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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 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2026-02-25

No results posted yet for this study

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

Interventions

DEVICE

INBENTUS VERSATILE Ventilation

INBENTUS VERSATILE ventilation according to protocol specifications and clinical needs

Sponsors & Collaborators

  • Hospital Universitario Virgen de la Arrixaca

    collaborator OTHER

  • Iberania Contract Research

    collaborator UNKNOWN

  • Iconic Solutions By Murcia SL

    lead INDUSTRY

Principal Investigators

  • Antonio Alarcón, Regulatory Affairs Director · Iconic Solutions By Murcia SL

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-29
Primary Completion
2026-11-30
Completion
2026-11-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07432191 on ClinicalTrials.gov