search
Back to results

Wired Magnetically Assisted Capsule Endoscopy and Esophageal Varices

Primary Purpose

Esophageal Varices

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
wired magnetic assisted capsule endoscopy
esophagogastroduodenoscopy
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Esophageal Varices focused on measuring upper endoscopy, biliary atresia

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    wired magnetic assisted capsule endoscopy

    esophagogastroduodenoscopy

    Arm Description

    Outcomes

    Primary Outcome Measures

    Aerosol-generating amount

    Secondary Outcome Measures

    Full Information

    First Posted
    August 24, 2023
    Last Updated
    August 24, 2023
    Sponsor
    National Taiwan University Hospital
    Collaborators
    Insight Medical Solutions
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT06017102
    Brief Title
    Wired Magnetically Assisted Capsule Endoscopy and Esophageal Varices
    Official Title
    Difference in Aerosol-generating Amount Between Wired Magnetic-assisted Capsule Endoscopy System and Esophagogastroduodenoscopy Examination of Varices in Biliary Atresia Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2024 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Taiwan University Hospital
    Collaborators
    Insight Medical Solutions

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Esophageal Varices
    Keywords
    upper endoscopy, biliary atresia

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    wired magnetic assisted capsule endoscopy
    Arm Type
    Experimental
    Arm Title
    esophagogastroduodenoscopy
    Arm Type
    Other
    Intervention Type
    Device
    Intervention Name(s)
    wired magnetic assisted capsule endoscopy
    Intervention Description
    once
    Intervention Type
    Device
    Intervention Name(s)
    esophagogastroduodenoscopy
    Intervention Description
    once
    Primary Outcome Measure Information:
    Title
    Aerosol-generating amount
    Time Frame
    1-2 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jia-Feng Wu, PhD
    Phone
    +886 23123456
    Ext
    271718
    Email
    wjf@ntu.edu.tw
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fang-Yu Tseng
    Phone
    +886 23123456
    Ext
    271737
    Email
    vanny7306@yahoo.com.tw

    12. IPD Sharing Statement

    Learn more about this trial

    Wired Magnetically Assisted Capsule Endoscopy and Esophageal Varices

    We'll reach out to this number within 24 hrs