Esophageal and Gastric Diseases With Robotically Controlled Magnetic Capsule Endoscopy (MACEOES)

September 30, 2025 updated by: László Madácsy Md, PhD, Bács-Kiskun County Teaching Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hungary
    • --None---
      • Székesfehérvár, --None---, Hungary, 8000
        • Recruiting
        • Endo-Kapszula Privat Medical Cenbter
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Every patient who met the eligibility criteria and had MCCE examination with esophageal protocol.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Capsule endoscopy patients
Patients swallowed the capsules in left lateral position, leaning on their left forearms and elbows, while we were positioning the magnet tightly against their backs. With the magnetic field vector X,Y,Z axis 180, -90 and 90, respectively. After swallowing the capsules with a small amount of water, they remained in this left lateral decubitus position.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bács-Kiskun County Teaching Hospital

Investigators

  • Principal Investigator: László Madácsy, Prof., Bacs-Kiskun County Teaching Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2017

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

August 22, 2019

First Submitted That Met QC Criteria

August 22, 2019

First Posted (Actual)

August 28, 2019

Study Record Updates

Last Update Posted (Estimated)

October 3, 2025

Last Update Submitted That Met QC Criteria

September 30, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BacsKiskunCTH

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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