Trial Outcomes & Findings for Feasibility of Non-contact Magnetically-controlled Capsule Endoscopy During COVID-19 Pandemic (NCT NCT04389333)
NCT ID: NCT04389333
Last Updated: 2022-01-05
Results Overview
The number of participants with complete observation. Complete observation of the mucosa means over 90% of the mucosa observed in gastric cardia, fundus, body, angulus, antrum and pylorus.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
During the procedure
Results posted on
2022-01-05
Participant Flow
Participant milestones
| Measure |
Non-contact MCE Examination
After an overnight fasting and drinking 1000 mL water and simethicone for gastric dilatation and preparation, the study subject positions himself (herself) on the examination bed in Room A, while the operating doctor sits in Room B at the remote control workstation instructing her to swallow the capsule via the audio-visual exchange system. After the capsule entering the stomach, the doctor manipulated the two joysticks on the remote control workstation, mobilizing the robotic magnetic arm, and simultaneously driving the precise movement and rotation of the capsule to perform the gastric examination. In order to simplify the examination procedure, the data recorder was put on the examination bed. The patient lay down after swallowing the capsule under the remote guidance of the endoscopist.
non-contact magnetically-controlled capsule endoscopy: The novel non-contact magnetically-controlled capsule endoscopy (MCE) system (Ankon Technologies, Wuhan, China) (Figure 1) added a remote control workstation and an audio-visual exchange system to the original well-establish MCE system, which consisted of a robotic magnetic arm, a workstation (currently bypassed) and a capsule endoscope.
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MCE Examination
After an overnight fasting and drinking 1000 mL water and simethicone for gastric dilatation and preparation, the subjects put on the data recorder with the help of an endoscopist. Then, the endoscopist activated the capsule with the capsule locator. The patient was instructed to assume the supine or left lateral decubitus position and to swallow the capsule with a small amount of water to effectively observe the esophagus and dentate line. Then, under the guidance of the endoscopist face to face, the subject turned over on the bed to complete the examination.
non-contact magnetically-controlled capsule endoscopy: The novel non-contact magnetically-controlled capsule endoscopy (MCE) system (Ankon Technologies, Wuhan, China) (Figure 1) added a remote control workstation and an audio-visual exchange system to the original well-establish MCE system, which consisted of a robotic magnetic arm, a workstation (currently bypassed) and a capsule endoscope.
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|---|---|---|
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Overall Study
STARTED
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20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Feasibility of Non-contact Magnetically-controlled Capsule Endoscopy During COVID-19 Pandemic
Baseline characteristics by cohort
| Measure |
ncMCE Group
n=20 Participants
The ncMCE system adds a remote control workstation and an audio-visual exchange system to the original well-established MCE system, which was developed and tested at our medical center \[10\]. To simplify the preparation process, we embedded the data recorder in the examination bed. The ncMCE system separates endoscopists and patients in two rooms (control room for the endoscopist and examination room for patients), offering physical isolation for noninvasive gastric examination during the pandemic.
|
MCE Group
n=20 Participants
The MCE system (Ankon Technologies Co., Ltd. Shanghai, China) consists of a guidance C-arm magnet robot, a computer workstation with ESNavi software, endoscopic capsule, capsule locator, and a vest-like data recorder that can receive capsule signals from both sides.
|
Total
n=40 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
46.1 years
STANDARD_DEVIATION 14.8 • n=99 Participants
|
53.5 years
STANDARD_DEVIATION 9.2 • n=107 Participants
|
49.8 years
STANDARD_DEVIATION 12.72 • n=206 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
20 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
History of abdominal surgery
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Diabetes
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Smoking history
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Drinking history
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Indication:Symptoms
|
18 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Indication:Health checkup
|
2 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Indication:Abdominal pain
|
9 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Indication:Abdominal distension
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Indication: Acid reflux
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Indication: Others
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: During the procedureThe number of participants with complete observation. Complete observation of the mucosa means over 90% of the mucosa observed in gastric cardia, fundus, body, angulus, antrum and pylorus.
Outcome measures
| Measure |
ncMCE Group
n=20 Participants
The ncMCE system adds a remote control workstation and an audio-visual exchange system to the original well-established MCE system, which was developed and tested at our medical center \[10\]. To simplify the preparation process, we embedded the data recorder in the examination bed. The ncMCE system separates endoscopists and patients in two rooms (control room for the endoscopist and examination room for patients), offering physical isolation for noninvasive gastric examination during the pandemic.
|
MCE Group
n=20 Participants
The MCE system (Ankon Technologies Co., Ltd. Shanghai, China) consists of a guidance C-arm magnet robot, a computer workstation with ESNavi software, endoscopic capsule, capsule locator, and a vest-like data recorder that can receive capsule signals from both sides.
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|---|---|---|
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Number of Participants With Complete Observation
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20 Participants
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20 Participants
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SECONDARY outcome
Timeframe: During the procedureManeuverability score was the sum of four subjective scores rated by the operator (signal transmission quality score, operating comfort score, gastric visualization score and study subject compliance score), each of which ranged from 1 to 5 denoting the lowest to the highest degree of satisfaction and the range of total score from 0 to 20. The higher the score, the better the maneuverability.
Outcome measures
| Measure |
ncMCE Group
n=20 Participants
The ncMCE system adds a remote control workstation and an audio-visual exchange system to the original well-established MCE system, which was developed and tested at our medical center \[10\]. To simplify the preparation process, we embedded the data recorder in the examination bed. The ncMCE system separates endoscopists and patients in two rooms (control room for the endoscopist and examination room for patients), offering physical isolation for noninvasive gastric examination during the pandemic.
|
MCE Group
n=20 Participants
The MCE system (Ankon Technologies Co., Ltd. Shanghai, China) consists of a guidance C-arm magnet robot, a computer workstation with ESNavi software, endoscopic capsule, capsule locator, and a vest-like data recorder that can receive capsule signals from both sides.
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|---|---|---|
|
Maneuverability Score
Transmission quality
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4.5 score on a scale
Interval 4.5 to 5.0
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5 score on a scale
Interval 5.0 to 5.0
|
|
Maneuverability Score
Comfortableness
|
5 score on a scale
Interval 5.0 to 5.0
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5 score on a scale
Interval 5.0 to 5.0
|
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Maneuverability Score
Visualization
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5 score on a scale
Interval 5.0 to 5.0
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5 score on a scale
Interval 4.0 to 5.0
|
|
Maneuverability Score
Compliance of patients
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5 score on a scale
Interval 5.0 to 5.0
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5 score on a scale
Interval 5.0 to 5.0
|
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Maneuverability Score
Total
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19.25 score on a scale
Interval 18.63 to 20.0
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20 score on a scale
Interval 19.0 to 20.0
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SECONDARY outcome
Timeframe: During the procedureGET was defined as the time taken for the endoscopist to complete the gastric examination to his or her satisfaction
Outcome measures
| Measure |
ncMCE Group
n=20 Participants
The ncMCE system adds a remote control workstation and an audio-visual exchange system to the original well-established MCE system, which was developed and tested at our medical center \[10\]. To simplify the preparation process, we embedded the data recorder in the examination bed. The ncMCE system separates endoscopists and patients in two rooms (control room for the endoscopist and examination room for patients), offering physical isolation for noninvasive gastric examination during the pandemic.
|
MCE Group
n=20 Participants
The MCE system (Ankon Technologies Co., Ltd. Shanghai, China) consists of a guidance C-arm magnet robot, a computer workstation with ESNavi software, endoscopic capsule, capsule locator, and a vest-like data recorder that can receive capsule signals from both sides.
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|---|---|---|
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Gastric Examination Time(GET)
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12.3 minute
Interval 7.5 to 16.3
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7.2 minute
Interval 6.5 to 8.9
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SECONDARY outcome
Timeframe: After the procedure(within 5 days)The investigators use a satisfaction questionnaire to evaluate the comfort and acceptability of each patient by two sub questionnaires, which was pre-procedure patient perception (3 items, ranged from 0 to 12 ) and post-procedure patient satisfaction (12 items, ranged from 0 to 48) .The higher the score, the worse the patient's satisfaction.
Outcome measures
| Measure |
ncMCE Group
n=20 Participants
The ncMCE system adds a remote control workstation and an audio-visual exchange system to the original well-established MCE system, which was developed and tested at our medical center \[10\]. To simplify the preparation process, we embedded the data recorder in the examination bed. The ncMCE system separates endoscopists and patients in two rooms (control room for the endoscopist and examination room for patients), offering physical isolation for noninvasive gastric examination during the pandemic.
|
MCE Group
n=20 Participants
The MCE system (Ankon Technologies Co., Ltd. Shanghai, China) consists of a guidance C-arm magnet robot, a computer workstation with ESNavi software, endoscopic capsule, capsule locator, and a vest-like data recorder that can receive capsule signals from both sides.
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|---|---|---|
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the Comfort and Acceptability of Patients
Post-procedure patient satisfaction
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45 score on a scale
Interval 42.3 to 46.8
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44 score on a scale
Interval 42.0 to 45.0
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the Comfort and Acceptability of Patients
Pre-procedure patient perception
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9 score on a scale
Interval 8.0 to 9.0
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9 score on a scale
Interval 8.0 to 9.0
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SECONDARY outcome
Timeframe: after the procedure(within 5 days)It was calculated using the following formula: number of patients with positive findings divided by the total number of patients that underwent examination.
Outcome measures
| Measure |
ncMCE Group
n=20 Participants
The ncMCE system adds a remote control workstation and an audio-visual exchange system to the original well-established MCE system, which was developed and tested at our medical center \[10\]. To simplify the preparation process, we embedded the data recorder in the examination bed. The ncMCE system separates endoscopists and patients in two rooms (control room for the endoscopist and examination room for patients), offering physical isolation for noninvasive gastric examination during the pandemic.
|
MCE Group
n=20 Participants
The MCE system (Ankon Technologies Co., Ltd. Shanghai, China) consists of a guidance C-arm magnet robot, a computer workstation with ESNavi software, endoscopic capsule, capsule locator, and a vest-like data recorder that can receive capsule signals from both sides.
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|---|---|---|
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The Total Number of Patients Who Who Had a Diagnosis of Positive Findings
Polyp
|
2 Participants
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3 Participants
|
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The Total Number of Patients Who Who Had a Diagnosis of Positive Findings
Erosion
|
2 Participants
|
1 Participants
|
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The Total Number of Patients Who Who Had a Diagnosis of Positive Findings
Ulcer
|
0 Participants
|
2 Participants
|
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The Total Number of Patients Who Who Had a Diagnosis of Positive Findings
Total
|
4 Participants
|
6 Participants
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OTHER_PRE_SPECIFIED outcome
Timeframe: During and within 2 weeks after the procedurePopulation: Each patient was followed up for 2 weeks by telephone and hospital information system to confirm capsule excretion and any adverse events (AEs), including COVID-19 infection.
Each patient was followed up for 2 weeks by telephone and hospital information system to confirm capsule excretion and any adverse events (AEs), including COVID-19 infection.
Outcome measures
| Measure |
ncMCE Group
n=20 Participants
The ncMCE system adds a remote control workstation and an audio-visual exchange system to the original well-established MCE system, which was developed and tested at our medical center \[10\]. To simplify the preparation process, we embedded the data recorder in the examination bed. The ncMCE system separates endoscopists and patients in two rooms (control room for the endoscopist and examination room for patients), offering physical isolation for noninvasive gastric examination during the pandemic.
|
MCE Group
n=20 Participants
The MCE system (Ankon Technologies Co., Ltd. Shanghai, China) consists of a guidance C-arm magnet robot, a computer workstation with ESNavi software, endoscopic capsule, capsule locator, and a vest-like data recorder that can receive capsule signals from both sides.
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|---|---|---|
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Adverse Events
|
0 Participants
|
0 Participants
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Adverse Events
ncMCE Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MCE Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Zhuan Liao
National Clinical Research Center for Digestive Diseases Department of Gastroenterology
Phone: 21-31161004
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place