Esophageal and Gastric Diseases With Robotically Controlled Magnetic Capsule Endoscopy (MACEOES)
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|ClinicalTrials.gov Identifier: NCT04068480|
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : August 30, 2019
|Condition or disease|
|Video Capsule Endoscopy|
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.
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|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|
Patient refered for small bowel capsule endoscopy in conventional indication.
- Reflux esophagitis [ Time Frame: 1 year ]Proportion and the severity of reflux (Los Angeles classification) comparing to gastroscopy
- Diseases [ Time Frame: 1 year ]Proportion of other disorders of oesophagus and stomach comparing to gastroscopy
- Stomach examination [ Time Frame: 1 year ]Analyze the visualisation of gastric mucosa with MACE system
- Restrain time [ Time Frame: 1 year ]Analysing the correlation with MACE system between esophageal restrain time and diagnostic yield
- Cleaning [ Time Frame: 1 year ]Analysis of stomach preparation with a special software concerning the percentage of clean and covered areas.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04068480
|Contact: Milan Szalai, M.D.||firstname.lastname@example.org|
|Endo-Kapszula Privat Medical Cenbter||Recruiting|
|Székesfehérvár, Hungary, 8000|
|Contact: Milan Szalai, M.D. +36203777818 email@example.com|
|Principal Investigator:||László Madácsy, Prof.||Bács-Kiskun County Teaching Hospital|