New device aims to filter toxic iron from blood in liver failure patients
NCT ID NCT06340269
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new medical device called MEX-CD1 in 11 adults with acute-on-chronic liver failure (ACLF), a serious condition where the liver suddenly stops working. The device works like a dialysis machine to filter excess iron from the blood. The main goals were to see if the device is safe and if it removes iron as expected. Each participant received three treatments over one week.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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11 people
The number who actually took part.
- Started
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Jun 2024
- Finished
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Oct 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Male or female subjects ≥18 years and ≤80 years * Subject is able to provide informed consent to participate in the study, otherwise written consent must be obtained on behalf of the subject by a next of kin or legal representative in accordance with local ethical and legal requirements * History of an acute decompensation event (including but not limited to ascites, gastrointestinal bleeding, hepatic encephalopathy and/or acute bacterial infections), occurring within ≤6 weeks of screening * Cirrhosis (diagnosed based on clinical, biological, morphological parameters or liver biopsy) * Subject with: * ACLF Grade 2, 3a or 3b based on the CLIF-C OF score * Under continuous renal replacement therapy (CRRT) or any organ support device that requires catheter placement Exclusion Criteria: * Subjects with acute or sub-acute liver failure without an underlying cirrhosis * Subjects not considered appropriate for full active treatment including organ support or those with a Do Not Attempt Cardio-Pulmonary Resuscitation order (DNACPR) * Subjects who have received any investigational drug or device within 30 days of dosing or who are scheduled to receive another investigational drug or device in the course of the study; concomitant observational studies are allowed * Evidence of uncontrolled seizures * In females: known pregnancy or lactating * Patients with a known allergy to shellfish * Patients for who, in the opinion of the investigator, it would be unsafe to be considered for the study * Vulnerable population according to Articles 64 to 68 of the Regulations (EU) 2017/745 on Medical Devices * Patient with weight \< 30 kg
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CHU Pontchaillou
Rennes, 35000, France
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Hôpital Croix Rousse, Service d'hépatologie et gastroentérologie
Lyon, Auvergne-Rhône-Alpes, 69317, France
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Other studies related to the condition(s) this trial covers.
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