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.

NCT07432191 | Recruiting

• 1 other identifier: IMIB-VTL-2023-01
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Respiratory Distress Syndrome (ARDS); Hypoventilation Syndrome; Hypercapnia; Pneumonia; Hypoxemia; COPD (Chronic Obstructive Pulmonary Disease); Postoperative Respiratory Distress

Outcome Measures

Primary Outcomes (2)

• Primary Safety Endpoint

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

  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

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

Study Arms (1)

INBENTUS VERSATILE ventilation according to protocol specifications

EXPERIMENTAL

Device: INBENTUS VERSATILE

Interventions

INBENTUS VERSATILE DEVICE

INBENTUS VERSATILE ventilation according to protocol specifications and clinical needs

INBENTUS VERSATILE ventilation according to protocol specifications

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Iconic Solutions By Murcia SL: lead
• Iberania Contract Research: collaborator
• Hospital Universitario Virgen de la Arrixaca: collaborator

Study Sites (1)

Hospital Universitario Virgen de la Arrixaca

Murcia, 30120, Spain

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome; Pneumonia; Pulmonary Disease, Chronic Obstructive; Hypoxia; Hypercapnia

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Respiratory Tract Infections; Infections; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Antonio Alarcón, Regulatory Affairs Director

  Iconic Solutions By Murcia SL

  STUDY DIRECTOR

Central Study Contacts

Mar Gomez, Clinical Operations Manager

CONTACT

+34 868965272; mar.gomez@inbentus.com

Antonio Alarcón, Regulatory Affairs Director

CONTACT

+34 868965272; a.alarcon@inbentus.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 25, 2026
• Study Start: May 29, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 14, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: UNK
• Access Criteria: Raw individual patient data (IPD) data will not be publicly available. However, aggregated statistical results or study conclusions may be published for the commercial support of the device.

Locations

ES (1)