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

Summary

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.

Conditions

• Gastric Diseases,
• Gastric Ulcer,
• Gastric Polyps,
• Early Gastric Cancer,
• Chronic Gastritis

Interventions

DEVICE

MCE

DEVICE

Standard gastroscopy

Sponsors & Collaborators

• RenJi Hospital

  collaborator OTHER

• Nanfang Hospital, Southern Medical University

  collaborator OTHER

• Chinese PLA General Hospital

  collaborator OTHER

• General Hospital of Beijing PLA Military Region

  collaborator OTHER

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  collaborator OTHER

• Shandong Provincial Hospital

  collaborator OTHER_GOV

• Peking Union Medical College Hospital

  collaborator OTHER

• Changhai Hospital

  lead OTHER

Principal Investigators

• Zhaoshen Li, Prof. · Changhai Hospital

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-08-31

Primary Completion

2015-01-31

Completion

2015-02-28

Countries

• China

Study Locations