Wired Magnetically Assisted Capsule Endoscopy and Esophageal Varices

Not Applicable

Recruiting

• Conditions: Esophageal Varices
• Interventions: Device: esophagogastroduodenoscopy; Device: wired magnetic assisted capsule endoscopy

• Registration Number: NCT06017102
• Lead Sponsor: National Taiwan University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-24
• Study First Submitted QC: 2023-08-24
• Study First Posted: 2023-08-30
• Study Start: 2023-09-05
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-11
• Last Update Posted: 2024-11-12
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
esophagogastroduodenoscopy	esophagogastroduodenoscopy	-
wired magnetic assisted capsule endoscopy	wired magnetic assisted capsule endoscopy	-

Primary Outcome Measures

Name	Time	Method
Aerosol-generating amount	1-2 days

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei City, Taiwan