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

Naval Military Medical University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Indicated for Upper GI Endoscopy; Gastric Symptoms

Treatments: Device: Standard gastroscopy; Device: MCE

Study type: Interventional

Funder types: Other

Identifiers

NCT01903629

AKE-1

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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70 participants in 1 patient group

magnetic-controlled capsule endoscocpy (MCE)

Experimental group

Description:

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

Treatment:

Device: Standard gastroscopy

Device: MCE