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Feasibility Pilot Study to Evaluate the Safety and Performance of the MEX-CD1 Medical Device in ACLF
Sponsor: Mexbrain
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.
Official title: Feasibility Pilot Study to Evaluate the Safety and Performance of the MEX-CD1 Medical Device in Acute on Chronic Liver Failure (ACLF)
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2024-06-21
Completion Date
2025-10
Last Updated
2025-05-08
Healthy Volunteers
No
Interventions
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.
Locations (2)
Hôpital Croix Rousse, Service d'hépatologie et gastroentérologie
Lyon, Auvergne-Rhône-Alpes, France
CHU Pontchaillou
Rennes, France