Magnetically Controlled Capsule for Assessment of Gastric Mucosa in Symptomatic Patients
Phase: NA
Conditions: Abdominal Pain, Gastritis, Gastric Ulcer, Gastric Cancer
Sponsor: George Washington University

Title Page
MAGNETICALLY CONTROLLED CAPSULE FOR 
ASSESSMENT OF GASTRIC MUCOSA IN SYMPTOMATIC 
PATIENTS (MAGNET)
Protocol Identifying Number: ISR- 191848
Principal Investigator:
Andrew C. Meltzer, MD, MS
George Washington University School of Medicine and Health 
Sciences Investigator Initiated Research
Funded by AnX Robotica 
Version Final 4.0
08/05/2021
IRB NUMBER: NCR191848
IRB APPROVAL DATE: 05/24/2023

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1. STATEMENT OF COMPLIANCE
The study will be conducted in accordance with the Declaration of Helsinki, the 
International Conference on Harmonization guidelines for Good Clinical Practice (ICH 
E6), ISO 14155, the Code of Federal Regulations on the Protection of Human Subjects 
(45 CFR Part 46), and FDA regulations: 21 CFR part 50, part 54 and part 56.
All personnel involved in the conduct of this study have completed human subjects’ 
protection training.
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2. SIGNATURE PAGE
The signature below constitutes the approval of this protocol and the attachments and 
provides the necessary assurances that this study will be conducted according to all 
stipulations of the protocol, including all statements regarding confidentiality, and 
according to local legal and regulatory requirements and applicable US federal 
regulations.
Principal Investigator or Clinical Site Investigator:
Signed:
Date:
Name:
Title:
Sponsor:
Signed:
Date:
Name:
Title:
IRB NUMBER: NCR191848
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Table of Contents
Contents
Title Page
1
1.
STATEMENT OF COMPLIANCE
2
2.
SIGNATURE PAGE
3
3.
LIST OF ABBREVIATIONS
6
4.
PROTOCOL SUMMARY
7
5.
SCHEMATIC OF STUDY DESIGN:
8
5.
KEY ROLES AND CONTACT INFORMATION
9
6.
INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE
10
6.1.
Background Information
10
6.2.
Rationale
11
6.3.
Potential Risks and Benefits 11
6.3.1.
Potential Risks 11
6.3.2.
Potential Benefits
13
6.3.3.
Discussion
14
7.
OBJECTIVES 15
7.1.
Primary Objective
15
7.2.
Secondary Objective 15
8.
STUDY OUTCOME MEASURES
16
8.1.
Primary Outcome:
16
8.2.
Secondary Outcomes:16
8.3.
Selected Outcomes Measures (see data collection sheets) 18
8.3.1.
Procedure time. 18
8.3.2.
Training to perform MCC.
18
8.3.3.
Fasting and MCC prep 18
8.3.4.
Scoring Anatomic Regions.
18
8.3.5.
Scoring Gastric Mucosal lesions.
18
8.3.6.
Lesions picked up by MCC and not by EGD.
18
8.3.7.
Measuring patient satisfaction (see MAGNET6, day 30).
19
9.
STUDY DESIGN
20
9.1.
Study Design 20
9.2.
Proposed Site 20
9.3.
Patient Safety 20
9.4.
Study procedure:
20
10.
STUDY ENROLLMENT AND WITHDRAWAL
23
10.1. Subject Inclusion Criteria
23
10.2. Subject Exclusion Criteria
23
10.3. Strategies for Recruitment and Retention
23
10.4. Subject Withdrawal
24
10.4.1. Reasons for Withdrawal
24
10.4.2. Handling of Subject Withdrawals
24
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10.4.3. Premature Termination or Suspension of Study
24
11.
DATA ENTRY SYSTEM
25
12.
ASSESSMENT OF SAFETY 25
12.1. Unanticipated Adverse Events
25
12.2. Assessment of Adverse Events
25
12.3. Serious Adverse Events
25
12.4. Reporting Procedures 26
13.
HYPOTHESIS AND ANALYSIS
27
13.1. Study Hypothesis
27
13.2. Sample Size Considerations 27
13.3. Cost-Effective Analysis
27
14.
STUDY OVERSIGHT 28
14.1. Monthly Reports
28
14.2. Annual Reports
28
15.
SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS
29
16.
QUALITY CONTROL AND QUALITY ASSURANCE30
17.
ETHICS/PROTECTION OF HUMAN SUBJECTS
31
17.1. Good Clinical Practices
31
17.2. Institutional Review Board
31
17.3. Informed Consent
31
17.4. Exclusion of Women, Minorities, and Children (Special Populations)
31
18.
PARTICIPANT CONFIDENTIALITY 31
19.
DATA HANDLING AND RECORD KEEPING
33
19.1. Data Management Responsibilities
33
19.2. Data Capture Methods
33
19.3. Schedule and Content of Reports
33
19.4. Study Records Retention
33
19.5. Protocol Deviations
33
20.
PUBLICATION/DATA SHARING POLICY
34
21.
REFERENCES
35
22.
APPENDICES 35
22.1. APPENDIX A: Schedule of Events
35
22.2. APPENDIX B – Document List (per request) 35
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3.
LIST OF ABBREVIATIONS
AC
Active Control
CFDA
Chinese Food and Drug Administration
CE
Capsule Endoscopy
CFR
Code of Federal Regulations
ED
Emergency Department
EGD
Esophagogastroduodenoscopy
FDA
Food and Drug Administration
GBS
Glasgow Blatchford Score
GI
Gastrointestinal
ICH
International Conference on Harmonization
IRB
Institutional Review Board
MCC
Magnetically Controlled Capsule
PCP
Primary Care Physician
RC
Research Coordinator
ST
Standard (Risk Assessment)
UC
Urgent Care
UGIB
Upper GI Bleed
US
United States
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4.
PROTOCOL SUMMARY
Title:
Magnetically Controlled Capsule For Assessment Of 
Gastric Mucosa In Symptomatic Patients: “MAGNET”
Précis:
This is a single-center prospective study examining the diagnostic utility of 
a single-use ingestible magnetically controlled capsule (MCC) endoscope 
(NaviCam™, AnX Robotica) which is remotely controlled by external 
hardware and software to visualize the mucosa of the stomach on patients 
with upper abdominal symptoms. Participants will be enrolled and tested at 
a central site referred from Emergency Departments (EDs), urgent cares 
(UCs) and primary care practices (PCPs) in the Washington, DC area and 
additional site(s) to be named. Total enrollment is estimated to be 72 
patients with a goal of following all patients with a traditional endoscopy to 
confirm findings. Aim 1 is to establish feasibility of this novel outpatient 
testing. Aim 2 is to demonstrate high-quality visualization of gastric 
anatomic landmarks. Aim 3 is a pilot study to compare visualization of 
gastric anatomic landmarks and lesions of MCC follow-up traditional EGD. 
We currently anticipate enrolling 2-3 patients per week over 30 weeks.
Objectives:
Aim 1: We aim to demonstrate feasibility of MCC in an outpatient primary 
and urgent care setting. Measured outcomes include duration of MCC test, 
linkage with EGD follow-up, image storage, image transfer, technician 
learning curve and documentation.
Aim 2: We aim to show that MCC can identify and photograph regions of 
stomach consistent with established visualized scoring systems for 
anatomic landmarks.
Aim 3: Pilot assessment of MCC compared to subsequent EGD to detect 
anatomic regions and gastric mucosal lesions.
Population:
An unselected pool of adult patients with an appropriate indication for 
upper endoscopy such as epigastric pain/burning, nausea and or 
vomiting, bloating, heartburn, iron deficiency anemia, unintended 
weight loss, abnormal imaging suggesting organic disease. In general, 
participants will be age ≥ 18, mixed gender, mixed race, 
hemodynamically stable with possible co-morbidities.
Site Number
1
Study 
Duration:
Time needed to reach sufficient study subjects plus additional time for 
analysis
Subject 
Duration:
30 days
Estimated 
Time to 
Complete:
12 months
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5.
SCHEMATIC OF STUDY DESIGN:
ED/ UC/ PCP
Visit
Prior to Enrollment
Time Point 0
Time 
Point 1
(Same day or
As soon as possible)
Time Point 2
<120 minutes 
(Estimated)
Time Point 3
GI Interpretation
Time Point 4
EGD Scheduled
Time Point 5 
Follow-up 
Day 30
Screen potential subjects for inclusion and exclusion criteria from a 
variety of referral sources.
Notify Research Coordinator (RC) of Potential Participant
RC will complete pre-screening and schedule MCC & informed consent
Investigator administers MCC and visualizes stomach; video transmitted to 
HIPAA compliant cloud to be read by GI Reading Group
Patient will be monitored for safety and an EGD will ideally be performed 
within 5 days of the MCC procedure, but will allow MCC procedure to be 
performed up to14 days either before or after an EGD.
Goal is to get an EGD performed within 5 days of the MCC procedure, but will 
allow MCC procedure to be performed up to14 days either before or after an 
EGD per standard of care. MCC and EGD read independently by board 
certified GI attendings. MCC read twice for inter-observer agreement.
Telephone Call and Chart Review: (1) Adverse Events (2) Patient Satisfaction
(3) EGD and MCC results communicated to participant if requested
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IRB APPROVAL DATE: 05/24/2023

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5.
KEY ROLES AND CONTACT INFORMATION
Andrew C. Meltzer, MD, MS, Principal Investigator 
Associate Professor
George Washington University School of Medicine and Health Sciences 
2120 L Street NW Suite 450
Washington, DC 20037
202-445-7044 (Cell)
ameltzer@mfa.gwu.edu
Anita Kumar, MD, Co-Investigator 
Assistant Professor, Gastroenterology
George Washington University School of Medicine and Health Sciences 
2120 L Street NW Suite 450
Washington, DC 20037 
abkumar@mfa.gwu.edu
Prof. David Cave, MD, PhD Co-Investigator 
Professor of Medicine
Division of Gastroenterology 
UMass Memorial Medical Center 
Worcester, MA
508-856-8399
drdrcave@gmail.com
Marie Borum, MD, Co-Investigator
Professor of Medicine
George Washington University School of Medicine and Health Sciences
2150 Pennsylvania Avenue
Washington, DC 20037
mborum@mfa.gwu.edu
Samuel J. Kallus, MD, Co-Investigator
Assistant Professor of Medicine
Division of Gastroenterology & Liver Diseases 
George Washington University School of Medicine and Health Sciences
22nd & I Street, NW
Washington, DC 20037
skallus@mfa.gwu.edu
Holly Liu, Regulatory Specialist       
Section of Clinical Research
George Washington University Medical Faculty Associates 
2150 Pennsylvania Avenue NW Suite 8-416
Washington, DC 20037
202-741-2483
hliu@mfa.gwu.edu
Priscilla Muhanji, Lead Research 
Coordinator
George Washington Medical Faculty Associates 
Department of Emergency Medicine
2120 L Street NW, Suite 450
Washington, DC 20037
202-741-2955
pmuhanji@mfa.gwu.edu
Nicole Hall, Research Coordinator
George Washington Medical Faculty Associates 
Department of Emergency Medicine
2120 L Street NW, Suite 450
Washington, DC 20037
nihall@mfa.gwu.edu
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Yan Ma, MA, MS, PhD, Biostatistician 
Departments of Epidemiology and Biostatistics 
Milken Institute School of Public Health 
George Washington University
950 New Hampshire Ave, NW 5th floor 
Washington, DC 20052
202-994-0955
yanma@gwu.edu
IRB NUMBER: NCR191848
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6.
INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC 
RATIONALE
6.1.
Background Information
Esophagogastroduodenoscopy (EGD) is one of the most common medical procedures 
and indications include epigastric pain, bloating, burning, heart-burn, excessive 
belching, nausea and/or, vomiting, anemia, weight loss. Access to EGD is limited by 
the cost, the need for an endoscopy specialist and the need for anesthesia. Lack of 
access to an EGD is a health disparity associated with increased gastric cancer 
mortality-to-incidence ratio (Tsai 2017). A novel approach to visualization of the upper 
GI tract is needed to increase access to care and improve diagnostic capabilities.
Magnetically controlled capsule (MCC) is the first wireless ingestible capsule endoscope 
that is able to be directed by operator to visualize all anatomic areas of the stomach 
(NaviCam™, AnX Robotica). This study will be the first US study to examine the 
feasibility of using MCC in patients with relevant symptoms to the stomach. The goal is 
to ascertain if the diagnostic capabilities of the MCC compared to EGD are comparable 
for symptomatic patients who have clinical indications for an EGD.
MCC offers potential advantages over traditional EGD including the ability to be 
performed 24 hours a day without sedation and to be performed by a clinician. In 
addition, the MCC is less invasive, does not cause discomfort, and enables the patient 
to pursue normal daily activities after the procedure. Non-specialist physicians can 
administer the MCC and interpretation can be done in real-time or asynchronously by GI 
specialists. The MCC may impact decisions regarding the need for hospitalization, the 
need for additional diagnostic testing such as biopsy, the need for additional therapeutic 
interventions such as endoscopic hemostasis and polypectomy, and the need for further 
risk stratification of disease. The eventual work-ﬂow may be similar to that of many 
current diagnostic tests such as radiologic examinations. This ability to transmit images 
could become especially important in rural communities or in communities that have 
limited access to a gastroenterologist or surgeon. Incorporation of the MCC into current 
practice could follow a trajectory similar to that of point-of-care ultrasonography, an 
imaging modality in which non-radiologist physicians have become increasingly skilled 
and for which indications continue to expand (Bennet 2018). The American Society of 
Gastrointestinal Endoscopy states that credentials for capsule endoscopy should be 
determined independently from other endoscopic procedures such as colonoscopy, 
sigmoidoscopy, or any other endoscopic procedure (ASGE 2005). The American 
Society for Gastrointestinal Endoscopy also emphasizes that sound medical training, 
appropriate patient selection, correct interpretation, and continued medical management 
for all patients. Capsule endoscopy requires only image interpretation and does not 
require procedural skill training associated with other
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endoscopic procedures; therefore, ED physicians, urgent care physicians and primary 
care doctors and mid-level practitioners can meet these criteria with basic training.
Contraindications to the MCC are similar to contraindications for established capsule 
endoscopy (CE) which has been performed safely in a variety of clinical settings [3]. 
The only absolute contraindication is intestinal obstruction [4]. There is a low risk of 
non-natural excretion of capsules estimated at less than 1 in 100 [5]. In general, the CE 
procedure poses signiﬁcantly less risk than traditional EGD, and multiple studies have 
shown that CE is well tolerated in patients with acute symptoms (Gralnek 2008, Sung 
2016, Meltzer 2013).
The cost of the capsule is an important factor that may affect future use in the ED and 
clinics. The use of MCC in the ED, urgent care and primary care can potentially lead to 
more patients being safely managed in an outpatient setting. MCC may be especially 
cost-effective if it reduces hospital admissions, need for anesthesia, missed work days 
or overall EGDs. Future technological developments in the MCC may allow for operator 
to collect biopsy samples and perform therapeutic functions.
6.2.
Rationale
In the United States, upper endoscopy is frequently performed for a variety of symptoms 
including heartburn, bloating, nausea, burping, and epigastric pain/burning. The 
prevalence of these symptoms may provide as much as 25% of a gastroenterologist’s 
office practice. In general, the diagnostic yield of an EGD is low. Without alarm 
symptoms, as many as 70% of procedures are negative for significant findings. One 
major indication is testing for H. pylori for which EGD may be unnecessary, because H. 
pylori detection can be accomplished by fecal antigen testing or breath testing as 
accurately as biopsy and less expensively.
We believe there is an opportunity to improve the risk stratification of patients that 
undergo endoscopy through the use of MCC. Our primary hypothesis is that MCC 
allows for visualization of the stomach of symptomatic patients referred from the 
emergency, urgent care and primary care settings with clinical symptoms appropriate 
for endoscopy. A prospective study is proposed to evaluate the feasibility, safety and 
accuracy of this novel diagnostic modality.
6.3.
Potential Risks and Benefits
6.3.1.
Potential Risks
Patients for whom study enrollment may interfere with standard clinical care will not be 
enrolled. Alternatives to study participation are for patient to receive standard of care 
treatment for symptoms which includes only an EGD or barium studies. We have 
considered a variety of potential risks to participants including cognitive, affective,
IRB NUMBER: NCR191848
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physical, legal/confidentiality and economic risks. The NaviCam MCC is manufactured 
by AnX Robotica and has been granted marketing authorization by the FDA through the 
de-novo process to confirm its safety and effectiveness profile.
Since its introduction to the Chinese market after being approved by the Chinese Food 
and Drug Agency (CFD) in 2012, the NaviCam MCC was subject to a series of clinical 
studies. Published studies involving more than 500 people in China have been 
published comparing MCC to gastroscope. In a pilot study in 34 healthy volunteers 
(Liao et al. 2012), 75 to 100% of gastric mucosa was visualized in 27 (79.4%) people 
and 50% to 75% in 7 (20.6%) people. Visualization of the gastric cardia, fundus, body, 
angulus, antrum and pylorus were subjectively assessed as complete in 82.4%, 85.3%, 
100.0%, 100.0%, 100.0% and 100.0% respectively. In a non-blinded comparative study 
in 68 patients (Zou et al. 2015) showed a diagnostic accuracy similar to standard 
gastroscopy: the positive percent agreement was 96.0%, and the negative percent 
agreement was 77.8%. The overall agreement was 91.2% with a κ value of 0.765 
(p<0.001). A total of 68 pathological findings were detected, of which 53 were identified 
by both methods. In a multi-center comparative study in 350 patients (Liao et al. 2016), 
the NaviCam detected gastric focal lesions in the whole stomach with 90.4% sensitivity, 
94.7% specificity, a PPV of 87.9%, a NPV of 95.9% and 93.4% accuracy. The 
NaviCam was preferred by almost all patients (95.7%), compared with gastroscopy. 
(Liao, 2016).
The physical risks associated with the NaviCam MCC are generally related to potential 
non-natural excretion. There is a small risk that the capsule could become stuck in the 
stomach or small intestine. Based on published and unpublished data of other types of 
capsule endoscopes, retained capsules have persisted in the GI tract for periods for 
many years without adverse event. In fact, a large retrospective review by Cheifetz, et 
al. found that a retained capsule is often asymptomatic or leads to a diagnosis. (Chifetz 
2006). Furthermore, the device is made of biocompatible materials and its internal parts 
are non-toxic. The incidence of capsule retention has been reported to be less than 1% 
but this figure may be higher in Crohn's disease or other conditions. The rate of 
surgical/endoscopic removal was noted to be 0.75% (Barkin, 2002).
Patients who are at increased risk of capsule retention are not appropriate study 
subjects including people with swallowing disorders or with known or suspected 
gastrointestinal obstructions, strictures or fistulas. In general, if a patient does not pass 
the MCC naturally through the upper GI tract due to gastroparesis, an EGD will be 
sufficient to retrieve the capsule. Given that all study patients will receive an EGD as 
part of their standard work-up for the disease, this does not pose a significant 
increased risk. Any patient with dysphagia will be excluded because a retained capsule 
in the esophagus is at risk of aspiration.
Patients will be advised not to have an MRI for 30 days. For patients who are unsure 
whether they excreted the MCC, an abdominal X-Ray or "Navicam capsule locator" 
may be required as an outpatient to confirm passage.
In order to maximize safety for all study subjects, only consented and enrolled subjects 
will be administered the MCC under the supervision of a physician and a sub- 
investigator/trained research associate responsible to the PI. In addition, the MCC will
be stored in a secure, limited access area. Product accountability log must include the12 
protocol number, investigative site name, product name, medical units (i.e., capsules),
serial number and subject ID number.
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We believe the study poses a low privacy risk to subjects as all data will be encrypted 
and no PHI will be stored with data. Data will be stored in a REDCap database that 
allows for the common collection of data from multiple sites.
Finally, the study has a low economic risk since the device and the interpretation of the 
device are not being billed to the subject or his/her insurance company. The follow-up 
EGD is considered standard of care and will be billed to the patient’s insurer. AnX 
Robotica, the manufacturer of the NaviCam has agreed to cover the cost of medical 
care and treatment for research injuries sustained by subjects enrolled in the study in 
accordance with the terms of the Clinical Trial Agreement and there is no economic risk 
expected as a result of unanticipated complications of the device as these will be 
covered by AnX Robotica, per the final negotiated terms in the Clinical Trial Agreement 
(currently under negotiation).
Major adverse events that occur will be reported directly to the principal investigator and 
overall study coordinator within 24 hours. Minor adverse events include inability to 
tolerate the MCC capsule, discomfort swallowing capsule, issues regarding video 
capture, issues regarding video transmission, erroneous video interpretation that has no 
significant impact on clinical care, protocol deviations, reactions to medication (pro- 
motility agent), delays in endoscopy interpretation, delays in EGD and others. All minor 
adverse events will be shared with the entire research team at regularly scheduled 
monthly calls or sooner at the PI’s discretion.
Any major adverse events that occur will be reported directly to the principal investigator 
who will be available to study subjects 24 hours a day. Severe adverse events will be 
reported to the entire research team, the sponsor, the DSMB and to IRB within 24 
hours. Updates will be provided after a full investigation is completed.  SAE’s will also 
be reported to the FDA. Potential major adverse events include delayed definitive care, 
and capsule retention in the small bowel, and any serious outcome that may be related 
to study protocol. A DSMB will be formed that includes experts in primary care, 
emergency medicine, and gastroenterology and research methodology. DSMB of 
approximately 3-5 multi-disciplinary persons will meet every 6 months during which a 
report will be produced by PI and as needed for SAE’s.
6.3.2.
Potential Benefits
Immediate potential benefits include a focused effort by the research team to visualize 
the stomach for all subjects and help ensure appropriate follow-up. Long-term potential 
benefits include more effective and efficient management of a variety of conditions that 
are common in the population.
Recently, the advantage of diagnostic tools that decrease exposure of 
healthcare providers to infectious diseases such as COVID-19 has become 
clearer.
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6.3.3.
Discussion
The evaluation of suspected symptoms in the stomach often requires an EGD by a 
gastroenterologist or surgeon and which may also entail hospitalization and procedural 
sedation by an anesthesiologist. While this traditional process is safe and effective, it is 
not efficient for low-risk patients and not timely for all high-risk patients. The opportunity 
to bring NaviCam MCC to the front-lines of US medical care may change how we 
manage GI symptoms. This trial is an important step toward demonstrating that 
NaviCam MCC is a safe and effective tool to diagnose patients who have upper GI 
symptoms and improve quality of care for those patients.
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7.
OBJECTIVES
7.1.
Primary Objective
 Aim 1) To demonstrate feasibility of MCC in an outpatient setting for patients 
with upper abdominal symptoms
Aim 2) To demonstrate high-quality visualization of gastric anatomic regions.
Aim 3) To pilot a comparison of MCC versus EGD regarding the ability to 
visualize both gastric anatomic regions and gastric lesions.
7.2.
Secondary Objective
1) To perform a cost-effective analysis of MCC v EGD.
2) To measure patient satisfaction for EGD v MCC.
3) To measure 30-day safety.
4) To compare international trials that compared EGD to MCC for detection of 
gastric lesions.
5) To measure the time required to visualize the stomach for MCC versus EGD.
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8.
STUDY OUTCOME MEASURES
8.1.
Primary Outcome:
Aim 1: Pilot and Feasibility Stage.
1) Implementation: Installation, Training, Site Requirements
2) Practicality: Duration of MCC test (minutes), Technician “learning curve,” Clinical 
Staff and Patient Satisfaction, Duration of fasting required 
3) Integration: Scheduling MCC, Linkage with EGD follow-up, Image storage, Image 
transfer, Documentation of Interpretation, Photo-documentation, Database 
development
Aim 2: High-Quality Visualization (90%) of Gastric Anatomic Landmarks 
Defined as visualization and photo-documentation of the following anatomical 
landmarks:
1) Lower Esophagus / Z line
2) Cardia / fundus
3) Body, lesser curvature AND/OR Body, greater curvature 
4) Anterior / Posterior walls
5) Angularis
6) Antrum
7) Pylorus
8) Duodenal Bulb
9) Duodenal Ampulla
Aim 3: MCC versus EGD for visualization of anatomic landmarks (see above) and 
gastric lesions in symptomatic patients
Defined as visualization and photo-documentation of the following structures and 
diseases:
1) Visible Lesions (Paris Classification if relevant)
2) Ulcers (Forrest Classification) erosions
3) Gastric Atrophy
4) Gastric Varices
5) Gastritis*
7) Submucosal lesions
8) “Does patient need a follow-up EGD?” Y/N (Opinion of endoscopist interpreting MCC 
based on MCC findings.)
* (not erythema but ‘chicken wire’ pattern intramucosal change in vascular pattern or 
hemorrhagic)
8.2.
Secondary Outcomes:
(1) Cost-effective analysis
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(2) 30-day follow-up for adverse events and safety 
(3) Patient Satisfaction of MCC versus EGD
(4) Replication of similar sensitivity and specificity of MCC to EGD to prior trials outside 
of the US for (a) Ulcers; (b) Cancer; (c) Inflammatory Changes
(5) Time spent visualizing the stomach for MCC versus EGD (minutes)
(6) Visualization of the duodenum
(7) Hiatus hernia 
8.3.
Selected Outcomes Measures (see data collection sheets)
8.3.1. Procedure time. 
 
When measuring procedure time of EGD and MCC, we will consider all components of procedure 
including anesthesia, prep, cleaning and preparing room for next patient and turn-around time. We 
will also measure total time for staff and for the clinician.
8.3.2. Training to perform MCC.
How long? How many cases needed?  Is there a learning curve to speed and accuracy?
8.3.3. Fasting and MCC prep

NPO Midnight the day before MCC. 
8.3.4. Scoring Anatomic Regions. 
After confirming that gastric emptying has been achieved with overnight fast -- we will use the 5-point 
visualization score described in Ching, 2019 for the following anatomic regions

Lower Esophagus / Z line

Corpus
o
Greater curvature
o
Lesser Curvature

Anterior Wall

Posterior Wall

Proximal stomach
o
Cardia/Fundus

Distal Stomach
o
Antrum/Pylorus/Angularis

Duodenum
o
Bulb
o
Ampulla
8.3.5. Scoring Gastric Mucosal lesions.
("yes/no")

Visible Lesions (Paris Classification if relevant) 

Ulcers (+/- Forrest Classification) 

Gastric Atrophy

Gastric Varices

Gastritis*

Hiatus hernia

Submucosal lesions

Plus: Does patient need endoscopic intervention?
8.3.6. Lesions picked up by MCC and not by EGD.

Healing lesions (especially ulcers) are natural course of disease therefore we assume that some 
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lesions will be detected by capsule but not by EGD if EGD is done a few days later. With photo-
documentation and two independent readers, we hope to assure that this phenomenon is a natural 
course of lesion and not a "false-positive" by MCC. 
8.3.7. Measuring patient satisfaction (see MAGNET7 and 8, day 7 and 30).

I felt the research team answered all my questions. Yes No

Did you feel any pain with swallowing? Yes No

How difficult was it to swallow the capsule? Very Easy Moderately Easy Neutral Moderately Difficult 
Very Difficult

Did you feel discomfort after swallowing while operator moved the capsule? Yes No

Did you notice the capsule pass during a bowel movement?? Yes No

Any other issues? Yes No

If yes, what were the issues? ____________________________

How much time in total approximately did you have to take out during your day for the capsule 
endoscopy procedure? ___ (we do not ask this)

 Did you feel like you needed to miss work after the capsule endoscopy procedure? Yes No 

(we do not ask this)

Did you need someone to take you home after the capsule endoscopy procedure? Yes No
 (we do not ask this) In the future, if both studies were equally accurate and you needed another 
examination of your stomach, would you prefer to have a traditional EGD or a capsule? EGD Capsule. 
Why?
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9.
STUDY DESIGN
9.1.
Study Design
Prospective Study of Diagnostic Utility of MCC
9.2.
Proposed Site
George Washington University (GWU) Medical Faculty Associates (MFA) in 
Washington, DC.
9.3.
Patient Safety
The study will be conducted in compliance with the Declaration of Helsinki, ICH-GCP 
guidelines, ISO 14155, and US regulations. Study design will be approved by the local 
IRB at each participating institution prior to commencement.
9.4.
Study procedure:
1. Screen potential adult patients with an appropriate indication for upper endoscopy 
such as epigastric pain/burning, nausea and or vomiting, bloating, heartburn, iron 
deficiency anemia, unintended weight loss, abnormal imaging suggesting organic 
disease from a larger pool of patients seen in an ED, Urgent Care, Primary Care and 
GI Clinic patients. In some settings, a research assistant will be on site to perform 
the screen. In other settings, the clinical staff will perform the screen or potential 
patients will be contacted by phone by RC. (Form used: Magnet 1)
2. Patients screened who are eligible will be approached about potential interest. (See 
full list of inclusion/ exclusion criteria). In some circumstances, patients will be given 
contact information for the research coordinator (RC), who will contact them as soon 
as possible to schedule MCC. In other circumstances, the research assistant will 
contact RC and attempt to schedule MCC before patient leaves the clinical setting.
3. RC will contact patients to complete screening, confirm eligibility, obtain verbal 
consent, and schedule both MCC and EGD (if EGD is not already scheduled). 
Formal written consent will be obtained by patient at the MCC location (2120 L 
Street, NW, suite 200).
4. Participants arrive at the MCC location for final screen, sign written consent and 
undergo MCC. All consented patients will be given a study ID and recorded in 
enrollment log. (Form used: Magnet 3) The patient’s demographics and images will 
be stored in a HIPAA compliant fashion.

BRIEF DESCRIPTION OF MCC PROCEDURE. The patient will be NPO 
midnight. They will come to the facility and will ingest the capsule per 
manufacturer’s protocol. (Manufacturer’s protocol says that the person 
will take 10ml of simethicone in 100ml of water 40min before capsule is 
ingested. The capsule will then be controlled externally by magnetic field 
by the examining health care provider in such a way that the major 
regions of the stomach are photo-documented with still images and 
video. This may involve changing the position of the patient and the 
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possible ingestion of additional water. The sequence of the examination
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will be pre-determined, and each area will have a predetermined number 
of images obtained as suggested by Gastroenterology Society guidelines.
5. Patient data collected will include the following elements: chief complaint of 
patient, history of present illness, past medical history, current medications 
(only PPIs and pain medication)..
6. At completion of MCC, video will be archived and patient satisfaction will be 
assessed. Capsule endoscopy will NOT be used for clinical decisions.
7. Patients will be instructed to return to the physician sooner, if concerning signs 
develop. A 7 and 30-day follow-up call and chart review is only performed if 
person is lost to follow-up will be conducted to check for symptom resolution 
and adverse events.
8. Esophagogastroduodenoscopy (EGD) will be performed as soon as possible in 
an appropriate endoscopy facility by an experienced endoscopist.
9. Endoscopic images will be stored in secure serve for later comparison with MCC 
images.
Summary of Research Strategy
❖PRE-SCREEN (DAY -7 to DAY -1)
➢Upper Abdominal Pain or Related Symptoms (Indications for an EGD)
▪
Performed in ED, UC, PCP offices or GI clinic
❖SCREEN (DAY -7 -> DAY 0)
➢More thorough screening questions and scheduling by RC (<24 hours)
▪
Performed by Telephone
❖ENROLL (DAY 0)
➢Signed Informed Consent procedure, more detailed questions and MCC 
Procedure performed
▪
Occurs at the GWU Medical Faculty Associates Building on 2120 L street.
▪
NaviCam MCC performed by trained Clinician.
▪
Reviewed by a Gastroenterologist.
▪
Scheduled for an EGD will ideally be performed within 5 days of the MCC 
procedure, but will allow MCC procedure to be performed up to14 days 
either before or after an EGD (paid by insurance as standard of care).
❖FOLLOW-UP (DAY 1-30)
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➢Day 7 and Day 30: Telephone Call plus CRISP Chart Review, only if lost to follow-up.
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10.
STUDY ENROLLMENT AND WITHDRAWAL
10.1.
Subject Inclusion Criteria
1. Individuals aged ≥ 18 years with upper GI symptoms (epigastric pain, 
bloating, burning, heart-burn, excessive belching, nausea and/or, 
vomiting, anemia, and weight loss) appropriate for an upper endoscopy 
evaluation.
2. Able to speak English
3. Able to understand and sign consent form
4. Able to undergo standard outpatient endoscopy
5. Indications for EGD Low blood (unexplained anemia)

Blood in vomit (hematemesis)

Upper abdominal or chest pain

Indigestion (dyspepsia)

GERD

Suspected ulcer

Unexplained weight loss

Gastric biopsy

Other
10.2.
Subject Exclusion Criteria
Individuals with one or more of the following will not be eligible for participation in the 
study:
1. Hemodynamic shock
2. Active hematemesis
3. Dysphagia, swallowing disorder
4. Suspected bowel obstruction or perforation
5. Gastroparesis
6. Crohn’s disease
7. Prior GI tract surgery that changes the gastrointestinal anatomy (e.g., Billroth I or II, 
esophagectomy, gastrectomy, bariatric procedure and small intestinal resection)
8. Presumed pregnant, trying to conceive or currently breastfeeding
9. Altered mental status (e.g., hepatic encephalopathy) that limits the ability to swallow 
a capsule
10.Expected to have Magnetic Resonance Imaging examination within 30 days.
11.No reliable contact information – no phone, no permanent address.
12.Pacemaker or ICD
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13.BMI ≥ 38
10.3.
Strategies for Recruitment and Retention
Email notifications will be sent to GW providers on the study to help recruit eligible 
patients at GW EDs, urgent care facilities and PCP offices. Existing RA’s stationed in 
those units will help spread the word about potential eligibility (i.e. stable for outpatient 
work-up, symptoms related to UGI tract.) Pre-screening will take place onsite. Full 
consent and interview for inclusion and exclusion criteria will occur by lead RC and PI at 
site of NaviCam.
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10.4.
Subject Withdrawal
10.4.1. Reasons for Withdrawal
A subject can withdraw at any time and for any reason. Subject should provide written 
notice to PI as to withdrawal intent. The PI can withdraw a patient from the study for 
noncompliance issues or serious medical conflicts.
10.4.2. Handling of Subject Withdrawals
If subject withdraws from the study, no further contact will be attempted or made by 
study staff. If patient is withdrawn from study by PI for non-compliance or health related 
concerns, study staff will notify subject via phone call and/or IRB approved letter, if 
direct contact cannot be made.
10.4.3. Premature Termination or Suspension of Study
Notification of all study subjects. No further data collection.
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11.
DATA ENTRY SYSTEM
For this protocol, REDCap database will be used for data entry screens corresponding 
to the study forms that will be developed and maintained by GWU. Clinical center staff 
will enter de-identified data into the REDCap database.
12. ASSESSMENT OF SAFETY
12.1.
Unanticipated Adverse Events
An unanticipated adverse event is an effect on health or safety caused by, or associated 
with, a device, if that effect or problem was not previously identified in nature, severity, 
or degree of incidence in the protocol, or any other unanticipated problem associated 
with a device that relates to the rights, safety, or welfare of subjects in the clinical study.
12.2.
Assessment of Adverse Events
All adverse events will be graded for severity as follows:
Mild: Sign or symptom, usually transient, requiring no special treatment and generally 
not interfering with usual activities.
Moderate: Sign or symptom, which may be ameliorated by simple therapeutic 
measures; yet, may interfere with usual activity.
Severe: Sign or symptom that are intense or debilitating and that interfere with usual 
activities. Recovery is usually aided by therapeutic measures.
The relationship of the adverse event to the study device is defined as follows: 
Probably related: Follows a reasonable temporal sequence from study device use 
delivery/retrieval and cannot be reasonably explained by known characteristics of the 
subject’s clinical data.
Possibly related: Follows a reasonable temporal sequence from study device 
delivery/retrieval but could have been produced by the subject’s clinical state regardless 
of the study device.
Not related: No relationship to study device activation is perceived.
12.3.
Serious Adverse Events
Adverse events will be reported within 24 hours to the Study PI, the local IRB and the 
sponsor.
Additional procedures are warranted for cases of serious adverse events which is 
defined by the FDA as an adverse event that:
a) Led to death,
b) Led to serious deterioration in the health of the subject, that either resulted in:
1) A life-threatening illness or injury, or
2) A permanent impairment of a body structure or a body function, or
3) In-patient or prolonged hospitalization, or
4) Medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function,
c) Led to fetal distress, fetal death or a congenital abnormality or birth defect
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12.4.
Reporting Procedures
All device related serious adverse events should be reported to the PI, Sponsor, GWU 
IRB, and FDA.
Unanticipated adverse events should be reported to the PI, Sponsor, and GWU IRB in a 
timely manner.
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13.
HYPOTHESIS AND ANALYSIS
13.1.
Study Hypothesis
Aim 1: We hypothesize that initiation of MCC pilot study will be feasible defined by 
outcomes related to (A) implementation, (B) Practicality and (C) Integration.
Aim 2: We hypothesize that MCC will meet established quality measures (≥90%) for 
visualization of stomach anatomy landmarks.
Aim 3: We hypothesize that the MCC will be similar to EGD at visualization of gastric 
lesions and/or disease.
13.2.
Sample Size Considerations
The sample size for this Proof of Concept study was not chosen for statistical 
consideration, as there are no formal statistical inferences planned. The size of the 
study is judged adequate for the preliminary evaluation objectives. All 72 participants 
will receive the MCC and will be referred to follow-up EGD. The base-line prevalence 
of lesions and the estimated loss to follow-up will provide information for formal 
sample size calculation for follow-up study.
We did not use a statistical justification but a practical justification to choose 72 
participants.  All 72 will get the MCC unless they are unable to tolerate the capsule. 
The issue of drop-out is relevant only to Aim 3 which pilots the concept of non-
inferiority compared to subsequent EGD.  We did not power this study to prove non-
inferiority --- this study will allow us to estimate baseline lesion prevalence and the 
likely drop-out rate. Moving forward, we be able to calculate an accurate sample size 
for a future larger definitive non-inferiority study.
For patients in whom visualization is limited by incomplete gastric emptying, we will 
record fasting time but exclude patient from assessment of MCC accuracy. 
13.3.
Cost-Effective Analysis
A cost-effective model will be constructed to compare MCC with traditional 
endoscopy. Full analysis plan is forthcoming.
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14.
STUDY OVERSIGHT
A Data Safety Monitoring Board (DSMB) consisting of appropriately qualified 
independent experts has been appointed by the PI to provide review of data on patient 
safety and study progress. The membership roster is maintained by site PI and study 
coordinator and is available from them as needed. PI will provide reports including 
adverse events.
The Data and Safety Monitoring Board provides ongoing evaluation of the study 
progress including patient accrual and retention, monitoring of adverse events, and the 
adequacy and efficiency of the analysis plan to discern outcomes that might require 
study modifications, or result in early cessation of the study due to its benefits or harms. 
The DSMB does not evaluate the scientific merit or methodology of the study, nor does 
it directly participate in the execution of a study’s protocol, monitor the budget, or 
approve sub-protocols or other modifications to the study.
The major responsibilities of the Board are:

To review the data analysis plan and make recommendations for additions or 
changes to the plan.

To assess the performance of the site and make appropriate recommendations 
regarding continuation, probationary status, or termination.

To consider patient accrual, overall study progress (timeline and follow-up 
participation), adverse effects and patient safety, and proper monitoring and 
reporting by the study team as these affect the ethical treatment of participants or 
the ethical conduct of research.

Report to the PI on any perceived problems with study conduct, enrollment, 
sample size, and data collection.
14.1.
Monthly Reports
Monthly Recruitment Reports - reports of the number of people screened and enrolled 
by month. Reports detailing recruitment, baseline patient characteristics, data quality, 
incidence of missing data and adherence to study protocol. Sponsor will have access to 
monthly status reports.
14.2.
Annual Reports
Data and Safety Monitoring Board (DSMB) Reports - The DSMB will prepare a written 
report which includes patient recruitment, baseline patient characteristics, center 
performance information with respect to data quality, timeliness of data submission and 
protocol adherence (in addition to safety and efficacy data). The reports also include 
adverse events, loss to follow-up and all outcome variables as described previously in 
this protocol.
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15.
SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS
Study staff will maintain appropriate medical and research records for this study, in 
compliance with Section 4.9 of ICH E6, Section 6.5 of ISO 14155, and regulatory and 
institutional requirements for the protection of confidentiality of subjects.
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16.
QUALITY CONTROL AND QUALITY ASSURANCE
QC procedures will be implemented on data entry system and data QC checks will be 
run on the database. Any missing data or data anomalies will be communicated to the 
site for clarification/resolution.
Following written SOPs, the monitors will verify that the clinical trial is conducted and 
data are generated, documented (recorded), and reported in compliance with the 
protocol, GCP, and the applicable regulatory requirements.
The investigational site will provide direct access to all trial related sites, source 
data/documents, and reports for the purpose of monitoring and auditing by the sponsor, 
and inspection by local and regulatory authorities.
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17.
ETHICS/PROTECTION OF HUMAN SUBJECTS
17.1.
Good Clinical Practices
The investigator will ensure that this study is conducted in full conformity with the 
principles set forth in The Belmont Report: Ethical Principles and Guidelines for the 
Protection of Human Subjects of Research, as drafted by the US National Commission 
for the Protection of Human Subjects of Biomedical and Behavioral Research (April 18, 
1979) and codified in 45 CFR Part 46 and/or the ICH E6.
17.2.
Institutional Review Board
The protocol, informed consent form(s), recruitment materials and all participant 
materials will be submitted to the IRB for review and approval. Approval of both the 
protocol and the consent form must be obtained before any participant is enrolled. Any 
amendment to the protocol will require review and approval by the IRB before the 
changes are implemented in the study.
17.3.
Informed Consent
Informed consent is a process that is initiated prior to the individual agreeing to 
participate in the study and continues throughout study participation. Extensive 
discussion of risks and possible benefits of study participation will be provided to 
participants and their families, if applicable. A consent form describing in detail the 
study procedures and risks will be given to the participant. Consent forms will be IRB- 
approved, and the participant is required to read and review the document or have the 
document read to him or her. The investigator or designee will explain the research 
study to the participant and answer any questions that may arise. The participant will 
sign the informed consent document prior to any study-related assessments or 
procedures. Participants will be given the opportunity to discuss the study with their 
surrogates or think about it prior to agreeing to participate. They may withdraw consent 
at any time throughout the course of the study. A copy of the signed informed consent 
document will be given to participants for their records. The rights and welfare of the 
participants will be protected by emphasizing to them that the quality of their clinical 
care will not be adversely affected if they decline to participate in this study or select to 
withdraw their consent. The consent process will be documented in the clinical or 
research record.
17.4.
Exclusion of Women, Minorities, and Children (Special Populations)
Adults ≥18 years of age will be included. Refer to Section 10 “Study Enrollment and 
Withdrawal” for the full inclusion and exclusion criteria.
18.
PARTICIPANT CONFIDENTIALITY
All records will be confidential. Subjects will not be identified in any reports or 
publications of this study. It is possible that representatives of regulatory agencies and 
from the study’s sponsor may come to (the university/hospital) to review study 
information. In that situation, copies of the relevant parts of the study records will be
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released with all identifying information removed. Access to study records will be limited 
to those who need the information for purposes of this study, as well as the patient’s 
healthcare providers should they need access to the information. All records are kept in 
a secure location and access is limited to research study personnel.
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19.
DATA HANDLING AND RECORD KEEPING
19.1.
Data Management Responsibilities
The site will maintain appropriate medical and research records for this trial in 
compliance with ICH E6, ISO 14155, and regulatory and institutional requirements for 
the protection of confidentiality of participants. As part of participating in this study, the 
site will permit authorized representatives of the PI to examine (and when permitted by 
applicable law, to copy) clinical records for the purposes of quality assurance reviews, 
audits, and evaluation of the study safety, progress, and data validity.
Source data are all information, original records of clinical findings, observations, or 
other activities in a clinical trial necessary for the reconstruction and evaluation of the 
trial. Examples include, but are not limited to, hospital records, clinical and office charts, 
laboratory notes, memoranda, recorded videos of upper GI tract, recorded data from 
automated instruments, copies or transcriptions certified after verification as being 
accurate and complete, microfiches, photographic negatives, microfilm or magnetic 
media, x-rays, and participant files and records kept at the pharmacy, at the 
laboratories, and medico-technical departments involved in the clinical trial. It is 
acceptable to use CRFs as source documents. Except for videos and digital images, all 
data will be collected on CRFs and a RedCap database.
Study participation will also be recorded in the medical record to ensure that anyone 
who would access the patient medical record has adequate knowledge that the patient 
is participating in a clinical trial.
19.2.
Data Capture Methods
Data will be captured both via handwritten source documents and a centralized web- 
based data entry system. The centralized web system will be Redcap and will be 
administered by GWUH.
19.3.
Schedule and Content of Reports
The recruitment and follow-up period will begin in November 2019 and continue through 
October 2021. Data queries will be generated and resolved during this time period 
through August 2022. Data close-out will be performed immediately following the end of 
the recruitment period.
19.4.
Study Records Retention
Study records will be maintained for at least 6 years post study closure and per IRB 
specifications.
19.5.
Protocol Deviations
Protocol deviations will be maintained through protocol deviations source 
documentation that is entered into the centralized databased. Protocol deviations will 
also be reported directly to study PI within 24 hours.
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20.
PUBLICATION/DATA SHARING POLICY
This study will ultimately lead to peer-reviewed journal manuscripts and peer-reviewed 
meeting presentations with a digital archive PubMed Central upon acceptance for 
publication.
1) Pilot and Feasibility
2) High Quality Photo-documentation with MCC
3) Non-Inferiority Pilot Study of Anatomic Landmarks 
4) Non-Inferiority Study of Gastric Lesions
5) Patient Satisfaction Study 
6) Cost-effective Analysis
7) Multi-center Pragmatic Patient Centered Outcomes Study (Additional Patients 
and Sites required)
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21.
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clinician's perspectives. Minerva Gastroenterol Dietol. 2008 Jun;54(2):189-207. Review. 
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Gralnek IM, Adler SN, Yassin K, Koslowsky B, Metzger Y, Eliakim R. Detecting 
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Cheifetz AS, Lewis BS. Capsule endoscopy retention: Is it a complication? J Clin 
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Meltzer AC, Ali MA, Kresiberg RB, et al. Video capsule endoscopy in the emergency 
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Tsai MC, Wang CC, Lee HL, et al. Health disparities are associated with gastric cancer 
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Barkin JS, Friedman S. Am J Gastroentrol 2002; 97:A83
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diseases: a two-center self-controlled comparative trial; Endoscopy online, 2015
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of Gastric Mucosa’s Complete Visualization by Applying Magnetic-Guided Capsule 
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in Pediatric Patients; Gastrointestinal Endoscopy, Volume 83, No. 5S : 2016
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controlled capsule endoscopy findings; 2018 Saudi journal of Gastroenterology
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Coated Aspirin; Gastroenterology Research and Practice Volume 2018
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IRB NUMBER: NCR191848
IRB APPROVAL DATE: 05/24/2023

35
MAGNET Protocol ISR-#191848 
Version_4.0 August 2021
22.
APPENDICES
22.1.
APPENDIX A: Schedule of Events
2019-2021

Consensus building, Protocol Development, FDA letter IRB submission (+/-
IDE)

Contract between primary sites GWU MFA and AnX Robotica

DSMB formation, steering committee convene, central MCC reading team call 
schedule established for January 2020 to January 2021; hiring of staff

MCC training and Site Visit by PI and team

Enrollment kick off

Monthly Calls for entire team, Status reports

Target Enrollment Reached, End recruitment DSMB report prepared

Data Cleaning

First manuscript Draft Prepared

Manuscript Submitted (To be discussed: Dissemination plan)
22.2.
APPENDIX B – Document List (per request)
Magnet 1: Magnet potential patient form 
Magnet 2: Patient eligibility screening
Magnet 3: Patient Data Collection Form
IRB NUMBER: NCR191848
IRB APPROVAL DATE: 05/24/2023

MAGNET Protocol ISR-#191848 
Version_4.0 August 2021
Magnet 4: Anatomic and Lesion Assessment (A)
Magnet 5: Anatomic and Lesion Assessment (B) 
Magnet 6: EGD and Lesion Assessment (C)
Magnet 7: Patient Follow-up Call Day 7
Magnet 8: Patient Follow-up Call Day 30 
Magnet 9: Patient CRISP Chart Review  
Magnet 10: Adverse Event Form/ Serious Event Form 
Magnet 11: Protocol Deviation
Magnet 12: Lost to Follow-up
IRB NUMBER: NCR191848
IRB APPROVAL DATE: 05/24/2023