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临床试验/NCT02886338
NCT02886338已完成不适用

Study of the Feasibility of Magnetic Navigated Capsule Endoscope in the Upper Gastrointestinal Tract Examination

Taipei Medical University WanFang Hospital1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2016年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
1
主要终点
Assess the Completeness of Capsule Endoscopy

研究概览

简要总结

External control of capsule endoscopy (CE) by means of an applied magnetic field is a possible way to maneuver the movement of CE in gastrointestinal (GI) tract. The aim of this study was to evaluate the safety and feasibility of magnetic maneuvering of a capsule endoscope in the upper gastrointestinal tract, including the esophagus, stomach and duodenum in healthy subjects.

详细描述

Since their introduction in clinical practice in 2000, capsule endoscopy (CE) have widely used as a noninvasive endoscopic examination of the gastrointestinal disorders. Compared with traditional endoscopy, CE has had a significant impact in gastroenterology for diagnoses of gastrointestinal (GI) diseases, largely owing to the following three reasons. First, wireless CE is much more comfortable for the patient. Second, it is much easier and safer to perform. Third, it allows visualization of anatomical regions currently precluded to traditional endoscopy. However, CE does not allow the operator to control the navigation. The movement of the capsule is passive, as it proceeds by means of visceral peristalsis and gravity. This makes the movement of the capsule purely random, so that some portions of the gastrointestinal surface are unable to be visualized. Moreover, if gastrointestinal lesions are identified, the endoscopist cannot maneuver the capsule to perform back and forth, or right and left movement to do further detailed observations. All of these factors contribute to limit the diagnostic values of CE examination.

External controllability of CE by means of an applied magnetic field is a possible solution to the maneuvering problem. However, there is no effective system with straightforward clinical applicability till now. This is ascribable to a lack of reliable magnetic instrumentation suitable for such a purpose. We have reported that using magnetic field navigator can effectively control the locomotion of CE. We have demonstrated, both in vitro and ex vivo, that magnetic field navigator has great potential and practicability of achieving high-precision rotation and controllable movement of CE.

The aim of this study was to evaluate the safety and feasibility of magnetic maneuvering of a capsule endoscope in the upper gastrointestinal tract, including the esophagus, stomach and duodenum in healthy subjects. The movement of the endoscopic capsule in the esophagus could be driven by an external magnetic control device. The external magnetic control device could also adjust the direction of movement of the capsule in the stomach and duodenum, which might make the examination of the whole upper gastrointestinal tract possible. The magnetic navigated CE would enable detailed investigations of the whole upper gastrointestinal tract, including the esophagus, stomach and duodenum. Using this remote magnetic manipulation, capsule endoscope might improve diagnostic accuracy and extend the examination of specific area of interest in the gastrointestinal tract.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Aged 20-65 adults had experience on insudative upper endoscopy without any contraindication.

排除标准

  • •Patient with obstruction of gastrointestinal tract.
  • •Pregnant woman.
  • •Patient implantation of pacemaker.
  • •Patient implanted with metal electronic devices、artificial joints or fixator.
  • •Patient with cancer.
  • •Patient with difficulty in swallowing.
  • •Patient with operation on the stomach.

研究组 & 干预措施

capsule endoscopy examination

Experimental

Capsule endoscopic examination for the esophagus, stomach and duodenum.

干预措施: capsule endoscopy (Device)

结局指标

主要结局

Assess the Completeness of Capsule Endoscopy

时间窗: The outcome measure was performed within 2 weeks after examination

Evaluate the completeness of capsule endoscopic examination. Visualization of the mucosa of esophagus, stomach and duodenum is analyzed separately during and after the capsule endoscopic examination by real time image and capsule video images. We evaluate the percentage of mucosa that can be clearly examined with a 5-point assessment scale (0%, 25%, 50%, 75% and 100% of the visibility of the mucosa of esophagus, stomach, and duodenum)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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