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

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)

Safety and Performace evidence of INBENTUS VERSATILE

EXPERIMENTAL

INBENTUS VERSATILE ventilation according to protocol specifications

Device: INBENTUS VERSATILE Ventilation

Interventions

INBENTUS VERSATILE Ventilation DEVICE

INBENTUS VERSATILE ventilation according to protocol specifications and clinical needs

Safety and Performace evidence of INBENTUS VERSATILE

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
• Hospital Universitario Virgen de la Arrixaca: collaborator
• Iberania Contract Research: 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): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: UNK
• Access Criteria: Raw IPD data is not going to be available for general public. We may share statistics conclusions for comecial device support.

Locations

ES (1)