Trial Outcomes & Findings for Wired Magnetically Assisted Capsule Endoscopy and Esophageal Varices (NCT NCT06017102)
NCT ID: NCT06017102
Last Updated: 2026-01-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
1 day
Results posted on
2026-01-23
Participant Flow
The recruitment period is from August 2023 to February 2025, conducted at the Gastroenterology Clinic of National Taiwan University Children's Hospital.
Participant milestones
| Measure |
Wired Magnetic Assisted Capsule Endoscopy
This prospective open-label trial enrolls 25 patients aged 6 or older with biliary atresia to undergo wired magnetic-assisted capsule endoscopy (MCE) for esophageal varices, based on the patient's or family's choice.
|
Esophagogastroduodenoscopy
Additionally, 25 patients aged 6 years or older with biliary atresia will undergo esophagogastroduodenoscopy for esophageal varices assessment as the control group.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Wired Magnetic Assisted Capsule Endoscopy
n=25 Participants
Participants in this group undergo wired magnetic-assisted capsule endoscopy to assess esophageal varices, which is a non-invasive method decided based on the patient's or family's choice.
|
Esophagogastroduodenoscopy
n=25 Participants
Participants in this group undergo esophagogastroduodenoscopy to assess esophageal varices, which is a traditional invasive method, with sedation based on the need.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
17.75 years
n=25 Participants
|
11.10 years
n=25 Participants
|
15.04 years
n=50 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=25 Participants
|
13 Participants
n=25 Participants
|
25 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=25 Participants
|
12 Participants
n=25 Participants
|
25 Participants
n=50 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Body height
|
158 cm
n=25 Participants
|
143 cm
n=25 Participants
|
155 cm
n=50 Participants
|
|
Body weight
|
53 kg
n=25 Participants
|
34.5 kg
n=25 Participants
|
50.15 kg
n=50 Participants
|
|
Liver cirrhosis
|
13 Participants
n=25 Participants
|
17 Participants
n=25 Participants
|
30 Participants
n=50 Participants
|
|
Ascites
|
4 Participants
n=25 Participants
|
2 Participants
n=25 Participants
|
6 Participants
n=50 Participants
|
|
Splenomegaly
|
14 Participants
n=25 Participants
|
19 Participants
n=25 Participants
|
33 Participants
n=50 Participants
|
|
Liver transplantation
|
10 Participants
n=25 Participants
|
8 Participants
n=25 Participants
|
18 Participants
n=50 Participants
|
|
Conscious sedation
|
0 Participants
n=25 Participants
|
20 Participants
n=25 Participants
|
20 Participants
n=50 Participants
|
|
< 19 years of age
|
13 Participants
n=25 Participants
|
19 Participants
n=25 Participants
|
32 Participants
n=50 Participants
|
|
ALT
|
22 IU/mL
n=25 Participants
|
36 IU/mL
n=25 Participants
|
30 IU/mL
n=50 Participants
|
|
Platelet
|
175 K/uL
n=25 Participants
|
104 K/uL
n=25 Participants
|
157.5 K/uL
n=50 Participants
|
|
Hb
|
13.1 g/dL
n=25 Participants
|
11.9 g/dL
n=25 Participants
|
12.45 g/dL
n=50 Participants
|
|
WBC
|
5.14 K/uL
n=25 Participants
|
4.2 K/uL
n=25 Participants
|
4.685 K/uL
n=50 Participants
|
|
Total bilirubin
|
1.14 mg/dL
n=25 Participants
|
0.87 mg/dL
n=25 Participants
|
0.985 mg/dL
n=50 Participants
|
|
Direct bilirubin
|
0.27 mg/dL
n=25 Participants
|
0.21 mg/dL
n=25 Participants
|
0.23 mg/dL
n=50 Participants
|
PRIMARY outcome
Timeframe: 1 dayPopulation: All 50 participants completed the trial.
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.
Outcome measures
| Measure |
Esophagogastroduodenoscopy
n=25 Participants
25 patients aged 6 years or older with biliary atresia undergoing conventional esophagogastroduodenoscopy (EGD) for esophageal varices survey will be enrolled as the "control group."Both groups will prospectively enter the study after providing informed consent and signing the consent form. All patients will fast appropriately according to endoscopic examination guidelines before the procedure.Patients undergoing conventional EGD may choose to receive conscious sedation based on clinical needs.
|
Wired Magnetic Assisted Capsule Endoscopy
n=25 Participants
In this study, 25 patients aged 6 years or older with biliary atresia undergoing Magnetic-Assisted Capsule Endoscopy (MACE) for esophageal varices survey will be enrolled as the "study group.Patients undergoing MACE will be advised to keep their lips closed and wear a surgical mask during the examination.
|
|---|---|---|
|
Aerosol-generating Amount
1.0 μm
|
11792 Particles generated
Interval 3148.0 to 25064.0
|
3506 Particles generated
Interval 949.0 to 8100.0
|
|
Aerosol-generating Amount
2.5 μm
|
7042 Particles generated
Interval 2784.0 to 14070.0
|
1978 Particles generated
Interval 803.0 to 7421.0
|
|
Aerosol-generating Amount
4.0 μm
|
1066 Particles generated
Interval 360.0 to 2314.0
|
362 Particles generated
Interval 109.0 to 1316.0
|
|
Aerosol-generating Amount
0.3 μm
|
8195 Particles generated
Interval 0.0 to 95738.0
|
0 Particles generated
Interval 0.0 to 57030.0
|
|
Aerosol-generating Amount
0.5 μm
|
13296 Particles generated
Interval 3570.0 to 57254.0
|
1483 Particles generated
Interval 0.0 to 13233.0
|
|
Aerosol-generating Amount
5.0 μm
|
433 Particles generated
Interval 113.0 to 1454.0
|
185 Particles generated
Interval 41.0 to 639.0
|
|
Aerosol-generating Amount
7.0 μm
|
143 Particles generated
Interval 63.0 to 5701.0
|
41 Particles generated
Interval 0.0 to 217.0
|
|
Aerosol-generating Amount
10.0 μm
|
68 Particles generated
Interval 0.0 to 632.0
|
0 Particles generated
Interval 0.0 to 129.0
|
SECONDARY outcome
Timeframe: 1 dayPopulation: All 50 participants completed the trial.
The total number of particles of each size divided by examination time to calculate per-minute production; comparison between the two groups.
Outcome measures
| Measure |
Esophagogastroduodenoscopy
n=25 Participants
25 patients aged 6 years or older with biliary atresia undergoing conventional esophagogastroduodenoscopy (EGD) for esophageal varices survey will be enrolled as the "control group."Both groups will prospectively enter the study after providing informed consent and signing the consent form. All patients will fast appropriately according to endoscopic examination guidelines before the procedure.Patients undergoing conventional EGD may choose to receive conscious sedation based on clinical needs.
|
Wired Magnetic Assisted Capsule Endoscopy
n=25 Participants
In this study, 25 patients aged 6 years or older with biliary atresia undergoing Magnetic-Assisted Capsule Endoscopy (MACE) for esophageal varices survey will be enrolled as the "study group.Patients undergoing MACE will be advised to keep their lips closed and wear a surgical mask during the examination.
|
|---|---|---|
|
Particles Generated Per Minute
2.5 μm per min
|
760 Particles generated per minute
Interval 230.0 to 2294.0
|
127 Particles generated per minute
Interval 60.0 to 548.0
|
|
Particles Generated Per Minute
4.0 μm per min
|
117 Particles generated per minute
Interval 28.0 to 326.0
|
20 Particles generated per minute
Interval 7.0 to 83.0
|
|
Particles Generated Per Minute
5.0 μm per min
|
69 Particles generated per minute
Interval 16.0 to 178.0
|
10 Particles generated per minute
Interval 2.0 to 38.0
|
|
Particles Generated Per Minute
7.0 μm per min
|
22 Particles generated per minute
Interval 6.0 to 72.0
|
3 Particles generated per minute
Interval 0.0 to 16.0
|
|
Particles Generated Per Minute
10.0 μm per min
|
10 Particles generated per minute
Interval 0.0 to 69.0
|
0 Particles generated per minute
Interval 0.0 to 14.0
|
|
Particles Generated Per Minute
0.3 μm per min
|
1394 Particles generated per minute
Interval 0.0 to 13768.0
|
0 Particles generated per minute
Interval 0.0 to 4060.0
|
|
Particles Generated Per Minute
0.5 μm per min
|
2060 Particles generated per minute
Interval 417.0 to 4713.0
|
1493 Particles generated per minute
Interval 0.0 to 1753.0
|
|
Particles Generated Per Minute
1.0 μm per min
|
1366 Particles generated per minute
Interval 367.0 to 3466.0
|
221 Particles generated per minute
Interval 113.0 to 829.0
|
SECONDARY outcome
Timeframe: 1 dayPopulation: All 50 participants completed the trial.
We recorded the number of participants who had esophageal varices after completion of the examination.
Outcome measures
| Measure |
Esophagogastroduodenoscopy
n=25 Participants
25 patients aged 6 years or older with biliary atresia undergoing conventional esophagogastroduodenoscopy (EGD) for esophageal varices survey will be enrolled as the "control group."Both groups will prospectively enter the study after providing informed consent and signing the consent form. All patients will fast appropriately according to endoscopic examination guidelines before the procedure.Patients undergoing conventional EGD may choose to receive conscious sedation based on clinical needs.
|
Wired Magnetic Assisted Capsule Endoscopy
n=25 Participants
In this study, 25 patients aged 6 years or older with biliary atresia undergoing Magnetic-Assisted Capsule Endoscopy (MACE) for esophageal varices survey will be enrolled as the "study group.Patients undergoing MACE will be advised to keep their lips closed and wear a surgical mask during the examination.
|
|---|---|---|
|
Number of Participants With Esophageal Varices
|
22 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 1 dayPopulation: All 50 participants completed the trial.
We recorded the number of participants who had gastric varices after completion of the examination.
Outcome measures
| Measure |
Esophagogastroduodenoscopy
n=25 Participants
25 patients aged 6 years or older with biliary atresia undergoing conventional esophagogastroduodenoscopy (EGD) for esophageal varices survey will be enrolled as the "control group."Both groups will prospectively enter the study after providing informed consent and signing the consent form. All patients will fast appropriately according to endoscopic examination guidelines before the procedure.Patients undergoing conventional EGD may choose to receive conscious sedation based on clinical needs.
|
Wired Magnetic Assisted Capsule Endoscopy
n=25 Participants
In this study, 25 patients aged 6 years or older with biliary atresia undergoing Magnetic-Assisted Capsule Endoscopy (MACE) for esophageal varices survey will be enrolled as the "study group.Patients undergoing MACE will be advised to keep their lips closed and wear a surgical mask during the examination.
|
|---|---|---|
|
Number of Participants With Gastric Varices
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 1 dayPopulation: All 50 participants completed the trial.
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.
Outcome measures
| Measure |
Esophagogastroduodenoscopy
n=25 Participants
25 patients aged 6 years or older with biliary atresia undergoing conventional esophagogastroduodenoscopy (EGD) for esophageal varices survey will be enrolled as the "control group."Both groups will prospectively enter the study after providing informed consent and signing the consent form. All patients will fast appropriately according to endoscopic examination guidelines before the procedure.Patients undergoing conventional EGD may choose to receive conscious sedation based on clinical needs.
|
Wired Magnetic Assisted Capsule Endoscopy
n=25 Participants
In this study, 25 patients aged 6 years or older with biliary atresia undergoing Magnetic-Assisted Capsule Endoscopy (MACE) for esophageal varices survey will be enrolled as the "study group.Patients undergoing MACE will be advised to keep their lips closed and wear a surgical mask during the examination.
|
|---|---|---|
|
Questionnaire Assessments
Patient's willingness to undergo the same procedure again
|
4 score on a scale
Interval 3.0 to 5.0
|
4 score on a scale
Interval 3.0 to 4.5
|
|
Questionnaire Assessments
Pain level
|
0 score on a scale
Interval 0.0 to 3.0
|
3 score on a scale
Interval 1.0 to 4.0
|
SECONDARY outcome
Timeframe: 1 dayPopulation: All 50 participants completed the trial.
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.
Outcome measures
| Measure |
Esophagogastroduodenoscopy
n=25 Participants
25 patients aged 6 years or older with biliary atresia undergoing conventional esophagogastroduodenoscopy (EGD) for esophageal varices survey will be enrolled as the "control group."Both groups will prospectively enter the study after providing informed consent and signing the consent form. All patients will fast appropriately according to endoscopic examination guidelines before the procedure.Patients undergoing conventional EGD may choose to receive conscious sedation based on clinical needs.
|
Wired Magnetic Assisted Capsule Endoscopy
n=25 Participants
In this study, 25 patients aged 6 years or older with biliary atresia undergoing Magnetic-Assisted Capsule Endoscopy (MACE) for esophageal varices survey will be enrolled as the "study group.Patients undergoing MACE will be advised to keep their lips closed and wear a surgical mask during the examination.
|
|---|---|---|
|
Examination Time
|
7 min
Interval 5.0 to 10.0
|
15 min
Interval 9.5 to 19.0
|
SECONDARY outcome
Timeframe: 1 dayPopulation: All 50 participants completed the trial.
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.
Outcome measures
| Measure |
Esophagogastroduodenoscopy
n=25 Participants
25 patients aged 6 years or older with biliary atresia undergoing conventional esophagogastroduodenoscopy (EGD) for esophageal varices survey will be enrolled as the "control group."Both groups will prospectively enter the study after providing informed consent and signing the consent form. All patients will fast appropriately according to endoscopic examination guidelines before the procedure.Patients undergoing conventional EGD may choose to receive conscious sedation based on clinical needs.
|
Wired Magnetic Assisted Capsule Endoscopy
n=25 Participants
In this study, 25 patients aged 6 years or older with biliary atresia undergoing Magnetic-Assisted Capsule Endoscopy (MACE) for esophageal varices survey will be enrolled as the "study group.Patients undergoing MACE will be advised to keep their lips closed and wear a surgical mask during the examination.
|
|---|---|---|
|
Completion Rate
Esophagus
|
25 Participants
|
25 Participants
|
|
Completion Rate
Stomach
|
25 Participants
|
25 Participants
|
|
Completion Rate
Duodenum
|
25 Participants
|
23 Participants
|
Adverse Events
Wired Magnetic Assisted Capsule Endoscopy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Esophagogastroduodenoscopy
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Wired Magnetic Assisted Capsule Endoscopy
n=25 participants at risk
MACE will be advised to keep their lips closed and wear a surgical mask during the examination.
|
Esophagogastroduodenoscopy
n=25 participants at risk
Patients undergoing conventional EGD may choose to receive conscious sedation based on clinical needs.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Decreased Oxygen Saturation
|
0.00%
0/25 • Adverse event data were collected on the day of the examination, up to 1 day.
|
4.0%
1/25 • Number of events 1 • Adverse event data were collected on the day of the examination, up to 1 day.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place