An interventional study of INBENTUS VERSATILE in Acute Respiratory Distress Syndrome (ARDS), Pneumonia and COPD (Chronic Obstructive Pulmonary Disease), sponsored by Iconic Solutions By Murcia SL. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Iconic Solutions By Murcia SL · Not applicable, Interventional, and Supportive care
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.
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.
1,387 studies on the registry are indexed under Respiratory Distress Syndrome; 283 are open to participants now.
This study's planned enrollment of 81 is above the median of 60 across 822 interventional studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →This is the only study on the registry with Iconic Solutions By Murcia SL as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Any participant determined by the research team to be hemodynamically unstable, defined as:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: INBENTUS VERSATILE
INBENTUS VERSATILE ventilation according to protocol specifications and clinical needs
Primary Safety Endpoint
Serious adverse events related to INBENTUS VERSATILE is defined as the primary safety endpoint
Time frame: 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
Time frame: From 3 to 48 hours of mechanical ventilation under the study device
Plan to share: 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.
Supporting information: Clinical study report
Time frame: UNK
Access criteria: 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.
No publications or documents are linked to this record.
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Respiratory Distress Syndrome →