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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.

ConditionsAcute Respiratory Distress Syndrome (ARDS)PneumoniaCOPD (Chronic Obstructive Pulmonary Disease)Postoperative Respiratory DistressHypoventilation SyndromeHypoxemiaHypercapnia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIconic Solutions By Murcia SL

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Participants requiring anesthetic delivery systems or aerosol nebulizer systems.

Participants requiring modifications to the ventilator circuit, such as those treated with nitric oxide (iNO).

MAP < 65 mmHg despite vasoactive drugs.

Systolic Blood Pressure > 180 mmHg.

Trial design

Design model

Single group

Treatments tested in this trial

  • INBENTUS VERSATILE

    Device

    INBENTUS VERSATILE ventilation according to protocol specifications and clinical needs

Treatment groups

81 Participants
are divided into 1 treatment group
Group A: INBENTUS VERSATILE ventilation according to protocol specificationsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Iconic Solutions By Murcia SL

Lead sponsor

Hospital Universitario Virgen de la Arrixaca

Collaborator

Iberania Contract Research

Collaborator

Source ClinicalTrials.gov
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