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

This study has been completed.
Sponsor:
Collaborators:
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 Medical Systems Corporation
Siemens AG
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT01555840
First received: March 7, 2012
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

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 Intervention
Gastric Focal Lesion
Device: Magnetically Guided Capsule (MGCE)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: "EVALUATION CLINIQUE D'UNE CAPSULE A GUIDAGE MAGNETIQUE POUR L'EXPLORATION GASTRIQUE "Capsule Dirigée Versus Gastroscopie à Haute Définition""

Resource links provided by NLM:


Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:
  • Accuracy of magnetically guided capsule endoscopy (MGCE) as compared to unblinded gastroscopy in the diagnosis of focal lesions. [ Time Frame: 2 days ] [ Designated as safety issue: No ]
    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:
  • Accuracy of capsule endoscopy in the diagnosis of diffuse and minor lesions [ Time Frame: 2 days ] [ Designated as safety issue: No ]
    - Accuracy of capsule endoscopy in the diagnosis of diffuse and minor lesions [ Time Frame: within 2 days ] [ Designated as safety issue: No ]

  • Examination times of capsule and conventional gastroscopy [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Examination times of capsule and conventional gastroscopy

  • Patient acceptance of capsule gastroscopy and conventional gastroscopy [ Time Frame: 2 days ] [ Designated as safety issue: No ]

    Patient acceptance of capsule gastroscopy and conventional gastroscopy

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

  • Adverse events of both procedures [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    Adverse events of both procedures


Enrollment: 189
Study Start Date: November 2011
Study Completion Date: June 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01555840

Locations
France
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 Medical Systems Corporation
Siemens AG
Investigators
Principal Investigator: J F Rey, MD Institut Arnault Tzanck, St. Laurent du Var, France
  More Information

Publications:
Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT01555840     History of Changes
Other Study ID Numbers: 2010-A01442-37(AFSSAPS)
Study First Received: March 7, 2012
Last Updated: December 17, 2013
Health Authority: France: Committee for the Protection of Personnes

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

ClinicalTrials.gov processed this record on October 20, 2014