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.
Recruiting
N/A
Interventional Study
Acute Respiratory Distress Syndrome (ARDS)
Pneumonia
COPD (Chronic Obstructive Pulmonary Disease)
Postoperative Respiratory Distress
Hypoventilation Syndrome
Hypoxemia
Hypercapnia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Supportive Care
- Participants needed
- 81 (estimated)
- Sponsor
- Iconic Solutions By Murcia SL · Industry
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
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 discha…
Trial Locations
Loading…
Loading trial locations…
Eligibility Criteria
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 aeroso…
Contacts