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NCT06017102 Clinical Trial

Wired Magnetically Assisted Capsule Endoscopy and Esophageal Varices

Esophageal Varices Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06017102
Other study ID # 202210059DIPA
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 5, 2023
Est. completion date December 31, 2024

Study information
Verified date May 2024
Source National Taiwan University Hospital
Contact Jia-Feng Wu, PhD
Phone +886 23123456
Email wjf@ntu.edu.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 6 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• wired magnetic assisted capsule endoscopy
once
• esophagogastroduodenoscopy
once

Locations
Country Name City State
Taiwan National Taiwan University Hospital Taipei City

Sponsors (2)
Lead Sponsor Collaborator
National Taiwan University Hospital Insight Medical Solutions

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Aerosol-generating amount 1-2 days
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