Wired Magnetically Assisted Capsule Endoscopy and Esophageal Varices

NCT06017102 | Completed Results

• 1 other identifier: 202210059DIPA
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Varices

Keywords

upper endoscopy; biliary atresia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Particles Generated Per Minute

  1 day

• Number of Participants With Esophageal Varices

  1 day

• Number of Participants With Gastric Varices

  1 day

• Questionnaire Assessments

  1 day

• Examination Time

  1 day

Study Arms (2)

wired magnetic assisted capsule endoscopy

EXPERIMENTAL

Device: wired magnetic assisted capsule endoscopy

esophagogastroduodenoscopy

OTHER

Device: esophagogastroduodenoscopy

Interventions

wired magnetic assisted capsule endoscopy DEVICE

once

wired magnetic assisted capsule endoscopy

esophagogastroduodenoscopy DEVICE

once

esophagogastroduodenoscopy

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Biliary atresia patients \> 6 years old
• Vital signs are stable
• Without acute gastrointestinal bleeding

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Insight Medical Solutions: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Esophageal and Gastric Varices; Biliary Atresia

Interventions

Endoscopy; Endoscopy, Digestive System

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Diagnostic Techniques, Digestive System; Digestive System Surgical Procedures

Limitations and Caveats

The limitation of this study is that the sample size for each group is not large. This limitation is due to the rarity of biliary atresia, with an incidence of only 1.5 cases per 10,000 in Taiwan. Additionally, since the examination equipment differs between the two groups, a double-blind design could not be implemented.Because biliary atresia cases are prone to infection and bleeding, it is not ethically appropriate to have each patient undergo both groups.

Results Point of Contact

• Title: Dr. Jia-Feng Wu
• Organization: National Taiwan University Hospital

wjf@ntu.edu.tw

+886 23123456

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: August 30, 2023
• Study Start: September 5, 2023
• Primary Completion: February 4, 2025
• Study Completion: February 4, 2025
• Last Updated: January 23, 2026
• Results First Posted: January 23, 2026

Record last verified: 2025-02

Locations

TW (1)