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

N

Naval Military Medical University

Status

Completed

Conditions

Outpatients

Treatments

Device: DS-MCE

Study type

Interventional

Funder types

Other

Identifiers

NCT03457909
DS-MCE-esophagus and stomach

Details and patient eligibility

About

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.

Full description

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.

Enrollment

25 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

25 participants in 1 patient group

DS-MCE
Experimental group
Description:
outpatients who have esophagus symptoms will take DS-MCE and conventional endoscopy examination examination successively.
Treatment:
Device: DS-MCE

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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