Magnetic-controlled Capsule Endoscopy vs. Gastroscopy for Detection of Gastric Diseases (MCE)

July 19, 2015 updated by: Zhaoshen Li, Changhai Hospital

Magnetic-controlled Capsule Endoscopy vs. Gastroscopy for Detection of Gastric Diseases: A Prospective Self-controlled Comparative Multicenter Trial

A new Magnetic-controlled Capsule Endoscopy (MCE) was developed by ANKON and got SFDA's approval in China in 2013. It has recently been evaluated to compare the diagnostic accuracy of MCE with that of standard gastroscopy for gastric diseases in 70 patients with encouraging results (In Press). To further testify the diagnostic accuracy of MCE for both the diffuse and focal diseases in stomach, we performed this single-blinded multi-center prospective study compared MCE with gastroscopy in patients with gastric symptoms and indication for upper GI Endoscopy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

350

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200433
        • Shanghai Changhai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients presented with gastric symptoms and ready for the first Upper GI endoscopy
  • Patients with known focal gastric diseases: gastric ulcer, gastric polyps, early gastric cancer, gastric stromal tumors and so on.
  • Age of 18 years to 70 years

Exclusion Criteria:

  • Patients with impaired bowel movement from ileus or organic digestive diseases
  • Patients with known large and obstructing tumors of the upper GI tract
  • Patients after upper GI surgery or abdominal surgery altering GI anatomy
  • Patients under full anticoagulation
  • Patient in poor general condition
  • Patients using equipment that may be affected by radio transmission
  • Patients using equipment that may be affected by magnetic field
  • Pregnancy or suspected pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MCE
patients were assigned to swallow MCE first, followed by the gastroscopy
Device: MCE
Other Names:
  • magnetic-controlled capsule endoscopy
Active Comparator: Standard gastroscopy
patients were assigned to swallow MCE first, followed by the gastroscopy
Device: Standard gastroscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of subjects diagnosed with gastric diffuse lesions by MCE Versus Standard Gastroscopy
Time Frame: 2 days
2 days
Number of gastric focal lesions founded by MCE Versus Standard Gastroscopy
Time Frame: 2 days
2 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Volume of water and drugs used for gastric preparation
Time Frame: 1 hour
1 hour
Scores of the cleanliness of stomach after preparation
Time Frame: 1 day
1 day
Percentage of patients in whom there was complete visualization of the gastric surface in the antrum, body, and fundus and identification of the cardia and pylorus
Time Frame: 1 day
1 day
Examination times of MCE and standard gastroscopy
Time Frame: 1 day
1 day
Patient acceptance of MCE and standard gastroscopy
Time Frame: 3 days
3 days
Adverse events of both procedures
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Collaborators

Peking Union Medical College Hospital
Chinese PLA General Hospital
RenJi Hospital
Nanfang Hospital of Southern Medical University
Shandong Provincial Hospital
Wuhan Union Hospital, China
General Hospital of Beijing PLA Military Region

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

August 12, 2014

First Submitted That Met QC Criteria

August 15, 2014

First Posted (Estimate)

August 19, 2014

Study Record Updates

Last Update Posted (Estimate)

July 21, 2015

Last Update Submitted That Met QC Criteria

July 19, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCE-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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