Comparative Study of the Magnetically Guided Capsule Endoscopy Versus High Definition Gastroscopy

Summary

A capsule steered by magnetic field force developed by Siemens and Olympus has recently been evaluated in a pilot series in man with encouraging results (Rey JF, Ogata H, Hosoe N, Ohtsuka K, Ogata N, Ikeda K, Aihara H, Pangtay I, Hibi T, Kudo S, Tajiri H. Feasibility of stomach exploration with a guided capsule endoscope. Endoscopy. 2010;42:541-5. Epub 2010 Jun 30.18). This blinded prospective study investigates the accuracy of the magnetically guided capsule (MGCE) compared to gastroscopy in patients with focal lesions and / or gastric symptoms and indication for upper GI Endoscopy.

Conditions

• Gastric Focal Lesion

Interventions

DEVICE

Magnetically Guided Capsule (MGCE)

"a) MGCE capsule The MGCE capsule is custom-made for observation of the stomach. It is 31 mm in length and 11 mm in diameter and equipped with two image sensors. It contains a permanent magnet to enable magnetic guidance in the stomach by magnetic field." "b) Guidance system The magnet guidance system is custom-made to guide the MGCE capsule inside the stomach. It has a footprint of 1m× 2m and generates a very low level magnetic fields." c) Conventional gastroscope

Sponsors & Collaborators

• Institute Arnault Tzanck, France

  collaborator OTHER

• Centre Hospitalier Universitaire de Nice

  collaborator OTHER

• Keio University

  collaborator OTHER

• Showa University Northern Yokohama Hospital, Japan

  collaborator UNKNOWN

• The Jikei University School of Medicine, Japan

  collaborator UNKNOWN

• Olympus Corporation

  collaborator INDUSTRY

• Siemens AG

  collaborator INDUSTRY

• Universitätsklinikum Hamburg-Eppendorf

  lead OTHER

Principal Investigators

• J F Rey, MD · Institut Arnault Tzanck, St. Laurent du Var, France

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

SINGLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-11-30

Primary Completion

2012-05-31

Completion

2012-06-30

Countries

• France

Study Locations