NCT05547412

Validation of Velocity Curvature Index as a Diagnostic Biomarker Tool for Assessment of Large Vessel Stroke

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 27 (actual)
• Sponsor: NovaSignal Corp. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke
• Acute Ischemic Stroke

Interventions

Type	Name	Description
DEVICE	NovaGuide 2 Intelligent Ultrasound System	The NovaGuide 2 Intelligent Ultrasound system is an adjunctive mobile, non-invasive, non-ionizing radiation transcranial Doppler (TCD) diagnostic ultrasound system. The system contains a transcranial doppler ultrasound equipment combined with robotic mechanisms used to position ultrasound probes, which assist the user in the acquisition of cerebral blood flow velocity (CBFV) data via a patient's temporal acoustic windows.

Timeline

• Start date: 2022-09-21
• Primary completion: 2023-01-16
• Completion: 2023-01-31
• First posted: 2022-09-21
• Last updated: 2024-04-09
• Results posted: 2024-04-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study