Actively Recruiting
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.
Led by Iconic Solutions By Murcia SL · Updated on 2026-02-25
81
Participants Needed
1
Research Sites
74 weeks
Total Duration
On this page
Sponsors
I
Iconic Solutions By Murcia SL
Lead Sponsor
H
Hospital Universitario Virgen de la Arrixaca
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants 18 years of age or older at the time of consent
- Require invasive mechanical ventilation for a period of at least 3 hours
- Provide written informed consent
You will not qualify if you...
- Require anesthetic delivery systems or aerosol nebulizer systems
- Need modifications to the ventilator circuit, such as treatment with nitric oxide (iNO)
- Are hemodynamically unstable, defined as mean arterial pressure (MAP) below 65 mmHg despite vasoactive drugs, systolic blood pressure above 180 mmHg, diastolic blood pressure above 110 mmHg, or severe volume loss (>30% of blood volume) with persistent hypoperfusion
- Have a life expectancy of less than 12 months
- Are pregnant at the time of informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hospital Universitario Virgen de la Arrixaca
Murcia, Spain, 30120
Actively Recruiting
Research Team
M
Mar Gomez, Clinical Operations Manager
CONTACT
A
Antonio Alarcón, Regulatory Affairs Director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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