N/A
N=50
Wired Magnetically Assisted Capsule Endoscopy and Esophageal Varices
Esophageal Varices
Bottom Line
View on ClinicalTrials.gov: NCT06017102 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcome: Primary: Aerosol-generating Amount — 8195; 0; 13296; 1483 Particles generated
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- wired magnetic assisted capsule endoscopy (Device); esophagogastroduodenoscopy (Device)
- Age
- Pediatric, Adult, Older Adult · 6+ yrs
- Sex
- All
- Sponsor
- National Taiwan University Hospital
- Primary completion
- Feb 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Aerosol-generating Amount |
8195; 0; 13296; 1483; 11792; 3506 | — |
| SECONDARY Particles Generated Per Minute |
1394; 0; 2060; 1493; 1366; 221 | — |
| SECONDARY Number of Participants With Esophageal Varices |
22; 10 | — |
| SECONDARY Number of Participants With Gastric Varices |
2; 3 | — |
| SECONDARY Questionnaire Assessments |
0; 3; 4; 4 | — |
| SECONDARY Examination Time |
7; 15 | — |
| SECONDARY Completion Rate |
25; 25; 25; 25; 25; 23 | — |
Summary
The goal of this clinical trial is to compare the safeness and effectiveness of traditional esophagogastroduodenoscope (EGD) and wired magnetically assisted capsule endoscopy (MACE) in the diagnosis of esophageal varices in biliary atresia (BA) patients. The main questions it aims to answer are:
* Subjects who do wired magnetically assisted capsule endoscopy do not need to open the mouths during the process, this study also want to know whether wired magnetically assisted capsule endoscopy can reduce the generation of droplets.
* Diagnostic accuracy between traditional esophagogastroduodenoscope and wired magnetically assisted capsule endoscopy in biliary atresia patients with esophageal varices.
Participants will do either traditional esophagogastroduodenoscope or wired magnetically assisted capsule endoscopy.
Eligibility Criteria
Inclusion Criteria
- Biliary atresia patients > 6 years old
- Vital signs are stable
- Without acute gastrointestinal bleeding
Exclusion Criteria
- Patients with metal implants, metal stent, artificial joints, bone plates, and bone screw
- Patients with electronic devices, such as pacemakers, cochlear implants, or other implanted electronic medical devices
- Throat or esophageal obstruction leading to dysphagia patients
- Consciousness disturbance patients unable to swallow
- Patients with acute upper gastrointestinal bleeding
- Patients with platelet lower than 40K or PT INR > 1.5
Data sourced from ClinicalTrials.gov (NCT06017102). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.