Condition: Acute Respiratory Distress Syndrome (ARDS) · Pneumonia · COPD (Chronic Obstructive Pulmonary Disease) · Sponsor: Iconic Solutions By Murcia SL
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.
This description comes directly from the study's public registry record.
Mar Gomez, Clinical Operations Manager · +34 868965272 · mar.gomez@inbentus.com
Antonio Alarcón, Regulatory Affairs Director · +34 868965272 · a.alarcon@inbentus.com
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| Hospital Universitario Virgen de la Arrixaca | Murcia, Spain | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07432191