Acute Respiratory Distress Syndrome (ARDS)NCT07432191
Medical Device Clinical Trial Without CE Marking to Evidence Safety and Performance of the INBENTUS VERSATILE Ventilator in Patients Requiring Assisted/Controlled Mechanical Ventilation and Weaning.
A study testing INBENTUS VERSATILE in people with Acute Respiratory Distress Syndrome (ARDS) and Pneumonia, run by Iconic Solutions By Murcia SL at 1 site in Spain.
Trial summary
Pre-market clinical trial on 81 aldults participants to evidence safety and performance of the non-CE-marked medical device INBENTUS VERSATILE ventilator. The 81 aldult participants are ventilated between 3 and 48 hours with invasive mechanical ventilation (IMV) in assisted/controlled mode and weaning under partial… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome (ARDS), Pneumonia, COPD (Chronic Obstructive Pulmonary Disease)
- What is being tested?
- INBENTUS VERSATILE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteSpain
- Study dates
- 29 May 2025to Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Participants requiring anesthetic delivery systems or aerosol nebulizer systems.
- Participants requiring modifications to the ventilator circuit, such as those treated with nitric oxide (iNO).
- Any participant determined by the research team to be hemodynamically unstable, defined as:
- MAP < 65 mmHg despite vasoactive drugs.
- Systolic Blood Pressure > 180 mmHg.
- Diastolic Blood Pressure > 110 mmHg.
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- Severe volume loss (>30% of blood volume) with persistent signs of hypoperfusion.
- Life expectancy of less than 12 months.
- Pregnant women at the time of informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Virgen de la Arrixaca
Murcia, 30120
About this study
Pre-market clinical trial on 81 aldults participants to evidence safety and performance of the non-CE-marked medical device INBENTUS VERSATILE ventilator.
The 81 aldult participants are ventilated between 3 and 48 hours with invasive mechanical ventilation (IMV) in assisted/controlled mode and weaning under partial pressure support or volume support, followed by monitoring period until ICU discharge, hospital discharge or 30 days.
Read more
The study design differentiates between a Validation Cohort (up to 20 participants) for device validation and a Study Cohort (up to 61 participants) for safety and performance confirmation.
Serious Adverse Events related to study device and/or its procedure is defined as the primary safety endpoint, whereas technical failure rate is defined as the primary performance endpoint.
- Conditions
- Acute Respiratory Distress Syndrome (ARDS), Pneumonia, COPD (Chronic Obstructive Pulmonary Disease), Postoperative Respiratory Distress, Hypoventilation Syndrome, Hypoxemia
- Being tested
- INBENTUS VERSATILE
- Medical subject headings
- Respiratory Distress Syndrome, Pneumonia, Pulmonary Disease, Chronic Obstructive, Hypoxia, Hypercapnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INBENTUS VERSATILEDevice
INBENTUS VERSATILE ventilation according to protocol specifications and clinical needs
| Study group | Role | What they receive |
|---|---|---|
| INBENTUS VERSATILE ventilation according to protocol specifications | Experimental | Not described Receives: Device: INBENTUS VERSATILE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint
Serious adverse events related to INBENTUS VERSATILE is defined as the primary safety endpoint
Measured: From 3 to 48 hours of mechanical ventilation under the study device
Primary Performance Endpoint
Technical failure rate of INBENTUS VERSATILE is defined as the primary performance endpoint
Measured: From 3 to 48 hours of mechanical ventilation under the study device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start29 May 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress Syndrome (ARDS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iconic Solutions By Murcia SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Universitario Virgen de la Arrixaca, Iberania Contract Research
- Responsible party
- Sponsor
- Investigators
- Antonio Alarcón, Regulatory Affairs Director, Study director, Iconic Solutions By Murcia SL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07432191
- Sponsor's protocol ID
- IMIB-VTL-2023-01
- Status last verified
- Sep 2026
- First submitted
- 5 Feb 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Raw individual patient data (IPD) data will not be publicly available. However, aggregated statistical results or study conclusions may be published for the commercial support of the device.