Mild to Moderate Acute Respiratory Distress SyndromeNCT04617093
Post-Market Study of Low-flow ECCO2R Using PrismaLung+
A study testing PrismaLung+ in people with Mild to Moderate Acute Respiratory Distress Syndrome, run by Vantive Health LLC at 10 sites in France.
Trial summary
PrismaLung+ is intended to provide extracorporeal carbon dioxide removal (ECCO2R) as a standalone therapy or in combination with continuous renal replacement therapy (CRRT). This study is a multi-centre, prospective, open-label, single-arm study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mild to Moderate Acute Respiratory Distress Syndrome
- What is being tested?
- PrismaLung+
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 10 sitesFrance
- Study dates
- 30 Apr 2021to 10 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient age is ≥ 18 years old
- Patient is expected to receive ECCO2R for a minimum of 24 hours
- 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
- 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.
Who cannot join
- Patients body weight < 30 kg
- Patients with a contraindication for systemic anticoagulation with heparin
- Patients with a platelet count < 50,000/µL
- Patients on MV > 7 days
- Patients with very severe, or stage 4 (as per GOLD staging System) chronic obstructive pulmonary disease (COPD)
- Current or history of heparin-induced thrombocytopenia
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- Patients who are pregnant and/or breastfeeding
- Patients not expected to survive the duration of the planned study treatment period (24 hours)
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
Investigational Site
Besançon, 25030
Investigational Site
Colombes, 92700
Investigational Site
Créteil, 94010
Investigational Site
Lille, 59037
Investigational Site
Marseille, 13354
Investigational Site
Montpellier, 34295
Investigational Site
Paris, 75013
Investigational Site
Paris, 75651
Investigational Site
Strasbourg, 67098
Investigational Site
Vandœuvre-lès-Nancy, 54511
About this study
Official title: A Post-Market Study of Performance and Safety of Low-flow Extracorporeal Carbon Dioxide Removal Using PrismaLung+ in Patients With Mild to Moderate Acute Respiratory Distress Syndrome
PrismaLung+ is intended to provide extracorporeal carbon dioxide removal (ECCO2R) as a standalone therapy or in combination with continuous renal replacement therapy (CRRT). This study is a multi-centre, prospective, open-label, single-arm study. Adult patients with mild or moderate acute respiratory distress syndrome (ARDS) requiring mechanical ventilation were planned to receive ultra-lung protective ventilation (ULPV) associated with ECCO2R using PrismaLung+. The study will assess the capability of PrismaLung+ to allow ULPV, defined as a tidal volume (VT) of 4 mL/kg of predicted body weight, and confirm the safety of PrismaLung+.
- Being tested
- PrismaLung+
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrismaLung+Device
Overall, up to 60 adult patients will be initiated on ECCO2R using PrismaLung+. A minimum of approximately 15 patients will be treated with ECCO2R using PrismaLung+ as standalone therapy and another minimum of approximately 15 patients will receive ECCO2R using PrismaLung+ in combination with CRRT.
| Study group | Role | What they receive |
|---|---|---|
| Total Patient Population | Experimental | The planned PrismaLung+ treatment period for this study is 24 hours. Neuromuscular blockade and sedation will be required for the first 24 hours of ECCO2R treatment and thereafter, will be used at the discretion of the attending physician. Patients will require systemic anticoagulation with heparin during ECCO2R treatment. Blood warming during ECCO2R treatment will occur using the TherMax blood warmer. Receives: Device: PrismaLung+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants achieving ultra-lung protective ventilation (ULPV) 8 and 24 hours following ECCO2R initiation
Must maintain PaCO2 < 50 mmHg. ULPV is defined as defined as a tidal volume (VT) of 4 mL/kg of predicted body weight.
Measured: 8 and 24 hours following ECCO2R initiation
Adverse Events related to study device
Adverse event related to the use of a study device. This definition includes AEs resulting from insufficient or inadequate instructions for use, deployment, implantation, installation, or operation, or any malfunction of the study device.
This definition includes any event resulting from use error or from intentional misuse of the study device.
Measured: Day 1 to Day 28
Adverse Events related to study procedure
Adverse events related to the study procedure (ECCO2R or ECCO2R in combination with CRRT), irrespective of relatedness to the device.
Measured: Day 1 to Day 28
Adverse Device Effect (ADE)
This includes study device and study procedure related adverse events.
Measured: Day 1 to Day 28
Adverse Events leading to study withdrawal
Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in patients, users or other persons, in the context of a clinical investigation leading to study withdrawal.
Measured: Day 1 to Day 28
Adverse events of special interest (AESIs)
The AESI's for this study include significant bleeding events (i.e. require administration of ≥ 1 unit of packed red blood cells (pRBC) or result in a related SAE).
Measured: Day 1 to Day 28
Secondary outcomes (1)
Carbon dioxide clearance after ECCO2R treatment
CO2 clearance (mL/min) will be summarized descriptively by group and in total
Measured: 8 hours following ECCO2R initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start30 Apr 2021
- Primary completion5 Dec 2023
- Study completion10 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild to Moderate Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vantive Health LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04617093
- Sponsor's protocol ID
- BXU542357
- Status last verified
- Sep 2025
- First submitted
- 30 Oct 2020
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Combes A, Levy B, Tapponnier R, Capellier G, Mekontso Dessap A, Duburcq T, Castelain V, Forel JM, Uhel F, Mayaux J, Goldstein J, Kurz J, Harenski K, Montgomery W, Parreno R, Jaber S. A prospective clinical evaluation of new ECCO2R technology in mild to moderate ARDS patients: assessing ultra-lung-protective ventilation with PRISMALUNG. Crit Care. 2026 Jan 6;30(1):15. doi: 10.1186/s13054-025-05827-4.
PubMed 41495763
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Market Study of Performance and Safety of Low-flow Extracorporeal Carbon Dioxide Removal Using PrismaLung+ in Patients With Mild to Moderate Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT04617093
- Acronym / sponsor ID
- BXU542357
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Vantive Health LLCIndustry (pharma, biotech, devices)
- Collaborators
- Baxter Healthcare Corporation
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 5 Dec 2023 (actual)
- Study completion
- 10 Jan 2024 (actual)
- First posted
- 5 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PrismaLung+ is intended to provide extracorporeal carbon dioxide removal (ECCO2R) as a standalone therapy or in combination with continuous renal replacement therapy (CRRT). This study is a multi-centre, prospective, open-label, single-arm study. Adult patients with mild or moderate acute respiratory distress syndrome (ARDS) requiring mechanical ventilation were planned to receive ultra-lung protective ventilation (ULPV) associated with ECCO2R using PrismaLung+. The study will assess the capability of PrismaLung+ to allow ULPV, defined as a tidal volume (VT) of 4 mL/kg of predicted body weight, and confirm the safety of PrismaLung+.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total Patient Population | Experimental | Device: PrismaLung+The planned PrismaLung+ treatment period for this study is 24 hours. Neuromuscular blockade and sedation will be required for the first 24 hours of ECCO2R treatment and thereafter, will be used at the discretion of the attending physician. Patients will require systemic anticoagulation with heparin during ECCO2R treatment. Blood warming during ECCO2R treatment will occur using the TherMax blood warmer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient age is ≥ 18 years old
- Patient is expected to receive ECCO2R for a minimum of 24 hours
- Patient has mild or moderate ARDS according to the Berlin definition:
- 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.
Key exclusion criteria (9 listed)
- Patients body weight < 30 kg
- Patients with a contraindication for systemic anticoagulation with heparin
- Patients with a platelet count < 50,000/µL
- Patients on MV > 7 days
- Patients with very severe, or stage 4 (as per GOLD staging System) chronic obstructive pulmonary disease (COPD)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrismaLung+Overall, up to 60 adult patients will be initiated on ECCO2R using PrismaLung+. A minimum of approximately 15 patients will be treated with ECCO2R using PrismaLung+ as standalone therapy and another minimum of approximately 15 patients will receive ECCO2R using PrismaLung+ in combination with CRRT. | Device | Total Patient Population |
Primary outcome
Number of participants achieving ultra-lung protective ventilation (ULPV) 8 and 24 hours following ECCO2R initiation
Time frame: 8 and 24 hours following ECCO2R initiation
Must maintain PaCO2 < 50 mmHg. ULPV is defined as defined as a tidal volume (VT) of 4 mL/kg of predicted body weight.
Adverse Events related to study device
Time frame: Day 1 to Day 28
Adverse event related to the use of a study device. This definition includes AEs resulting from insufficient or inadequate instructions for use, deployment, implantation, installation, or operation, or any malfunction of the study device. This definition includes any event resulting from use error or from intentional misuse of the study device.
Adverse Events related to study procedure
Time frame: Day 1 to Day 28
Adverse events related to the study procedure (ECCO2R or ECCO2R in combination with CRRT), irrespective of relatedness to the device.
Adverse Device Effect (ADE)
Time frame: Day 1 to Day 28
This includes study device and study procedure related adverse events.
Adverse Events leading to study withdrawal
Time frame: Day 1 to Day 28
Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in patients, users or other persons, in the context of a clinical investigation leading to study withdrawal.
Adverse events of special interest (AESIs)
Time frame: Day 1 to Day 28
The AESI's for this study include significant bleeding events (i.e. require administration of ≥ 1 unit of packed red blood cells (pRBC) or result in a related SAE).
1 secondary outcome
Carbon dioxide clearance after ECCO2R treatment
Time frame: 8 hours following ECCO2R initiation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Derived from this study: PubMed 41495763Combes A, Levy B, Tapponnier R, Capellier G, Mekontso Dessap A, Duburcq T, Castelain V, Forel JM, Uhel F, Mayaux J, Goldstein J, Kurz J, Harenski K, Montgomery W, Parreno R, Jaber S. A prospective clinical evaluation of new ECCO2R technology in mild to moderate ARDS patients: assessing ultra-lung-protective ventilation with PRISMALUNG. Crit Care. 2026 Jan 6;30(1):15. doi: 10.1186/s13054-025-05827-4.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PrismaLung+ in people with Mild to Moderate Acute Respiratory Distress Syndrome, run by Vantive Health LLC at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants achieving ultra-lung protective ventilation (ULPV) 8 and 24 hours following ECCO2R initiation (time frame: 8 and 24 hours following ECCO2R initiation). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04617093, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025; AzTrials last refreshed its copy on 31 Oct 2026.