Esophageal and Gastric Diseases With Robotically Controlled Magnetic Capsule Endoscopy
MACEOES
Study of Esophageal and Gastric Diseases With Robotically Controlled Magnetic Capsule Endoscopy
1 other identifier
observational
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 15, 2017
CompletedFirst Submitted
Initial submission to the registry
August 22, 2019
CompletedFirst Posted
Study publicly available on registry
August 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
October 3, 2025
September 1, 2025
9.1 years
August 22, 2019
September 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Reflux esophagitis
Proportion and the severity of reflux (Los Angeles classification) comparing to gastroscopy
1 year
Diseases
Proportion of other disorders of oesophagus and stomach comparing to gastroscopy
1 year
Stomach examination
Analyze the visualisation of gastric mucosa with MACE system
1 year
Secondary Outcomes (2)
Restrain time
1 year
Cleanliness
1 year
Study Arms (1)
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.
Eligibility Criteria
Every patient who met the eligibility criteria and had MCCE examination with esophageal protocol.
You may qualify if:
- \- patients referred for small bowel capsule endoscopy in any indication
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Endo-Kapszula Privat Medical Cenbter
Székesfehérvár, --None---, 8000, Hungary
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
László Madácsy, Prof.
Bács-Kiskun County Teaching Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
August 22, 2019
First Posted
August 28, 2019
Study Start
November 15, 2017
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2027
Last Updated
October 3, 2025
Record last verified: 2025-09