Trials / Completed
CompletedNCT03363724
Validation of HaGuide Software Module Accuracy in Mapping STN Boundaries in Parkinson's Disease Patients Who Underwent DBS Procedure
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 103 (actual)
- Sponsor
- Alpha Omega Engineering Ltd. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | HaGuide version 1.0 software module |
Timeline
- Start date
- 2016-12-01
- Primary completion
- 2017-03-30
- Completion
- 2017-03-30
- First posted
- 2017-12-06
- Last updated
- 2017-12-06
Source: ClinicalTrials.gov record NCT03363724. Inclusion in this directory is not an endorsement.