Detachable String Magnetically Controlled Capsule Endoscopy for Completely Viewing of Esophagus and Stomach
2019年8月21日 更新者：Zhuan Liao、Changhai Hospital
A Novel Detachable String Magnetically Controlled Capsule Endoscopy (DS-MCE) for Viewing Esophagus and Stomach
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
25
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Shanghai
-
Shanghai、Shanghai、中国、200433
- Changhai Hospital
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- outpatients who have esophagus symptoms.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：DS-MCE
outpatients who have esophagus symptoms will take DS-MCE and conventional endoscopy examination examination successively.
|
During the DS-MCE examination,the capsule is allowed to travel down into gastric cardia,from where the string is slowly pulled to allow the capsule to view the esophagus retrogradely.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants With Successful Separation of Capsule and String, and Complete Viewing of Esophagus and Stomach
大体时间：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.
|
up to 2 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of DS-MCE Associated Adverse Events
大体时间：up to 2 weeks
|
evaluate the safety of DS-MCE.Record any adverse event during the procedure and after the procedure.Patients will be followed up by telephone to inquire about the symptoms of abdominal distention, abdominal pain,vomiting and other discomfort.
Follow up to the end of the capsule expulsion.
|
up to 2 weeks
|
|
Duration of Time Capsule is Within the Esophagus
大体时间：up to 2 weeks
|
time from the capsule swallowed to the capsule entering the gastric cardia to examine the stomach
|
up to 2 weeks
|
|
Z-line Visualization
大体时间：up to 2 weeks
|
Z-line represents the normal esophagogastric junction where the squamous mucosa of the esophagus and columnar mucosa of the stomach meet.We can devide the Z-line into four quadrants under capsule endoscopy.
Observing all the four quadrants is considered to be a complete observation of Z-line.
In this study,the number of participants with at least two quadrants of Z-line visualized was used to evaluate the Z-line visulization.
|
up to 2 weeks
|
|
Quality Score of Z-line Images
大体时间：up to 2 weeks
|
grade (mild, moderate,and severe) of air-bubble and saliva interference on the Z-line view(0, no intraluminal gas bubble; 1, a few gas bubbles, no limitation of interpretation; 2, an increased amount of intraluminal foam/gas bubbles, moderate limitation of visibility; 3, an amount of foam/gas bubbles)
|
up to 2 weeks
|
|
Degree of Comfort
大体时间：up to 2 weeks
|
evaluate patient's degree of comfort throughout the procedure.Patients will be asked to fill in a questionnaire to give scores about degree of comfort throughout the procedure.Overall discomfort was scored on a scale of 0 to 10 (0, no discomfort; 10, the overall discomfort of EGD).
|
up to 2 weeks
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Zhuan Liao、Changhai Hospital
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年3月7日
初级完成 (实际的)
2018年7月10日
研究完成 (实际的)
2018年8月1日
研究注册日期
首次提交
2018年2月4日
首先提交符合 QC 标准的
2018年3月1日
首次发布 (实际的)
2018年3月8日
研究记录更新
最后更新发布 (实际的)
2019年9月23日
上次提交的符合 QC 标准的更新
2019年8月21日
最后验证
2019年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
DS-MCE的临床试验
-
Changhai HospitalShanghai Zhongshan Hospital; Ruijin Hospital; Shanghai General Hospital, Shanghai Jiao Tong University... 和其他合作者招聘中
-
Changhai HospitalQilu Hospital of Shandong University; First Affiliated Hospital Xi'an Jiaotong University; Ruijin... 和其他合作者完全的
-
Oulu University HospitalLoisto Terveys, Oulu; Fysios Kastelli, Oulu; Faskia-Markus, Oulu邀请报名
-
Changhai HospitalShanghai Children's Hospital; Xian Children's Hospital尚未招聘