Post-Market Study of Low-flow ECCO2R Using PrismaLung+

NCT04617093 | Completed

• 1 other identifier: BXU542357
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 10

Brief 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. 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+.

Conditions

Mild to Moderate Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  Day 1 to Day 28

• Adverse Device Effect (ADE)

  This includes study device and study procedure related adverse events.

  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.

  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).

  Day 1 to Day 28

Secondary Outcomes (1)

• Carbon dioxide clearance after ECCO2R treatment

  8 hours following ECCO2R initiation

Study Arms (1)

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.

Device: PrismaLung+

Interventions

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.

Total Patient Population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Vantive Health LLC: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (10)

Investigational Site

Besançon, 25030, France

Location

Investigational Site

Colombes, 92700, France

Location

Investigational Site

Créteil, 94010, France

Location

Investigational Site

Lille, 59037, France

Location

Investigational Site

Marseille, 13354, France

Location

Investigational Site

Montpellier, 34295, France

Location

Investigational Site

Paris, 75013, France

Location

Investigational Site

Paris, 75651, France

Location

Investigational Site

Strasbourg, 67098, France

Location

Investigational Site

Vandœuvre-lès-Nancy, 54511, France

Location

Related Publications (1)

• Combes A, Levy B, Tapponnier R, Capellier G, Dessap AM, 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. doi: 10.1186/s13054-025-05827-4. Online ahead of print.

  PMID: 41495763 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2020
• First Posted: November 5, 2020
• Study Start: April 30, 2021
• Primary Completion: December 5, 2023
• Study Completion: January 10, 2024
• Last Updated: October 1, 2025

Record last verified: 2025-09

Locations

FR (10)