A Novel Detachable String Magnetically Controlled Capsule Endoscopy (DS-MCE) for Viewing Esophagus and Stomach
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Number of Participants With Successful Separation of Capsule and String, and Complete Viewing of Esophagus and Stomach
研究概览
简要总结
The purpose of the study is to determine the safety and feasibility of the new technique,detachable string magnetically controlled capsule endoscopy(DS-MCE)for evaluating gastric and esophagus diseases.
详细描述
Esophageal capsule endoscopy(ECE)provides a novel noninvasive approach to visualize the esophagus.The main drawback for the use of ECE is its unreliable transit time which often renders an inadequate visualization of the esophagus.Thus investigators have developed the detachable string magnetically controlled capsule endoscopy(DS-MCE) which can control the movement of the capsule through the string.
This study is a prospective, single-centered, self-controlled pilot study.Outpatients who have esophagus symptoms will take conventional endoscopy examination and DS-MCE successively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •outpatients who have esophagus symptoms.
排除标准
- •known or suspected complex history of gastrointestinal obstruction, stenosis or fistula.
- •dysphagia or delayed gastric emptying.
- •known or suspected possibility of active bleeding of digestive tract.
- •a history of abdominal operation.
- •pacemaker implantation and gastrointestinal pacemaker users.
- •patients who are allergic to simethicone or pronase.
- •pregnant women,mental patients.
- •other circumstances that doctors consider inappropriate for the study.
研究组 & 干预措施
DS-MCE
outpatients who have esophagus symptoms will take DS-MCE and conventional endoscopy examination examination successively.
干预措施: DS-MCE (Device)
结局指标
主要结局
Number of Participants With Successful Separation of Capsule and String, and Complete Viewing of Esophagus and Stomach
时间窗: up to 2 weeks
evaluate the feasibility of the novel DS-MCE examination. The successful separation of the capsule and string was evaluated by the capsule entering the stomach and and the string being pulled out.Complete viewing of esophagus and stomach was evaluated by completing the procedure from the capsule being swallowed, the esophagus observed retrograde, to the string being pulled out after separating from the capsule.This primary outcome indicated how many participatns completed the DS-MCE examination successfully.
次要结局
- Number of DS-MCE Associated Adverse Events(up to 2 weeks)
- Duration of Time Capsule is Within the Esophagus(up to 2 weeks)
- Z-line Visualization(up to 2 weeks)
- Quality Score of Z-line Images(up to 2 weeks)
- Degree of Comfort(up to 2 weeks)
研究者
Zhuan Liao
associate professor
Changhai Hospital