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 now · Not applicable
Conditions studied: Acute Respiratory Distress Syndrome (ARDS), Pneumonia, COPD (Chronic Obstructive Pulmonary Disease), Postoperative Respiratory Distress, Hypoventilation Syndrome, Hypoxemia, Hypercapnia
In brief
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.
Key facts
- Study ID
- NCT07432191
- Run by
- Iconic Solutions By Murcia SL
- People needed
- 81
- Starts
- 2025-05-29
- Expected to finish
- 2026-11-01
- Last updated by the study team
- 2026-02-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
- Hospital Universitario Virgen de la Arrixaca — Murcia, Spain (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.