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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
350
Shanghai Changhai Hospital
Shanghai, China
Number of subjects diagnosed with gastric diffuse lesions by MCE Versus Standard Gastroscopy
Time frame: 2 days
Number of gastric focal lesions founded by MCE Versus Standard Gastroscopy
Time frame: 2 days
Volume of water and drugs used for gastric preparation
Time frame: 1 hour
Scores of the cleanliness of stomach after preparation
Time frame: 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
Examination times of MCE and standard gastroscopy
Time frame: 1 day
Patient acceptance of MCE and standard gastroscopy
Time frame: 3 days
Adverse events of both procedures
Time frame: 2 weeks
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