NCT06267248Enrolling By Invitation不适用
Pre-pilot Study of Spine Registration Using 3D Scanning
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Spine Registration
研究概览
简要总结
The primary objective is to assess the capability of the device as measured by its consistency, its accuracy, and feedback from surgical staff over the study period.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients that require exposure of posterior bony anatomy for visualization as standard of care.
- •Patients will have had a CT scan performed prior to the procedure as standard of care, or is expected to have a CT scan intraoperatively as standard of care.
- •Clinically planned for spine surgery.
- •Able to provide written informed consent from subject, using IRB approved consent form and agrees to comply with protocol requirements.
- •Patients who do not speak English will be allowed to participate, with the expectation that the site will provide interpreter services to help with the consent process.
排除标准
- •Language problems that would prevent from properly understanding instructions in any language.
- •Patients less than 18 years of age or older than 80 years of age
- •Patients who are excluded from consideration for the surgical procedure are therefore excluded from the research study.
- •Special populations: pregnant women, prisoners.
- •Minimally invasive spine surgery that does not expose the necessary bone/s.
- •Spine surgery without posterior exposure.
- •Patients considered high risk for anesthesia, as determined by operative surgeon
结局指标
主要结局
Spine Registration
时间窗: Throughout the surgical procedure
Closely match the Advanced Scanners optical scan of the partially exposed surface of the patient vertebra to the corresponding patient's preoperative MRI and/or CT scan, thereby learning the position of the rest of the vertebra. This endpoint includes registration of the relevant preoperative MRI or CT scan portion to the portion scanned by Advanced Scanners.
次要结局
- Vertebral Shift Measurement(Throughout the surgical procedure)
- Determination Of Bony Exposure Requirements(Throughout the surgical procedure)
研究者
研究点 (1)
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