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New device aims to help ventilator patients breathe easier by scrubbing CO2 from blood

NCT ID NCT07326215

Disease control Sponsor: Vantive Health LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 17, 2026 · Updated 4 times

Summary

This study tests a device called PrismaLung+ that removes carbon dioxide from the blood of critically ill patients who are on breathing machines. The trial will include 99 adults with acute respiratory distress syndrome or kidney injury. Half will receive standard care plus the device, while the other half gets standard care alone. The goal is to see if the device safely lowers carbon dioxide levels and improves outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PrismaLung+ device (extracorporeal carbon dioxide removal system)
What this could lead to
If successful, this device could help critically ill patients on ventilators by safely lowering carbon dioxide levels, potentially reducing lung damage and improving recovery.
What could go wrong
This is an early-stage trial with only 99 participants, so results may not apply to all patients. The device requires blood thinning, which carries bleeding risks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 99 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥ 18 years old. 2. Invasive mechanical ventilation patients with PaCO2 \> 50 mmHg and pH \< 7.4 under LPV strategy (RR \< 25/min, DP \< 15 cmH2O). 3. Expected to be able to tolerate ECCO2R for a minimum of 2h. 4. Patients signed a written informed consent; if the right to consent cannot be exercised due to loss of decision-making ability or impairment of consciousness, the legal representative or immediate family member must sign the informed consent document after fully understanding the research content. Exclusion Criteria: 1. Body weight \< 30 kg. 2. Has a contraindication for systemic anticoagulation with heparin according to the Investigator. 3. Patient unable to establish extracorporeal circulation access or has a high risk of establishing such access, as judged by the Investigator. 4. Allergic to the investigational device/tubing, and/or to the CRRT filters/tubing if combined with CRRT treatment. 5. Expected to require extracorporeal membrane oxygenator (ECMO) treatment within 24h after enrollment. 6. Patient's primary disease is expected to worsen rapidly or require other surgical intervention within 24h after enrollment. 7. Diagnosed as brain dead or in a vegetative state. 8. Pregnant and/or breastfeeding. 9. Plans to participate in other device studies within 30 days before screening or during the study period or has completed any clinical drug study within 5 half lives of the investigational drug. 10. Patients is considered as unsuitable for participating in the study, as judged by the Investigator.

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Conditions

The condition(s) this trial relates to.

acute kidney injury acute respiratory distress syndrome adult acute respiratory distress syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute kidney injury Acute respiratory distress syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    10 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • China-Japan Friendship Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100029, China

  • Sichuan Provincial People's Hospital

    RECRUITING

    Chengdu, Sichuan, 610072, China

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310016, China

  • The First Affiliated Hospital Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310003, China

  • The First Affiliated Hospital of Guangzhou Medical University

    NOT_YET_RECRUITING

    Guangzhou, Guangdong, 510630, China

  • The First Affiliated Hospital of Harbin Medical University

    RECRUITING

    Harbin, Heilongjiang, 150001, China

  • The First Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, Jiangxi, 330006, China

  • The University of Hong Kong-Shenzhen Hospital

    RECRUITING

    Shenzhen, Guangdong, 518053, China

  • ZhongShan Hospital Fudan University

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

  • Zhongda Hospital Southeast University

    RECRUITING

    Nanjing, Jiangsu, 210009, China

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