HaGuide version 1.0 (Neuro-Omega Ltd.) is a software module add-on to the FDA cleared Neuro-Omega System (K123796). It was designed to facilitate the use of Neuro-Omega's system by automatically mapping visually the depth of STN landmarks intra-operatively. HaGuide algorithm computes and displays the STN entry and exit, as well as introduces a detection of a distinct DLOR-VMNR boundary. HaGuide visual display is added to the UI and it is supplementing and not replacing the previously cleared standard display (visual and audio) of the system.
Study Type
OBSERVATIONAL
Enrollment
103
HaGuide vs. Neurosurgeon measurements
Percent agreement between HaGuide software measurements and expert Neurosurgeon/Electrophysiologist measurements
Time frame: 2 weeks
DLOR vs. VMNR
Length (mm) of Dorso-Lateral Oscillatory Region (DLOR) vs. Ventro-Medial Non-Oscillatory Region (VMNR);
Time frame: 2 weeks
DLOR Entry/exit
Entry/exit from DLOR (depth in mm)
Time frame: 2 weeks
STN Length
Length of STN track (mm
Time frame: 2 weeks
DBS implant optimal track Identification
Percent agreement in DBS implant optimal track Identification by percent agreement between HaGuide and Neurosurgeon choice of optimal track for DBS implant
Time frame: 2 weeks
Sites/Users comparison
Sub-group analysis to determine the variation between sites by percent agreement between HaGuide software measurements and expert Neurosurgeon/Electrophysiologist measurements
Time frame: 2 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.