Prospective Assessment of the Quality of the Image and the Usability of the C-ARM ARCO FP-Rk521S Used in Surgical Conventional Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Digital scale of image quality
研究概览
简要总结
THALES-EVAQUAL study assesses the quality of the images generated by C-ARM ARCO FP-Rk521S and its ability to be used during surgery.
详细描述
Expected performance of TED developped technology compared to current equipment (intensifier tube) represent a significant improvement; especially in term of image rendering, irradiation dose reduction and ergonomy.
THALES-EVAQUAL is a prospective,monocentric, unrandomized, and uncontrolled study which objective is to assess C-ARM ARCO FP-Rk521S in term of quality of image. It also evaluates its ability to be used during Orthopedic, neurological and neurological surgeries.
Patient included in the study will have a surgery during which C-ARM is used. This study doesn't modify the medical care of the patient.
After each surgery, a digital scale of image quality will be filled by the surgeon for each aquisition. Other feedback questionnaires regarding the suitability of the device and the satisfaction of the surgeon will also be completed.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject having signed the non-objection form;
- •Requiring one of the following surgical procedures:
- •Urology: soft ureteroscopy, uteroscopy, sacral neuromodulation, JJ sent placement.
- •Orthopedics: vertebroplasty, gamma nail placement, sacro-iliac screw fixation.
- •Neurology: spinal surgery
排除标准
- •Subject who refuse to participate in the study;
- •Who are under legal protection measure or unable to express their consent (guardianship, curatorship);
- •Deprived of liberty by judicial or administrative decision.
结局指标
主要结局
Digital scale of image quality
时间窗: up to 5 hours
Digital scale of image quality completed for each acquisition by the surgeon
次要结局
未报告次要终点