Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04865640
Status:
COMPLETED
Last Update Posted:
2021-04-30
First Post:
2021-04-23
Brief Title:
Clinical Validation Study for Noninvasive Cardiopulmonary Management Device
Sponsor:
Analog Device Inc
Organization:
Analog Device Inc
Study Overview
Official Title:
Clinical Validation Study for Noninvasive Cardiopulmonary Management Device
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
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:
The ADI At-Home CPM Cardiopulmonary Management System is a non-invasive device that measures and trends a variety of biological parameters
This study will be conducted as a prospective non-randomized study with two study armscohorts - one of healthy adult patients one of pathologic patients who fit into the intended use population of the CPM System
This study will be conducted as a prospective non-randomized study with two study armscohorts - one of healthy adult patients one of pathologic patients who fit into the intended use population of the CPM System
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None