New lung support device shows promise for ARDS patients
NCT ID NCT04617093
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a device called PrismaLung+ that removes carbon dioxide from the blood, allowing doctors to use gentler breathing machine settings to help lungs heal. It included 63 adults with mild to moderate acute respiratory distress syndrome (ARDS) who were already on a ventilator. The main goals were to see if the device could safely enable ultra-protective lung ventilation and to track any side effects like bleeding.
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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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63 people
The number who actually took part.
- Started
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Apr 2021
- Finished
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Jan 2024
- 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 years and older
- 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: 1. Patient age is ≥ 18 years old 2. Patient is expected to receive ECCO2R for a minimum of 24 hours 3. Patient has mild or moderate ARDS according to the Berlin definition: * 100 mm Hg \< PaO2/FiO2 ≤ 300 mm Hg, with PEEP ≥ 5 cm H2O, and * Bilateral lung opacities not fully explained by effusions, lobar/lung collapse, or nodules, and * Respiratory failure not fully explained by cardiac failure or fluid overload 4. Written informed consent to participate in the study from the patient, if possible, or from the identified authorized representative if the patient is unable to provide consent. Exclusion Criteria: 1. Patients body weight \< 30 kg 2. Patients with a contraindication for systemic anticoagulation with heparin 3. Patients with a platelet count \< 50,000/µL 4. Patients on MV \> 7 days 5. Patients with very severe, or stage 4 (as per GOLD staging System) chronic obstructive pulmonary disease (COPD) 6. Current or history of heparin-induced thrombocytopenia 7. Patients who are pregnant and/or breastfeeding 8. Patients not expected to survive the duration of the planned study treatment period (24 hours) 9. Patients currently participating in another interventional clinical study, except if the patient is in an investigational medicinal product study, already in follow-up without further administration of study drug, and has not received any investigational medicinal product within 5 half-lives
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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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Investigational Site
Besançon, 25030, France
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Investigational Site
Colombes, 92700, France
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Investigational Site
Créteil, 94010, France
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Investigational Site
Lille, 59037, France
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Investigational Site
Marseille, 13354, France
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Investigational Site
Montpellier, 34295, France
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Investigational Site
Paris, 75013, France
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Investigational Site
Paris, 75651, France
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Investigational Site
Strasbourg, 67098, France
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Investigational Site
Vandœuvre-lès-Nancy, 54511, France