Wired Magnetically Assisted Capsule Endoscopy and Esophageal Varices

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06017102

Collaborator

Insight Medical Solutions (Other)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Varices	Device: wired magnetic assisted capsule endoscopy Device: esophagogastroduodenoscopy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: wired magnetic assisted capsule endoscopy

Device: wired magnetic assisted capsule endoscopy

once

Other: esophagogastroduodenoscopy

Device: esophagogastroduodenoscopy

once

Outcome Measures

Primary Outcome Measures

Aerosol-generating amount [1-2 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

National Taiwan University Hospital
Insight Medical Solutions

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

National Taiwan University Hospital

ClinicalTrials.gov Identifier:

NCT06017102

Other Study ID Numbers:

202210059DIPA

First Posted:

Aug 30, 2023

Last Update Posted:

Aug 30, 2023

Last Verified:

May 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by National Taiwan University Hospital

upper endoscopy

biliary atresia

Additional relevant MeSH terms:

Esophageal and Gastric Varices

Biliary Atresia

Varicose Veins

Study Results

No Results Posted as of Aug 30, 2023