Feasibility of Non-contact Magnetically-controlled Capsule Endoscopy During COVID-19 Pandemic: a Prospective, Open-label, Pilot, Randomized Trial
Phase: NA
Conditions: Gastrointestinal Disease, Infectious Disease, Capsule Endoscopy
Sponsor: Changhai Hospital

Protocol
Noncontact magnetically controlled capsule endoscopy for infection-free gastric examination during
the COVID-19 pandemic: a pilot, open-label, randomized study

Table of Contents
CHAPTER 1: ADMINISTRATIVE INFORMATION.................................................................................................... 1
1.1 Title...................................................................................................................................................................... 1
1.2 Trial registration...................................................................................................................................................1
1.3 Protocol version................................................................................................................................................... 1
1.4
Details of applications.......................................................................................................................................1
CHAPTER 2: INTRODUCTION..................................................................................................................................... 2
2.1 Introduction and rationale.................................................................................................................................... 2
2.2 Study design.........................................................................................................................................................2
2.3 Monitoring plan....................................................................................................................................................2
2.8 Ethical issues........................................................................................................................................................2
2.9 Benefits and risks assessment, group relatedness................................................................................................ 3
CHAPTER 3: ELIGIBILITY AND SCREENING............................................................................................................3
3.1 Study Population.................................................................................................................................................. 3
3.2 Diagnostic work-up before randomization...........................................................................................................3
3.2.1 Body temperature measurement and nucleic acid test.............................................................................. 3
3.2.2 Informed consent...............................................................................................................................................3
CHAPTER 4: INTERVENTIONS AND OUTCOMES...................................................................................................4
4.1 MCE system and ncMCE system.........................................................................................................................4
4.2 Study intervention................................................................................................................................................ 4
4.3 Study outcomes.................................................................................................................................................... 4
4.3.1 Primary efficacy outcome......................................................................................................................... 4
4.3.2 Secondary efficacy outcomes....................................................................................................................5
CHAPTER 5: DATA MANAGEMENT........................................................................................................................... 5
5.1 Case report forms................................................................................................................................................. 5
5.2 Data collection..................................................................................................................................................... 5
5.3 Data entry and modification.................................................................................................................................5
5.4 Data summary and report.....................................................................................................................................5
CHAPTER 6: SAFETY REPORTING AND MEDICAL MANAGEMENT................................................................... 6
6.1 Adverse events..................................................................................................................................................... 6
6.1.1 Definition.................................................................................................................................................. 6
6.1.2 Recording.................................................................................................................................................. 6
6.2 Serious adverse events......................................................................................................................................... 6
6.2.1 Definition.................................................................................................................................................. 6
6.2.2 Measurements and reporting.....................................................................................................................7
6.3 Unexpected adverse device events (UDAE)........................................................................................................ 7
6.4 Relationship determination.................................................................................................................................. 7
6.5 Device deficiency.................................................................................................................................................7
CHAPTER 7: MISCELLANEOUS CONSIDERATIONS............................................................................................... 7
7.1 Trace to the source............................................................................................................................................... 7
7.2 Confidentiality......................................................................................................................................................8
7.3 Discontinuation of the study................................................................................................................................ 8
7.4 Protocol deviation and violation.......................................................................................................................... 8
7.5 Protocol amendments...........................................................................................................................................8
CHAPTER 8: STATISTICAL CONSIDERATIONS...................................................................................................... 9
Appendix 1.Comparison between ncMCE and MCE...................................................................................................... 10
Appendix 2.Questionnaire 1 Improved questionnaire for pre-procedure perception and post-procedure satisfaction....11
Appendix 3.Questionnaire 2 Maneuverability questionnaire...........................................................................................12

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CHAPTER 1: ADMINISTRATIVE INFORMATION
1.1 Title

Noncontact magnetically controlled capsule endoscopy for infection-free gastric examination during the COVID-19
pandemic: a pilot, open-label, randomized study
1.2 Trial registration

ClinicalTrials.gov identifier: NCT04389333
1.3 Protocol version

Version 1.0 published on Feb 3rd, 2020.
1.4
Details of applications

Investigation site (institution): Changhai Hospital

Principal investigator: Zhuan Liao

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CHAPTER 2: INTRODUCTION
2.1 Introduction and rationale
COVID-19, a respiratory disease that spreads via direct contact or through droplet transmission, has caused a major disruption in
the healthcare system since it was first identified in 2019 [1]. Endoscopic procedures during the pandemic were divided
into urgent endoscopy, semi-urgent endoscopy, and elective endoscopy, with the aim of preventing infection among healthcare
professionals and providing necessary medical services [2]. For patients who required urgent gastroscopy, the face-to-face
contact with endoscopists, aggressive suctioning, and coughing [3] during examination brought opportunities for transmission.
Considering the reduced endoscopy volume in most endoscopy departments, diagnosis of patients who
needed semi-urgent endoscopy and elective endoscopy may have been delayed [4]. Therefore, focusing on how to return to
gradually return to provision of routine endoscopy services while maintaining safety for endoscopists deserves attention [5].
Capsule endoscopy provides a great view of the gastrointestinal tract through use of a miniature, pill-sized camera and it is as
accurate as other gastrointestinal endoscopy modalities [6]. Its unique advantages include single use, excellent tolerance, and
minimal medical staff requirement, which reduces the risk of exposure to pathogenic microorganisms and cross-infection [7] and
makes it an appropriate method for examining and triaging an endoscopy department during the COVID-19 pandemic [8].
However, capsule endoscopy cannot be used to avoid face-to-face contact between endoscopists and patients who have
asymptomatic COVID-19 cases [9]. Herein, we describe a novel noncontact magnetically controlled capsule endoscopy (ncMCE)
system using a remote control system to separate endoscopists and patients physically, which was developed and tested in our
medical center [10,11]. The objective of the present study was to evaluate the feasibility and safety of ncMCE for gastric
examination.
2.2 Study design
This study was a pilot, open-label, randomized controlled trial approved by the institutional review board of Shanghai Changhai
Hospital and registered at ClinicalTrials.gov (NCT 04389333). All of the diagnostic and therapeutic modalities were carried out in
accordance with the approved guidelines.
2.3 Monitoring plan
During the clinical trial, the clinical trial inspector appointed by the bidding unit will conduct regular on-site inspection visits to
the research hospital. The clinical trial supervisor is the main contact between the applicant and the researcher. The inspectors
must follow the quality management standards and SOP of clinical trials of medical devices, visit the experimental units regularly
or according to the actual situation for clinical supervision, urge the progress of clinical trials, check and confirm the correctness
and completeness of the records and reports of all data and the input of case reports, and be consistent with the original data, so as
to ensure that clinical trials are carried out in accordance with the clinical trial plan.
The specific contents of the inspectors include:

Confirm that facilities remain acceptable.

Ensure the implementation of the test plan by researchers during the experiment.

Verify that all data records and reports are correct and complete and consistent with the original data.

Research instruments should be supplied, stored, distributed and retrieved in accordance with relevant regulations, and to
make corresponding records;

The violation of the scheme and SAE should be faithfully recorded and remedied in time.

Perform source data verification and review.

Complete a written monitoring report after each visit.
An independent Data and safety monitoring committee (DSMC) appointed by the ethics committee, the Shanghai and National
Medical Products Administration provided trial regular oversight.
2.8 Ethical issues
Before implementation of the clinical investigation, the investigator shall submit the clinical investigation plan (CIP), informed
consent and other relevant documents to the medical ethics committee of the hospital where the clinical investigation will be

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implemented. Only after ethical approval is obtained from the Ethics Committee, the study can get underway. Any modification to
the CIP must be approved by the ethics committee before implementation. Serious adverse events (SAEs) that occur during the
clinical investigation should be timely submitted to the Ethics Committee in written form.
This trial will be conducted in accordance with the protocol, Good Clinical Practice (GCP) and applicable regulatory requirements.
All investigators undertaking this work have undertaken the necessary GCP training.
2.9 Benefits and risks assessment, group relatedness
In ncMCE
group, patients could not only have systematic physical examination for free, but also have the possibility of
FC-related symptoms improvement. The risks are that of vibration, capsule swallowing and re-interventions (surgery, endoscopy,
radiology).
In placebo group, the same systematic physical examination and professional medical advice were provided throughout the study
period. The risks are that of capsule swallowing and re-interventions (surgery, endoscopy, radiology).
The AEs including gastrointestinal (GI) symptoms such as abdominal pain, bloating, fever, nausea, vomiting, diarrhea; abnormal
results of physical examinations and laboratory tests and capsule retention. All AEs reported spontaneously by the 107 subjects or
observed by the investigator or his staff will be recorded.
Re-interventions (surgery, endoscopy, radiology) should be applied when necessary for safety consideration.
CHAPTER 3: ELIGIBILITY AND SCREENING
3.1 Study Population
This study was a pilot, open-label, randomized controlled trial approved by the institutional review board of Shanghai Changhai
Hospital and registered at ClinicalTrials.gov (NCT 04389333). All of the diagnostic and therapeutic modalities were carried out in
accordance with the approved guidelines.Beginning on March 26, 2020, we consecutively recruited 40 patients in Changhai
Hospital using predefined inclusion criteria and exclusion criteria. After fully understanding the procedure of ncMCE and this
study, patients who gave informed consent were randomly assigned into ncMCE and MCE groups (in a 1:1 ratio) by using a
stratified block randomization (fixed block size four). Randomization was based on a computer-generated list of random numbers
using SPSS software (version 22.0, SPSS Inc., Chicago, Illinois, United States). Only after the enrolled participants completed all
baseline assessments did the endoscopist inform them about their allocation. Eligible patients were adults (≥18 years of age)
undergoing outpatient MCE. Patients with any of the following conditions were excluded: (1) dysphagia or symptoms of gastric
outlet obstruction, suspected or known intestinal stenosis, overt gastrointestinal bleeding, fistulas and strictures; (2) history of
upper gastrointestinal surgery or suspected delayed gastric emptying; (3) poor general condition, asthma or claustrophobia; (4)
implanted metallic devices such as pacemakers, defibrillators, artificial heart valves or joint prostheses; (5) pregnancy or mental
illness; (6) current participation in another clinical study; or (7) difficulty communicating.
3.2 Diagnostic work-up before randomization
3.2.1 Body temperature measurement and nucleic acid test
For safety reasons, we conducted nucleic acid test and body temperature test for each patient undergoing MCE before entering the
examination room.
3.2.2 Informed consent
The principles of informed consent in the current edition of the Declaration of Helsinki will be implemented. Written informed
consent will be obtained from patients before inclusion in the trial.
The investigator must introduce this study in detail to the patients, including content, purpose, intended efficacy, possible AEs, and
countermeasures before signed the informed consent and patients will be given as much time as they need to make a decision.
The informed consent form shall be signed jointly by the investigator and the patient. It is in duplicate, and each party maintains
one copy.

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CHAPTER 4: INTERVENTIONS AND OUTCOMES
4.1 MCE system and ncMCE system
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
signal from both sides [12]. 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 endoscopist and patients in two
rooms (control room for endoscopist and examination room for patients), offering physical isolation for noninvasive gastric
examination during the pandemic [11].
4.2 Study intervention

Patients were required to report personal history and have chest computed tomography or nucleic acid testing to exclude
COVID-19 infection within 3 days before their examination. Patients who are confirmed to have a COVID-19 infection and
symptoms of pneumonia should be treated at special medical institutions first. Only when this population needs immediate
endoscopy should those procedures be done in specific wards that have COVID-19 infection prevention protocols in place [13].
On arrival at the hospital in the morning after an overnight fast (> 8 hours), each patient took a 400-mg simethicone suspension
dissolved in 100 mL water 40 minutes before they ingested the capsule ingestion according to standardized gastric preparation
[14]. Another 800 to 1000 mL of water could be taken 10 minutes before capsule ingestion to distend the stomach [12]. Then, a
patient’s hands were disinfected and they were given the data recorder after entering the examination room. Next, a patient laid
down on the examination bed next to the computer workstation, assumed the supine or left-lateral decubitus position, and
swallowed the capsule, which had already been activated. An endoscopist controlled capsule movement with the help of a magnet
robot using two joysticks in front of the workstation or automatically using a default mode. To ensure that the gastric mucosa was
completely visualized, the endoscopist directed a patient to change position to supine and right-lateral decubitus. In the ncMCE
group, a patient and the endoscopist entered two rooms through different routes and gastric preparation was under the remote
guidance [15]. The audio-visual exchange system provided a platform for the endoscopist to see and communicate with a patient
during examination. The data recorder was embedded in the examination bed to avoid cross-infection of COVID-19 among
patients and simplify the disinfection process.Enhanced personal protective equipment (PPE) including an N95 mask, isolation
gown with water resistance, head cover, eye protection, and face shield [11] should be worn by medical staff in the capsule
endoscopy examination room when performing MCE. The steps for donning and doffing PPE were strictly followed, according to
the standard process [16]. Medical masks were used as basic PPE for endoscopists in the ncMCE group (Supplementary material,
Table 1) [17]. After each examination, the returned data recorder was disinfected using ultraviolet light, 75% alcohol, or ethylene
oxide and the sheets on the bed were replaced.
4.3 Study outcomes
4.3.1 Primary efficacy outcome
The primary endpoints were feasibility assessed by completion rate (CR) and safety evaluated by the occurrence of AE. CR was
defined as complete observation of the cardia, fundus, body, angulus, antrum, and pylorus of the stomach with no technical
failure. Technical failure included incomplete observation, direct contact in the ncMCE group, and examination discontinuation.
The safety of ncMCE was evaluated 2 weeks after the procedure for any AEs, such as infection with SARS-CoV-2 and
capsule-related AEs including abdominal pain, nausea, vomiting, and capsule impaction or retention. In the current study, the
endoscopist was continuously monitored for infection until 2 weeks after the last examination.

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4.3.2 Secondary efficacy outcomes
Secondary endpoints included maneuverability score, pre-procedure perception and post-procedure satisfaction of patients, gastric
examination time (GET), and diagnostic yield (DY). The maneuverability of the ncMCE system was evaluated with a
questionnaire that consisted of signal transmission quality (stability and fluency), endoscopist comfort (strength needed to control
joysticks and degree of fatigue), visualization of gastric mucosa (whether the mucus, foam in the stomach, and gastric fullness
affected observation of gastric mucosa) and compliance of patients (patient ability to readily and correctly follow verbal
instructions to change positions to assist in optimizing gastric views). The score for each index was 1 to 5, with 1 as the worst and
5 as the best, respectively, and a total ranging from 4 to 20. All patients were asked about the comfort and acceptability of the
procedure using an improved pre-procedure perception and post-procedure satisfaction questionnaire, which was reviewed ease of
swallowing, pain or discomfort experienced during and after the procedure, overall tolerability and convenience of the procedure,
and knowledge, necessity for, and acceptability of ncMCE (Questionnaire 1) [18]. GET was defined as the time taken for gastric
examination and determined using a digital stopwatch in the ESNavi software. DY or detection rate was calculated using the
following formula: number of patients with positive findings divided by the total number of patients that underwent examination.
CHAPTER 5: DATA MANAGEMENT
5.1 Case report forms
The case report form is filled out by the researcher, and each enrolled case has one. After the completed case report form is
checked by the clinical inspector, the first link is handed over to the data manager for data entry and management. CRF should
include the patient's name, gender, age, identification (ID) number, phone number, address, diagnosis, clinical evaluation index,
etc. During the study, the data of GET, maneuverability questionnaire, pre-procedure perception and post-procedure satisfaction
questionaire, diagnostic results, combined medication and AEs were recorded in the CRF.
CRFs will be treated as confidential documents and held securely in accordance with regulations. CRFs shall be restricted to the
personnel approved by the Chief Investigator and recorded on the ‘Study Delegation Log.’ The investigator shall sign the CRF to
confirm the accuracy of the data recorded.
5.2 Data collection
Information on the basic characteristics of the enrolled patients was collected prospectively. 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. The maneuverability questionnaire for the endoscopist
and improved questionnaire on pre-procedure perception and post-procedure satisfaction for patients were completed
after the examination. To avoid systematic bias, a single endoscopist (W.Z.) performed each examination and made
the diagnoses for all enrolled patients immediately. The evaluation of completion was made by another blinded
researcher (J.H.Z.).
5.3 Data entry and modification
Data entry and modification: The data of CRF were input by the independent double-entry method. Data managers check the data
in the case report form and find out that questions are asked by clinical inspector. Data managers modify and confirm the data
according to the researchers' answers, and if necessary, a clinical inspector can issue the questionnaires again.
After data entry and inspection, data managers, main researchers, bidders and statistic analysts jointly audit the data, and complete
the final definition and judgment of the analysis population.
5.4 Data summary and report
The principal investigator writes a clinical investigation summary report in accordance to CONSORT guidelines and archives the
data. Any changes to the original statistical plan should be stated and justified in the CIP and/or in the final report.

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CHAPTER 6: SAFETY REPORTING AND MEDICAL MANAGEMENT
6.1 Adverse events
6.1.1 Definition
6.1.1.1 Adverse event (AE)
An AE is any adverse medical event, unintended disease or injury, or any unfavorable clinical sign (including an abnormal
laboratory finding) that occurs to the subject, user, or another person, whether or not related to the investigational device. This
includes events related to:
All events related to the investigation or control device.
All events related to the investigation process (all processes in the CIP).
Note: For users or others, the AEs here are limited to all of those related to the investigational device.
6.1.1.2 Adverse device effect (ADE)
Adverse events related to use of investigational medical device:
Include AEs caused by inadequate or inappropriate descriptions of usage, deployment, implantation, installation, operation, or any
fault of the investigational medical device.
Include AEs caused by use error or deliberate misuse of the investigational medical device.
6.1.1.3 Adverse event severity determination
Observe the procedure, severity, actions taken and outcome of AEs and fill them in the adverse event report form. According to
the following criteria, the severity of AEs can be classified into mild, moderate, and severe.
Mild: Transient or mild discomfort that does not affect daily life and action; no special measures or medical intervention/therapy
required.
Moderate: Mild effect on daily life and activity; take measures or medical intervention/therapy if necessary.
Severe: Serious effect on daily life and activity; special measures or medical intervention/therapy required; hospitalization if
necessary.
6.1.2 Recording
All AEs reported by the patients or discovered from Electronic Medical Record were assessed for severity and relationship with
study treatment by the investigators, with appropriate measures taken in time and detailedly documented.
6.2 Serious adverse events
6.2.1 Definition
SAEs can be defined as any events leading to death or serious deterioration of health during clinical trials, including:
Fatal disease or injury;
Leading to permanent defect of body structure or function;
Requires hospitalization;
Medical or surgical intervention is needed to avoid permanent defects in body structure or function.

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6.2.2 Measurements and reporting
Table List of contact information for SAE reporting
When SAE occur in our clinical trials, the researchers should immediately take appropriate treatment measures for the subjects,
and report in writing to the management department of clinical trials of medical devices in the clinical trial institutions under their
jurisdiction and notify the applicants.
SAEs had to be reported the principal investigator and to DSMC, ethics committee and the local provincial food and drug
administration within 24 hours. For death events, the investigation sites and investigator should provide the ethics committee and
sponsor with all information they need.
6.3 Unexpected adverse device events (UDAE)
Unexpected adverse device events refer to serious adverse health or safety effects, life-threatening problems or deaths caused by
or associated with devices that are unaware of their nature, severity or frequency in research programs, instructions for use and
instructions for clinical trials, or any other serious unexpected problems related to ncMCE.
6.4 Relationship determination
The reporting investigator will complete the SAE report in the CRFs, including date of event, admissions, diagnosis details, date
of discharge，whether result in the experiment and its sequela. Researchers should give targeted treatment and follow-up to AEs
until symptoms disappear or remain stable.
Any adverse event should be judged on the basis according to the following criteria:
Irrelevant: There was no correlation between AE and the use of ncMCE .
possibly irrelevant: The occurrence of AE is more likely to be related to other factors, such as combination of drugs or
accompanying diseases, or the occurrence time of AE indicates that it is unlikely to have a causal relationship with ncMCE .
Possibly relevant: AE may be caused by the use of ncMCE . There is a reasonable time sequence for the occurrence of incidents
and the use of research-related devices and can exclude the effect of concomitant treatment and combined medication.
Affirmative relevant: The type of adverse event has been identified as a side effect of ncMCE
and cannot be explained by other
reasons. The occurrence order of the event strongly suggests causality.
6.5 Device deficiency
Device deficiency refers to deficiency of a medical device in identification, quality, durability, reliability, safety or performance.
Medical device deficiencies include malfunction, misuse or use error and inadequate labeling.
The investigator shall record the discovered device deficiencies during the clinical investigation and analyze the cause of the event
together with the sponsor, form a written analysis report, and propose a suggestion on continuation, suspension or termination of
the investigation, which will be reported by the medical device clinical investigation management department to the Ethics
Committee for review.
Both investigators and subjects can make a complaint against the treatment product and control product at any phase of the
clinical study.
CHAPTER 7: MISCELLANEOUS CONSIDERATIONS
7.1 Trace to the source
Contacts
phone or fax
Changhai Hospital
Tel.: +86-021-31162338
Shanghai Municipal Food and Drug Administration
Tel.: +86-021-23111111
State Food and Drug Administration
Tel.: +86-010-88331776

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Source data refers to original record of clinical findings, observations, and other activities in the clinical investigation, as well as
all information in its approved copy, which can be used for clinical investigation reconstruction and evaluation. This clinical
investigation includes: name, date of birth and gender of subjects; investigation identification code, CIP number, name of the
investigational device; start date of subjects screening or enrolling; investigational device use date and quantity; signature of
investigators; serious adverse events and handling information; date of collection, outcomes and date of report of laboratory
specimens, signature of inspector; signature of CRA.
A source file is a printed file, a video file, or an electronic file containing source data. Informed consent form, subjects screening
form and enrollment log, subject identification code list, medical documents of subjects (such as medical records or investigation
medical records, including physical and chemical examination reports), investigational device use records, lab records, serious
adverse event report and memo. The source file is the first-hand source of clinical investigation data records. Any observations
and examination results in the clinical investigation shall be recorded the source file in a timely, accurate, complete, standardized
and authentic manner.
7.2 Confidentiality
This agreement and the contents of this clinical trial and all ancillary information are confidential. Researcher shall bear the
responsibility of confidentiality; including patent, manufacturing process and data provided by the applicant to the researcher that
has not yet been published, and shall not be disclosed to any third party unless the consent of the applicant is obtained, and the
confidentiality obligation still works at the end of this trial.
7.3 Discontinuation of the study
A study participant may be discontinued from the study if the investigator believes that it is not safe for the participant to continue.
And subjects can withdraw from the study at any time
The sponsor should ensure that all investigators in the clinical investigation strictly follow the CIP and promptly point out when
the investigation sites and investigators do not observe relevant laws, the GCP and this CIP and give a timely correction; if the
situation gets worse or the inobservance remains uncorrected, the sponsor should terminate the clinical investigation, and report to
the local provincial food and drug administration, and China Food and Drug Administration (CFDA).
7.4 Protocol deviation and violation
Deviations from the CIP are mainly manifested as the following:

Loss to follow up;

Subjects do not meet the inclusion/exclusion criteria;

Investigators or subjects are not in strict compliance with the CIP or subject compliance is poor;

Investigation is terminated due to adverse events.
If there is a deviation from the CIP during investigation, the investigator shall promptly notify the sponsor, the investigation sites
and ethics committee.
7.5 Protocol amendments
Before clinical investigation, the CIP will be discussed and revised jointly by investigators and implementers who will sign the
final copy and submit it to the ethics committee for approval before implementation.
If there is a problem with the CIP during practical implementation of the clinical investigation, a revision is necessary. The plan of
revision shall be proposed to the implementer for a multi-center discussion. After then, the responsible unit will carry out revision
and submit the revised CIP in a written form to the implementer and investigation units for signing. Finally, send it to the ethics
committee again for approval before implementation.
If new data important related to the product for verification is found, the informed consent form must be modified and sent to the
ethics committee for approval.

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CHAPTER 8: STATISTICAL CONSIDERATIONS
As a pilot study to evaluate the feasibility and safety of ncMCE, the sample size was not calculated [19]. Considering the capsule
endoscopy volume of Changhai Hospital during the pandemic, we planned to recruit 40 patients into two groups. Basic
characteristics were presented as means with standard deviations for continuous variables such as age, body mass index (BMI),
and percentages for binary variables including sex, medical history, and symptoms. Quantitative data were summarized with
parametric statistics, mean and standard deviation, or nonparametric statistics, median, and interquartile range (IQR), whereas
categorical data were presented as Under the condition of normal distribution and homogeneity of variance, variance analysis was
used to compare the difference in mean between groups, while a K-W test was used to compare the difference in distribution
between groups and Fisher’s test was used to compare the two and disordered multi-classification data of subjects under the
condition that homogeneity of variance was not satisfied. All reported Pvalues are two-sided and differences that reached P < 0.05
were considered statistically significant. Statistical analyses were performed with SPSS (version 22.0, SPSS Inc., Chicago, Illinois,
United States).

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Appendix 1.Comparison between ncMCE and MCE.
The capsule is 26.7 mm in length, 11.8 mm in diameter, and 4.5±0.5 g in weight, with a guidance magnet robot to control. The
field of view is 140 degrees and the depth of view is 0 to 30 mm. After examination with an adaptive frame rate of 8 frames per
second (fps), we got the image with 480×480 resolution.

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Appendix 2.Questionnaire 1 Improved questionnaire for pre-procedure perception and post-procedure satisfaction.

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Appendix 3. Questionnaire 2 Maneuverability questionnaire