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

NCT07326215 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2026-02-17

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

PrismaLung+

PrismaLung+ is a medical device that provides ECCO2R as a stand-alone therapy or in combination with CRRT. The planned treatment duration with PrismaLung+ for patients in the study group is 7 days. However, the Investigator can discontinue PrismaLung+ treatment before 7 days if ECCO2R is no longer required. Following the 7-day treatment period, the Investigator will assess the patient's condition to determine whether to continue ECCO2R. Patients will require systemic anticoagulation with heparin during ECCO2R treatment. Continuous renal replacement therapy may be administered concurrently to patients during the study, if needed, at the discretion of the Investigator. During the study, patients will be given active treatment for their primary disease.

OTHER

Invasive Mechanical Ventilation

According to the standard clinical practice of IMV, oral or nasal endotracheal intubation can be used for IMV. The initial mode of IMV and ventilatory parameters will be determined based on the patient's condition, and an appropriate patient-centered LPV approach will be selected to adjust the ventilatory parameters to achieve the study LPV strategy. Appropriate treatments other than ECCO2R will be provided for this group. Continuous renal replacement therapy may be administered concurrently to patients during the study, if needed, at the discretion of the Investigator. During the study, patients will be given active treatment for their primary disease.

Sponsors & Collaborators

  • Vantive Health LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-11
Primary Completion
2026-08-31
Completion
2026-08-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07326215 on ClinicalTrials.gov