NCT05546346招募中不适用
Clinical Application of Wearable Magnet Tracking System for Capsule Endoscopes
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- The duration of time
研究概览
简要总结
The investigators developed a wearable magnet tracking system, which provided a non-invasive and high accuracy method for capsule endoscopes localization. Data fusion from multiple sensors expanded positioning range and proposed localization algorithm overcame shortcomings of existing systems. This clinical trial was conducted to verify effectiveness and stability of the tracking system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged between 18 and 75
- •agree to give written informed consent
排除标准
- •dysphagia or symptoms of gastric outlet obstruction, suspected or known intestinal stenosis, overt gastrointestinal bleeding, history of upper gastrointestinal surgery or abdominal surgery altering gastrointestinal anatomy, or postabdominal radiation
- •congestive heart failure, renal insufficiency, under therapeutic anticoagulation, in poor general condition (American Society of Anesthesiologists class III/IV), claustrophobia, metallic parts, a pacemaker or other implanted electromedical devices, or artificial heart valves
- •pregnancy or suspected pregnancy
- •exclusion criteria for standard magnetic resonance imaging examination such as the presence of surgical metallic devices, even though its low magnetic field technically would not interferewith such devices
- •currently participating in another clinical study
研究组 & 干预措施
wearable magnet tracking system
Experimental
干预措施: wearable magnet tracking system (Device)
结局指标
主要结局
The duration of time
时间窗: 12 months
the length of time of the tracking system used in continuous acquisition of the magnetic field strength values
次要结局
未报告次要终点
研究者
研究点 (1)
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