Video Capsule EndoscopyMACEOESNCT04068480
Esophageal and Gastric Diseases With Robotically Controlled Magnetic Capsule Endoscopy
An observational study of Video Capsule Endoscopy and Esophageal Diseases, run by Bács-Kiskun County Teaching Hospital at 1 site in Hungary.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Video Capsule Endoscopy, Esophageal Diseases
- Type of treatment
- Pill or oral medicine
- How many people
- 300 participants
- Where
- 1 siteHungary
- Study dates
- 15 Nov 2017to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Every patient who met the eligibility criteria and had MCCE examination with esophageal protocol.
Who may be able to join
- patients referred for small bowel capsule endoscopy in any indication
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hungary1 site, 1 recruiting
- Recruiting
Endo-Kapszula Privat Medical Cenbter
Székesfehérvár, --None---, 8000
Milan Szalai, M.D., +36203777818, dr.szalai.milan@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Video Capsule Endoscopy, Esophageal Diseases
- Keywords
- capsule endoscopy, magnetically assisted capsule endoscopy, MCCE, Esophagus, non-invasive endoscopy
- Medical subject headings
- Esophageal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Reflux esophagitis
Proportion and the severity of reflux (Los Angeles classification) comparing to gastroscopy
Measured: 1 year
Diseases
Proportion of other disorders of oesophagus and stomach comparing to gastroscopy
Measured: 1 year
Stomach examination
Analyze the visualisation of gastric mucosa with MACE system
Measured: 1 year
Secondary outcomes (2)
Restrain time
Analysing the correlation with MCCE system between esophageal transit time and diagnostic yield.
Measured: 1 year
Cleanliness
Analysis of stomach preparation with a special software concerning the percentage of clean and covered areas.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start15 Nov 2017
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Video Capsule EndoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bács-Kiskun County Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, László Madácsy Md, PhD, Bács-Kiskun County Teaching Hospital
- Investigators
- László Madácsy, Prof., Principal investigator, Bács-Kiskun County Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04068480
- Sponsor's protocol ID
- BacsKiskunCTH
- Acronym
- MACEOES
- Status last verified
- Sep 2025
- First submitted
- 22 Aug 2019
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Esophageal and Gastric Diseases With Robotically Controlled Magnetic Capsule Endoscopy
- ClinicalTrials.gov ID
- NCT04068480
- Acronym / sponsor ID
- MACEOES / BacsKiskunCTH
- Conditions
- Video Capsule Endoscopy, Esophageal Diseases
- Keywords
- capsule endoscopy, magnetically assisted capsule endoscopy, MCCE, Esophagus, non-invasive endoscopy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Bács-Kiskun County Teaching HospitalUniversity, hospital or other
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Every patient who met the eligibility criteria and had MCCE examination with esophageal protocol.
Key inclusion criteria (1 listed)
- patients referred for small bowel capsule endoscopy in any indication
Key exclusion criteria (6 listed)
- known or suspected stricture in the GI tract
- previous surgery with bowel anastomosis
- swallowing complaints
- dementia
- implanted cardioverter defibrillator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reflux esophagitis
Time frame: 1 year
Proportion and the severity of reflux (Los Angeles classification) comparing to gastroscopy
Diseases
Time frame: 1 year
Proportion of other disorders of oesophagus and stomach comparing to gastroscopy
Stomach examination
Time frame: 1 year
Analyze the visualisation of gastric mucosa with MACE system
2 secondary outcomes
Restrain time
Time frame: 1 year
Cleanliness
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
László Madácsy, Prof. principal investigator
Bács-Kiskun County Teaching Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Video Capsule Endoscopy and Esophageal Diseases, run by Bács-Kiskun County Teaching Hospital at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Milan Szalai, M.D. (0036203777818, dr.szalai.milan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reflux esophagitis (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025; AzTrials last refreshed its copy on 1 Nov 2026.