Clinical Evaluation of the OEC Elite MD for Vascular Procedures
Conditions: Interventional Vascular Conditions
Sponsor: GE Healthcare

 
 
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Clinical Study Protocol: 
Clinical Evaluation of the OEC Elite MD for Vascular Procedures 
(Study # 104-2017-GES-0005) 
Version: 1.0; 20/Oct/2017 
Sponsor: 
 
General Electric Company, acting through its GE Healthcare Business 
3000 N. Grandview Blvd 
Waukesha, WI 53188 
Sponsor Contact:  
Beth Heckel, Clinical Affairs Project Manager 
Tel:  
 
1-262-312-7269 
E-mail:   
Beth.Heckel@med.ge.com 
Medical Monitor:  
Ron Von Jako, MD, PhD, Medical Director 
Tel:  
 
1-617-669-3200 
E-mail:   
Ron.VonJako@med.ge.com 
Investigational Device/Product: OEC Elite™ CFD Mobile 
Fluoroscopy System--Motorized Configuration 
Modality: Surgery 
 
FOR QUALIFIED INVESTIGATORS, STUDY STAFF, AND THEIR 
ETHICS COMMITTEE(S) ONLY 
CONFIDENTIALITY STATEMENT 
Information in this RESEARCH STUDY PROTOCOL is for investigators, site personnel 
involved with the study, ethics committee(s), and/or their authorized representative(s) except 
as required to obtain consent from study participants or as otherwise required by law. Once 
signed, the terms of the protocol are binding for all parties. 

Study Title: Clinical Evaluation of the OEC Elite MD for Vascular Procedures 
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1. BACKGROUND AND JUSTIFICATION 
 Mobile Fluoroscopy and Vascular Procedures 
Over the past 25 years, fluoroscopically guided interventional procedures have rapidly increased 
worldwide. 2, 3 Fluoroscopy guidance provides surgeons and interventional specialists with the improved 
ability to assess anatomy and implant materials, 4 as well as guide catheters, guidewires, and stents 
through small vessels and pathways throughout the human body. 2  
In modern angiography, fluoroscopy provides necessary imaging guidance during dynamic vascular 
procedures, such as aortic aneurysm repairs, percutaneous artery angioplasty, and angiographic 
examinations. 5 Preoperative fluoroscopy may also be necessary for arteriography of the aorta and other 
vessels to determine precise anatomical relations when the proximal landing zone of a stent graft cannot 
be determined by non-invasive imaging. 6 Furthermore, peripheral angiography is regarded as the most 
accurate imaging tool for definitive diagnostics and preoperative planning of surgical and endovascular 
interventions in patients with advanced arterial disease.. 7 
Gastrointestinal imaging has significantly evolved since the 1950s and fluoroscopy maintains a critical 
role in GI radiology. Mobile fluoroscopy is accepted as safe and effective for use during intraoperative 
cholangiography and external percutaneous biliary drainage procedures, and fluoroscopic imaging of 
upper gastrointestinal series has demonstrated better tumor localization when compared to endoscopic 
examination. 
In contemporary clinical practice, complicated urologic procedures, including endourologic procedures 
such as retrograde cholangiopancreatography and upper urinary tract procedures are increasingly being 
performed using mobile C-arm fluoroscopy. With the advent of more complex fluoroscopically guided 
procedures, new interventional techniques and devices, such as the device under investigation in this 
study, are being developed and introduced to the market.  
This prospective clinical study is being conducted to acquire image guidance adequacy data from 
physicians conducting clinically-indicated vascular, gastrointestinal (GI), urology and pain management 
procedures for engineering use, as deemed appropriate by the Sponsor, for the investigational OEC 
EliteTM CFD Mobile Fluoroscopy System –Motorized Configuration (OEC Elite) in the vascular 
configuration. Clinical procedures included in this study will involve three (3) anatomical regions of 
interest – extremities and neck, thorax, and abdomen and pelvis. These regions are being targeted 
because they represent the range of clinical applications and anatomical regions intended for OEC Elite 
in the vascular configuration.  
 Pre-Clinical Trials and Previous Clinical (human) Experience 
GE Healthcare (GEHC), the study Sponsor, is a manufacturer of mobile fluoroscopy equipment and has 
extensive experience in conducting clinical trials.  
A GEHC-sponsored study of human cadaveric tissue was conducted as part of feasibility and optimization 
of the investigational device’s predicate, the OEC 9900 Elite (Study Title: A Diagnostic Capability Bench 
Study of An SSXI Mobile Fluoroscopy System and the OEC® 9900 Elite Mobile Fluoroscopy System; 
GEHC Study Number: 104-2014-GES-0003). A preclinical study using the swine animal model was 
recently conducted by the Sponsor for software optimization of the vascular configuration prior to 
implementing investigational OEC Elite in the vascular configuration in the clinical setting (Study Title: A 
Preclinical Imaging Study of the OEC Elite Vascular System; GEHC Study Number 104-GES-2016-0001). 

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In addition, the Sponsor has conducted research on previous non-motorized CFD (flat panel detector) 
systems. Imaging Evaluation of the OEC Elite Mobile Fluoroscopy System (GEHC Study Number 104-
GES-2015-0003) was conducted to gather image data for a regulatory submission on the OEC Elite CFD. 
Two other studies, Clinical Evaluation of the OEC Elite Vascular Mobile Fluoroscopy System (GEHC 
Study Number 104-2016-PTHS-0005) and Evaluation of the OEC Elite Vascular Mobile Fluoroscopy 
System (GEHC Study Number 104-2017-GES-0001) were conducted to gather workflow and survey data. 
 Controls and Minimization of Bias 
All reasonable attempts will be made to control and minimize bias during this study, including the 
following: 
• 
Subjects will be consecutively enrolled from the patients screened until the accrual quota is filled, 
with the intent of limiting selection bias; 
• 
Spectrum bias will be limited by using a population expected to be representative of the general 
population at the investigational site, without regard to race or ethnicity. 
2. DEVICE/PRODUCT DESCRIPTION 
 Identity, Mechanism, and Function 
Name:  
OEC Elite™ CFD Mobile Fluoroscopy System--Motorized Configuration 
Modality/Type: 
Surgery 
Manufacturer:  
GE OEC Medical Systems, Salt Lake City, UT, USA 
Software version: The most current version available will be used. 
Regulatory Status:  
Pre-market 
Note: A record of number of devices issued, along with applicable identification numbers (e.g. 
serial/lot/batch) and components/accessories used in this study will be retained by the Sponsor as part of 
the clinical history file (CHF), as required by applicable laws and regulations. 
The OEC Elite™ CFD Mobile Fluoroscopy System--Motorized Configuration (OEC Elite) is a medical 
device centrally comprised of a mobile C-arm with flat-panel detector and a mobile workstation that 
displays resultant images. The device includes hardware and software capable of generating and 
receiving x-ray signals to produce images of bone and living tissues, and a mobile workstation that 
includes image display and user interface. As with the predicate device, the investigational device is 
motorized and uses a tableside Remote User Interface (RUI) to enable the operator to move the C-arm 
without touching it. The central difference between the predicate OEC 9900 Elite MD device and the 
investigational system is the replacement of an image intensifier detector with a flat-panel detector. 
For this study, the OEC Elite (Figure 1) will be provided to the investigational site in the VAS MTS 
configuration with a 31-cm flat panel detector.  

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Figure 1 – Investigational OEC Elite Mobile Fluoroscopy System 
The research device, instructions for use, or packaging shall indicate that the research device is for use in 
a research investigation, in accordance with applicable regulations in Canada per Medical Device 
Regulations (SOR/98-282), Part 3, Sections 79-88 and other applicable laws and regulations. 
The investigational device will be exclusively used for research procedures and only as set forth in an 
Ethics Committee (EC) approved study protocol, in accordance with applicable laws and regulations. 
 Intended Use 
The OEC Elite Mobile Fluoroscopy System is designed to provide fluoroscopic and digital spot images of 
adult and pediatric populations during diagnostic, interventional, and surgical procedures. Examples of a 
clinical application may include: orthopedic, gastrointestinal, endoscopic, urologic, neurologic, vascular, 
critical care, and emergency procedures. 
This study will include vascular, gastrointestinal (GI), urology and pain management procedures in an 
adult population. Study procedures will be conducted in accordance with the site’s standard of care. 
 Concomitant/Ancillary Administrations 
 Medications and Biologic Products 
No medications or biologic products will be administered as part of study procedures. 
 Laboratory Tests and Sample Processing 
No laboratory tests or sample processing is planned as part of the study procedures. 
 Accountability 
Accurate and adequate records will be maintained for all devices, from time of shipment to the site until 
return or disposal of all devices issued by the Sponsor as part of this study, as required by applicable 

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laws and regulations. The Principal Investigator will be ultimately responsible for the security and integrity 
of research devices at the investigational site during the study. 
 Issuance 
The Sponsor will provide the site with devices, including necessary hardware and software components 
of the device. The Sponsor will provide necessary maintenance for the investigational device(s) installed 
at the sites. GE technical support will be available, as needed, to maintain integrity of study data. 
 Disposition 
Upon completion of the study, Sponsor-provided devices at the investigational site will be de-installed by 
Sponsor-authorized engineers and returned to the Sponsor, or otherwise dispositioned, in accordance 
with applicable laws and regulations. Identifiable subject information will be removed from the device(s) 
prior to dispositioning devices.  
 Anticipated Risks and Benefits 
The device under study has undergone risk assessment, in accordance with International Standards 
Organization (ISO) 14971:2012, and risks have been mitigated to levels as low as reasonably practicable 
(ALARP). 
The investigational OEC Elite is expected to present similar potential risks to patients, operators, or 
others in this study as the predicate commercial device, OEC 9900 Elite, when used under similar clinical 
indications for use. The risks of study participation are not expected to be different than those of non-
study procedures. Because basic image guided fluoroscopy will be used for conventional procedure 
applications, there will be no post-trial care or follow-up required by this study. 
As with all x-ray devices, OEC Elite uses the minimum possible ionizing x-ray radiation dose, which is 
within acceptable limits set forth by applicable local laws and regulations necessary to complete a 
procedure. Because the radiation dose and procedural duration widely vary for the procedures included in 
this study, there is no prospective per-procedure maximum radiation dose or duration prescribed by this 
protocol. All procedures will be conducted per the clinical standards of the site and the medical discretion 
of physicians performing the clinically indicated study procedures. 
In the unlikely event that a device error prevents or impairs image acquisition, it is possible that a subject 
may require alternative or additional imaging to complete an intervention or exam. If imaging is not 
adequate or diagnostic-quality images cannot be obtained using the investigational device, the subject 
will not undergo additional investigational imaging. Necessary medical care will be provided by the sites, 
and equivalent, site-provided commercial fluoroscopy systems (e.g. the predicate device or equivalent) 
will be readily available throughout the study.  
Subjects who undergo additional or elongated imaging procedures may be at a small increased risk 
because of additional x-ray exposure and possible additional procedure time, which may also impact the 
duration and/or dosages of anesthesia and contrast administration. 
Subjects are not expected to benefit directly from study participation; however, the results may benefit 
future patients by helping to better understand the device under study. 
 Risk Category and Rationale 
In Canada, the OEC EliteTM CFD Mobile Fluoroscopy System—Motorized Configuration is a Class III 
medical device, as defined by Schedule 1, Part 1, Rule 8 of the Medical Devices Regulations (SOR/98-

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282). Use of OEC Elite is not expected to pose significant risk to human subjects in accordance with the 
standards of Health Canada’s Medical Device Regulations, Part 3 – Medical Devices for Investigational 
Testing Involving Human Subjects (SOR/98-282, §79-88). 
3. PURPOSE OF THE STUDY 
The purpose of the study is to collect survey data on the use of the OEC Elite based on the routine 
clinical use of the device. 
 Study Objectives:  
 Primary Objective: 
The primary objective is to collect investigator feedback on imaging guidance adequacy of the OEC Elite during 
clinical procedures. 
 
 Secondary Objective(s): 
The secondary objectives of this study are to collect image data acquired during clinical procedures and to 
collect investigator feedback via surveys on the use of the system during clinical procedures. 
 Study Endpoints 
 Primary Endpoints: 
The primary endpoint is the per-subject investigator report of imaging guidance adequacy to complete the 
procedure (Y/N). 
 Secondary Endpoints:  
The secondary endpoints are the total number of surveys reflecting the investigator opinion of procedures 
performed and the image data collected. 
4. STUDY DESIGN 
 Summary of Study Design 
This is a pre-market, Clinical, open label, prospective, non-randomized research study conducted at one 
(1) site in Canada.  
 Study Population 
The study population will be adults undergoing vascular, gastrointestinal (GI), urology or pain 
management procedures for which use of the OEC Elite system in the vascular configuration would be 
prescribed. This population is expected to be representative of the general population that would require 
mobile fluoroscopic imaging with C-arm devices, such as OEC Elite. Pediatric patients (i.e. patients 
younger than 18 years old) will not be enrolled in this study. 
 Number Subjects/Cases 
Up to 40 subjects may be enrolled the site. Enrollment may be discontinued at any time prior to reaching 
40 subjects at the discretion of the sponsor. 

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 Protection of Vulnerable Subjects 
Vulnerable subjects are individuals whose willingness to volunteer in a clinical investigation could be 
unduly influenced by the expectation, whether justified or not, of benefits associated with participation or 
of retaliatory response from senior members of a hierarchy in case of refusal to participate.  
The Sponsor shall avoid improper influence on, or inducement of, the subject, monitor, any 
investigator(s), or other parties participating in, or contributing to, the clinical investigation. 
All investigators shall avoid improper influence on, or inducement of, the subject, Sponsor, monitor, other 
investigator(s), or other parties participating in, or contributing to, the clinical investigation. 
This study does not examine any groups of subjects who are vulnerable subjects in the country in which 
the study is being conducted. 
 Eligibility Criteria 
 Inclusion Criteria  
Subjects who meet all the following inclusion criteria may be included: 
1) Male or female between the ages of 18 and 85 years (≥18 and ≤85 years old); 
2) Clinical indication for procedures including vascular, gastrointestinal (GI), urology or pain 
management  for which mobile fluoroscopy has been prescribed for image guidance;  
3) Able and willing to comply with study procedures; and 
4) Able and willing to provide written informed consent to participate. 
 Exclusion Criteria  
Subjects who meet any of the following exclusion criteria will be excluded: 
1) Pregnant or suspected to be pregnant based on the opinion of and as documented by a medically 
qualified physician investigator;  
2) Expected to be at increased risk due to study participation (e.g. due to allergies, sensitivities), in 
the medical opinion of an investigator; or 
3) Previously participated in this study, or enrolled in another active GEHC study or other research 
study that could be expected to interfere with participation in study procedures, in the opinion of 
the investigator. 
 Recruiting and Screening  
Subjects will be recruited for potential enrollment at the site from an adult population scheduled for a 
clinical procedure with mobile fluoroscopy. Subjects will be screened for enrollment against the inclusion 
and exclusion criteria, and enrollment determinations will be made by the site investigator. Recruitment, 
screening, and enrollment will be conducted per the standard procedures of the investigational site. All 
participation will be voluntary. 
Following recruitment, a subject will be considered enrolled (the point of enrollment) once he/she signs 
and dates the informed consent form (ICF). Once enrolled, the subject will be assigned a unique subject 
number, which will not contain information that could identify him/her (e.g. subject name or date of birth). 
The unique subject number will be used to label case report form (CRF) data for the subject throughout 
his/her participation in the study. 

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 Criteria for Withdrawal/Discontinuation 
A subject may withdraw from study participation at any time, for any reason. The investigator may 
withdraw a subject at any time, for any reason. The reasons for withdrawal and discontinuation for any 
subject shall be recorded and reported to the Sponsor. The EC should be notified per their notification of 
subject withdrawal policy. 
If a subject withdraws or is withdrawn, all efforts will be made to complete and report study data up to the 
time of withdrawal. A complete final evaluation at the time of the subject’s withdrawal shall be made and 
recorded on a CRF. If the reason for withdrawal is related to an adverse event (AE) or serious adverse 
event (SAE), monitoring of the subject will continue until the outcome is evident. 
Any data collected for the subject, up until the time of withdrawal or discontinuation, may still be included 
in the study results and provided to the Sponsor, unless the subject requests that their data not be used. 
The site shall document all requests by subjects regarding their data use. 
5. STUDY PROCEDURES  
 Subject Preparation 
Study staff will confirm that each subject is eligible and willing to comply with applicable site requirements 
prior to starting study procedures. No preparation beyond that required by the investigational site is 
required before procedures. 
 Description of Study Procedures 
Each subject will undergo his/her clinically indicated vascular, gastrointestinal (GI), urology and pain 
management procedure with fluoroscopic imaging conducted using the investigational OEC Elite device. 
Prescribed treatments (e.g. contrasts, anesthesia) will be administered according to the standard of care.  
 Follow-up  
No follow-up will be conducted as part of this study. Subjects will be followed for AEs from the time they 
enter the procedural room containing the investigational device until the study procedure ends and they 
exit the procedural room. 
 Malfunction/Error Handling 
The site should report the occurrence and resolution of any procedures terminated due to non-
recoverable malfunctions (i.e. malfunctions or errors with OEC Elite that prevent image collection and are 
not able to be immediately resolved by the device operator). The site should also report recoverable 
errors (i.e. issues with the device that do not prevent image collection and are able to be resolved 
immediately by the device operator) and operator errors. The occurrence of any recoverable error, 
operator error, or non-recoverable malfunction will be reported on the subject’s CRF. 
In uncommon cases, the research procedures using the investigational device may need to be terminated 
unexpectedly. If the investigator suspects that a subject would be at increased risk, or that the subject’s 
clinical procedure will not be able to be completed using the investigational device in this study, the 
investigator may terminate the procedure at any time and for any reason. In some cases, it may not be 
feasible to end a procedure; in which case, equivalent, site-provided commercial fluoroscopy equipment 
(such as the predicate device or equivalent) may be used. The site will ensure that access to alternative 
commercial fluoroscopy equipment is maintained during all procedures. All patient care and management 

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decisions for terminated procedures will be made outside of this study according to the sites’ standard 
clinical practices and the subject’s regular physician’s or investigator’s medical judgment. 
6. STUDY DATA COLLECTION AND ASSESSMENTS 
 Operating Physicians 
At the completion of a procedure, the physician (e.g. interventional specialist or surgeon) conducting the 
procedure will provide feedback on the capability of the system by completing a User Survey. Survey data 
will be recorded on case report forms (CRFs). 
7. QUALIFICATION AND TRAINING PLAN 
 Staff Qualifications 
All members of the study staff participating in the conduct of the Clinical investigation shall be qualified by 
education, training, and/or experience to perform their tasks. Qualifications shall be documented 
appropriately, as per ISO 14155:2011.  
 Training Plan for the Protocol and Research Device/Product 
Before starting the study, the study staff will be trained on the clinical investigation requirements set forth 
in this study protocol, including completion of Informed Consent Forms (ICFs), CRFs, and other study 
documentation. Training will also be provided to ensure appropriate storage and handling of data, and all 
study staff will be required to be trained on Good Clinical Practice (GCP) guidelines per ISO 14155: 2011. 
A record of all formal training will be stored in the Site Regulatory Binder and provided to the Sponsor for 
inclusion in the Sponsor’s CHF. Documentation of training will include: 
• 
Title of Training 
• 
Training objectives 
• 
Training logistics (trainer and training methods) 
• 
Documentation of trainees 
• 
Training content (e.g. device operation, protocol review and CRF completion) 
Study staff directly operating or maintaining the research device will be trained based on device operation 
and safety. A copy of the device operator manual will be provided to the site along with Sponsor-provided 
training. 
The PI will be ultimately responsible for execution of this study, in accordance with the protocol, and for 
device use in this study by members of the study staff. 
 Case Report Form 
The study procedure CRF will report the following: 
• 
Basic demographic 
• 
Type of procedure or technique being performed 
• 
Anatomical region being imaged 
• 
Contrast information 

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• 
User Evaluation Survey 
• 
Guidance Adequacy 
8. SAFETY 
 Anticipated Adverse Events 
The study design is not expected to pose additional risk to patients above that required by routine 
diagnostic, surgical, or interventional procedures that are clinically indicated for the patient and related to 
use of the OEC Elite.  
All subjects included in this study will require imaging during a diagnostic exam or surgery per their 
clinically indicated procedure. Intraoperative imaging with OEC Elite and similar commercial mobile C-arm 
devices produce ionizing radiation at levels generally considered safe, but in extremely rare cases, may 
pose risks of deterministic tissue effects (e.g. skin reddening, cataracts, and hair loss) and very small 
increases in lifetime cancer risk. These side effects would be risks whether or not patients participate in 
this study, and they are extremely rare when a mobile C-arm is used for procedures similar to the 
proposed study procedures. These risks generally occur only in patients exposed to excessive amounts 
of x-ray radiation in a short time or excessive amounts over a long period of time concentrated to a single 
region. These events are unusual for mobile C-arms.  
Subjects may also require prescribed medications, such as contrast (“dye”), anesthesia, and other 
medicines that are not expected to change as a result from participation in this study. These medications 
have widely recognized side effects that include allergic reactions, itching, swelling, burning, bleeding, 
mental confusion, lung infection, stroke, heart attack, and other potentially serious metabolic 
complications. Patients would be at risk for these side effects whether or not they participate in this study. 
Patients will receive consultation on possible benefits and risks specific to their recommended procedures 
according to the standard of care outside of this study, and the procedures for this study will not influence 
these discussions.  
Patient participation in this study is not expected to increase risks for side effects from imaging, contrast, 
anesthesia, or other medication administration or to negatively impact the results of the procedure 
compared to equivalent procedures performed outside of this study, using commercially available 
devices. 
There are potential risks to subjects participating in this study that are associated with unexpected device 
issues or procedural complications. These risks include: 
• 
Longer duration of patient procedures, which are expected to be minimal (accounting for time to 
transfer patient to alternative, commercial device and/or mitigate any other procedural or device 
issues) and are not expected to significantly increase the total duration of the procedure.  
• 
Additional imaging, which could involve using an alternative, commercial system available at the 
site. 
• 
Extension or interruption of regular medical care or medication administration, including 
prolongation; re-administration of medicines, including contrast, anesthesia, and other medicinal 
agents; or delay of ending anesthesia or other medications. 
These events are expected to be rare, but the risks for side effects normally related to surgery, imaging, 
contrast, anesthesia, or other medication administration may be increased for affected patients. To 
minimize the impact of these risks, alternative, commercially available mobile fluoroscopy systems 

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available at the sites will be placed in an accessible location during all procedures that use investigational 
devices. 
There is always a chance of unexpected risks. Throughout the study, the Sponsor will evaluate and 
update safety information in study documents.  
 Adverse Event Definitions 
Adverse Event (AE): any untoward medical occurrence, unintended disease or injury, or untoward 
clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not 
related to the investigational medical device [ISO 14155:2011 3.2]. This includes events related to the 
investigational device or the comparator and to the procedures involved. For users or other persons, this 
is restricted to events related to the investigational medical device. 
Serious Adverse Event (SAE): an adverse event that led to death; led to a serious deterioration in the 
health of the subject, that either resulted in a life-threatening illness or injury, a permanent impairment of 
a body structure or a body function, or in-patient or prolonged hospitalization, or medical or surgical 
intervention to prevent life-threatening illness or injury or permanent impairment to body structure or a 
body function; or led to fetal distress, fetal death or a congenital abnormality or birth defect. Planned 
hospitalization for a pre-existing condition, or a procedure required by the protocol without serious 
deterioration in health, is not considered a SAE [ISO 14155:2011 3.37]. 
Adverse Device Effect (ADE): an adverse event related to the use of an investigational medical device 
[ISO 14155:2011 3.1]. This includes any adverse events resulting from insufficient or inadequate 
instructions for use, deployment, implantation, installation, or operation, or any malfunction of the 
investigational medical device. This includes any event that is a result of a user error or intentional misuse 
of the investigational device [ISO 14155:2011 3.43]. 
Serious Adverse Device Effect (SADE): an adverse device effect that has resulted in any of the 
consequences characteristic of a serious adverse event [ISO 14155:2011 3.36]. 
Device deficiency: an inadequacy of a medical device with respect to its identity, quality, durability, 
reliability, safety, or performance, such as malfunctions, use errors, and inadequate labelling [ISO 
14155:2011 3.15]. 
Unanticipated serious adverse device effect (USADE): a serious adverse device effect, which by its 
nature, incidence, severity, or outcome has not been identified in the current version of the risk analysis 
report [ISO 14155:2011 3.42]. In the United States, any serious adverse effect 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 study documents, will be 
reported in accordance with 21 CFR §812.3 and applicable laws and regulations. 
 Documentation of Safety Events 
All adverse events (AE), including all serious adverse events (SAE), are required to be collected, 
investigated, and documented during the study reporting period, as defined in the study procedure set 
forth in this protocol. Documentation will include: 
• 
Description of Event 
• 
Date of onset and resolution  
• 
Severity (mild, moderate, or severe)  
 
Mild: Symptom(s) barely noticeable to the subject or does not make the subject 
uncomfortable. The AE does not influence performance or functioning. Prescription drugs 
are not ordinarily needed for relief of symptom(s). 

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 
Moderate: Symptom(s) of a sufficient severity to make the subject uncomfortable. 
Performance of daily activities is influenced. Treatment of symptom(s) may be needed. 
 
Severe: Symptom(s) of a sufficient severity to cause the subject severe discomfort. 
Treatment for symptom(s) may be given. 
• 
Serious (yes/no)  
• 
Causal relationship to investigational medical device? (not related, possibly related, or related) 
 
Not related: The adverse event is reasonably expected to be related to (or caused by) a 
concurrent illness, effect of another device/drug or other cause, and is unlikely related to 
the investigational product. 
 
Possibly related: The adverse event is reasonably expected to be related to the 
investigational product, and an alternative etiology is equally or less likely compared to 
the potential relationship to investigational product. 
 
Related: There is a strong relationship to investigational product or recurs on re-
challenge, and another etiology is unlikely or there is no other reasonable medical 
explanation for the event. 
• 
Treatment given and/or action taken (procedure stopped, withdrawn from study, or no action) 
• 
Anticipated (yes/no) 
 Reporting of Safety Events and Device 
Deficiencies/Complaints 
The following events are to be reported to the Sponsor within 72 hours of the event occurrence and to the 
EC per their policy: 
• 
All SAEs and USADEs 
• 
All device issues that could possible lead to an SAE 
Additional follow-up information may be requested by the Sponsor. In addition, safety information may be 
shared with regulatory agencies and other participating sites, as required by applicable law and regulation. 
 Device Deficiencies 
Device deficiencies should be reported to the study Sponsor contact identified on the cover page of this 
protocol. All device deficiencies will to be collected, fully investigated, and documented in the source 
document and appropriate Sponsor document during the study reporting period. The PI is responsible for 
notifying the Sponsor in the event that there is any device issue that could potentially lead to a SAE. 
9. ETHICAL CONDUCT OF THE STUDY 
The study will be carried out in accordance with the protocol and with principles enunciated in the current 
version of the Declaration of Helsinki; the guidelines of Good Clinical Practice (GCP) for medical devices, 
as set forth by ISO 14155:2011 and ISO 14971:2012; applicable requirements of Health Canada’s 
Medical Device Regulations (SOR/98-282); and other applicable regulatory authority requirements of 
Canada, as necessary. 
The study will be conducted and reported in accordance with applicable policies of the local Ethics 
Committee (EC) and governing regulatory authorities. 

Study Title: Clinical Evaluation of the OEC Elite MD for Vascular Procedures 
Study No: 104-2017-GES-0005 
 
 
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If national or regional EC requirements are less strict than the requirements of GCP, such as ISO 
14155:2011 for medical devices, the Sponsor shall apply the requirements of this International Standard 
to the greatest extent possible, irrespective of any lesser requirements, and shall record such efforts. 
 Ethics Committee 
The responsible site PI will ensure that approval from an appropriately constituted EC is attained for the 
clinical study prior to enrolling subjects. The PI will also ensure that documentation of approval is 
maintained for the duration of the study.  
The PI will ensure that the Sponsor is notified of any withdrawal of EC approval within 5 working days of 
such occurrence. If approval is terminated or suspended, the PI will promptly notify the Sponsor and 
provide written explanation. 
 Regulatory Agencies and Competent Authority 
The Sponsor will obtain approval from the local regulatory agency or competent authority (CA), Health 
Canada, before the start of the clinical trial, if necessary, per applicable local laws and regulations. Any 
additional requirements imposed by the EC or CA shall be followed, when applicable. 
 Management of Protocol Modifications and Amendments  
Substantial amendments will only be implemented after EC approval.  
A deviation is any instance(s) of failure to follow, intentionally or unintentionally, the requirements of the 
protocol. Under emergency circumstances, deviations from the protocol to protect the rights, safety, and 
wellbeing of human subjects may proceed without prior approval of the Sponsor and the EC/CA. Such 
deviations shall be documented and reported to the Sponsor and the EC as soon as possible. Deviations 
will be reported as: 
• 
Critical Deviations: Deviations that significantly affect the safety, efficacy, integrity, or conduct of 
the study. These deviations must be reported to the Sponsor no later than 5 working days from 
awareness of occurrence and reported to the EC per the deviation reporting policy.  
• 
Non-Critical Deviations: Protocol deviations that do not significantly affect the safety, efficacy, 
integrity, or conduct of the trial. These deviations must be documented on the CRF Protocol 
Deviation page and will be reviewed by the study monitor. 
Non-substantial modifications may be made during the normal course of device optimization, 
maintenance, and feasibility testing. Non-substantial modifications will be communicated to the CA as 
soon as possible, if applicable, and to the EC per their policy.  
 Participant Information and Informed Consent 
The investigator will explain to each participant the nature of the study, its purpose, the procedures 
involved, the expected duration of exposure to the investigational device, the potential risks and benefits, 
and any potential discomforts. Each participant will be informed that participation in the study is voluntary, 
that he/she may withdraw from the study at any time, and that withdrawal of consent will not affect his/her 
subsequent medical assistance and treatment. The participant must be informed that his/her medical 
records may be examined by authorized individuals other than their treating physician. 

Study Title: Clinical Evaluation of the OEC Elite MD for Vascular Procedures 
Study No: 104-2017-GES-0005 
 
 
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All participants for the study will be provided with an ICF, describing the study and providing sufficient 
information to allow the participant to make an informed decision about his/her participation in the study. 
Informed consent documents will be subject to approval by the EC prior to enrolling subjects in the study. 
The participant should read and consider the statement before signing and dating the ICF, and shall be 
given a copy of the signed document. The ICF must also be signed and dated by the investigator (or 
his/her designee), and it shall be retained as part of the study records. 
 Early Termination of the Study 
The Sponsor may terminate the study prematurely according to certain circumstances. Examples of such 
circumstances include ethical concerns, insufficient participant recruitment, participant safety concerns, 
alterations in accepted clinical practice that make the continuation of a clinical trial unwise, early evidence 
of benefit or harm of the research product, or for any other reason. 
10. 
STATISTICAL METHODS 
  Statistical Hypothesis  
No statistical hypothesis is being tested in this study. 
  Sample Size Determination 
The sample size is based on the Sponsor’s previous clinical experience and the expectation that enough 
procedures using the OEC Elite will be performed to demonstrate clinical performance. 
  Statistical Analysis 
No statistical analysis is prospectively planned. 
 Interim Analysis 
No interim analyses are intended to be conducted as part of this study. 
  Handling of Missing Data  
Analysis will be based on collected data, and no imputation will be done for missing data. 
  Deviation(s) from the Original Statistical Plan 
Any changes or deviations from the original statistical plan specified in this protocol will be described and 
justified in study final report, per ISO 14155:2011. 
11. 
 QUALITY ASSURANCE AND CONTROL 
  Data Management 
Data management processes for handling study data will be maintained by the Sponsor. 
 Completion of Case Report Forms (CRFs) 
The data reported on the CRFs shall be derived from source documents and be consistent with these 
source documents. Paper CRFs will be used to collect data. The Sponsor will provide CRFs and train 
study staff on completion of CRFs using Good Documentation Practices (GDP). CRF Completion 
Guidelines (CCG) may be provided by the Sponsor to help facilitate training. 

Study Title: Clinical Evaluation of the OEC Elite MD for Vascular Procedures 
Study No: 104-2017-GES-0005 
 
 
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CRFs are to be completed as information becomes available at the site. CRFs should be signed by 
indicated parties, in indicated area(s), to certify the contents of the form. The PI is ultimately responsible 
for ensuring completion of CRFs. 
If discrepancies are discovered on paper CRFs during monitoring, the Sponsor’s representative will 
ensure that the study staff makes necessary corrections directly to the CRF(s) prior to collection.  
Following CRF collection, the Sponsor will review the data. A Data Clarification Form (DCF) may be 
provided to the site to correct or clarify discrepancies. 
If a site discovers discrepancies after CRF collection, the site may notify the Sponsor and request data 
modification.  
 Data Handling and Record Keeping  
All documents and data shall be produced and maintained in a manner that assures control and 
traceability. 
 Source Data and Documents 
Source data includes information in original records, certified copies of original records of clinical findings, 
observations, or other activities for the study. Source documents for each subject must be retained 
throughout the investigation, including printed or electronic documents containing source data. Elements 
should include: 
• 
Source data and documentation relevant to data recorded for subject screening and CRF 
corroboration. 
• 
Subject records containing the completed ICFs and CRFs. 
• 
Regulatory binder containing the protocol and any subsequent amendments, EC submissions 
and approvals, blank ICF(s), and site logs. 
• 
Reference manuals containing investigator responsibilities, Sponsor, AE/SAE and informed 
consent guidelines, applicable study aids and training materials, and supplier instructions. 
The PI or institution shall provide direct access to source data during and after the clinical investigation for 
monitoring, audits, EC review, and regulatory authority inspections.  
 Archiving 
All study data must be archived for a minimum of three (3) years after study termination or premature 
termination of the clinical trial. No source documents or study records will be destroyed without Sponsor 
notification and approval. 
12. 
MONITORING PLAN 
In collaboration with the site, the Sponsor will ensure proper monitoring of the study to confirm that all the 
research requirements are met. Monitoring visits will oversee the progress of a clinical investigation and 
ensure that it is conducted, recorded, and reported in accordance with the protocol, written procedures, 
GCP ISO 14155:2011, and the applicable regulatory requirements. 

Study Title: Clinical Evaluation of the OEC Elite MD for Vascular Procedures 
Study No: 104-2017-GES-0005 
 
 
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  Confidentiality and Data Protection 
The investigator affirms and upholds the principle of the participant's right to privacy, and the investigator 
shall comply with applicable privacy laws. Especially, anonymity of the participants shall be guaranteed 
when presenting the data at scientific meetings or publishing data in scientific journals. 
All individual subject medical information obtained as a result of this study will be considered confidential, 
and disclosure to third parties will be prohibited. Subject confidentiality will be further ensured by utilizing 
subject identification code numbers. For data verification purposes, authorized representatives of the 
Sponsor, CA, or EC may require direct access to parts of the medical records relevant to the study, 
including subject medical history. 
 Storage of Images and Associated Health Data 
Images will be collected or disclosed to the Sponsor as part of this study. No patient information beyond 
what is captured on the associated Case Report Forms will be collected. Fully de-identified data and 
images, which have had all personal identifying information removed, may be stored and used by the 
Sponsor indefinitely. The Sponsor and/or its authorized representatives may use any de-identified data 
collected in this study for future technology and engineering development, education, marketing, or other 
possible uses. 
  Publication Policy 
The results of this study may not be used in future publications. 
 

Study Title: Clinical Evaluation of the OEC Elite MD for Vascular Procedures 
Study No: 104-2017-GES-0005 
 
 
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REFERENCES 
      
1. ISO. Clinical investigation of medical devices for human subjects - Good Clinical Practice: 
International Organization for Standardization; 2011. ISO 14155:2011(E). 
2. Miller DL. Overview of contemporary interventional fluoroscopy procedures. Health Physics. 
2008;95(638):638-644. 
3. Miller DL, Vano E, Bartal G, et al. Occupational Radiation Protection in Interventional Radiology: A 
Joint Guideline of the Cardiovascular and Interventional Radiology Society of Europe and the Society 
of Interventional Radiology. J Vasc Interv Radiology. May 2010;21(5):607-615. 
4. Palacio E, Ribeiro A, Gavassi B, et al. Exposure of the surgical team to ionizing radiation during 
orthopedic surgical procedures. Revista Brasileira De Ortopedia (RBO). 2014;49(3):227-232. 
5. Ho P, Cheng SWK, Wu PM, et al. Ionizing radiation absorption of vascular surgeons during 
endovascular procedures. Journal of Vascular Surgery. September 2007;46(3):455-459. 
6. Sullivan TM, Taylor SM, Blackhurst DW, et al. Has endovascular surgery reduced the number of open 
vascular operations performed by an established surgical practice. Journal of Vascular Surgery. 
September 2002;36(3):514-519. 
7. Mayberg MR, Winn HR. Endarterectomy for Asymptomatic Carotid Artery Stenosis. Journal of the 
American Medical Association. May 1995;273(18):1459-1461. 
8. Food and Drug Administration Center for Devices and Radiological Health. Guidance for Industry and 
Food and Drug Administration Staff: Guidance for the Submission of 510(k)s for Solid State X-ray 
Imaging Devices. 2016. 
 
 

Study Title: Clinical Evaluation of the OEC Elite MD for Vascular Procedures 
Study No: 104-2017-GES-0005 
 
 
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APPENDIX A – STUDY SITE AND INVESTIGATOR LIST  
The following investigators at each study site will be responsible for the conduct of this study:  
Investigator(s):1 
 
Investigator Name, Dr. Theodore 
Rapanos 
Associate Professor 
Division of Vascular Surgery 
Tel:  
905-521-2100 x44652 
e-mail:  
rapanost@mcmaster.ca  
Site Name Hamilton General Hospital 
Address:   237 Barton St. East 
 Hamilton, ON L8L 2X2 
1 The role of the Principal Investigator is to implement and manage the conduct of the investigation as well as 
ensure data integrity and the rights, safety, and well-being of humans involved in the study [ISO 14155:2011 9.1]. Co-
Investigators share all responsibilities of the Principal Investigator, and Sub-investigators share only those 
responsibilities designated by the Principal Investigator.