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.
Recruiting · NCT07432191 · Interventional (participants receive a specific treatment) · Lead sponsor: Iconic Solutions By Murcia SL
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
- 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.
- 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.
Where it is running
1 location listed.
- Hospital Universitario Virgen de la Arrixaca - Murcia, Spain