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.

Sponsor
Iconic Solutions By Murcia SL
Study ID
NCT07432191
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • INBENTUS VERSATILE Ventilation — DEVICE
    INBENTUS VERSATILE ventilation according to protocol specifications and clinical needs

Study Details

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.

Key Dates

First listed
Feb 25, 2026
Start date
May 29, 2025
Status verified
Feb 2026
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
81 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Safety and Performace evidence of INBENTUS VERSATILE
    INBENTUS VERSATILE ventilation according to protocol specifications

Primary Outcome Measure

Primary Safety Endpoint [ Time Frame: From 3 to 48 hours of mechanical ventilation under the study device ]

Central Contacts

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