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

NCT03363724 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 103

Last updated 2017-12-06

No results posted yet for this study

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.

Conditions

  • Parkinson Disease
  • Deep Brain Stimulation

Interventions

OTHER

HaGuide version 1.0 software module

Sponsors & Collaborators

  • University of Colorado, Denver

    collaborator OTHER

  • Hadassah Medical Organization

    collaborator OTHER

  • Swedish Medical Center

    collaborator OTHER

  • Alpha Omega Engineering Ltd.

    lead INDUSTRY

Principal Investigators

  • John A Thompson, Dr. · University of Colorado, Denver

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2017-03-30
Completion
2017-03-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03363724 on ClinicalTrials.gov