Pilot Usability Evaluation of GI Genius™ XR Software Running on a Virtual Reality Headset During Routine CRC Screening and Surveillance Colonoscopies
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Adverse events
研究概览
简要总结
This pilot study will evaluate the usability and safety of software GI Genius™ XR in the Apple Vision Pro™ virtual reality headset when used in conjunction with the GI Genius™ system during routine screening and surveillance colonoscopy procedures. GI Genius™ XR enables colonoscopists to view the standard live endoscopic video feed within a virtual reality environment as an alternative to the conventional endoscopy tower display. The system provides a virtual screen that mirrors the tower video output without any image analysis or interpretation, allowing users to adjust screen size and position for optimal visualization and situational awareness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for patient:
- •Male or female aged ≥ 45 years;
- •Scheduled for routine CRC screening or surveillance colonoscopy;
- •Written informed consent to participate.
- •Inclusion Criteria for endoscopist:
- •Male or female board-certified gastroenterologists experienced with CRC screening and surveillance colonoscopy;
- •Written informed consent to participate.
排除标准
- •for patient:
- •Not able to comply with the protocol requirement;
- •Implanted or worn medical device (pacemaker, defibrillator, insulin pump, etc.).
- •Exclusion Criteria for endoscopist:
- •Not able to comply with the protocol requirement;
- •Implanted or worn medical device (pacemaker, defibrillator, insulin pump, etc.);
- •Risk of falls;
- •Seizures;
- •Heart disease;
- •Pregnant;
- •Migraines;
- •Eye or vision disorder;
- •Inner ear disorder;
- •Psychological disorder.
结局指标
主要结局
Adverse events
时间窗: Day 1
Collection and analysis of any adverse event.
GI Genius™ XR critical tasks
时间窗: Day 1
Correct execution of critical tasks through a questionnaire
Use effects
时间窗: Day 1
Use effects of the virtual reality headset on endoscopists through a questionnaire.
Problem resolution process
时间窗: Day 1
Management of non-specific problem resolution through a questionnaire.
Time management
时间窗: During the procedure
Time to complete key tasks during the procedure.
Interruption management
时间窗: Day 1
Number and severity of interruptions related to headset messages or other user device interactions.
User feedback on usability
时间窗: Day 1
Thematic analysis of qualitative feedback on headset integration.
次要结局
- System Usability Score(Through study completion, an average of 3 months)