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NCT Number: NCT06017102

Wired Magnetically Assisted Capsule Endoscopy and Esophageal Varices

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.

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Key information

Conditions

Esophageal Varices Bile Duct Diseases Biliary Atresia Biliary Tract Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Abnormalities Digestive System Diseases Esophageal Diseases Esophageal and Gastric Varices Gastrointestinal Diseases Hypertension, Portal Liver Diseases

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

wired magnetic assisted capsule endoscopy

Device

once

esophagogastroduodenoscopy

Device

once

Primary outcomes

  1. Aerosol-generating Amount

    Time frame: 1 day

    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.

Secondary outcomes

  1. Particles Generated Per Minute

    Time frame: 1 day

    The total number of particles of each size divided by examination time to calculate per-minute production; comparison between the two groups.

  2. Number of Participants With Esophageal Varices

    Time frame: 1 day

    We recorded the number of participants who had esophageal varices after completion of the examination.

  3. Number of Participants With Gastric Varices

    Time frame: 1 day

    We recorded the number of participants who had gastric varices after completion of the examination.

  4. Questionnaire Assessments

    Time frame: 1 day

    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.

  5. Examination Time

    Time frame: 1 day

    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.

  6. Completion Rate

    Time frame: 1 day

    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.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Collaborators

  • Insight Medical Solutions

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 30, 2023
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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