Esophageal VaricesNCT06017102

Wired Magnetically Assisted Capsule Endoscopy and Esophageal Varices

A study testing wired magnetic assisted capsule endoscopy and esophagogastroduodenoscopy in people with Esophageal Varices, run by National Taiwan University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 6 years and older
Conditions the study is for: Esophageal Varices
What is being tested?: wired magnetic assisted capsule endoscopy and esophagogastroduodenoscopy
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteTaiwan
Study dates: 5 Sep 2023to 4 Feb 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

National Taiwan University Hospital
Taipei

Other trials in Taiwan

About this study

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

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
Being tested: wired magnetic assisted capsule endoscopy, esophagogastroduodenoscopy
Keywords: upper endoscopy, biliary atresia
Medical subject headings: Esophageal and Gastric Varices, Biliary Atresia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

wired magnetic assisted capsule endoscopyDevice
once
esophagogastroduodenoscopyDevice
once

Study groups in NCT06017102
Study group	Role	What they receive
wired magnetic assisted capsule endoscopy	Experimental	Not described Receives: Device: wired magnetic assisted capsule endoscopy
esophagogastroduodenoscopy	Other	Not described Receives: Device: esophagogastroduodenoscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 1 day

Secondary outcomes (6)

Particles Generated Per Minute
The total number of particles of each size divided by examination time to calculate per-minute production; comparison between the two groups.
Measured: 1 day
Number of Participants With Esophageal Varices
We recorded the number of participants who had esophageal varices after completion of the examination.
Measured: 1 day
Number of Participants With Gastric Varices
We recorded the number of participants who had gastric varices after completion of the examination.
Measured: 1 day
Questionnaire Assessments
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.
Measured: 1 day
Examination Time
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.
Measured: 1 day
Completion Rate
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.
Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Sep 20234 Feb 2025

First posted30 Aug 2023
Study start5 Sep 2023
Primary completion4 Feb 2025
Study completion4 Feb 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Esophageal VaricesStudies of the same condition, open and under way.
More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06017102
Sponsor's protocol ID: 202210059DIPA
Status last verified: Feb 2025
First submitted: 24 Aug 2023
Last updated: 23 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Esophageal Varices trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Difference in Aerosol-generating Amount Between Wired Magnetic-assisted Capsule Endoscopy System and Esophagogastroduodenoscopy Examination of Varices in Biliary Atresia Patients
ClinicalTrials.gov ID: NCT06017102
Acronym / sponsor ID: 202210059DIPA
Conditions: Esophageal Varices
Keywords: upper endoscopy, biliary atresia
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: National Taiwan University HospitalUniversity, hospital or other
Collaborators: Insight Medical Solutions
Study start: 5 Sep 2023 (actual)
Primary completion: 4 Feb 2025 (actual)
Study completion: 4 Feb 2025 (actual)
First posted: 30 Aug 2023 (actual)
Results: Posted 23 Jan 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
wired magnetic assisted capsule endoscopy	Experimental	Device: wired magnetic assisted capsule endoscopy
esophagogastroduodenoscopy	Other	Device: esophagogastroduodenoscopy

Who may qualify

Ages: 6 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
wired magnetic assisted capsule endoscopyonce	Device	wired magnetic assisted capsule endoscopy
esophagogastroduodenoscopyonce	Device	esophagogastroduodenoscopy

Primary outcome

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.

6 secondary outcomes

Particles Generated Per Minute
Time frame: 1 day
Number of Participants With Esophageal Varices
Time frame: 1 day
Number of Participants With Gastric Varices
Time frame: 1 day
Questionnaire Assessments
Time frame: 1 day
Examination Time
Time frame: 1 day
Completion Rate
Time frame: 1 day

Results and safety

Results posted to the registry on 23 Jan 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Wired Magnetic Assisted Capsule Endoscopy	25	25
Esophagogastroduodenoscopy	25	25

Primary outcome: Aerosol-generating Amount

Time frame: 1 day. Median (Inter-Quartile Range). Unit: Particles generated

Measure	Esophagogastroduodenoscopy n = 25	Wired Magnetic Assisted Capsule Endoscopy n = 25
0.3 μm	8195 (0 to 95738)	0 (0 to 57030)
0.5 μm	13296 (3570 to 57254)	1483 (0 to 13233)
1.0 μm	11792 (3148 to 25064)	3506 (949 to 8100)
2.5 μm	7042 (2784 to 14070)	1978 (803 to 7421)
4.0 μm	1066 (360 to 2314)	362 (109 to 1316)
5.0 μm	433 (113 to 1454)	185 (41 to 639)
7.0 μm	143 (63 to 5701)	41 (0 to 217)
10.0 μm	68 (0 to 632)	0 (0 to 129)

Population analysed: All 50 participants completed the trial.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected on the day of the examination, up to 1 day.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Wired Magnetic Assisted Capsule Endoscopy	0 of 25 (0%)	0 of 25 (0%)	0 of 25
Esophagogastroduodenoscopy	0 of 25 (0%)	1 of 25 (4%)	0 of 25

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Esophageal Varices

Enrolling by invitationObservational study
Case-Specific Health Care Professional Clinical Survey for Concerto Versa™ Detachable Coils
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Not yet recruitingObservational study
Baveno VIII Criteria for Portal Hypertension in Egyptian Patients
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Recruiting
A Prospective, Multicenter, Randomized Controlled Trial Investigating the Impact of Fasting Duration on Postoperative Rebleeding Following Esophageal Variceal Ligation.
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Not yet recruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing wired magnetic assisted capsule endoscopy and esophagogastroduodenoscopy in people with Esophageal Varices, run by National Taiwan University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Aerosol-generating Amount (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06017102.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.