Actively Recruiting
Study of Esophageal and Gastric Diseases With Robotically Controlled Magnetic Capsule Endoscopy
Led by Bács-Kiskun County Teaching Hospital · Updated on 2025-10-03
300
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of a robotically controlled magnetic capsule endoscopy (MCCE) system to examine the esophagus and stomach, focusing on improving non-invasive screening methods for esophageal and gastric diseases. This observational study investigates the safety and effectiveness of the Ankon MCCE system in patients referred for small bowel capsule endoscopy, with an emphasis on enhancing visualization of the esophagus, especially the Z-line, through new swallowing protocols and manual capsule control. Participants swallow a magnetic capsule while positioned on their left side, with the magnet placed against their back to guide the capsule through the esophagus and stomach. The system includes a magnetic capsule, an external control magnet, data recording equipment, and a computer workstation for real-time tracking. The study evaluates how different swallowing techniques affect the capsule's transit time and imaging quality, aiming to improve the detection of esophageal mucosal abnormalities. During the study, participants undergo the MCCE procedure and are monitored for outcomes such as reflux esophagitis, other esophageal diseases, and stomach examination results over one year. Researchers assess aspects like the capsule's restrain time and the cleanliness of the imaging area. The study involves no sedation, and patients' safety and comfort are closely observed. Participation lasts for the duration necessary to complete the capsule endoscopy and follow-up assessments within a year.
CONDITIONS
Brief Title
Esophageal and Gastric Diseases With Robotically Controlled Magnetic Capsule Endoscopy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients referred for small bowel capsule endoscopy for any reason
You will not qualify if you...
- Known or suspected narrowing (stricture) in the gastrointestinal tract
- Previous surgery involving bowel connection (anastomosis)
- Difficulty swallowing
- Dementia
- Implanted cardioverter defibrillator
- Unable to sign informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single procedure visit
Participants undergo examination of the esophagus and stomach using robotically controlled magnetic capsule endoscopy to evaluate esophageal abnormalities and gastric diseases.
1 visit (in-person)
Duration - Up to 1 year
Participants are monitored for reflux esophagitis, gastric diseases, and stomach condition for up to 1 year following the capsule endoscopy procedure.
Trial Site Locations
Total: 1 location
1
Endo-Kapszula Privat Medical Cenbter
Székesfehérvár, --None---, Hungary, 8000
Actively Recruiting
Research Team
M
Milan Szalai, M.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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