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.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07432191

Enrollment

Registered

2026-02-25

Start date

2025-05-29

Completion date

2026-12-01

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DEVICEINBENTUS VERSATILE

INBENTUS VERSATILE ventilation according to protocol specifications and clinical needs

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Primary Safety Endpoint	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
Primary Performance Endpoint	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

Countries

Spain

Contacts

CONTACTMar Gomez, Clinical Operations Manager

mar.gomez@inbentus.com+34 868965272

CONTACTAntonio Alarcón, Regulatory Affairs Director

a.alarcon@inbentus.com+34 868965272

STUDY_DIRECTORAntonio Alarcón, Regulatory Affairs Director

Iconic Solutions By Murcia SL

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 15, 2026