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Validation of HaGuide Software Module Accuracy in Mapping STN Boundaries in Parkinson's Disease Patients Who Underwent DBS Procedure

Parkinson Disease Clinical Trial

Official title:
A Retrospective, Multi-Center, Clinical Validation of HaGuide Software Module Accuracy in Mapping Sub-thalamic Nucleus (STN) Boundaries in Parkinson's Disease Patients Who Underwent Deep Brain Stimulation (DBS) Procedure

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03363724
Study type Observational
Source Alpha Omega Engineering Ltd.
Contact
Status Completed
Phase N/A
Start date December 2016
Completion date March 30, 2017
View Details
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