Wired Magnetically Assisted Capsule Endoscopy and Esophageal Varices

Difference in Aerosol-generating Amount Between Wired Magnetic-assisted Capsule Endoscopy System and Esophagogastroduodenoscopy Examination of Varices in Biliary Atresia Patients

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.

Study Overview

• Status: Completed
• Conditions: Esophageal Varices
• Intervention / Treatment: Device: wired magnetic assisted capsule endoscopy; Device: esophagogastroduodenoscopy

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: wired magnetic assisted capsule endoscopy	Device: wired magnetic assisted capsule endoscopy; once
Other: esophagogastroduodenoscopy	Device: esophagogastroduodenoscopy; once

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aerosol-generating Amount	Aerosol-generating amount were measured using the MET ONE airborne particle counter [DR-528 Handheld Particle Counter (Met One Instruments, Inc., Grants Pass, OR)]. The device was placed on a platform at the same horizontal level as the patient lying flat, to capture airborne particles (sizes: 0.3-10 μm).Background environmental values were measured prior to each procedure and subtracted to determine net aerosol generation. Results are expressed as the total number of particles generated.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Particles Generated Per Minute	The total number of particles of each size divided by examination time to calculate per-minute production; comparison between the two groups.	1 day
Number of Participants With Esophageal Varices	We recorded the number of participants who had esophageal varices after completion of the examination.	1 day
Number of Participants With Gastric Varices	We recorded the number of participants who had gastric varices after completion of the examination.	1 day
Questionnaire Assessments	After the procedure, we assessed the patient's pain level using a Visual Analogue Scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates severe pain. We also evaluated the patient's willingness to undergo the same procedure again using a questionnaire scored from 0 to 5, where 0 indicates no willingness and 5 indicates strong willingness to repeat the procedure.	1 day
Examination Time	Examination time is defined as the procedure duration, measured from insertion of the examination device into the participant's mouth to complete removal of the device.	1 day
Completion Rate	Completion rate was defined as the proportion of participants in whom successful examination of each anatomical segment (esophagus, stomach, and duodenum) was achieved.Successful completion for each segment was defined as the device reaching and examining the target segment.	1 day

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Collaborators: Insight Medical Solutions

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2023
• Primary Completion (Actual): February 4, 2025
• Study Completion (Actual): February 4, 2025

Study Registration Dates

• First Submitted: August 24, 2023
• First Submitted That Met QC Criteria: August 24, 2023
• First Posted (Actual): August 30, 2023

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 6, 2026
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: biliary atresia; upper endoscopy
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Biliary Tract Diseases; Liver Diseases; Esophageal Diseases; Congenital Abnormalities; Bile Duct Diseases; Digestive System Abnormalities; Hypertension, Portal; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Biliary Atresia; Esophageal and Gastric Varices; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Diagnostic Techniques, Surgical; Diagnostic Techniques, Digestive System; Digestive System Surgical Procedures; Endoscopy; Endoscopy, Digestive System
• Other Study ID Numbers: 202210059DIPA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No