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

"EVALUATION CLINIQUE D'UNE CAPSULE A GUIDAGE MAGNETIQUE POUR L'EXPLORATION GASTRIQUE "Capsule Dirigée Versus Gastroscopie à Haute Définition""

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.

Study Overview

• Status: Completed
• Conditions: Gastric Focal Lesion
• Intervention / Treatment: 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 Type: Interventional
• Enrollment (Actual): 189
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Cote Azur
    • Saint-Laurent du Var, Cote Azur, France, 06721
      • Institut Arnault Tzanck , Avenue du Docteur Maurice Donat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 "

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of magnetically guided capsule endoscopy (MGCE) as compared to unblinded gastroscopy in the diagnosis of focal lesions.	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.	2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of capsule endoscopy in the diagnosis of diffuse and minor lesions	- Accuracy of capsule endoscopy in the diagnosis of diffuse and minor lesions [ Time Frame: within 2 days ] [ Designated as safety issue: No ]	2 days
Examination times of capsule and conventional gastroscopy	Examination times of capsule and conventional gastroscopy	1 hour
Patient acceptance of capsule gastroscopy and conventional gastroscopy	Patient acceptance of capsule gastroscopy and conventional gastroscopy; After the two examinations are finished, patients fill out the questionnaire.	2 days
Adverse events of both procedures	Adverse events of both procedures	14 days

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Collaborators: Centre Hospitalier Universitaire de Nice; Olympus Corporation; Keio University; Siemens AG; Institute Arnault Tzanck, France; Showa University Northern Yokohama Hospital, Japan; The Jikei University School of Medicine, Japan
• Investigators: Principal Investigator: J F Rey, MD, Institut Arnault Tzanck, St. Laurent du Var, France

Publications and helpful links

General Publications

• Rey JF, Ogata H, Hosoe N, Ohtsuka K, Ogata N, Ikeda K, Aihara H, Pangtay I, Hibi T, Kudo SE, Tajiri H. Blinded nonrandomized comparative study of gastric examination with a magnetically guided capsule endoscope and standard videoendoscope. Gastrointest Endosc. 2012 Feb;75(2):373-81. doi: 10.1016/j.gie.2011.09.030. Epub 2011 Dec 9.
• 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 Jul;42(7):541-5. doi: 10.1055/s-0030-1255521. Epub 2010 Jun 30.
• Denzer UW, Rosch T, Hoytat B, Abdel-Hamid M, Hebuterne X, Vanbiervielt G, Filippi J, Ogata H, Hosoe N, Ohtsuka K, Ogata N, Ikeda K, Aihara H, Kudo SE, Tajiri H, Treszl A, Wegscheider K, Greff M, Rey JF. Magnetically guided capsule versus conventional gastroscopy for upper abdominal complaints: a prospective blinded study. J Clin Gastroenterol. 2015 Feb;49(2):101-7. doi: 10.1097/MCG.0000000000000110.

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: March 7, 2012
• First Submitted That Met QC Criteria: March 14, 2012
• First Posted (Estimate): March 15, 2012

Study Record Updates

• Last Update Posted (Actual): June 18, 2019
• Last Update Submitted That Met QC Criteria: June 15, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Gastroscopy; Magnetically guided capsule endoscopy (MGCE)
• Other Study ID Numbers: 2010-A01442-37(AFSSAPS)