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

Phase 3

Completed

• Conditions: Gastric Diseases,; Gastric Ulcer,; Early Gastric Cancer,; Chronic Gastritis; Gastric Polyps,
• Interventions: Device: MCE; Device: Standard gastroscopy

• Registration Number: NCT02219529
• Lead Sponsor: Changhai Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-12
• Study First Submitted QC: 2014-08-15
• Study First Posted: 2014-08-19
• Primary Completion: 2015-01
• Study Completion: 2015-02
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-19
• Last Update Posted: 2015-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MCE	MCE	patients were assigned to swallow MCE first, followed by the gastroscopy
Standard gastroscopy	Standard gastroscopy	patients were assigned to swallow MCE first, followed by the gastroscopy

Primary Outcome Measures

Name	Time	Method
Number of subjects diagnosed with gastric diffuse lesions by MCE Versus Standard Gastroscopy	2 days
Number of gastric focal lesions founded by MCE Versus Standard Gastroscopy	2 days

Secondary Outcome Measures

Name	Time	Method
Volume of water and drugs used for gastric preparation	1 hour
Scores of the cleanliness of stomach after preparation	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	1 day
Examination times of MCE and standard gastroscopy	1 day
Patient acceptance of MCE and standard gastroscopy	3 days
Adverse events of both procedures	2 weeks

Trial Locations

Locations (1)

Shanghai Changhai Hospital; 🇨🇳 Shanghai, China