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.

Iconic Solutions By Murcia SL81 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Acute Respiratory Distress Syndrome (ARDS)Pneumonia COPD (Chronic Obstructive Pulmonary Disease)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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: 1. Participants requiring anesthetic delivery systems or aerosol nebulizer systems. 2. Participants requiring modifications to the ventilator circuit, such as those treated with nitric oxide (iNO). 3. Any participant determined by the research team to be hemodynamically unstable, defined as: 1. MAP \< 65 mmHg despite vasoactive drugs. 2. Systolic Blood Pressure \> 180 mmHg. 3. Diastolic Blood Pressure \> 110 mmHg. 4. Severe volume loss (\>30% of blood volume) with persistent signs of hypoperfusion. 4. Life expectancy of less than 12 months. 5. Pregnant women at the time of informed consent.

Outcomes

Primary Outcomes

Primary Safety Endpoint

Serious adverse events related to INBENTUS VERSATILE is defined as the primary safety endpoint

Time frame: From 3 to 48 hours of mechanical ventilation under the study device

Primary Performance Endpoint

Technical failure rate of INBENTUS VERSATILE is defined as the primary performance endpoint

Time frame: From 3 to 48 hours of mechanical ventilation under the study device

Central Contacts

Mar Gomez, Clinical Operations Manager

CONTACT

+34 868965272 mar.gomez@inbentus.com

Antonio Alarcón, Regulatory Affairs Director