Trials / Recruiting
RecruitingNCT07432191
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 81 (estimated)
- Sponsor
- Iconic Solutions By Murcia SL · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DEVICE | INBENTUS VERSATILE Ventilation | INBENTUS VERSATILE ventilation according to protocol specifications and clinical needs |
Timeline
- Start date
- 2025-05-29
- Primary completion
- 2026-11-01
- Completion
- 2026-11-01
- First posted
- 2026-02-25
- Last updated
- 2026-02-25
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT07432191. Inclusion in this directory is not an endorsement.