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

Naval Military Medical University

Status and phase: Completed; Phase 3

Conditions: Gastric Diseases,; Gastric Polyps,; Early Gastric Cancer,; Chronic Gastritis; Gastric Ulcer,

Treatments: Device: Standard gastroscopy; Device: MCE

Study type: Interventional

Funder types: Other

Identifiers

NCT02219529

MCE-1

Details and patient eligibility

About

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.

Enrollment: 350 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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350 participants in 2 patient groups

MCE

Experimental group

Description:

patients were assigned to swallow MCE first, followed by the gastroscopy

Treatment:

Device: MCE

Standard gastroscopy

Active Comparator group

Description:

patients were assigned to swallow MCE first, followed by the gastroscopy

Treatment:

Device: Standard gastroscopy