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
Among 62 studies in Respiratory Distress Syndrome with a site in Spain — 9 open to participants now, 10 under way, 2 of them phase 3. Respiratory Distress Syndrome · Spain.
Among the 62 studies in Respiratory Distress Syndrome with a site in Spain, this one is the 23rd largest by planned enrollment of the 37 interventional ones that give a count, is one of 3 that started in 2025, is one of 12 with no phase, and was the 62nd registered.
1,387 studies on the registry are indexed under Respiratory Distress Syndrome; 283 are open to participants now.
Browse Respiratory Distress Syndrome studies →9 of the 62 studies in Respiratory Distress Syndrome with a site in Spain are open now. Recruiting first, the newest first:
Fundacion del Hospital Nacional de Paraplejicos para la Investigacion y la Integracion · Sites in Spain
University College Dublin · Sites in Spain, Croatia, Czechia and 6 more countries
Ricard Mellado Artigas · Sites in Spain
BioAegis Therapeutics Inc. · Sites in Spain, United States, Belgium and 10 more countries
PEACHES BIOTECH · Sites in Spain
A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →
Of the 193 Respiratory Distress Syndrome studies recruiting now, 118 (61%) set no upper age limit and 48 (25%) stop at 75 or younger; 51 take children under 18; 8 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
62 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 15 · Phase 3 9 · Phase 4 2
First in 2001; this study’s year is marked. 3 started in 2025.
This study's planned enrollment of 81 is above the median of 60 across 822 interventional studies indexed under Respiratory Distress Syndrome.
Median enrollment 100 across the 37 interventional studies, 361 across the 24 observational. Of the 40 that completed or were terminated, 5 (13%) have results posted.
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17 of 62 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Iconic Solutions By Murcia SL as lead sponsor.
Iconic Solutions By Murcia SL has 1 study filed under Respiratory Distress Syndrome — fewer than ten, so there is no comparison to draw.
5 of the studies in Respiratory Distress Syndrome with a site in Spain that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05624450Phase 3AstraZenecaEfficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen | 2027-11-04 |
| NCT07432191Iconic Solutions By Murcia SLMedical 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. | 2026-12 |
| NCT04460859Unity Health TorontoRecruitmEnt Assessed by eleCtRical Impedance Tomography | 2026-12 |
| NCT05388708University of MichiganARDS in Children and ECMO Initiation Strategies Impact on Neurodevelopment (ASCEND) | 2027-06-30 |
| NCT05947955BioAegis Therapeutics Inc.Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS) | 2027-10-01 |
Among the 62 studies in Respiratory Distress Syndrome with a site in Spain, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
Started May 2025 (actual). Primary completion is estimated for Dec 2026, 19 months after the start.
Of 270 interventional studies with no phase under Respiratory Distress Syndrome, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 42. This study's planned 19 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Respiratory Distress Syndrome →