New ventilator aims to help patients breathe easier in the ICU
NCT ID NCT07432191
First seen Jun 27, 2026 · Last updated Sep 15, 2026 · Updated 2 times
Summary
This trial is testing a new ventilator called INBENTUS VERSATILE in 81 adults who need help breathing. The study checks if the device is safe and works well for conditions like ARDS, pneumonia, and COPD. Participants will use the ventilator for 3 to 48 hours and be monitored until they leave the hospital or for up to 30 days.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- INBENTUS VERSATILE ventilator (a breathing machine)
- What this could lead to
- If successful, this ventilator could offer a safe and effective option for helping patients breathe during serious illness.
- What could go wrong
- This is an early-stage trial with only 81 participants, so results may not apply to everyone. The device is not yet CE-marked, meaning it hasn't been fully approved for use.
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
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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
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About 81 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Participants ≥ 18 years of age at the time of consent. * Participants requiring invasive mechanical ventilation for a period of ≥3 hours. * Participants must provide written informed consent. Exclusion Criteria: 1. Participants requiring anesthetic delivery systems or aerosol nebulizer systems. 2. Participants requiring modifications to the ventilator circuit, such as those treated with nitric oxide (iNO). 3. Any participant determined by the research team to be hemodynamically unstable, defined as: 1. MAP \< 65 mmHg despite vasoactive drugs. 2. Systolic Blood Pressure \> 180 mmHg. 3. Diastolic Blood Pressure \> 110 mmHg. 4. Severe volume loss (\>30% of blood volume) with persistent signs of hypoperfusion. 4. Life expectancy of less than 12 months. 5. Pregnant women at the time of informed consent.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Hospital Universitario Virgen de la Arrixaca
RECRUITINGMurcia, 30120, Spain
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