Esophageal and Gastric Diseases With Robotically Controlled Magnetic Capsule Endoscopy

Recruiting

• Conditions: Video Capsule Endoscopy; Esophageal Diseases

• Registration Number: NCT04068480
• Lead Sponsor: Bács-Kiskun County Teaching Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2017-11-15
• Study First Submitted: 2019-08-22
• Study First Submitted QC: 2019-08-22
• Study First Posted: 2019-08-28
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-21
• Last Update Posted: 2023-08-23
• Primary Completion: 2023-12-31
• Study Completion: 2024-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• patients referred 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
• inability to sign the informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reflux esophagitis	1 year	Proportion and the severity of reflux (Los Angeles classification) comparing to gastroscopy
Diseases	1 year	Proportion of other disorders of oesophagus and stomach comparing to gastroscopy
Stomach examination	1 year	Analyze the visualisation of gastric mucosa with MACE system

Secondary Outcome Measures

Name	Time	Method
Restrain time	1 year	Analysing the correlation with MCCE system between esophageal transit time and diagnostic yield.
Cleanliness	1 year	Analysis of stomach preparation with a special software concerning the percentage of clean and covered areas.

Trial Locations

Locations (1)

Endo-Kapszula Privat Medical Cenbter; 🇭🇺 Székesfehérvár, Hungary