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Esophageal and Gastric Diseases With Robotically Controlled Magnetic Capsule Endoscopy (MACEOES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04068480
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : August 30, 2019
Sponsor:
Information provided by (Responsible Party):
László Madácsy Md, PhD, Bács-Kiskun County Teaching Hospital

Brief Summary:
Magnetically assisted capsule endoscopy (MACE) is a novel tool to examine the upper GI tract. The position of these new method in the examination of esophagus and stomach disorders is not clear until now.

Condition or disease
Video Capsule Endoscopy

Detailed Description:

Magnetic capsule endoscopy (MACE) systems were developed over the past 5-10 years to investigate the upper GI tract, especially the stomach. The new Navicam MACE system is composed of a magnetic capsule endoscope, an external controller magnet, a data recording set and a computing workstation, and with the aid of the appropriate software a real time follow up and controlling of the magnetic capsule inside the body is possible. This methodology could be an optimal non-invasive method of choice for gastric cancer and Barrett esophagus screening in high risk population in the near future.

Esophagogastroduodenoscopy (EGD) is the gold standard diagnostic test, however it is very uncomfortable for patients without sedation.

The aim of our present study was a feasibility study to assess the safety and efficacy of Ankon MACE to investigate gastric and esophageal disorders in patients referred to small bowel capsule endoscopy investigations into our endoscopy and to develop and test a method with MACE for esophageal investigation and to analyse the visualisation of stomach mucose with automatic and manual capsule maneuvering.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Study of Esophageal and Gastric Diseases With Robotically Controlled Magnetic Capsule Endoscopy
Actual Study Start Date : November 15, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine


Group/Cohort
Capsule endoscopy
Patient refered for small bowel capsule endoscopy in conventional indication.



Primary Outcome Measures :
  1. Reflux esophagitis [ Time Frame: 1 year ]
    Proportion and the severity of reflux (Los Angeles classification) comparing to gastroscopy

  2. Diseases [ Time Frame: 1 year ]
    Proportion of other disorders of oesophagus and stomach comparing to gastroscopy

  3. Stomach examination [ Time Frame: 1 year ]
    Analyze the visualisation of gastric mucosa with MACE system


Secondary Outcome Measures :
  1. Restrain time [ Time Frame: 1 year ]
    Analysing the correlation with MACE system between esophageal restrain time and diagnostic yield

  2. Cleaning [ Time Frame: 1 year ]
    Analysis of stomach preparation with a special software concerning the percentage of clean and covered areas.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Every patient how met the eligibility criteria and had MACE examination with oesophageal protocol
Criteria

Inclusion Criteria:

- patient refered for small bowel capsule endoscopy in any indication

Exclusion Criteria:

  • known or suspected stricture in the GI tract
  • previous surgery with bowel anastomosis
  • swallowing complaints
  • dementia
  • implanted cardioverter defibrillator
  • implanted

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): NCT04068480


Contacts
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Contact: Milan Szalai, M.D. 0036203777818 dr.szalai.milan@gmail.com

Locations
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Hungary
Endo-Kapszula Privat Medical Cenbter Recruiting
Székesfehérvár, Hungary, 8000
Contact: Milan Szalai, M.D.    +36203777818    dr.szalai.milan@gmail.com   
Sponsors and Collaborators
Bács-Kiskun County Teaching Hospital
Investigators
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Principal Investigator: László Madácsy, Prof. Bács-Kiskun County Teaching Hospital
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Responsible Party: László Madácsy Md, PhD, Clinical Professor, Bács-Kiskun County Teaching Hospital
ClinicalTrials.gov Identifier: NCT04068480    
Other Study ID Numbers: BacsKiskunCTH
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by László Madácsy Md, PhD, Bács-Kiskun County Teaching Hospital:
capsule endoscopy
magnetically assisted capsule endoscopy
MACE
Esophagus
Additional relevant MeSH terms:
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Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases