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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Gastric Diseases, Gastric Ulcer, Gastric Polyps, Early Gastric Cancer, Chronic Gastritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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MCE

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

Group Type EXPERIMENTAL

MCE

Intervention Type DEVICE

Standard gastroscopy

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

Group Type ACTIVE_COMPARATOR

Standard gastroscopy

Intervention Type DEVICE

Interventions

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MCE

Intervention Type DEVICE

Standard gastroscopy

Intervention Type DEVICE

Other Intervention Names

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magnetic-controlled capsule endoscopy

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No