Prospective, Multi-Center, Randomized Study to Evaluate the OrthoCor Active System for Pain Relief
Phase: NA
Conditions: Pain
Sponsor: Caerus Corporation

 
 
 
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Prospective, Multi-Center, Randomized Study to Evaluate the 
OrthoCor Active System for Pain Relief  
 
 
Investigational Product: 
OrthoCor Active System  
Protocol Number: 
OCM-OAS-01 Version 3.0 
Date: 
07September2022 
ClinicalTrials.gov Number: 
NCT05244187 
 
 
 
 
 
 
 
 
 
This investigational protocol contains confidential information for use by the Principal Investigators and their 
designated representatives and applicable ethics committee/institutional review board and regulatory authorities 
participating in this clinical investigation.  It should be held confidential and maintained in a secure location. It 
should not be copied or made available for review by any person or firm without the prior written consent of Caerus 
Corporation. 

 
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1.0 
ADMINISTRATIVE INFORMATION 
1.1 Contacts 
Medical, Clinical and Operational Support 
Sponsor Name: 
Caerus Corporation 
 
 
Sponsor Telephone Number 
+1 651-440-9345 
 
 
 
 
Manufacturer and Sponsor Address: 
Caerus Corporation 
 
12251 Red Fox Road 
Arden Hills, MN 55112 
1.2 Protocol Administrative Information 
Protocol Number:  
OCM-OAS-01 
Revision Number: 
Version 3.0 
Protocol Date: 
07-Sep-2022 
Investigational Product: 
 
      OrthoCor Active System  
 
 
 
1.3 Amendment History:  
Date  
Amendment Number 
Amendment Type  
30-Nov-2021 
Original 
Original protocol, version 1.0 
18-Jan-2022 
1 
Amended protocol, version 2.0 
07-Sep-2022 
2 
Amended protocol, version 3.0 

 
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1.4 Sponsor Protocol Approval 
Representatives of Caerus Corporation. 
This study will be conducted with the highest respect for the individual participants in 
accordance with the requirements of this clinical study protocol and in accordance with the 
following: 
● The ethical principles that have their origin in the Declaration of Helsinki. 
● International Conference on Harmonisation Harmonised Tripartite Guideline for Good 
Clinical Practice E6 (ICH GCP E6). 
All applicable laws and regulations, including, without limitation, data privacy laws and 
regulations. 
 
SIGNATURES 
 
Kai Kroll, Caerus CEO or Designee 
          Date 
 
 
 
 
 
David Rothkopf, MEDIcept Regulatory 
Affairs 
           Date 
 
 
 
 
 
Steven Walfish, MEDIcept Biostatistician 
            Date 
 
 
 
 
Adelina Paunescu, MEDIcept Clinical 
Operations 
            Date 

 
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INVESTIGATOR AGREEMENT 
 
I will provide copies of the clinical trial protocol and all pertinent information to all individuals 
responsible to me who assist in the conduct of the study.  I will discuss this material with them to 
ensure they are fully informed regarding the investigational products and the conduct of the 
study.  
 
I will obtain written informed consent from all participating subjects/patients in accordance with 
requirements as specified in ICH Guideline for Good Clinical Practice; Section 4.8 and I will 
fulfill all responsibilities for submitting pertinent information to the Institutional Review Board 
(IRB).  I will use only the informed consent form approved by the Sponsor and the IRB or its 
representative. 
 
I understand that this study will not be initiated without approval of the appropriate Institutional 
Review Committee and that all administrative requirements of the governing body of the 
institution will be complied with fully. 
 
I also agree to report all information or data in accordance with the protocol and I agree to report 
without unjustified delay, all Adverse Events (AEs) and Serious Adverse Events (SAEs) that 
could have led to any Unanticipated Adverse Device Events (UADEs).  
 
I further agree that Caerus Corporation and/or designee will have access to any original source 
documents from which electronic or paper case report form (CRF) information may have been 
generated.  
 
I also agree to have control over all clinical supplies (including investigational products) 
provided by Caerus Corp. and/or designee and collect and handle all clinical specimens in 
accordance with the protocol. I further agree not to originate or use the name of Caerus Corp., 
OrthoCor Medical and/or OrthoCor Active System, or any of its employees, in any publicity, 
news release or other public announcement, written or oral, whether to the public, press or 
otherwise, relating to this protocol, to any amendment hereto, or to the performance hereunder, 
without the prior written consent of Caerus Corporation. 
 
 
 

 
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I herewith declare that I agree with the protocol described in detail in this document and agree to 
conduct the study in accordance with the protocol and in compliance with Good Clinical Practice 
and all applicable regulatory requirements. 
 
 
Investigator Name (print) 
 
 
Investigator Signature 
 
 
Date 
 
 
Name of Facility 
 
 
Location of Facility (City) 
 
 
 
 

 
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TABLE OF CONTENTS 
1.0 
ADMINISTRATIVE INFORMATION 
2 
1.1 Contacts 
2 
1.2 Protocol Administrative Information 
2 
1.3 Amendment History: 
2 
1.4 Sponsor Protocol Approval 
3 
2.0 
PROTOCOL SYNOPSIS 
8 
3.0 
LIST OF ABBREVIATIONS 
11 
4.0 
INTRODUCTION 
12 
4.1. Background and Significance 
12 
4.2. Previous Experience 
12 
4.3. Name and Intended Use 
13 
4.4. Indication for Use 
14 
5.0 
STUDY RATIONALE 
14 
6.0 
DEVICE DESCRIPTION 
14 
7.0 
STUDY OBJECTIVES and ENDPOINTS 
16 
8.0 
STUDY DESIGN 
16 
8.1 
Study Details 
16 
8.2 
Number of Clinical Sites 
16 
8.3 
Subject Population 
16 
8.4 
Inclusion Criteria 
17 
8.5 
Exclusion Criteria 
17 
9.0 
SUBJECT PARTICIPATION AND STUDY DURATION 
17 
9.1 
Site selection Criteria 
18 
9.2 
Screening Process 
18 
9.3 
Baseline/Enrollment and Study Evaluations 
18 
9.4 
Study Exit 
19 
9.5 
Study Schedule of Assessments 
19 
10.0 
ADVERSE EVENTS 
20 
10.1 
Adverse Event Definitions 
21 
10.2 
Adverse Event Reporting 
21 
10.3 
OrthoCor Active System Malfunctions 
22 
11.0 
STATISTICAL ANALYSIS 
22 
11.1 
Primary Endpoints 
22 
11.2 
Safety Variables 
22 

 
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11.3 
Handling Missing Data 
22 
11.4 
Interim Analysis 
22 
11.5 
Demographics 
22 
11.6 
Safety 
23 
12.0 
RISK – BENEFIT ASSESSMENT 
23 
12.1 
Potential Risks 
23 
12.2 
Potential Benefit 
23 
12.3 
Minimization of Anticipated Risks 
23 
13.0 
QUALITY ASSURANCE 
23 
14.0 
ETHICAL CONSIDERATIONS 
24 
14.1 
Institutional Review Board (IRB) 
24 
14.2 
Informed Consent Process 
24 
14.3 
Protection of Patient Confidentiality 
25 
15.0 
STUDY MANAGEMENT 
26 
15.1 
Required documents from Investigator (prior to study start) 
26 
15.2 
Investigational Device Management 
26 
15.3 
Study Training 
27 
15.4 
Data Collection 
27 
15.5 
Monitoring of the Study 
27 
15.6 
Investigator Site Termination 
28 
15.7 
Site Close-out 
28 
16.0 
STUDY SUSPENSION OR EARLY TERMINATION 
28 
17.0 
RESPONSIBILITIES 
29 
17.1 
Sponsor Responsibilities 
29 
17.2 
Sponsor Maintenance of Study Records 
30 
17.3 
Investigator Responsibilities 
30 
17.4 
Investigator Maintenance of Study Records 
30 
18.0 
DATA MANAGEMENT 
31 
18.1 
Data Entry 
31 
18.2 
Data Cleaning and Monitoring 
31 
18.3 
Final Clinical Study Report 
32 
18.4 
Publication Policy 
32 
19.0 
REFERENCES 
33 
20.0 
APPENDICES 
34 
 

 
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2.0 
PROTOCOL SYNOPSIS 
Sponsor 
Caerus Corporation 
Protocol Title: 
Prospective, Multi-Center, Randomized Study to Evaluate the 
OrthoCor Active System for Pain Relief  
Protocol Number 
OCM-OAS-01 
Investigational 
Device: 
OrthoCor Active System 
Device Description: 
The OrthoCor Active System is a portable (battery operated) 
non-invasive device that delivers Pulsed Electromagnetic Field 
(PEMF) therapy for General Use of temporary pain relief, 
utilizing wraps that position the therapy, such as on the ankle, 
back, knee, wrist, elbow, shoulder, foot, or neck. The microchip 
delivers the pulsed RF signal to the tissue target via the inductive 
coupling with an applicator coil. The system also uses 
disposable, single-use, air activated OrthoPods that provide heat. 
Study Objective: 
The objective of this study is to evaluate the OrthoCor Active 
System in individuals prescribed its use in comparison with 
Standard of Care (SOC) intervention. Pain assessments will be 
conducted utilizing the Mankoski Pain Scale. 
Study Design: 
Prospective, Multi-Center, Randomized, Open Label Study.  
Subject Population: 
Both males and females, presenting to the designated study sites 
with pain in superficial soft tissue, such as in the ankle, back, knee, 
wrist, elbow, shoulder, foot, or neck who are prescribed the use of 
the OrthoCor Active System or Standard of Care (SOC) 
intervention. 
Rationale: 
According to the Centers for Disease Control and Prevention, 50 
million adults in the United States have chronic daily pain, with 19.6 
million adults experiencing high impact chronic pain that interferes 
with daily life or work activities. 
Clinical best practices may recommend a collaborative, multimodal, 
multidisciplinary, patient-centered approach to treatment 
for various acute and chronic pain conditions to achieve optimal 
patient outcomes. For improved functionality, activities of 
daily living, and quality of life, clinicians are encouraged to 
consider and prioritize, when clinically indicated, nonpharmacologic 
approaches to pain management. 
An alternative treatment option can be the use of restorative 
therapies. Restorative therapies play a significant role in acute and 
chronic pain management, and positive clinical outcomes are more 
likely if restorative therapy is part of a multidisciplinary treatment 
plan following a comprehensive assessment. Patient outcomes 
related to restorative and physical therapies tend to emphasize 

 
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improvement in outcomes, but there is value in restorative therapies 
to help maintain functionality.  
 
The Orthocor Active System delivers OrthoCor’s patented Pulsed 
Electromagnetic Field (PEMF) therapy, a noninvasive, temporary 
relief for pain. The key to OrthoCor’s therapy is the use of 
specialized PEMF technology. In particular, PEMF works at the 
source of injuries, and helps accelerate the body’s natural anti-
inflammatory and recovery responses. Inside every Active System is 
the OrthoCor, a microchip that delivers PEMF directly to the source 
of injuries. Furthermore, PEMF has been shown to stimulate 
reaction pathways that result in pain and inflammation reduction. 
 
Study Assessment/ 
Evaluation: 
Pain assessments will be conducted utilizing the Mankoski Pain 
Scale which will be compared to the pain assessments of subjects 
who were prescribed the Standard of Care (SOC) intervention. 
Study Endpoints: 
Primary Safety Endpoint:  
The safety endpoint of this study will be the adverse events reported 
with the OrthoCor Active System pain after 2 weeks of use. 
 
Primary Efficacy Endpoint:  
The efficacy endpoint of this study will be the comparison of the 
OrthoCor Active System pain assessment scores to the Standard of 
Care (SOC) intervention after 2 weeks of use. 
Exploratory 
Assessment: 
Exploratory Assessment:  
The exploratory assessment of this study will be the performance of 
the OrthoCor Active System after an additional 2 weeks of use and 
is intended for research and publication only. 
Number of Patients: 
Up to 100 subjects will be enrolled in order to achieve up to 50 
using the OrthoCor Active System and up to 50 using the Standard 
of Care (SOC) intervention. The patients will be enrolled 
consecutively at the participant site until enrollment is met.  
 
For the exploratory assessments, the 50 subjects who received SOC 
will have the opportunity to cross-over and use the OrthoCor Active 
system.  
Number of Sites: 
Five (5) sites are anticipated 
Anticipated Study 
Duration: 
3-5 months 
Study Eligibility 
Criteria 
Inclusion Criteria:  
Participants must meet ALL of the following: 
1. Individuals presenting with pain in superficial soft tissue, such 
as ankle, back, knee, wrist, elbow, shoulder, foot, or neck pain, 

 
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or minor muscular and joint aches and pains associated with 
over exertion, strains, sprains, or arthritis 
2. Prescribed use of the OrthoCor Active System or Standard of 
Care (SOC) intervention 
3. Willing and able to provide informed consent or obtain consent 
from legal authorized representative (LAR)  
Exclusion Criteria:  
Participants must not meet ANY of the following:  
1. Have a cardiac pacemaker, cardioverter defibrillator, 
neurostimulator, infusion pump or any active medical implant 
2. Have an implanted metallic lead or any type of wire coil 
implant, or any implanted system that may contain lead 
3. Current or expected use of opioids 
4. Who are or may be pregnant 
5. Have an open wound at the area of application 
6. Are not capable or fully aware to the sensation of heat 
7. Have poor circulation or heart disease 
8. Have diabetes 
9. Under the age of 18 or individuals with open bone growth plates 
10. Unable to provide consent or obtain consent from a LAR 
11. Unwilling or unable to use the OrthoCor Active System or 
Standard of Care (SOC) intervention 
12. Unwilling or unable to complete the daily pain assessment 
13. Enrolled in a study to evaluate an investigational drug 
14. Prisoner or under incarceration 
Statistical Analysis 
Primary efficacy analyses 
The primary effectiveness endpoint of this study is the change from 
baseline of the OrthoCor Active System compared to the Standard 
of Care (SOC) intervention. 
 
 
 

 
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3.0 
LIST OF ABBREVIATIONS 
Abbreviation Definitions 
AE 
Adverse Event 
CFR 
Code of Federal Regulations 
CIOMS 
Council for International Organizations, Medical Sciences 
CRF / eCRF 
Case Report Form/ Electronic Case Report Form  
CRO 
Contract Research Organization  
EDC 
Electronic Data Capture 
eDiary 
Electronic Diary 
FDA 
Food and Drug Administration  
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act 
ICF 
Informed Consent Form 
ICH 
International Council for Harmonisation 
IFU 
Instructions For Use 
IRB 
Institutional Review Board 
LAR 
Legal Authorized Representative 
PD 
Protocol Deviation  
PEMF 
Pulsed Electromagnetic Field 
PI 
Principal Investigator 
POC 
Point of Care 
RF 
Radio Frequency 
SAE 
Serious Adverse Event 
SADE 
Serious Adverse Device Effect 
SD 
Standard Deviation  
SDV 
Source Data Verification  
SID 
Subject Identification Number 
SOC 
Standard of Care 
UADE 
Unanticipated Adverse Device Effect 
WOCBP 
Women of Child Bearing Potential 
 
 
 
 
 
 
 
 

 
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4.0 
INTRODUCTION 
4.1. Background and Significance  
According to the Centers for Disease Control and Prevention, 50 million adults in the United 
States have chronic daily pain, with 19.6 million adults experiencing high impact chronic 
pain that interferes with daily life or work activities. Clinical best practices may recommend 
a collaborative, multimodal, multidisciplinary, patient-centered approach to treatment for 
various acute and chronic pain conditions to achieve optimal patient outcomes. For improved 
functionality, activities of daily living, and quality of life, clinicians are encouraged to 
consider and prioritize, when clinically indicated, nonpharmacologic approaches to pain 
management.1 
 
An alternative treatment option can be the use of restorative therapies. Restorative therapies 
play a significant role in acute and chronic pain management, and positive clinical outcomes 
are more likely if restorative therapy is part of a multidisciplinary treatment plan following a 
comprehensive assessment.1 
 
The OrthoCor Active System uses specialized Pulsed Electromagnetic Field (PEMF) 
technology to relieve pain and reduce edema through safe, clinically proven therapy. PEMF 
is a low-level, time-varying electromagnetic field that penetrates superficial soft tissue, 
helping to accelerate the body’s natural anti-inflammatory and recovery responses. Inside 
every OrthoCor Active System is proprietary electronic circuitry that delivers PEMF to the 
source of injuries. PEMF has been shown to stimulate reaction pathways that result in pain 
and inflammation reduction. OrthoCor’s patented PEMF accelerates the binding of calcium 
(Ca2+) to calmodulin (CaM), the process responsible for the body’s natural, anti-
inflammatory nitric oxide (NO) cascade 2-5.  NO is a key element in the body’s natural 
healing process.  It is also a vasodilator, increasing blood and lymphatic flow.3 Additionally, 
NO down-regulates interleukin-1 beta (IL1β) and inducible nitric oxide synthase (iNOS), 
which leads to reduced cyclooxygenase-2 (COX-2) and prostaglandins – molecules 
responsible for causing inflammation and pain 2-5.  Unlike other systemic COX-2 inhibitors 
such as nonsteroidal anti-inflammatory drugs (NSAIDs), OrthoCor’s targeted PEMF signals 
stimulate localized reaction pathways, thereby reducing pain and inflammation without the 
risks and side effects associated with NSAIDs2-5. 
 
4.2. Previous Experience  
In previous clinical studies, OrthoCor Active System was clinically proven to reduce pain, 
swelling and provide lasting relief without the use of pain medications or invasive 
procedures. 
 
OrthoCor Medical Inc. conducted a prospective, double blind, placebo controlled, 
randomized pilot study (2014-2016), enrolling 80 patients with Kellgren-Lawrence knee 
arthritis who used the OrthoCor knee system, which showed a significant 60% reduction in 
the mean pain score within the first 3 days of use compared with the sham group 2. 
 

 
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A preliminary study6 conducted by OrthoCor Medical Inc. in 33 patients suffering from knee 
osteoarthritis utilizing the OrthCor knee system, showed reduced pain and stiffness after 15 
days of treatment with a 43% reduction in pain score (Figure 3) and a 79% improvement in 
activity limitations, symptoms, emotions, and overall quality of life (Figure 2).  
  
 
 
 
4.3. Name and Intended Use 
The OrthoCor Active System is a portable (battery operated) non-invasive shortwave 
diathermy medical device which applies electromagnetic energy at a radio frequency (RF) of 
27.12 MHz for the treatment of pain in superficial soft tissue, such as in the ankle, back, 
knee, wrist, elbow, shoulder, foot, or neck. The OrthoCor Active System delivers the pulsed 
RF signal of 6.5+0.5 Ws/cm3 to the tissue target via the inductive coupling with an applicator 
coil. The system also uses disposable, single-use, air activated OrthoPods that provide heat 
for the temporary relief of minor muscular & joint aches & pains associated with over-
exertion, strains, sprains, and arthritis. 
 

 
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4.4. Indication for Use 
The OrthoCor Active System is indicated for adjunctive use in the treatment of pain, and 
temporary relief of minor muscular and joint aches and pains associated with over-exertion, 
strains, sprains, and arthritis. 
 
5.0 
STUDY RATIONALE 
The objective of this study is to evaluate the OrthoCor Active System in individuals presenting 
with post-operative pain and edema in superficial soft tissue. The OrthoCor Active System will 
be compared to the SOC intervention. 
 
6.0 
DEVICE DESCRIPTION 
The OrthoCor Active System includes the following components: 
 
Multi-Use 
● The Active System can be used in multiple body locations, some examples are shown 
below   
 
 
 
Figure 1. OrthoCor Active System Multi-Use (Not to scale). 
 
 
The OrthoCor Active system has PEMF and heat as the active components as provided by the 2 
OrthoPods inserted in the body specific wraps for the purpose of holding them in place.  
 
The OrthoPods are the same for all body location configurations and only the wrap is modified 
for the purpose of holding them in the treated area. 

 
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Figure 2. Image shows the Use of OrthoCor Active Ankle System (Not to scale). 
Figure 3. Image shows the Use of OrthoCor Active Back System (Not to scale). 
Figure 4. Image shows the Use of OrthoCor Active Knee System (Not to scale). 
Figure 5. Image shows the Use of OrthoCor Active Wrist System (Not to scale). 
Figure 6. Image shows the Use of OrthoCor Active Elbow System (Not to scale). 
Figure 7. Image shows the Use of OrthoCor Active Shoulder System (Not to scale). 
Figure 8. Image shows the Use of OrthoCor Active Neck System (Not to scale). 
 
Single-Use 
● OrthoPods 
 
 
 
 

 
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Instructions for Use manual is provided to the patient with the product (see Appendix A).  
7.0 
STUDY OBJECTIVES and ENDPOINTS 
The primary objectives are to compare the pain assessment scores of the SOC intervention to 
the OrthoCor Active System pain assessment scores.  
The primary effectiveness endpoint of this study is the change from baseline of the OrthoCor 
Active System compared to the SOC intervention. 
8.0 
STUDY DESIGN  
8.1 
Study Details 
This is a prospective, multi-center, randomized, open label study that will enroll up to 100 
subjects.   
8.2 
Number of Clinical Sites  
The trial will be conducted in up to five (5) participating sites in the USA.  
8.3 
Subject Population       
The target population for this measurement consists of both males and females, presenting to 
the designated study sites with pain in superficial soft tissue, such as in the ankle, back, knee, 
wrist, elbow, shoulder, foot, or neck who are prescribed the use of the OrthoCor Active System 
or Standard of Care (SOC) intervention. 
Eligible subjects must meet the inclusion and exclusion criteria described in Sections 8.4 and 
8.5. Any questions from the investigative site regarding a potential subject’s eligibility for 
enrollment must be discussed with the Sponsor (or designee) prior to consenting and enrolling 
the subject into the study for the investigational measurement. 
It is estimated that up to 100 subjects may be enrolled into the study.  
Patients will be enrolled consecutively at each participant site until up to 50 using the OrthoCor 
Active System and up to 50 using the Standard of Care (SOC) intervention have enrolled. The 
CRO will stratify the arms (OrthoCor Active System vs SOC) by selecting the arm 
alternatively. The patients will be enrolled consecutively at the participant site until enrollment 
is met. 
As part of exploratory research extension, patients using the OrthoCor Active system will have 
the opportunity to continue on the trial for an additional 2 weeks. Participants assigned SOC 
have the opportunity to cross-over using the OrthoCor Active system for the additional 2 
weeks. Participation in the exploratory extension is optional.  

 
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8.4 
Inclusion Criteria 
Participants must meet ALL of the following criteria: 
1. Individuals presenting with pain in superficial soft tissue, such as ankle, back, knee, 
wrist, elbow, shoulder, foot, or neck pain, or minor muscular and joint aches and 
pains associated with over exertion, strains, sprains, or arthritis 
2. Prescribed use of the OrthoCor Active System or Standard of Care (SOC) 
intervention 
3. Willing and able to provide informed consent or obtain consent from legal authorized 
representative (LAR)  
 
8.5 
Exclusion Criteria 
Participants must not meet ANY of the following criteria: 
1. Have a cardiac pacemaker, cardioverter defibrillator, neurostimulator, infusion pump 
or any active medical implant 
2. Have an implanted metallic lead or any type of wire coil implant, or any implanted 
system that may contain lead 
3. Current or expected use of opioids 
4. Who are or may be pregnant 
5. Have an open wound at the area of application 
6. Are not capable or fully aware to the sensation of heat 
7. Have poor circulation or heart disease 
8. Have diabetes 
9. Under the age of 18 or individuals with open bone growth plates 
10. Unable to provide consent or obtain consent from a LAR 
11. Unwilling or unable to use the OrthoCor Active System or Standard of Care (SOC) 
intervention 
12. Unwilling or unable to complete the daily pain assessment 
13. Enrolled in a study to evaluate an investigational drug 
14. Prisoner or under incarceration 
9.0 
SUBJECT PARTICIPATION AND STUDY DURATION  
Potential study subjects are males and females presenting to the designated study sites with 
pain in superficial soft tissue, such as in the ankle, back, knee, wrist, elbow, shoulder, foot, or 
neck who are prescribed the use of the OrthoCor Active System or Standard of Care (SOC) 
intervention. This will be a one-time on-site visit with data collection for 14 days.  
All study participants will have the opportunity to continue in the research extension with data 
collection for another 14 days. Participation in the exploratory extension is optional. 

 
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9.1 
Site selection Criteria 
The trial will be conducted at up to five (5) sites. The sites will be selected by the CRO and 
agreed upon by the Sponsor. 
● The institution/collection site must have access to the necessary equipment and 
supplies that are needed for the study and for study data collection. 
● Clinical research study experience and resources that demonstrate good compliance 
with study requirements and timely, complete documentation of subject visits.   
● Investigative team should designate a study coordinator to manage the study. 
● Ability to adhere to the standards of Good Clinical Practice (GCP) and ICH E6(R2).  
● Agree to comply with data collection requirements and data entry timelines. 
● Study site will respond to queries from CRO, Caerus Corporation (or designee) in a 
timely manner. 
● Willingness to allow personnel from CRO, Caerus Corporation (or designee) access 
to, Investigator’s study records, data, and subject files as they pertain to the study. 
9.2 
Screening Process 
Subjects will be prescreened for eligibility and if qualified will be approached with the study 
information and asked if they are willing to participate.  
Informed consent will be obtained per section 14.2. All patients who sign a consent form are 
considered study subjects. A study participant is considered enrolled after they have signed an 
informed consent form and after the inclusion/exclusion criteria have been met. 
After an IRB approved Informed Consent Form is obtained and study inclusion/exclusion 
criteria are met, the study assessment will begin immediately. 
9.3 
Baseline/Enrollment and Study Evaluations 
A study specific Subject Identification Number (SID) will be assigned in consecutive order 
after informed consent is obtained.    
The following data will be collected:  
● Patient demographics (at minimum Gender, Age and Race)  
● Surgical Date 
● Patient Pain Assessment 
● Patient self-reported pre-existing conditions (list, if confirmed), if available 
● OrthoCor Active System or SOC intervention use details 
● Device information (serial number on OrthoCor Active System and OrthoPods) 
● Concomitant Pain Medication Use 
● Pregnancy Test Results  
 

 
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For those subjects that elect to participate in the research exploratory extension, the patient 
pain assessment will be collected for another 2 weeks. The extension data will be used for 
research and publication only. 
OrthoCor Active System: Subject(s) are to apply a fully charged brace with a new set of 
OrthoPods over the affected area for a total of 2 hours at their first convenient opportunity  
each day. Subject(s) should be instructed to contact the site if they experience unusual 
sensations or discomfort during the use of the brace. 
9.4 
Study Exit 
Subjects will be considered to have completed and exit the study after 14 consecutive days of 
OrthoCor Active System or SOC intervention use and the daily OrthoCor Patient Pain eDiary 
and relevant data is completed. 
If significant improvement is noted in the subjects using the OrthoCor Active System after 32 
subjects are enrolled into each treatment group, the study will be considered completed and all 
subjects will have the option to move into the research extension portion. The remaining 
subjects on SOC will have the ability to move into the active group even if they have not 
reached or have declined to participate in the research extension.  
9.5 
Study Schedule of Assessments 
In the evening of each day the subject should rate their pain using the provided scale and record 
their rating in the eDiary.  Refer to Table 1 Schedule of Assessments.  
 
 

 
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Table 1.  Schedule of Assessments 
Assessments 
Screening/Baseline 
(Day 0) 
Day 1 - 14 
Research Extension 
(if applicable) 
Day 15 – 30 
Inclusion/Exclusion Criteria 
X 
 
 
Demographics 
X 
 
 
Surgical Date 
X 
 
 
Pain Assessment 
X 
X 
X 
Self-reported Pre-Existing 
Conditions* 
X* 
 
 
OrthoCor Active System/SOC 
Intervention Use 
 
X 
X 
Device Information 
X 
 
 
OrthoPod Information 
X 
X 
X 
Concomitant Pain Medication Use 
X 
X 
X 
Adverse Event, related to the test 
device 
 
X 
X 
Pregnancy test for WOCBP 
X 
 
 
* Information to be collected if available 
10.0 ADVERSE EVENTS 
Adverse events (AEs) may occur during the study. 
Each adverse event will be recorded in the corresponding subject’s eDiary. Each adverse event 
will be assessed by the Investigator as to its relationship and level of relatedness to the 
investigational device and/or assessment.  In addition, the Investigator will identify the date of 
onset, severity, and duration of the AE. All adverse events will be monitored until they are 
adequately resolved or explained.  If an AE continues after the evaluation, the Sponsor and 
Investigator should discuss the need and/or methods for continued surveillance of the event. 
The Investigator must submit to the Sponsor a report of any Serious Adverse Event (SAE), Serious 
Adverse Device Effect (SADE) or Unanticipated Adverse Device Effect (UADE) within 24 hours 
of knowledge of the event. 
Sponsor Contact:   
Udaya Joshi 
Telephone:                  651-440-9329 
Email:                         ujoshi@CaerusCorp.com  
 
In addition, the Investigator will report adverse events to the reviewing IRB (as applicable) 
according to the local reporting requirements. 
 
 

 
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10.1 
Adverse Event Definitions 
Adverse Event 
An adverse event is any undesirable clinical occurrence in a subject whether it is considered 
to be device-related or not. 
Serious Adverse Event 
An adverse event is considered "serious" if, in the view of either the Investigator or Sponsor, 
it results in any of the following outcomes:  
● 
Death 
● 
Life-threatening 
● 
Hospitalization (initial or prolonged) 
● 
Disability or permanent change 
● 
Congenital Anomaly/Birth Defect 
● 
Required Intervention to Prevent Permanent Impairment or Damage 
● 
Other Serious (Important Medical Events) 
Anticipated Adverse Events include those that are reasonably expected to occur in 
association with the use of OrthoCor Active System (see Appendix B).  
Unanticipated Adverse Device Effects (UADE) 
Any serious adverse effect on health or safety, 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 application (including 
a supplementary plan or application), or any other unanticipated serious problem associated 
with a device that relates to the rights, safety, or welfare of subjects (21CFR812.3).   
10.2 
Adverse Event Reporting 
Adverse events occurring after the baseline assessment but after the study product use will be 
documented on the appropriate AE report form.  All adverse events will be recorded from 
day 1 until a subject’s participation in the trial is considered complete, i.e., at screen failure, 
completion of study participation (if applicable), subject’s demise, or when a subject is 
discontinued / withdrawn.   
It is the responsibility of the Investigators to inform their IRB of adverse events as required 
by their local IRB procedures.  
Anticipated observations related to the study procedure will be tabulated but will not be 
categorized as adverse events unless they require mitigation by the treating physician or are 
greater in severity, duration or degree of incidence than anticipated.    
Investigators must notify Caerus Corporation (or designee) within 72 hours of discovering 
any Unanticipated Adverse Device Events (UADE).  Investigators are required to submit a 
report of a UADE to the reviewing IRB as soon as possible, but in no event later than 10 

 
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working days after the Investigator first learns of the event.  UADEs must be documented as 
appropriate in the eDiary. 
The Sponsor’s evaluation of the UADE must be reported to the FDA, all reviewing IRBs, 
and participating Investigators within 10 working days of knowledge of the event by the 
Sponsor.  All UADE will be reported to the FDA according to regulatory reporting 
requirements found in CFR 812.46. 
10.3 
OrthoCor Active System Malfunctions 
Any suspected OrthoCor Active System malfunction will be recorded in the eDiary.  A list of 
all adverse events expected in this patient population, adverse events associated with the 
standard of care and treatment of these patients, as well as with the OrthoCor Active System 
can be found in Appendix B.  
11.0 STATISTICAL ANALYSIS 
The primary effectiveness endpoint of this study is the change from baseline of the OrthoCor 
Active System compared to the SOC intervention results after 14 days.   
 
11.1 
Primary Endpoints 
The primary objective is to compare the pain assessment scores of the SOC intervention to 
the OrthoCor Active System pain assessment scores after 14 days.  
 
11.2 
Safety Variables 
This is a non-significant risk study.  Because no additional procedures are required to 
perform the investigational test, safety will be monitored via the reported Adverse Events in 
this study. The descriptive table of Adverse Events will be the extent of safety reporting. 
11.3 
Handling Missing Data 
Only subjects with non-missing data for the OrthoCor Active System or the SOC will be 
used in the statistical analysis, i.e., a complete case analysis.   
11.4 
Interim Analysis 
No interim analyses are planned for this study. 
11.5 
Demographics 
Subject demographics will be summarized using descriptive statistics (mean, median, SD, 
minimum, maximum), number of subjects for continuous variables (e.g., age), and frequency 
distributions (number and percentage of subjects) for categorical variables (e.g., gender, race).     
 
 

 
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11.6 
Safety 
All adverse events for subjects in the safety population will be reported.   
● Serious Adverse Events 
● Non-serious Adverse Events Device Related Adverse Event  
● Device Related Serious Adverse Events 
Results will include the number of subjects experiencing each type of event as well as the 
number of events. 
12.0 RISK – BENEFIT ASSESSMENT 
12.1 
Potential Risks 
There are no known risks associated with the use of the OrthoCor Active System other than 
the normal minor risks/discomforts associated with the OrthoPods, which could result in 
localized burns and/or skin sensitivity and irritation.   
Potential risks associated with the OrthoCor Active System do not differ from those of the 
commonly used non-invasive in-vitro devices that provide RF and heat treatment to localized 
area(s).  
The following are adverse events or side effects that may occur as a result of the OrthoCor 
Active System assessment:  
a) Loss of confidentiality due to study participation. 
Subjects will be monitored closely as part of this study for the detection of symptoms to 
allow for early treatment or intervention, if necessary. 
12.2 
Potential Benefit 
There is no direct benefit to the patient for enrolling in this study. However, the study will 
provide an opportunity to gain a better understanding of the ability of the OrthoCor Active 
System to effectively be used in the palliative treatment of pain in superficial soft tissue.  
12.3 
Minimization of Anticipated Risks 
Risks associated with the OrthoCor Active System are minimized by design.  The Sponsor will 
monitor the study for any trends that would indicate a safety issue.   
13.0 QUALITY ASSURANCE 
This study will be conducted in accordance with elements of E6 Good Clinical Practice Integrated 
Addendum to ICH E6 (R1) (ICH E6(R2), 9 November 2016), abbreviated requirements of 21 CFR 
812.2(b) for Non-significant Risk (NSR) device studies, the Declaration of Helsinki, the Belmont 
Report, and IRB requirements. 

 
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All documents and data shall be produced and maintained in such a way to assure control of 
documents and data to protect the patient’s privacy as far as reasonably practicable.  The Sponsor 
(or designee) and representatives of the FDA or other regulatory authorities are permitted to inspect 
the study documents (e.g., study protocol, CRF, and original study-relevant medical records/files) 
as needed.  All attempts will be made to preserve patient confidentiality.  
All clinical sites are subject to audit by Sponsor (or designee) for protocol adherence, accuracy of 
data, and compliance with applicable regulations.  Any evident pattern of non-compliance with 
respect to these standards will be cause for corrective action. 
The study protocol, data-recording procedures, data handling as well as study reports are subject 
to an independent clinical Quality Assurance audit by the Sponsor, its designee, or health 
authorities. 
14.0 ETHICAL CONSIDERATIONS 
The rights, safety, and wellbeing of clinical investigation subjects shall be protected consistent 
with the ethical principles outlined in the Declaration of Helsinki.  This shall be understood, 
observed, and applied at every step in this clinical investigation.  
It is expected that all parties will share in the responsibility for ethical conduct in accordance with 
their respective roles in the investigation.  The Sponsor and the Investigator shall avoid improper 
influence or inducement of the patient, Monitor, Investigator, or other parties participating in or 
contributing to the clinical investigation.   
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; 21 CFR, part 50, the Declaration of Helsinki, CIOMS, and the International 
Ethical Guidelines for Biomedical Research Involving Human Subjects (2002). 
14.1 
Institutional Review Board (IRB)  
The participating institution must provide for the review and approval of this protocol, the 
associated informed consent documents, any patient facing materials, and recruitment material, 
if applicable, by an appropriate Institutional Review Board (IRB). Any amendments to the 
protocol or consent materials must also be approved before they are placed into use. 
14.2 
Informed Consent Process  
Informed consent will be obtained as outlined in 21 CFR Part 50 and the Good Clinical 
Practice: Integrated Addendum to ICH E6 (R1) (ICH E6(R2), 9 November 2016).  

 
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Informed consent is a process that is initiated prior to an individual agreeing to participate in 
the study and continues throughout the individual’s study participation. Extensive discussion 
of risks and possible benefits of the OrthoCor Active System will be provided to the subjects. 
Consent forms describing in detail the study interventions/products, study procedures, and 
risks are given to the subject and written documentation of informed consent is required prior 
to collecting study data and/or specimens. Consent forms will be IRB-approved, and the 
subject or subject’s family member/legally authorized representative will be asked to read 
and review the document.  
Upon reviewing the document, the Investigator will explain the research study to the subject 
and answer any questions that may arise. The subjects should have the opportunity to discuss 
the study with their surrogates or think about it prior to agreeing to participate.  
Subjects may withdraw consent at any time throughout the course of the trial. A copy of the 
informed consent document will be given to the subjects for their records. The rights and 
welfare of the subjects will be protected by emphasizing to them that the quality of their 
medical care will not be adversely affected if they decline to participate in this study.  
14.3 
Protection of Patient Confidentiality  
At all times throughout the clinical investigation, confidentiality will be observed by all parties 
involved.  All data shall be secured against unauthorized access.  Privacy and confidentiality 
of information about each patient shall be preserved in the reports and in any publication.  Each 
patient participating in this study will be assigned a unique identifier.  All CRFs will be tracked, 
evaluated, and stored using only this unique identifier.   
The investigational site will maintain a confidential study patient list (paper or electronic) 
identifying all enrolled patients.  This list will contain the assigned study patient’s unique 
identifier and name.  The Site Principal Investigator (PI) bears responsibility for keeping this 
list confidential.  This list will not be provided to the Sponsor and is only to be used at the 
study center. 
Monitors and auditors will have access to the study patient list and other personally identifying 
information of study patients to ensure that data reported in the eDiary corresponds to the 
person who signed the ICF and the information contained in the original source documents.  
Such personally identifying information may include, but is not limited to, the patient’s name, 
address, date of birth, gender, race, and medical record number.   
Any source documents copied for monitoring purposes by the Sponsor will have patient 
identifiable information redacted and be identified by using the assigned patient’s unique 
identifier in an effort to protect patient confidentiality.   

 
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15.0 STUDY MANAGEMENT 
This study will be conducted in accordance with elements of E6 Good Clinical Practice Integrated 
Addendum to ICH E6 (R1) (ICH E6(R2), 9 November 2016), Abbreviated Requirements of 21 
CFR 812 for NSR device studies, the Declaration of Helsinki, the Belmont Report, and any 
conditions imposed by the reviewing IRB or US FDA or other regulatory agency.   
Sponsor has the overall responsibility for the conduct of the study according to all applicable 
regulatory requirements.  Sponsor will have certain direct responsibilities and will delegate other 
responsibilities to the Principal Investigator.  Sponsor and Principal Investigator will ensure that 
the study is conducted according to all applicable regulations.  All personnel to participate in the 
conduct of this clinical trial will be qualified by education and / or experience to perform their 
tasks.   
Sponsor, Investigator, or any person acting for or on behalf of the Sponsor or Investigator shall act 
in accordance with the applicable standards, guidelines, and regulations. 
15.1 
Required documents from Investigator (prior to study start) 
At a minimum, the following documents will be provided by the investigational site to the 
Sponsor: 
● 
Signed Investigator Agreement  
● 
Signed Protocol Signature Page 
● 
IRB approval   
● 
IRB approved Informed Consent Form (ICF) 
● 
Investigator’s current Curriculum Vitae 
● 
Investigator’s current Medical License 
 
15.2 
Investigational Device Management 
The OrthoCor Active System is FDA cleared for commercial use in the United States.  The 
Sponsor shall maintain adequate records of the disposition of all investigational product for 
this trial.  A copy of the Instructions for Use (IFU) will accompany each study device.  
 
The OrthoCor Active System and pods will be distributed according to the Caerus process for 
subjects enrolled to use the device. The site will complete the subject enrollment form and 
email the completed form to OCStudy@medicept.com, the CRO, who will alternatively 
allocate the OrthoCor Active System or standard of care (SOC) to the enrolled subjects.  Then, 
the Principal Investigator prescribes the enrolled participant who are allocated to the OrthoCor 
Active System group to receive the device using OrthoCor’s Prescriber Prescription Form. 
This required documentation is then submitted to the Sponsor and the participant will receive 
a call from the Sponsor to confirm their address. The participant will receive their device in 3 
to 5 days. 
 

 
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15.3 
Study Training  
The study device is intended for use by the patient.  The Investigator and study staff will receive 
Sponsor-led training on the proper use of the device to ensure the study team is familiar with 
its use prior to study enrollment and participation. The Investigator (or designee) is responsible 
for the adequate study specific training of each patient. The Sponsor will train each subject on 
the device usage.  
Each study center will undergo protocol initiation including but not limited to a review of the 
following: 
● 
Study Protocol 
● 
Study Procedures and Assessments 
● 
Process for obtaining Informed Consent and completing Informed Consent Form 
● 
Reporting requirements 
● 
Consent process 
● 
eCRF / eDiary completion and Good Documentation Practices 
● 
Study device overview and usage 
● 
Protection of patient confidentiality 
15.4 
Data Collection 
Study data will be collected using eCRFs and an Electronic Diary (eDiary).  The eDiary is 
designed to accommodate the specific features of the trial design.  Modification of the eDiary 
will only be made if deemed necessary by the Sponsor.   
15.5 
Monitoring of the Study 
Caerus Corporation or designee will monitor the study to ensure that it is conducted in 
accordance with the protocol and the following guidelines and standards: ISO 14155, the Code 
of Federal Regulations 21 CFR Part 812 and country specific regulations.   
During monitoring visits, the following documents must be made available for review: all 
CRFs, all source documents such as medical records and clinic charts and any other study 
related documents.  In addition, the OrthoCor Active device and associated supplies 
accountability will be verified.   
Caerus Corporation or designee intends to monitor the investigational site at an interval 
consistent with the screening rate. If a severe protocol deviation (PD) is noted, Caerus 
Corporation will recommend corrective action.  If there is no response by the Investigator, 
Caerus Corporation will cease product shipment, discontinue the investigation, and notify the 
IRB and FDA. 

 
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15.6 
Investigator Site Termination 
Caerus Corporation reserves the right to terminate the investigational site from the study for 
any of the following reasons: 
● 
Repeated failure to complete eCRF 
● 
Failure to obtain Informed Consent 
● 
Failure to report Serious Adverse Events 
● 
Loss of or unaccountable investigational device inventory 
● 
Repeated protocol violations 
● 
Failure of Investigator to comply with training or Instructions for Use 
● 
Failure to screen at least 10 patients and within any 2-week period  
● 
Persistent non-compliance with the protocol 
● 
Persistent non-compliance with IRB or regulatory requirements 
15.7 
Site Close-out 
At the time of the site close-out visit, the Monitor will collect all outstanding study documents, 
ensure that the Investigator’s files are accurate and complete, review record retention 
requirements with the Investigator, make a final accounting of all study supplies, and ensure 
that all applicable requirements are met for the study.  The observations and actions made at 
this visit will be documented in a final closeout report.   
 
16.0 STUDY SUSPENSION OR EARLY TERMINATION 
The study can be discontinued at the discretion of Sponsor for reasons including, but not 
limited to, the following: 
● Unexpectedly high occurrence of adverse events unknown to date in respect to their 
nature, severity, or duration, or the unexpected incidence of known adverse events 
● Obtaining new scientific knowledge that shows that the study is no longer valid or 
necessary 
● Insufficient recruitment of patients 
● Unanticipated adverse device effect (UADE) presenting an unreasonable risk to 
patients (Sponsor may terminate the study immediately) 
If the study is discontinued or suspended prematurely, the Sponsor shall promptly inform all 
Investigator(s) / Investigational center(s) of the termination or suspension and the reason(s) for 
this.  The IRB shall also be informed promptly and provided with the reason(s) for the 
termination or suspension by the Sponsor or by the Site PI / investigational center(s).  
Regulatory authorities and the personal physicians of the patients may also need to be informed 
if deemed necessary.   

 
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17.0 RESPONSIBILITIES 
17.1 
Sponsor Responsibilities 
Caerus Corporation is the manufacturer of the OrthoCor Active System, the investigational 
device, and is the Sponsor of this study.  Sponsor has the overall responsibility of the study 
and will work to ensure compliance with the Investigational Plan, elements of Good Clinical 
Practice: Integrated Addendum to ICH E6 (R1) (ICH E6(R2), 9 November 2016), signed 
study agreements and 21 CFR 812.2(b).   
The Sponsor/CRO will be responsible for, but not limited to, conducting the following tasks:  
● 
Select qualified Investigators 
● 
Select qualified Monitors and other contract study personnel 
● 
Provide the Investigational Plan and any subsequent amendments 
● 
Sign the protocol  
● 
Provide appropriate information and device training to Investigators and site staff  
● 
Promptly inform the Investigators and where applicable Institutional Review 
Boards (IRBs), if the study is prematurely terminated or suspended and the reason 
for the termination or suspension 
● 
Provide protocol initiation training to include investigational device instructions for 
use, the Investigational Plan, eCRF/eDiary completion guidelines, and guidelines 
for obtaining informed consent 
● 
Coordinate ongoing communication with Monitors and study site to resolve any 
problems concerning the protocol or data collection.  Every effort will be made to 
ensure compliance with the protocol 
● 
Retain ownership of all clinical data generated in this study and control the use of 
the data for purposes of regulatory submissions to the FDA. 
● 
Protect patient confidentiality  
● 
Collect, store, and keep secure, at a minimum, the following documents: 
− 
A current Curriculum Vitae and if applicable, medical license of each 
Investigator 
− 
The name of the institutions where the study will be conducted 
− 
The IRB approval, in writing, and relevant correspondence 
− 
Correspondence with FDA (as required) 
− 
Investigator Agreement  
− 
Protocol Signature Page 
− 
Appropriate insurance certificates (as necessary) e.g., CLIA/CAP  
− 
IRB Approved ICF 
− 
Names / contact information for Monitor(s) 
− 
Copies of signed and dated eCRFs 

 
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− 
Records of any adverse events and adverse device effects 
− 
Statistical analyses and underlying supporting data 
− 
Final report 
17.2 
Sponsor Maintenance of Study Records 
The Sponsor will be responsible for maintaining study records per 21 CFR 812.140(b) and 
ICH E6 (R1) and ICH E6(R2). 
The Sponsor will be responsible for monitoring the investigation per 21 CFR 812.46 and 
ICH E6 (R1) and ICH E6(R2). 
The Sponsor will be responsible for reporting per 21 CFR 812.50(b). 
17.3 
Investigator Responsibilities 
The Site PI will be responsible for the following tasks:   
• 
Conduct or supervise the trial as written in the clinical protocol. 
• 
Ensure that all associates and study team members are informed about their duties and 
obligations. 
• 
Understand the investigational device, including potential risks and side effects. 
• 
Ensure that the investigational device is properly handled, dispensed, and administered. 
• 
Monitor and report all adverse events, protocol violations, and unanticipated problems 
that occur during the study. 
• 
Maintain accurate study records, submit data to Sponsor, if applicable, and make the 
data available for monitoring and inspection. 
• 
Ensure that the rights, safety, and welfare of human subjects in your study. Obtain 
informed consent from each subject. 
• 
Complete Data Forms for each subject. 
• 
Maintain the study IRB approval, and inform Sponsor of withdrawal of IRB approval 
• 
Submit progress reports and final reports to IRB and/or Sponsor 
• 
Notify the Sponsor and/or IRB of any study protocol deviations (PDs) or Serious 
Adverse Event (SAE), Serious Adverse Device Effect (SADE) or Unanticipated 
Adverse Device Effect (UADE) within 24 hours of knowledge of the event. 
17.4 
Investigator Maintenance of Study Records  
The Investigator will be responsible for maintaining study records per 21 CFR 812.140(a) 
and ICH E6 (R1) and ICH E6(R2). 
The Site PI will allow auditing of their clinical investigation procedure(s). 

 
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Each Investigator will provide a completed Financial Disclosure statement confirming that 
they have no personal financial interest connected to the study or Sponsor, prior to study 
initiation and upon request at later time points in the study if needed. 
The Investigator is responsible for maintaining study records for every subject participating in 
the study.  The study center will also maintain original source documents from which study-
related data are derived. 
The Investigator must ensure that all study subject records are stored for at least 2 years after 
the latter of the following two dates: the date on which the investigation is terminated or 
completed, or the date that the records are no longer required for purposes of supporting a 
premarket approval application or a notice of completion of a product development 
protocol.  To avoid error, the study site should contact Sponsor prior to the destruction of study 
records to ensure that they no longer need to be retained.  In addition, Sponsor should be 
contacted if the Investigator plans to leave the investigational site so that arrangements can be 
made for the handling or transfer of study records. 
In the event of an FDA audit, the Investigator must allow FDA access to the study records for 
inspection and copying.  The Investigator must inform Caerus Corporation of any FDA audit 
and provide Caerus Corporation with a copy of Form FDA 483 (List of Observations) if issued. 
18.0 DATA MANAGEMENT 
Data will be handled as applicable, per ICH E6 (R1) and ICH E6(R2).   
18.1 
Data Entry  
Qualified personnel assigned by the Principal Investigator and/or the Sponsor will perform 
data entry.   
All data will be collected on source documents and source document verification (SDV) will 
be conducted to ensure data collected are reliable and allow reconstruction and evaluation of 
the study. An eDiary will be completed for every subject who signs a written Informed Consent 
Form and is enrolled in the study. Data for this study will be entered and accepted from the 
site into a 21 CFR Part 11 Compliant Electronic Diary (eDiary) system. The study coordinator 
shall complete the eCRF by adding or updating subject information during screening.  
18.2 
Data Cleaning and Monitoring  
Once data has been entered, the Monitor shall view the eCRF and verify the data with the 
source documents. In the SDV process, information reported by the Investigator is compared 
with the original records to ensure that it is complete, accurate, and valid. Throughout the 
course of the study Data Management shall also review the data. This review will ensure that 
missing out-of-range or incomplete data is queried and resolved. 

 
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A database lock will occur once all data has been entered, SDV is completed, all queries 
resolved, quality assurance procedures completed and the data has been deemed clean. 
All study related data should be entered in the EDC within 5 business days of the subject’s 
study enrollment. 
The Monitor shall generate queries for data errors and discrepancies discovered in their review 
of source documents. When queries are necessary, the Monitor will select the appropriate field 
and generate an electronic query. Upon notification, the Site Coordinator will respond with a 
reason for the discrepancy and document that data is correct as documented or will provide a 
corrected resolution to the data field. The Monitor shall review the resolution and close the 
query, if appropriate. If additional information is required, the Monitor will continue the 
process until all data requirements are satisfied. 
Queries will also be generated by data management, for mistakes and discrepancies 
encountered during data review and through logic checks. When queries are necessary, the 
data manager will select the appropriate field and generate the electronic query. Upon 
notification, the site coordinator will respond with a reason for discrepancy and document that 
data is correct as documented or will provide a corrected resolution to the data field. The data 
manager shall review the query resolution and close the query when appropriate. If further 
information is required for resolution to the query the data manager will initiate the process 
until all data requirements are satisfactory. 
18.3 
Final Clinical Study Report  
A final report will be completed, even if the study is prematurely terminated.  
18.4 
Publication Policy 
Information concerning the study device, patent applications, processes, unpublished scientific 
data, the Protocol, and other pertinent information is confidential and remains the property of 
the Sponsor.  
At the conclusion of the trial, the results may be prepared and used in support of an FDA 
submission and provided at a major meeting(s). The publication of results from any center 
experience within the trial is not allowed unless there is written consent from the Sponsor.  
A publication strategy plan will be developed as a collaboration between the Principal 
Investigators and the Sponsor, Caerus Corporation. 
 
 

 
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19.0 REFERENCES 
1.  U.S. Department of Health and Human Services (2019, May). Pain Management Best 
Practices Inter-Agency Task Force Report: Updates, Gaps, Inconsistencies, and 
Recommendations. Retrieved from U. S. Department of Health and Human Services 
website: https://www.hhs.gov/ash/advisory-committees/pain/reports/index.html 
(https://www.hhs.gov/sites/default/files/pmtf-final-report-2019-05-23.pdf ) 
2. Fred R. Nelson, Raimond Zvirbulis, Arthur A. Pilla (Rheumatol Int 2013). Non-invasive 
electromagnetic field therapy produces rapid and substantial pain reduction in early knee 
osteoarthritis: a randomized double-blind pilot study, 33(8), 2169–2173. 
doi:10.1007/s00296-012-2366-8 
3. Berish Strauch; Charles Herman; Richard Dabb; Louis J. Ignarro; Arthur A. Pilla (Aesthet 
Surg 2009). Evidence-Based Use of Pulsed Electromagnetic Field Therapy in Clinical 
Plastic Surgery, 29(2), 135–143. doi:10.1016/j.asj.2009.02.001 
4. Mechanisms and Therapeutic Applications of Time-Varying and Static Magnetic Fields 
Arthur A.  Pilla, In:  Handbook of Biological Effects of Electromagnetic Fields, 3rd 
Edition.  Barnes F, Greenebaum  B,  eds,  CRC  Press,  2006,  in  press 
5. State of The Art in Electromagnetic Therapeutics: Soft Tissue Applications.  Arthur A 
Pilla.  Bioelectrochemistry Laboratory, Department of Orthopedics, Mount Sinai School 
of Medicine, New York, NY 10029 USA. In: Electricity and Magnetism in Biology and 
Medicine, F Bersani, ed. Plenum, NY, 1999, pp. 871-874. 
6. Kin-Joe Sham and Kristopher Siverhus. Effects of PEMF and heat therapy in treating 
osteoarthritis knee pain: a preliminary clinical study. OrthoCor Medical Clinical Study 
Summary. 
 
 
 

 
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20.0 APPENDICES 
 
APPENDIX A. OrthoCor Active System - INSTRUCTIONS FOR USE (IFU) 
APPENDIX B. ADVERSE EVENTS 

 
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APPENDIX A.  
OrthoCor Active System - INSTRUCTIONS FOR USE (IFU) 
 
 

 
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APPENDIX B.  
Adverse Events 
 
The following adverse events are unexpected but may occur with use of OrthoCor Active 
System: 
● Patient injury during use such as skin irritation or burns.