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

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

PHASE1/PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Gastric Symptoms Indicated for Upper GI Endoscopy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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magnetic-controlled capsule endoscocpy (MCE)

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

Group Type EXPERIMENTAL

MCE

Intervention Type DEVICE

MCE first, followed by standard gastroscopy

Standard gastroscopy

Intervention Type DEVICE

Interventions

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MCE

MCE first, followed by standard gastroscopy

Intervention Type DEVICE

Standard gastroscopy

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No