Detachable String Magnetically Controlled Capsule Endoscopy for Completely Viewing of Esophagus and Stomach

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-07

Study Completion Date

2018-08-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Outpatients

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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DS-MCE

outpatients who have esophagus symptoms will take DS-MCE and conventional endoscopy examination examination successively.

Group Type EXPERIMENTAL

DS-MCE

Intervention Type DEVICE

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.

Interventions

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DS-MCE

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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes