Esophageal and Gastric Diseases With Robotically Controlled Magnetic Capsule Endoscopy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Video Capsule Endoscopy, Esophageal Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hungary
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Study of Esophageal and Gastric Diseases With Robotically Controlled Magnetic Capsule Endoscopy
Overview
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.
Primary outcome measures
- Reflux esophagitis [Time frame: 1 year]
- Diseases [Time frame: 1 year]
- Stomach examination [Time frame: 1 year]
Secondary outcome measures (2)
- Restrain time [Time frame: 1 year]
- Cleanliness [Time frame: 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Hungary · 1 center
- Endo-Kapszula Privat Medical Cenbter — Székesfehérvár
Identifiers
NCT: NCT04068480 · BacsKiskunCTH