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.

Study Overview

• Status: Recruiting
• Conditions: Pneumonia; Hypoxemia; Hypercapnia; Acute Respiratory Distress Syndrome (ARDS); Hypoventilation Syndrome; COPD (Chronic Obstructive Pulmonary Disease); Postoperative Respiratory Distress
• Intervention / Treatment: Device: INBENTUS VERSATILE Ventilation

• Study Type: Interventional
• Enrollment (Estimated): 81
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mar Gomez, Clinical Operations Manager; Phone Number: +34 868965272; Email: mar.gomez@inbentus.com
• Study Contact Backup: Name: Antonio Alarcón, Regulatory Affairs Director; Phone Number: +34 868965272; Email: a.alarcon@inbentus.com

Study Locations

• Spain
  • Murcia, Spain, 30120
    • Recruiting
    • Hospital Universitario Virgen de la Arrixaca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Safety and Performace evidence of INBENTUS VERSATILE; INBENTUS VERSATILE ventilation according to protocol specifications	Device: INBENTUS VERSATILE Ventilation; INBENTUS VERSATILE ventilation according to protocol specifications and clinical needs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Iconic Solutions By Murcia SL
• Collaborators: Hospital Universitario Virgen de la Arrixaca; Iberania Contract Research
• Investigators: Study Director: Antonio Alarcón, Regulatory Affairs Director, Iconic Solutions By Murcia SL

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: February 5, 2026
• First Submitted That Met QC Criteria: February 18, 2026
• First Posted (Actual): February 25, 2026

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 18, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Lung Diseases, Obstructive; Signs and Symptoms, Respiratory; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pulmonary Disease, Chronic Obstructive; Respiratory Distress Syndrome; Pneumonia; Hypoxia; Hypercapnia
• Other Study ID Numbers: IMIB-VTL-2023-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

It is expected to share statistics study results based on IPD data for comercial device support.

Nevertheless, It is not expected to share raw IPD data with other investigators to develop further publications.

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No