NCT07432191Recruiting
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.
Source: ClinicalTrials.gov · Last updated 14 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 81 (estimated)
- First submitted
- 5 Feb 2026
- Start date
- 29 May 2025
- Primary completion date
- Dec 2026
- Lead sponsor
- Iconic Solutions By Murcia SL
- Diseases
- COPD
- NCT number
- NCT07432191
What you commit to
- Study type: Interventional
- Planned participants: 81
- From 29 May 2025 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Severe volume loss (\>30% of blood volume) with persistent signs of hypoperfusion.
Other
- Participants requiring anesthetic delivery systems or aerosol nebulizer systems.
- Life expectancy of less than 12 months.
- Pregnant women at the time of informed consent.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario Virgen de la Arrixaca Coordinator of this site? Confirm its status | Murcia | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.