NCT01367392已完成4 期
Confirmation of Clinical Effectiveness and Safety of CT-guided Needle Placement in the Liver With the Aid of the ActiSight Needle Guidance System
ActiViews Ltd.1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2011年6月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- accuracy
研究概览
简要总结
The purpose of this study is to confirm the safety and effectiveness of the ActiSight™ Needle Guidance System with CT-guided percutaneous (through the skin) liver biopsies and ablations . The device used in this study is designed to assist the physician in guiding the needle towards the suspected area. This device does not change the procedure of liver biopsy or ablation. The only difference is that a small adhesive pad is placed on the skin and a miniature video camera is attached to the end of the needle. This camera does not enter the body.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
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
- 否
入选标准
- •Male or non-pregnant female subjects, between the ages of 18 and 80 at the time of enrollment.
- •Subjects scheduled for clinically indicated CT guided percutaneous needle placements in the liver who meet the desired target population described above.
- •Written informed consent to participate in the study.
- •Ability to comply with the requirements of the study procedures.
- •Verified home address and phone number to facilitate study follow-up.
排除标准
- •Significant coagulopathy that cannot be adequately corrected.
- •Subjects who participated in an active stage of any drug, intervention or treatment trial within 30 days of enrollment.
- •Subjects with preexisting conditions, which, in the opinion of the investigator, interfere with the conduct of the study.
- •Subjects who are uncooperative or cannot follow instructions.
- •Mental state that may preclude completion of the study procedure.
- •Pregnant or nursing female subjects.
结局指标
主要结局
accuracy
时间窗: during the procedure
Frequency of placing the needle at a location suitable for the planned intervention, as determined by the investigator reviewing the CT images.
次要结局
- radiation(during the procedure)
- total number of scans(during the procedure)
- time(during the procedure)
研究者
研究点 (1)
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