Esophageal and Gastric Diseases With Robotically Controlled Magnetic Capsule Endoscopy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBács-Kiskun County Teaching Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
known or suspected stricture in the GI tract
previous surgery with bowel anastomosis
swallowing complaints
dementia
Trial population
Every patient who met the eligibility criteria and had MCCE examination with esophageal protocol.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
300 Participants
are grouped into 1 trial groupGroup A: Capsule endoscopy patients
Trial outcomes
Primary outcomes
1
Reflux esophagitis
Proportion and the severity of reflux (Los Angeles classification) comparing to gastroscopy
Time frame
1 year2
Diseases
Proportion of other disorders of oesophagus and stomach comparing to gastroscopy
Time frame
1 year3
Stomach examination
Analyze the visualisation of gastric mucosa with MACE system
Time frame
1 yearSecondary outcomes
1
Restrain time
Analysing the correlation with MCCE system between esophageal transit time and diagnostic yield.
Time frame
1 year2
Cleanliness
Analysis of stomach preparation with a special software concerning the percentage of clean and covered areas.
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov