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NCT Number: NCT04068480

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Endo-Kapszula Privat Medical Cenbter

Székesfehérvár, --None---, 8000, Hungary

Location status: Recruiting

Location contact

Milan Szalai, M.D.

CONTACT

[email protected]

+36203777818

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Reflux esophagitis

    Time frame: 1 year

    Proportion and the severity of reflux (Los Angeles classification) comparing to gastroscopy

  2. Diseases

    Time frame: 1 year

    Proportion of other disorders of oesophagus and stomach comparing to gastroscopy

  3. Stomach examination

    Time frame: 1 year

    Analyze the visualisation of gastric mucosa with MACE system

Secondary outcomes

  1. Restrain time

    Time frame: 1 year

    Analysing the correlation with MCCE system between esophageal transit time and diagnostic yield.

  2. Cleanliness

    Time frame: 1 year

    Analysis of stomach preparation with a special software concerning the percentage of clean and covered areas.

Study contacts

Contact information is provided by the study sponsor or research team.

Milan Szalai, M.D.

CONTACT

[email protected]

0036203777818

Sponsors and collaborators

Lead sponsor

Bács-Kiskun County Teaching Hospital

Other

Registry information

Official study title

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

Acronym: MACEOES

Important dates

Study start
2017
Primary completion
2026
Study completion
2027
First posted
Aug 28, 2019
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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