Ignite Creation Date:
2025-12-24 @ 3:27 PM
Ignite Modification Date:
2026-01-16 @ 9:29 AM
Study NCT ID:
NCT06524492
Status:
COMPLETED
Last Update Posted:
2025-03-11
First Post:
2024-07-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Flow Measurements in Functional CSF Shunts and Off-Shunt Locations with a Second-Generation Thermal Device
Sponsor:
Rhaeos, Inc.
Organization:
Study Overview
Official Title:
Measurements of Flow in Functional Cerebrospinal Fluid Shunts and Off-Shunt Locations with a Second-Generation Wireless Thermal Anisotropy Measurement Device
Status:
COMPLETED
Status Verified Date:
2025-03
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:
This study compares the performance of two generations of non-invasive cerebrospinal fluid (CSF) shunt flow assessment devices. Measurements of functional implanted shunts and off-shunt locations will assess the diagnostic non-inferiority of the second-generation device to the first-generation device.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: