Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
Study NCT ID:
NCT05547412
Status:
TERMINATED
Last Update Posted:
2024-04-09
First Post:
2022-09-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Validation of Velocity Curvature Index as a Diagnostic Biomarker Tool for Assessment of Large Vessel Stroke
Sponsor:
NovaSignal Corp.
Organization:
Study Overview
Official Title:
Validation of Velocity Curvature Index as a Diagnostic Biomarker Tool for Assessment of Large Vessel Stroke
Status:
TERMINATED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
enrollment, administrative/finance
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VOICE
Brief Summary:
This study is a multi-center, multi-phase, multi-cohort, prospective, randomized, open, blinded endpoint (PROBE), non-significant risk (NSR) device study including up to 420 evaluable subjects measured with the study device(s) and up to 40 non-evaluable subjects for the training phase.
Detailed Description:
The purpose of this study is to collect robust data from NovaGuide 2 Intelligent Ultrasound System to validate the Velocity Curvature Index (VCI) as a diagnostic biomarker tool to drive clinical decision making for assessing cerebral vascular occlusions confirmed by standard of care Computed Tomography Angiography (CTA) imaging.
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?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U44NS109952 | NIH | None | https://reporter.nih.gov/quic… | View |