Comparative Study of the Magnetic-controlled Capsule Endoscopy Versus Standard Gastroscopy

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

A Double-center Self-controlled Comparative Study of the Magnetic-controlled Capsule Endoscopy Versus Standard Gastroscopy for Gastric Diseases

Passive video capsule endoscopy is the criterion standard for small-bowel diseases but cannot be used for the large gastric cavity.This blinded prospective study investigates the accuracy of the magnetic-controlled capsule endoscopy compared to gastroscopy in patients with gastric symptoms and indication for upper GI Endoscopy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 2
  • Phase 1

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 with gastric symptoms and indicated for Upper GI endoscopy
  • 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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: magnetic-controlled capsule endoscocpy (MCE)
patients were assigned to swallow MCE first, followed by the gastroscopy
Device: Standard gastroscopy
Device: MCE
MCE first, followed by standard gastroscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Accuracy of magnetic-controlled capsule endoscopy(MCE) Versus Standard Gastroscopy in the diagnosis of diffuse and local lesions
Time Frame: 2 days
2 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events of both procedures
Time Frame: 2 weeks
2 weeks
Examination times of capsule and standard gastroscopy
Time Frame: 1 hour
1 hour
Patient acceptance of capsule gastroscopy and standard gastroscopy
Time Frame: 3 days
3 days

Collaborators and Investigators

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

Sponsor

Changhai Hospital

Collaborators

Wuhan Union Hospital, China
Second Military Medical University

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

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

November 1, 2011

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

February 1, 2013

Study Registration Dates

First Submitted

July 17, 2013

First Submitted That Met QC Criteria

July 17, 2013

First Posted (ESTIMATE)

July 19, 2013

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

Other Study ID Numbers

  • AKE-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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