Magnetically controlled capsule endoscopy for esophageal and gastric diseases
Study of Esophageal and Gastric Diseases With Robotically Controlled Magnetic Capsule Endoscopy
This study is testing a new way to use a tiny camera capsule, controlled by magnets, to see if it can safely and effectively check for problems in the esophagus and stomach in patients who need a small bowel exam.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bács-Kiskun County Teaching Hospital Academic / other |
| Locations | 1 site (Székesfehérvár, --None---) |
| Trial ID | NCT04068480 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of magnetically controlled capsule endoscopy (MCCE) for examining esophageal abnormalities in patients referred for small bowel capsule endoscopy. The research aims to improve visualization of the esophagus, particularly the Z-line, by testing different capsule swallowing protocols. The Navicam MACE system allows real-time tracking of the capsule, potentially offering a non-invasive alternative to traditional endoscopy methods. The study focuses on enhancing the sensitivity and specificity of MCCE in detecting conditions like gastric cancer and Barrett's esophagus.
Who should consider this trial
Good fit: Ideal candidates include patients referred for small bowel capsule endoscopy without significant gastrointestinal tract abnormalities.
Not a fit: Patients with known or suspected strictures, previous bowel surgeries, swallowing difficulties, or cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a painless and effective screening method for esophageal and gastric diseases.
How similar studies have performed: While magnetically controlled capsule endoscopy is a relatively novel approach, preliminary studies suggest promising results in similar applications.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Székesfehérvár, --None---
- Endo-Kapszula Privat Medical Cenbter — Székesfehérvár, --None---, Hungary (Recruiting)
Study contacts
- Principal investigator: László Madácsy, Prof. — Bács-Kiskun County Teaching Hospital
- Study coordinator: Milan Szalai, M.D.
- Email: dr.szalai.milan@gmail.com
- Phone: 0036203777818
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.