Visualization of the Colon Through Use of the Magnetic Flexible Endoscope (MFE)
Phase: NA
Conditions: Colonoscopy
Sponsor: Vanderbilt University Medical Center

PROTOCOL TITLE: 
Visualization of the colon through use of the Magnetic Flexible Endoscope
(MFE) in healthy participants
NCT05833789 
Protocol Version Date: December 16, 2022

 
 
 
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Endoscope Controller 
 
Magnetic End-
Effector 
 
Robot Cart  
 
Endoscope Control 
Box  
 
3. PROTOCOL 
3.1 
Study Protocol 
3.1.1 Protocol Overview 
Investigational Device: Magnetic Flexible Endoscope 
Study Title: Visualization of the colon through use of the Magnetic Flexible Endoscope in 
healthy participants 
Study Design: Early Feasibility Study 
Number of Participants: 5 
Study Population: Adult healthy patients who are already scheduled for their standard of 
care colonoscopy screening examination. 
Study Duration:  Standard colonoscopy examinations for healthy individuals are relatively 
short duration outpatient procedures lasting on average 20 to 40 minutes in total procedure 
time and 90 to 180 minutes in total in-facility time. Navigation and inspection of the colon, 
from rectum to cecum, using the MFE will be a relatively short duration outpatient 
procedure lasting no more than 40 minutes in total procedure duration. As is standard of 
care at VUMC, a post-procedure follow-up phone call is then conducted 3-5 days post-
procedure. 
Schedule: (1) Screening of patients for meeting inclusion criteria; (2) Administration of 
pre-study survey; (3) Routine colonoscopy examination with a standard colonoscope; (4) 
Passage of the Magnetic Flexible Endoscope from rectum to cecum; (5) Post-study 
structured interview and single question survey; (6) Follow-up phone call 3-5 days post 
examination as per VUMC standard practice for patients who have undergone 
colonoscopy.  
3.0.0 Study Objective 
The objective of this early feasibility study is to determine if travel to the cecum from the 
rectum and visualization of the colon is possible using the Magnetic Flexible Endoscope 

 
 
 
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(MFE) system. 
3.0.1 Study Design 
3.0.1.0 Overview 
This early feasibility study will be a prospective clinical trial in which 5 patients will be enrolled. 
All patients will undergo their routine colonoscopy examination using the standard colonoscope, 
followed by passage of the Magnetic Flexible Endoscope. 
 
3.0.1.1 Study Endpoints 
PRIMARY 
1. Cecal intubation rate (success/fail) 
a. Successful cecal intubation will be confirmed per standard endoscopic 
practice of visualizing and photo documenting at least 2 of the 3 common 
cecal landmarks (ileocecal valve, triradiate fold, appendiceal orifice). 
SECONDARY 
1. Mucosal visibility 
a. An operator assessed score, the Colon Visualization Index (Appendix A), will 
be used.  
2. Patient tolerance 
a. Pain perception will be assessed with a validated pain score (Wong-Baker 
FACES Pain Rating Scale; Appendix B). Qualitative assessment of participant 
sentiment will be assessed with a post-study structured interview (Appendix 
C). 
3. Endoscopist experience 
a. The usability of the platform in terms of task load for the endoscopist will be 
assessed using the standardized validated NASA Task Load Index (TLX) 
instrument (Appendix D). 
3.0.2 Study Devices 
The Magnetic Flexible Endoscope (MFE) is an investigational device that consists of a flexible 
catheter with a magnet-embedded tip, a permanent magnet external to the patient manipulated by 
a collaborative medical robot, and a software control system (Figure 7).  The MFE maintains 
functionality of a traditional endoscope (i.e., illumination, viewing, irrigation, suction, lens 
cleansing, insufflation) and contains proprioceptive sensors that facilitate magnetic interaction. 
Knowledge of magnetic field properties allows for precise device movement while maintaining 
visualization as the MFE moves through the colon. 
 

 
 
 
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Figure 7. The MFE platform: (a) human certified collaborative medical robot with permanent magnet attached; (b) 
magnet-embedded tip with full functionality; (c) ultra-flexible catheter. 
 
The MFE is a Medical Electrical (ME) system comprising three categories of device: (1) 
commercially available products (both reusable and single-use/disposable), (2) MFE reusable 
parts and (3) MFE single-use parts. The following briefly summarizes the plan to manufacture 
these for clinical use, presented in the three categories mentioned.   
(1) Commercially available products   
These products include ME devices, non-ME devices and consumables. Each are chosen 
to integrate with the MFE device in order to perform its intended use. They are sourced 
and evaluated to ensure they meet the user and functional requirements, including 
showing conformity to the relevant standards and compatibility with the MFE (assessed 
via preclinical testing and assessment of the manufacturers’ accompanying 
documentation). Their details are included in the Bill of Materials to maintain 
traceability. These products are stored securely and used according to the manufacturers’ 
user manuals.    
(2) MFE reusable parts   
Several parts of the MFE system are designed and manufactured by the STORM Lab UK 
at the University of Leeds for re-use. Owing to the project scope, the number of these is 
significantly low (i.e. the robot cart). 
These parts are all designed and documented as described in the Design and 
Development Plan to ensure the quality objectives are met. They are then manufactured 
within the STORM Lab UK at the University of Leeds using principles of ISO 13485 and 
the following key elements:   
1. The designs are prototyped and tested thoroughly in preclinical testing and this 
includes evaluation, refinement and approval of the associated manufacturing 
protocol. The manufacturing protocols are continually developed alongside the 
prototypes (i.e. device is designed for manufacture and assembly – DFMA).   
2. Once the device design and accompanying manufacturing protocol are mature, 
Process Failure Mode and Effects Analysis (P-FMEA) are used to analyze the 
manufacturing steps in detail for unacceptable risks and appropriate controls. In 
this project, the controls take the form of (in increasing strength):  
i. Clear instruction and technical “Tips”   

 
 
 
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ii. Warnings and Cautions relating to process steps  
iii. Mandatory Quality Checks (QCs) in-line with the process steps and 
summarized in a QC checklist  
3. The components specified in the latest approved Bill of Materials are sourced 
from reputable suppliers and stored securely according to their datasheets.   
4. The part is manufactured (largely involving assembly tasks) by a named engineer 
who is familiar with the technology, according to the approved manufacturing 
protocol for that part. The QCs are designed to ensure each device is 100% 
inspected, with focus on high-risk process steps identified in P-FMEA.   
5. A QC checklist is filled-in for every device produced, capturing information like 
the device build, personnel involved and verification that all the QCs were 
performed.   
6. The device is labelled and stored according to the approved Instructions For Use, 
including in the required packaging and storage conditions.  The QC checklist is 
also securely stored as evidence of compliance to the manufacturing protocol, 
having a document ID that matches the device UID.  
   
(3) MFE single-use parts   
These parts include the main MFE Applied parts: endoscope and endoscope controller. 
The number of units produced is also limited, but not to the same extent as the re-usable 
parts. There are approximately 25-50 units of each single-use part planned to be produced 
during the entire life cycle of MFE version A_01 (MFE-A_01). The parts are all designed 
and documented as described in the Design and Development Plan.  
Owing to their need for greater biological safety consideration and the higher number of 
units being produced, the manufacture of these is outsourced to MDE s.r.l (a contract 
manufacturing organization supplier, under contract with the University of Leeds---the 
legal manufacturer). MDE s.r.l is based in Italy (Via F. Petrarca 165, 25068, Ponte 
Zanano, Sarezzo (BS), Italy, +39 030-238-2498, VAT: 04023300983) with appropriate 
experience, facilities, and ISO13485 certification (Appendix E). At a high-level, this 
ensures reliable, repeatable manufacture.    
In brief, the manufacturing process is as follows:   
1. Steps 1. – 3. From the previous section are followed.  
2. The components are received by MDE s.r.l before being labelled and stored 
according to their Quality Management System (QMS), including incoming 
component inspection.   
3. The part is manufactured (largely involving assembly tasks) by trained MDE s.r.l 
technicians - who are familiar with the technology from preclinical development 
within University of Leeds - and according to the approved manufacturing 
protocol for that part which they helped co-create to ensure compliance with their 
QMS and working-level Standard Operating Procedures (SOPs).   

 
 
 
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▪ The assembly (and some decontamination) is carried out within an ISO 7 
cleanroom.   
4. A Certificate of Conformity is supplied with the packaged devices that states, 
among other things, the device identity (e.g. Unique Identifier (UID) traceable to 
the approved technical file), that they have been built according to the approved 
manufacturing protocol within their qualified facilities and that they meet the 
technical requirements specified by the STORM Lab UK at the University of 
Leeds, e.g. “high level disinfected (HLD)” decontamination status.   
5. MDE s.r.l is then responsible for securely shipping the packaged devices to 
STORM Lab USA at Vanderbilt University Medical Center according to the 
Instructions for Use (IFU) (which includes transport considerations).   
The received devices are stored in the STORM Lab USA at Vanderbilt University 
Medical Center according to the IFU until they are required for use in clinical 
investigation, or until the expiry date on the package label elapses. The IFU includes 
instruction and warning relating to the visual inspection and physical testing of the device 
immediately prior to use in the patient.  
  
Single-use device shelf-life: 
The endoscope and endoscope controller are manufactured on-demand. This means that 
once a clinical investigation date is agreed by all required stakeholders, MDE s.r.l will be 
commissioned to manufacture the required number of devices. These will have labels that 
include the manufacture date and expiry date. This means that the effects of aging, 
including material degradation, are negligible; it also reduces the volume of 
microorganism growth inside the packaging (if any). This is a practical option for the 
project considering its use exclusively in clinical investigation and said investigations 
being small (e.g. the first planned trial includes only 5 participants). The worst-case 
(longest) shelf-life anticipated – and being included as an expiry date – will be 1 year 
from date of manufacture.   
Single-use device decontamination:   
We plan to follow the international guidelines for colonoscopy and pursue a “high level 
disinfected (HLD)” status for the endoscope and endoscope controller. We plan to 
achieve HLD status within the manufacturing process – managed by MDE s.r.l - and 
maintain it during storage until use via appropriate device packaging and clear IFU. We 
believe this is preferable than only decontaminating the devices prior to use (e.g. manual 
washing) in terms of risk because, in brief, manual washing presents increased risk of 
incomplete decontamination from human error and/or process inconsistencies, with the 
added risk of contamination of the device between washing and use.   
MDE s.r.l will manage the cleaning and decontamination process according to their QMS 
and to an extent that they can include the HLD status in the Certificate of Conformity 
supplied with the devices shipped to the STORM Lab USA at Vanderbilt University 
Medical Center.  
 
 

 
 
 
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All materials used in the Magnetic Flexible Endoscope have both been confirmed to be 
biocompatible and have been shown to withstand high level disinfection (HLD) using the 
processes described above. For all biocompatibility and HLD testing information please refer to 
Appendix F. 
 
3.0.3 Participant Selection 
3.0.3.0 Inclusion Criteria 
1. Male or female, 18 to 70 years of age. 
2. Able to provide written informed consent. 
3. ASA class < 3 
4. No significant medical problems 
5. Abdominal circumference < 96 cm 
3.0.3.1 Exclusion Criteria 
1. Patients who do not meet inclusion criteria 
2. Patients who are unable or unwilling to provide informed consent 
3. Magnetic implants and wearable devices (such as insulin pumps) 
4. Females who are pregnant. As part of routine pre-operative care, all females of 
childbearing potential will undergo either urine or blood pregnancy testing. 
5. Cancer positive subjects or any patients currently undergoing any treatment or therapy to 
treat, cure, or mitigate cancer. 
6. Symptoms consistent with coronavirus (COVID-19) --- pyrexia, new persistent cough, 
or anosmia --- or a positive coronavirus (COVID-19) PCR swab result 
7. Previous failed colonoscopy 
8. Colonic resection 
9. Severe diverticulosis 
10. Known or suspected colonic stricture 
11. Previous radiation therapy to the abdomen or pelvis 
12. Any active inflammatory bowel condition (e.g. active IBD or diverticulitis) 
13. Known or suspected bowel obstruction 
14. Presence of ascites 
15. Participants taking anticoagulant medications or antiplatelet therapy (excluding aspirin) 
within the last 7 days 
16. Known coagulation disorder (INR ≥ 1.5 or platelets < 150 x 109) 
17. Known to have phenylketonuria or G6PD deficiency 
18. Abdominal surgery within the last 6 months 
19. Drug or alcohol abuse 
 
3.0.4 Study Procedures 
3.0.4.0 Screening 
Potential subjects will be identified from the list of patients in the Vanderbilt University Medical 
Center Digestive Disease Center who are scheduled to undergo their standard colonoscopy 

 
 
 
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screening by members of the VUMC clinical research trained personnel team. Those participants who 
express interest in taking part in the research study will be asked to sign a written informed 
consent that has been approved by the Vanderbilt University Medical Center IRB. Participants 
will have the study explained to them and will be given the opportunity to read and review the 
consent document and have any questions addressed. Once informed consent is obtained, final 
eligibility for enrollment into the study will be determined based on the inclusion/exclusion 
criteria. 
Participants will undergo pre-operative and post-operative procedures as per routine standard of 
care for their VUMC colonoscopic exam. We anticipate enrolling 5 patients to complete the 
study. 
3.0.4.1 Day of Endoscopy 
The patient will be administered the Pre-Study Survey (Appendix G) consisting of the RAND 
36-Item Short Form Survey, PROMIS Scale v1.0 Gastrointestinal Belly Pain, PROMIS Scale 
v1.1 Gastrointestinal Gas and Bloating 13a, and PROMIS Scale v2.0 Pain Intensity 3a. 
Once the patient has been successfully prepared for the colonoscopy procedure and has been 
administered monitored anesthesia care (MAC) by the VUMC Anesthesia team as per routine 
care, the following steps will be followed. 
 Note: only step “B)” below deviates from the current standard clinical practice for 
colonoscopic examination of healthy patients. Step “B)” is when the investigational Non-
Significant Risk (NSR) device is used and the only step that is not usually performed during 
colonoscopic examinations.  
A) Colonoscopic assessment using a standard colonoscope. This assessment is the first step 
in the routine patient colonoscopy examination. During this step, the colonoscopist 
introduces a colonoscope into the patient to assess the rectum, colon, and cecum for 
polyps. This will be performed per standard of care without deviation from standard of 
care procedure.  
B) Colonoscopic visualization of the cecum using the Magnetic Flexible Endoscope (MFE). 
After the colonoscope assessment is complete, anesthesia is stopped, and the standard 
colonoscope is removed from the patient, the MFE device will be lubricated, introduced 
into the patient, and navigated to the cecum. Steps in sequential order are:   
1. The MFE device’s sterile packaging will be inspected and confirmed intact  
2. The MFE package will be opened  
3. The MFE will be lubricated   
4. The MFE will be inserted into the patient via the anus 
5. The MFE will be navigated to the cecum   
6. The MFE will be removed from the patient 
C)  Any adverse events occurring during the surgical procedure will be documented. Any 
 
adverse events that occur during the procedure will be documented and reported in 
 
accordance with 21 CFR 812 and Vanderbilt’s IRB protocols.   
 
3.0.4.2 Post-operative visit/follow up 

 
 
 
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In line with standard clinical practice for patients who have received MAC at VUMC, the patient 
is observed for a minimum of 30 minutes during the immediate post-operative period and then 
released to a chaperone to leave the endoscopy unit once standard VUMC post-anesthesia discharge 
parameters are met.  The patient then receives a post-operative phone call 3-5 days post procedure to inquire 
about status of the patient. 
Primary Endpoint: Successful navigation of the colon (from rectum to cecum), with successful 
cecal intubation using the MFE system. 
Secondary Endpoints: 
i. 
Mucosal visibility: Operator assessed score, the Colon Visualization Index (Appendix A), 
will be used. 
ii. 
Patient tolerance: Pain perception will be assessed with a validated pain score (Wong-
Baker FACES Pain Rating Scale; Appendix B). Qualitative assessment of participant 
sentiment will be assessed with a post-study structured interview (Appendix C). 
iii. 
Endoscopist experience: The usability of the platform in terms of task load for the 
endoscopist will be assessed using the standardized NASA Task Load Index (TLX) 
instrument (Appendix D). 
3.0.4.3 Participant Termination/Withdrawal 
Patients may be terminated from the study for the following reasons: 
- 
A change in patient’s health status that would preclude continuation in the study (e.g. cardiac 
event during endoscopic procedure). If this would occur, the patient will continue to be 
followed as per routine care. 
- 
If the patient changes their mind and requests to be withdrawn from study should this occur, 
data will continue to be collected unless the patient requests in writing for data collection to 
cease. 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
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3.0.5 Table of Procedures 
 
Table 2. Study Procedures 
Screening 
Endoscopic 
Examination  
Follow up  
Obtain Informed Consent 
X 
 
 
Review Inclusion/Exclusion Criteria 
X 
 
 
Review Medical History 
X 
 
 
Routine Pregnancy Testing (urine or 
blood) 
 
X a 
 
Colonoscope assessment of tissue  
 
X 
 
Colonoscopic Validation of target 
with the MFE 
 
Xb 
 
Review Adverse Events 
 
X 
X 
Colonoscopic Post-Op 
NASA/Questionnaire 
 
 
Xb 
(a) Performed pre-operatively for women of childbearing potential 
(b) The Investigational Step in this study procedure. All other steps within the protocol will be performed per the standard of care 
 
3.1 Data Analysis 
In this early feasibility study, our primary endpoint is safe, successful, cecal intubation with the 
MFE. Mucosal visibility, patient tolerance, and endoscopist feedback on the platform will also be 
captured as secondary endpoints.  
We will stop enrolling patients in this study if: 
1. We do not believe that additional patients should undergo the procedure because the risks 
of the procedure outweigh the potential benefits to participants 
and/or 
2. An unanticipated adverse effect would warrant that the study be stopped for 
assessment of the effect. 
 
3.2 Quality Assurance 
The conduction of this early feasibility study will be overseen by the PI. The PI will meet with 
the sub-investigators and research staff to assure protocol adherence and accuracy of data 
collection. Prior to study initiation, all study staff will be trained regarding the approved 
protocol. All data will be entered into a password protected RedCap database by qualified 
research staff. Any inconsistencies in the data will be reconciled and documented appropriately. 
As there will be only 5 subjects in this trial, all subject records will be reviewed by the PI. 
 
 
 

 
 
 
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3.3 Regulatory Considerations 
3.3.0 
Adverse Events/Effects 
3.3.0.0 
Definitions 
Adverse event is defined as any undesirable experience associated with the use of the device 
under study that appears or worsens during the clinical study from the period commencing with 
the surgical procedure through the time the participant completes the study, and that may or may 
not be related to the investigational device or study related procedures. 
A related adverse event is an event in which there is a reasonable possibility that the 
investigational device or study related procedures caused or contributed to the event. 
An unanticipated adverse device effect is defined as any serious adverse event on health or 
safety or any life-threatening problem or death caused by, or associated with, a device, if that 
effect, problem, or death was not previously identified in nature, severity, or degree of incidence 
in the investigational plan or any other unanticipated serious problem associated with a device 
that relates to the rights, safety, or welfare of subjects. 
A serious adverse event is defined as an adverse event whereby the patient outcome meets any of 
the following criteria: 
a. Results in death 
b. Is life-threatening (defined as an event in which the participant was at substantial risk of 
death at the time of the adverse event, or use or continued us of the device might have 
resulted in the death of the patient) 
c. Requires inpatient hospitalization 
d. Prolongs an existing hospitalization 
e. Results in persistent or significant disability (substantial disruption of a person’s ability to 
conduct normal life functions) 
f. Results in a congenital anomaly or birth defect 
g. Requires medical or surgical intervention to preclude permanent impairment of a body 
function or prevent permanent damage to a body structure. 
h. The event does not fit above criteria (a) through (g), but may jeopardize the patient and 
may require medical or surgical intervention to prevent any of (a) through (g) above. 
3.3.0.1 
Adverse Event Collection and Reporting 
The investigator and sub-investigators will assess on a routine basis if any adverse events occur 
during the colonoscopic procedure through the time the participant completes the study. All 
adverse events/complications that occur during this time period whether device related or not will 
be reported and recorded. 
Pre-existing conditions that are present at the time of enrollment into the clinical study will be 

 
 
 
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considered concurrent medical conditions and will not be recorded as adverse events unless the 
subject experiences a worsening or complication of such a concurrent condition, in which case the 
adverse event will be recorded and evaluated by the investigator. 
Patients will be closely monitored in a recovery room setting. All available clinical data, 
including exam findings, and clinical impressions, will be monitored. The investigator will 
evaluate any changes in physical status and will determine if the change is clinically important 
and different from what is anticipated in the course of treatment. 
Any events determined by the PI to be unanticipated adverse device effects will be reported to 
the reviewing IRB and the study team as soon as possible but not more than 10 working days 
after the investigator first learns of the effect. 
Any unanticipated adverse device effect will be immediately evaluated by the investigator. 
Should it be determined that the unanticipated adverse device effect presents an unreasonable 
risk to study subjects, the study or the part(s) of the study that present that risk will be terminated 
as soon as possible but not later than 5 working days after the investigator first receives notice of 
the effect. 
3.3.1 Protocol Deviations 
Protocol deviations are defined as any incidents involving non-adherence to the protocol and 
may result from actions of the participant, investigator, or staff. Protocol deviations will be 
recorded and will be reported to the reviewing IRB per IRB policy. Protocol deviations intended 
to protect the life or physical well-being of a participant in an emergency situation and any 
incidence of failure to obtain informed consent must be reported to the reviewing IRB as soon as 
possible but no later than 5 working days after the emergency occurred. Except for such an 
emergent situation, changes that may affect the scientific soundness of the investigational plan or 
the rights, safety or welfare of study participants, must be approved by the IRB prior to 
implementation. 
 

 
 
 
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3.3.2 
Sponsor Responsibilities 
The sponsor will select only qualified investigators to participate in the research study and will 
provide investigators with a study protocol and the information they need to properly conduct the 
study. The sponsor will also assure monitoring is conducted according to the monitoring plan. 
IRB approval of the study must be obtained prior to start of the study and this documentation will 
be kept on file. The sponsor will promptly notify the IRB of any significant new information 
about this investigation. 
3.3.3 
Investigator Responsibilities 
Investigators are responsible for conducting the study in accordance with the signed 
Investigator’s Letter of Agreement, the investigational plan, any IRB imposed conditions, and 
applicable FDA regulations for protecting the rights, safety, and welfare of subjects under the 
investigator’s care, and for obtaining informed consent from each research participant prior to 
any study-related procedures. Investigators are also responsible for maintaining control of the 
investigational device. 
This early feasibility study is being conducted at Vanderbilt University Medical Center, 
Nashville, TN, USA. Investigators may determine if potential subjects would be interested in 
taking part in the investigation prior to IRB approval, but written informed consent will not be 
obtained from study participants and study participation will not be allowed until IRB approval is 
received. 
The investigational device will only be used on research subjects with the investigator’s 
supervision and will not be used on any person who is not authorized under 21CFR812 to receive 
it. 
Investigator will disclose accurate financial information to allow complete and accurate 
certification or disclosure statements that may be required by Vanderbilt University Medical 
Center in compliance with the institutions policies, as appropriate, and will update these records 
promptly if any relevant changes occur during the course of the clinical study and for one year 
after the completion of this study. 
3.3.4 
Selection of Investigators 
All clinical investigators taking part in this study are accomplished gastrointestinal endoscopists 
who commonly perform endoscopic procedures as part of their practice. All understand and will 
comply with their responsibilities regarding adherence to the approved protocol and the signed 
Investigator’s Letter of Agreement. The research protocol will take place at Vanderbilt 
University Medical Center, Nashville, TN, USA with the principal investigator (PI) being Dr. Keith 
L. Obstein, MD, MPH, FASGE, FACG, AGAF. His curriculum vitae is included in Appendix H. 
3.3.5 
Informed Consent 
Once a potential study subject has been identified, a member of the research team will present 
the research study to the subject in person, via phone, or via secure electronic transfer (e.g. 
secure email or My Health at Vanderbilt electronic portal). The potential participant will be 
provided with a copy of the consent form to read and will be provided with an opportunity to ask 
questions. Once the study participant’s questions have been answered and prior to performing 
any study-related procedure, an IRB-approved consent form will be signed and dated by the study 

 
 
 
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participant and by the person obtaining informed consent. A copy of the signed consent form will 
be provided to the subject and the informed consent process will be documented in the study 
participant’s medical record. 
3.3.6 
Confidentiality 
Participants will receive a 3 digits identification number from 001 to 005 in the order of their 
enrollment. Patient identification numbers will be linked to their name on a password secured 
Vanderbilt University Medical Center RedCap Database only accessible by approved research 
study staff. Data from the hard copies of the completed surveys and questionnaires will be 
entered into a RedCap form and securely stored on a Vanderbilt University Medical Center 
password protected cloud platform accessible only by approved research study staff. The hard 
copies will then be destroyed after the data has been entered into electronic format. At the 
conclusion of the research study, the PI will maintain the information on the RedCap secure, 
encrypted, Vanderbilt University Medical Center system.  
3.4 
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4. RISK ANALYSIS 
4.1 Description, Analysis, and Mitigation of Risks 
There are inherent risks common to all endoscopic procedures. These risks are not unique to 
this research and are listed in the table below.   
 
Table 3. Risk Analysis and Mitigation 
Risks which are NOT UNIQUE to this research 
Potential 
Hazard 
Resultant Harm 
Risk Analysis Discussion and Mitigation Strategy