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.

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.

NCT Number	NCT07432191
Lead Sponsor	Iconic Solutions By Murcia SL Collaborators: Hospital Universitario Virgen de la Arrixaca, Iberania Contract Research
Conditions	Acute Respiratory Distress Syndrome (ARDS), Pneumonia, COPD (Chronic Obstructive Pulmonary Disease), Postoperative Respiratory Distress, Hypoventilation Syndrome, Hypoxemia, Hypercapnia
Enrollment	81 participants
Start Date	2025-05-29
Primary Completion	2026-11 (estimated)
Study Completion	2026-11 (estimated)
Updated on ClinicalTrials.gov	2026-02-25