Assessment of Operative Time, Precision, and Safety of an Augmented Reality Navigation System (Endosight) for the Guidance of Bone Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Procedure time
研究概览
简要总结
The goal of this clinical study is to evaluate the duration of the procedure, the precision (distance between the needle tip and the centre of the target), and the safety of endosight system in the guidance for bone biopsies.
详细描述
In this study results obtained in the prospective group will be compared with those obtained in the retrospective group.
Total N° of patients: 16
PROSPECTIVE GROUP (treated WITH the guidance of endosight):
N° of patients: 8
RETROSPECTIVE GROUP (treated WITHOUT the guidance of endosight):
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
all sensitive data regarding enrolled patients will be transmitted to the Outcomes Assessor anonymously (code assigned to the patient)
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
- •Patient with a bone lesion for which a percutaneous biopsy is indicated;
- •Informed consent signed by the patient for participation in the study.
排除标准
- •Age < 18 years;
- •Pregnant and lactating women (assessed through auto declaration of the patient)
结局指标
主要结局
Procedure time
时间窗: During bone biopsy procedure (after the bone sample has been collected)
Change in the total duration of the procedure (calculated from the time of local anesthesia injection to the time of bone sample collection)
Total number of CT-SCAN
时间窗: During bone biopsy procedure (after the bone sample has been collected)
Change in overall number of CT scans performed during the procedure (calculated as the total number of CT scans required to reach the target; from the 1° CT-scan (local anesthesia) to the last CT-scan (sample collection from the bone)
次要结局
- endosight accuracy(During bone biopsy procedure (after the bone sample has been collected))
- Total radiation dose(During bone biopsy procedure (after the bone sample has been collected))
- Operator satisfaction(During bone biopsy procedure (after the bone sample has been collected))
- Side effects(During bone biopsy procedure (after the bone sample has been collected))