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

Phase 1

Completed

• Conditions: Indicated for Upper GI Endoscopy; Gastric Symptoms
• Interventions: Device: MCE; Device: Standard gastroscopy

• Registration Number: NCT01903629
• Lead Sponsor: Changhai Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Primary Completion: 2012-12
• Study Completion: 2013-02
• Study First Submitted: 2013-07-17
• Study First Submitted QC: 2013-07-17
• Study First Posted: 2013-07-19
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-19
• Last Update Posted: 2015-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
magnetic-controlled capsule endoscocpy (MCE)	MCE	patients were assigned to swallow MCE first, followed by the gastroscopy
magnetic-controlled capsule endoscocpy (MCE)	Standard gastroscopy	patients were assigned to swallow MCE first, followed by the gastroscopy

Primary Outcome Measures

Name	Time	Method
Accuracy of magnetic-controlled capsule endoscopy(MCE) Versus Standard Gastroscopy in the diagnosis of diffuse and local lesions	2 days

Secondary Outcome Measures

Name	Time	Method
Examination times of capsule and standard gastroscopy	1 hour
Patient acceptance of capsule gastroscopy and standard gastroscopy	3 days
Adverse events of both procedures	2 weeks

Trial Locations

Locations (1)

Shanghai Changhai Hospital; 🇨🇳 Shanghai, China