance of the MEX-CD1 Medical Device in ACLF

NCT06340269 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2026-04-29

No results posted yet for this study

Summary

The goal of this clinical trial is to test the MEX-CD1 hemodialysis medical device in patients suffering from ACLF. The main questions it aims to answer are:

* Is the device safe when used according to the instructions for use?
* Does the device work as expected by removing the excess of free iron from the blood?

Patients will receive 3 MEX-CD1 Slow Low volume CVVHD within 1 week.

Conditions

  • Acute on Chronic Liver Failure
  • Multiple Organ Failure

Interventions

DEVICE

MEX-CD1 Dialysis

MEX-CD1 is a hyper-chelating colloidal solution that can be added to the dialysate to be used in Slow low-volume continuous veno-venous hemodialysis. One treatment will last 3 hours and 20 minutes. Patients enrolled are hospitalized in Intensive Care Unit.

Sponsors & Collaborators

  • Slb Pharma

    collaborator OTHER
  • Mexbrain

    lead INDUSTRY

Principal Investigators

  • Céline GUICHON, MD · Hôpital Croix Rousse, Service d'hépatologie et gastroentérologie

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2024-06-21
Primary Completion
2025-10-23
Completion
2025-10-23

Countries

  • France

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 NCT06340269 on ClinicalTrials.gov