Endo-Kapszula Privat Medical Cenbter
Székesfehérvár, --None---, 8000, Hungary
Location status: Recruiting
NCT Number: NCT04068480
Magnetically controlled capsule endoscopy (MCCE) is an outstanding opportunity for the painless endoscopic screening of the esophagus and stomach before small bowel examiantion. Further improvement in patients positioning might increase the esophageal transit time of the capsule endoscope and could improve the sensitivity and specificity of the esophageal MCCE investigation. Our present study aimed to compare the visualization of the esophagus (especially the Z-line) with different capsule swallowing protocols.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Székesfehérvár, --None---, 8000, Hungary
Location status: Recruiting
Magnetic controlled capsule endoscope (MCCE) systems have been developed over the last 10-15 years to examine the upper GI tract, particularly the stomach. The new Navicam MACE system consists of a magnetic capsule endoscope, an external control magnet, a data recording kit and a computer workstation. With the appropriate software, allows real-time tracking and monitoring of the capsule inside the body. This method may in the near future be an optimal non-invasive method for screening gastric cancer and Barrett's oesophagus in high-risk populations.
Esophagogastroduodenoscopy (EGD) is the gold standard diagnostic test, however it is very inconvenient for patients without sedation.
The aim of our present study was a feasibility study to evaluate the safety and efficacy of Ankon MCCE for the investigation of esophageal abnormalities in patients referred for small bowel capsule endoscopy in our endoscopy department, to develop and test a method to use MCCE for esophageal examination, and to analyze the visualization of esophageal mucosa with our newly developed capsule swallowing protocol and manual capsule maneuvering.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 1 year
Proportion and the severity of reflux (Los Angeles classification) comparing to gastroscopy
Time frame: 1 year
Proportion of other disorders of oesophagus and stomach comparing to gastroscopy
Time frame: 1 year
Analyze the visualisation of gastric mucosa with MACE system
Time frame: 1 year
Analysing the correlation with MCCE system between esophageal transit time and diagnostic yield.
Time frame: 1 year
Analysis of stomach preparation with a special software concerning the percentage of clean and covered areas.
Contact information is provided by the study sponsor or research team.
Bács-Kiskun County Teaching Hospital
Other
Study of Esophageal and Gastric Diseases With Robotically Controlled Magnetic Capsule Endoscopy
Acronym: MACEOES
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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