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NCT Number: NCT07432191

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.

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Key information

Conditions

Acute Respiratory Distress Syndrome (ARDS) COPD (Chronic Obstructive Pulmonary Disease) Chronic Disease Disease Attributes Hypercapnia Hypoventilation Syndrome Hypoxemia Hypoxia Infections Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Postoperative Respiratory Distress Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Virgen de la Arrixaca

Murcia, 30120, Spain

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

INBENTUS VERSATILE Ventilation

Device

INBENTUS VERSATILE ventilation according to protocol specifications and clinical needs

Primary outcomes

  1. Primary Safety Endpoint

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

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

  2. Primary Performance Endpoint

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Antonio Alarcón, Regulatory Affairs Director

CONTACT

[email protected]

+34 868965272

Mar Gomez, Clinical Operations Manager

CONTACT

[email protected]

+34 868965272

Sponsors and collaborators

Lead sponsor

Iconic Solutions By Murcia SL

Industry

Collaborators

  • Hospital Universitario Virgen de la Arrixaca
  • Iberania Contract Research

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 25, 2026
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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