Clinical Trial

A Study of the Efficacy and Safety of Extracorporeal Carbon Dioxide Removal Using PrismaLung+

Recruiting
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Summary
PrismaLung+ is a sterile, single-use medical device aimed at performing partial removal of carbon dioxide (CO2) from the patient's venous blood via diffusion through a membrane. The goal of this prospective, open label, randomized controlled study is to evaluate the efficacy and safety of PrismaLung+ on extracorporeal carbon dioxide removal (ECCO2R) in critically ill patients under invasive mechanical ventilation (IMV). Patients will be randomized to receive either IMV combined with ECCO2R (using PrismaLung+) in the study group or IMV alone in the control group, at a ratio of 2:1.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-12-23.
Status change: Not Yet Recruiting → Recruiting 2026-02-12
Trial Details
NCT Number NCT07326215
Lead Sponsor Vantive Health LLC
Conditions Acute Respiratory Distress Syndrome, Acute Kidney Injury
Enrollment 99 participants
Start Date 2025-12-11
Primary Completion 2026-08-31 (estimated)
Study Completion 2026-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-02-17