Validation of Neurokeeper's Algorithm on Patients Undergoing Carotid Endarterectomy

Recruiting

Phase N/A Results N/A

Trial Description

The primary objective of the study is to validate an EEG base algorithm system to detect and monitor changes in cerebral electrophysiological parameters as compared to clinical evaluation in patients undergoing Carotid Endarterectomy.
The secondary objectives is measure time from ICA clamping to algorithm asymmetry detection, time from clinical deterioration to algorithm asymmetry detection Thi study is a prospective, open label, single arm, self control, single center study.
This study will be conducted in 50 subjects according to the inclusions/exclusions criteria.

Conditions

Interventions

  • Neurokeeper stroke detector Device
    Intervention Desc: Electrophisoloigcal monitoring
    ARM 1: Kind: Experimental
    Label: Patients undergoing cartoid endarterectomy surgery

Trial Design

  • Observation: Cohort
  • Perspective: Prospective
  • Sampling: Non-Probability Sample

Trial Population

Patients undergoing Carotid Endarterectomy

Outcomes

Type Measure Time Frame Safety Issue
Primary Neurological detrioration detection No
Secondary Time from deterioration to detection No

Sponsors