NCT03363724已完成不适用
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
Alpha Omega Engineering Ltd.0 个研究点目标入组 103 人开始时间: 2016年12月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 103
- 主要终点
- HaGuide vs. Neurosurgeon measurements
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient was diagnosed with Parkinson's disease;
- •Patient underwent implantation of DBS electrode in the STN for the treatment of Parkinson's disease, using the Neuro-Omega device for navigation;
- •Procedure's MER digital recorded data is available;
排除标准
- •DBS performed for any other movement disorder other than Parkinson's Disease including Parkinsonism;
- •The recording has a high intensity of noise that will not allow re-analysis using the HaGuide software, in such cases the HaGuide software indicates that the signal is not valid for analysis;
- •Missing data for primary end-point on the respective patient medical chart;
- •The collected data that is used for the validation is with high step size resolution;
结局指标
主要结局
HaGuide vs. Neurosurgeon measurements
时间窗: 2 weeks
Percent agreement between HaGuide software measurements and expert Neurosurgeon/Electrophysiologist measurements
次要结局
- DLOR vs. VMNR(2 weeks)
- DLOR Entry/exit(2 weeks)
- STN Length(2 weeks)
- DBS implant optimal track Identification(2 weeks)
- Sites/Users comparison(2 weeks)
研究者
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