Esophageal and Gastric Diseases With Robotically Controlled Magnetic Capsule Endoscopy

Study of Esophageal and Gastric Diseases With Robotically Controlled Magnetic Capsule Endoscopy

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04068480

Acronym

MACEOES

Enrollment

300

Registered

2019-08-28

Start date

2017-11-15

Completion date

2027-12-31

Last updated

2025-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Diseases, Video Capsule Endoscopy

Keywords

capsule endoscopy, magnetically assisted capsule endoscopy, MCCE, Esophagus, non-invasive endoscopy

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Hungary

Contacts

Primary ContactMilan Szalai, M.D.

dr.szalai.milan@gmail.com0036203777818

Outcome results