Ignite Creation Date:
2024-05-06 @ 5:41 PM
Last Modification Date:
2024-10-26 @ 2:34 PM
Study NCT ID:
NCT05399017
Status:
UNKNOWN
Last Update Posted:
2022-06-03
First Post:
2022-05-24
Brief Title:
Clinical Evaluation of EZVent in Hospitalized Mechanically Ventilated Patients
Sponsor:
Triclinium Clinical Development Middle East and North Africa
Organization:
Triclinium Clinical Development Middle East and North Africa
Study Overview
Official Title:
Open-labeled Non-randomized Self-controlled Study to Evaluate the Safety and Performance of EZVent in Hospitalized Mechanically Ventilated Patients
Status:
UNKNOWN
Status Verified Date:
2022-06
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Investigation Device EZVent Ventilator System is designed for respiratory support in hospitalized mechanical ventilated patients The Ventilator is designed to be used for adults patients It is designed to be a stationary product suitable for service in hospitals critical care situations to provide continuous positive pressure respiratory support to the patient The ventilator met EDA ISO 80601-2-12 requirements on essential performance of critical care ventilator and other applicable international standards
Study Title Open-labeled non-randomized self-controlled study to evaluate the safety and performance of EZVent in hospitalized mechanically ventilated patients Investigational Device EZVent Ventilator System
Purpose Evaluation of the safety and performance of EZVent in hospitalized mechanically ventilated patients
Objectives Evaluation of the safety and performance of EZVent through monitoring the vital signs and arterial blood gases ABG in comparison to a commercial ventilator
Study Title Open-labeled non-randomized self-controlled study to evaluate the safety and performance of EZVent in hospitalized mechanically ventilated patients Investigational Device EZVent Ventilator System
Purpose Evaluation of the safety and performance of EZVent in hospitalized mechanically ventilated patients
Objectives Evaluation of the safety and performance of EZVent through monitoring the vital signs and arterial blood gases ABG in comparison to a commercial ventilator
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None