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

Not Applicable

Completed

• Conditions: Mild to Moderate Acute Respiratory Distress Syndrome

• Registration Number: NCT04617093
• Lead Sponsor: Vantive Health LLC

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+.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-30
• Study First Submitted QC: 2020-10-30
• Study First Posted: 2020-11-05
• Study Start: 2021-04-30
• Primary Completion: 2023-12-05
• Study Completion: 2024-01-10
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-25
• Last Update Posted: 2025-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of participants achieving ultra-lung protective ventilation (ULPV) 8 and 24 hours following ECCO2R initiation	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 procedure	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 Events leading to study withdrawal	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)	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).
Adverse Events related to study device	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 Device Effect (ADE)	Day 1 to Day 28	This includes study device and study procedure related adverse events.

Secondary Outcome Measures

Name	Time	Method
Carbon dioxide clearance after ECCO2R treatment	8 hours following ECCO2R initiation	CO2 clearance (mL/min) will be summarized descriptively by group and in total

Trial Locations

Locations (1)

Investigational Site; 🇫🇷 Vandœuvre-lès-Nancy, France