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

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ClinicalTrials.gov Identifier: NCT01555840
Recruitment Status : Completed
First Posted : March 15, 2012
Last Update Posted : December 19, 2013
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Gastric Focal Lesion Device: Magnetically Guided Capsule (MGCE)

Detailed Description:

The sudy takes place in a private hospital (Institute Arnault Tzanck, St. Laurent du Var) with an annual number of 4000 upper GI endoscopies. Patients will be recruited from this center and from the cooperating Department of Gastroenterology at the University of Nice by about half. After given written informed consent at least 24 hours prior the examination patients are included into the study. The examiners are blinded to the patients origin.

Participants will be recruited in two groups A) enriched population group (n=50): In both institutions, patients presenting for upper GI endoscopy with suspected or diagnosed focal lesions as follows; gastric tumors, submucosal tumor, gastric ulcer, polyp a)adenoma, b)hyperplastic polyp or angioectasia,ulcers for diagnostic confirmation, follow-up or planning of therapy will be informed and asked to participate in the study.

B) standard gastroscopy group (n=150): consecutive patients without prior gastroscopy presenting with the main indications reflux, upper abdominal complaints, anemia and anorexia. Here, recruitment is based on presenting symptoms.

6 endoscopists experienced in upper GI endoscopy (> 1000 examinations) and specifically trained in capsule gastroscopy (simulator, 10 gastric capsule cases) will perform capsule gastroscopy. 2 well trained endoscopists (> 1000 upper GI endoscopies), different from the capsule gastroscopists will perform subsequent gastroscopies. They receive standard information about gastroscopy indication from a list of indications. They are accompanied by a study nurse who knows patient details but ascertains examiner blindness and takes care of secondary unblinding during gastroscopy.

Gastroscopy is always performed after MGCE in this study with a maximum delay of 1 day but a minimum delay of 4 h due to water filling of the stomach with the capsule examination.

The study is a comparative study of capsule gastroscopy accuracy with conventio¬nal gastroscopy serving as gold standard as described above. Disease prevalence is enriched to include 25-30% of significant pathology such as tumors and ulcers. Confidence intervals will be calculated, e.g. for a disease prevalence of about 30% and 200 study cases, a sensitivity of 85% will have a 95% CI of 73-93%. Cross tabulation of the results of the index tests (including indeterminate and missing results) will be performed by the results of the reference standard. Study statistics will be done by Prof. Dr. Karl Wegscheider, University Hospital Hamburg/Eppendorf.

All patient data will be collected at Institut Arnault Tzanck in St. Laurent du Var. Data will be analyzed in pseudonymity way (code, age, sex) at the University of Hamburg. Original data will be stored for 10 years at Institut Arnault Tzanck in St. Laurent du Var

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 189 participants
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Study Start Date : November 2011
Primary Completion Date : May 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
patients requiring upper GI endoscopy
patients with upper abdominal complaints requiring upper GI endoscopy
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

Outcome Measures

Primary Outcome Measures :
  1. Accuracy of magnetically guided capsule endoscopy (MGCE) as compared to unblinded gastroscopy in the diagnosis of focal lesions. [ Time Frame: 2 days ]
    To evaluate the accuracy of MGCE, which is performed by the first examiner. After the MGCE examination, conventional gastroscopy is performed by the second examiner and then the results of the two studies are compared.

Secondary Outcome Measures :
  1. Accuracy of capsule endoscopy in the diagnosis of diffuse and minor lesions [ Time Frame: 2 days ]
    - Accuracy of capsule endoscopy in the diagnosis of diffuse and minor lesions [ Time Frame: within 2 days ] [ Designated as safety issue: No ]

  2. Examination times of capsule and conventional gastroscopy [ Time Frame: 1 hour ]
    Examination times of capsule and conventional gastroscopy

  3. Patient acceptance of capsule gastroscopy and conventional gastroscopy [ Time Frame: 2 days ]

    Patient acceptance of capsule gastroscopy and conventional gastroscopy

    • After the two examinations are finished, patients fill out the questionnaire.

  4. Adverse events of both procedures [ Time Frame: 14 days ]
    Adverse events of both procedures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with gastric focal lesions (Group A)
  • Patients with gastric symptoms and indicated for Upper GI endoscopy (Group B)
  • Age of 18 years to 75 years"

Exclusion Criteria:

  • Patients with dysphagia or symptoms of gastric outlet obstruction
  • Patients with suspected or known intestinal stenoses
  • Overt GI bleeding
  • 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 (ASA III/IV)
  • Patients with claustrophobia
  • Patients using equipment that may be affected by radio transmission
  • Patients using equipment that may be affected by magnetic field
  • Pregnancy or suspected pregnancy "
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01555840

Institut Arnault Tzanck , Avenue du Docteur Maurice Donat
Saint-Laurent du Var, Cote Azur, France, 06721
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Institute Arnault Tzanck, France
Centre Hospitalier Universitaire de Nice
Keio University
Showa University Northern Yokohama Hospital, Japan
The Jikei University School of Medicine, Japan
Olympus Corporation
Siemens AG
Principal Investigator: J F Rey, MD Institut Arnault Tzanck, St. Laurent du Var, France
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT01555840     History of Changes
Other Study ID Numbers: 2010-A01442-37(AFSSAPS)
First Posted: March 15, 2012    Key Record Dates
Last Update Posted: December 19, 2013
Last Verified: December 2013

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
Magnetically guided capsule endoscopy (MGCE)