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

NCT01555840 | Completed

• 1 other identifier: 2010-A01442-37(AFSSAPS)
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Focal Lesion

Keywords

Magnetically guided capsule endoscopy (MGCE); Gastroscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Accuracy of capsule endoscopy in the diagnosis of diffuse and minor lesions

  2 days

• Examination times of capsule and conventional gastroscopy

  1 hour

• Patient acceptance of capsule gastroscopy and conventional gastroscopy

  2 days

• Adverse events of both procedures

  14 days

Study Arms (1)

patients requiring upper GI endoscopy

OTHER

patients with upper abdominal complaints requiring upper GI endoscopy

Device: Magnetically Guided Capsule (MGCE)

Interventions

Magnetically Guided Capsule (MGCE) DEVICE

"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

patients requiring upper GI endoscopy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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"

You may not qualify if:

• 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 "

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• Institute Arnault Tzanck, France: collaborator
• Centre Hospitalier Universitaire de Nice: collaborator
• Keio University: collaborator
• Showa University Northern Yokohama Hospital, Japan: collaborator
• The Jikei University School of Medicine, Japan: collaborator
• Olympus Corporation: collaborator
• Siemens AG: collaborator

Study Sites (1)

Institut Arnault Tzanck , Avenue du Docteur Maurice Donat

Saint-Laurent-du-Var, Cote Azur, 06721, France

Location

Related Publications (3)

• 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.

  PMID: 22154417 BACKGROUND

• 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.

  PMID: 20593331 BACKGROUND

• 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.

  PMID: 24618504 RESULT

Study Officials

• J F Rey, MD

  Institut Arnault Tzanck, St. Laurent du Var, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2012
• First Posted: March 15, 2012
• Study Start: November 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: June 1, 2012
• Last Updated: June 18, 2019

Record last verified: 2019-06

Locations

FR (1)