Ignite Creation Date:
2024-05-06 @ 7:32 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06040697
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2023-08-31
Brief Title:
Formative Usability Assessment of Wireless Thermal Anisotropy Devices
Sponsor:
Rhaeos Inc
Organization:
Rhaeos Inc
Study Overview
Official Title:
Formative Usability Assessment of Wireless Thermal Anisotropy Devices Measuring Flow in Cerebrospinal Fluid Shunts
Status:
RECRUITING
Status Verified Date:
2024-05
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:
Measurements of shunt flow will be performed non-invasively This study will generate usability data via observed tasks and comprehension questions to enable future device design improvements
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?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None