Pilot Study to Examine the Feasibility of the DISCSS™
Phase: NA
Conditions: Back Pain
Sponsor: Meagan Medical

 
 
Pilot Study to Examine the Feasibility of the DISCSS™ (Dynamic Interferential Spinal 
Cord Stimulation System)  
 
Protocol Number: DISCSS 01 
 
 
Sponsor:   
Meagan Medical 
 
14301 SE 1st Street 
 
Vancouver, WA 98684-3501 
 
 
 
Version 5.0:   
October 30, 2019 
 
 

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Table of Contents 
 
LIST OF ABBREVIATIONS .................................................................................................................... 5 
PROTOCOL SIGNATURE PAGE ........................................................................................................... 6 
1.0 
INTRODUCTION ........................................................................................................................... 7 
2.0 
STUDY OBJECTIVES ................................................................................................................... 8 
2.1 
Primary Objectives ..................................................................................................................... 8 
2.2 
Secondary Objective ................................................................................................................... 8 
3.0 
STUDY DESIGN ............................................................................................................................. 8 
3.1 
Description of Study Design ....................................................................................................... 8 
3.2 
Primary Endpoints ...................................................................................................................... 9 
3.3 
Secondary Endpoints .................................................................................................................. 9 
4.0 
STUDY ENROLLMENT AND WITHDRAWAL ....................................................................... 9 
4.1 
Inclusion Criteria ........................................................................................................................ 9 
4.2 
Exclusion Criteria ..................................................................................................................... 10 
4.3 
Early Discontinuation ............................................................................................................... 10 
4.4 
Missed Visits .............................................................................................................................. 11 
4.5 
Use of Data from Early Discontinuation Cases ...................................................................... 11 
4.6 
Treatment for Early Discontinuation Cases ........................................................................... 12 
5.0 
STUDY SCHEMA ........................................................................................................................ 12 
6.0 
STUDY PROCEDURES............................................................................................................... 12 
6.1 
Screening (Visit 1) ..................................................................................................................... 12 
6.2 
Implantation and Initiation of Background Commercial Trial SCS Device Phase (Visit 2)
 
13 
6.3 
Completion of Background Trial Commercial SCS Device Phase (Visit 3) ........................ 13 
6.4 
Washout Period ......................................................................................................................... 14 
6.5 
Initiation of Investigational Study Phase with DISCSS™ SCS Device (Visit 4) ................. 14 
6.6 
Completion of Experimental Study Phase with DISCSS™ SCS Device (Visit 5) ............... 15 
6.7 
Unscheduled Visits .................................................................................................................... 15 
6.8 
Study Completion ...................................................................................................................... 15 
7.0 
SCHEDULE OF EVALUATIONS .............................................................................................. 17 
8.0 
INVESTIGATIONAL PRODUCT .............................................................................................. 19 
8.1 
Description of Investigational Product ................................................................................... 19 

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8.2 
Risk Analysis ............................................................................................................................. 20 
8.3 
Methods to Minimize Risk ....................................................................................................... 20 
8.4 
Rationale for the Investigation................................................................................................. 20 
8.5 
Instructions for Use and Administration ................................................................................ 20 
8.6 
Packaging and Labeling ........................................................................................................... 21 
8.7 
Investigational Product Accountability................................................................................... 21 
8.8 
Return of Investigational DISCSS™ Device........................................................................... 22 
8.9 
Device Complications ................................................................................................................ 22 
9.0 
CONCOMITANT MEDICATIONS/THERAPIES ................................................................... 22 
10.0 
SAFETY REPORTING ................................................................................................................ 22 
10.1 
Overview and Definitions ......................................................................................................... 22 
10.2 
Safety Monitoring ..................................................................................................................... 23 
10.3 
Reporting Procedures for All Adverse Events ....................................................................... 23 
10.4 
Adverse Event Severity Assessment ........................................................................................ 24 
10.5 
Relationship to Device or Procedure ....................................................................................... 24 
10.6 
Timelines for Adverse Event Reporting .................................................................................. 24 
10.7 
Determination and Reporting of Unanticipated Adverse Device Effects ............................. 25 
10.8 
Study Termination .................................................................................................................... 26 
10.9 
Treatment of Adverse Events ................................................................................................... 26 
11.0 
Protocol Deviations ....................................................................................................................... 26 
12.0 
STATISTICAL CONSIDERATIONS ........................................................................................ 26 
13.0 
ETHICS & PROTECTION OF HUMAN SUBJECTS ............................................................. 27 
13.1 
Ethical Review ........................................................................................................................... 27 
13.2 
Regulatory Considerations ....................................................................................................... 27 
13.3 
Informed Consent ..................................................................................................................... 27 
13.4 
Participant and Data Confidentiality ...................................................................................... 28 
14.0 
CLINICAL MONITORING ........................................................................................................ 28 
15.0 
STUDY TRAINING ...................................................................................................................... 29 
16.0 
DATA HANDLING AND RECORDKEEPING ........................................................................ 30 
16.1 
Source Documents ..................................................................................................................... 30 
16.2 
Data Collection and Management Responsibilities ................................................................ 30 
16.3 
Study Records Retention .......................................................................................................... 30 
16.4 
Collection, Transfer and Archiving of Radiographic Imaging Data .................................... 31 

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16.5 
Transfer and Storage of Device Use Log................................................................................. 31 
16.6 
Publication and Data Sharing Policy ...................................................................................... 32 
17.0 
AUDITS AND INSPECTIONS .................................................................................................... 32 
18.0 
PUBLICATION PLAN................................................................................................................. 32 
19.0 
LITERATURE REFERENCES .................................................................................................. 33 
20.0 
APPENDICES ............................................................................................................................... 33 
Appendix I: Informed Consent Form ..................................................................................................... 33 
Appendix II: DISCSS™ Stimulator System User Guide ....................................................................... 33 
Appendix III: DISCSS™ Stimulator System Clinician Use Guide ...................................................... 33 
 
 
 

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LIST OF ABBREVIATIONS 
AE 
Adverse Event 
CFR 
Code of Federal Regulations 
CMP 
Clinical Monitoring Plan 
CRF 
Case Report Form 
CRO 
Contract Research Organization 
DISCSS™ 
Dynamic Interferential Spinal Cord Stimulation System 
eCRF 
Electronic Case Report Form 
EPG 
External Pulse Generator  
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act 
ICH E6 
International Conference on Harmonization Guidance for Industry, 
Good Clinical Practice:  Consolidated Guidance 
IDE 
Investigational Device Exemption 
IFC 
Interferential Current  
IFT 
Interferential stimulation therapy 
IRB 
Institutional Review Board 
ISO 
International Organization for Standardization 
NRS 
Numeric Rating Scale  
OHRP 
Office for Human Research Protections 
PI 
Principal Investigator 
SAE 
Serious Adverse Event 
SCS 
Spinal Cord Stimulation 
SOP 
Standard Operating Procedure 

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PROTOCOL SIGNATURE PAGE 
 
Pilot Study to Examine the Feasibility of the DISCSS™ (Dynamic Interferential Spinal Cord 
Stimulation System)  
 
Protocol Number: DISCSS™ 01 
Sponsor:  Meagan Medical 
Version 5.0 
October 30, 2019 
 
The above referenced trial will be carried out in accordance with Good Clinical Practice (GCP) 
as required by the following applicable regulations: 
• United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 
CFR part 46, 21 CFR part 50, 21 CFR part 56, and 21 CFR part 812 
• ICH E6 
 
I agree to ensure that all staff members involved in the conduct of this study are informed about 
their obligations in meeting the above commitments. 
 
Principal Investigator Printed Name 
 
Principal Investigator Signature 
 
Date of Principal Investigator Signature 
 
 
 
 
 

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1.0 
INTRODUCTION 
Chronic pain affects up to 20% of the population in developed nations.  This 
represents a profound impact on individuals and their families as well as a burden 
on employers and health care providers. The management for non-cancer related 
chronic pain varies.  The current standard of care is multidisciplinary and includes 
pharmacological, psychological and physical therapies, as well as surgical 
interventions.  Opioid analgesics are often prescribed, despite long-term 
contraindications.  For many patients the current multidisciplinary approach has 
not been effective or results in undesirable side effects.  Neuromodulation 
techniques may be an option for those individuals who have not benefited from 
other chronic pain interventions. 
The Meagan Medical, Inc., Dynamic Interferential Spinal Cord Stimulation 
System (DISCSS™) System is used to deliver spinal cord stimulation (SCS) via 
interferential stimulation therapy (IFT) for the purpose of providing pain relief. 
The DISCSS™ system is intended for use in an investigational device exemption 
(IDE) study to assess the efficacy of interferential spinal cord stimulation for 
treating chronic back pain. 
The mechanism of action for SCS was first proposed by Melzack and Wall in 
19651.  Dr. Norman Shealy published the ﬁrst report of electrical stimulation of 
the spinal cord in 19672.  Patients in whom SCS has been commonly applied are 
those with chronic back and leg pain and failed back surgery syndrome.  In 2010, 
Nevro entered the SCS market with high frequency stimulation at 10,000 pulses 
per second, and their studies in pain patients have demonstrated superior back 
pain relief with a less uncomfortable stimulation sensation than traditional low-
frequency SCS3,4 Meagan Medical has designed and developed a trial stimulator 
using interferential current (IFC) stimulation. IFC stimulation is a type of 
electrical stimulation that uses paired electrodes with two independent circuits 
carrying high-frequency and medium-frequency alternating currents. It is believed 
that IFC stimulation permeates the tissues more effectively and with less 
unwanted stimulation of cutaneous nerves. Meagan Medical calls their system the 
“Dynamic Interferential Spinal Cord Stimulation System” (DISCSS™).  
The DISCSS™ device utilizes two intersecting circuits of medium frequency sine waves 
that are in the range of 500-20,000 Hz.  The higher base frequencies reduce tissue 
reactance and the intersection of the two circuits produce a steerable “sweet spot” of 
stimulation that has a resultant beat frequency.  Due to these two advantages, the 
DISCSS™ is anticipated to result in more effective pain relief than other commercially 
available SCS systems.  This pilot feasibility study will explore and help determine 
optimal settings and configuration of the DISCSS™ System with patients that have 
completed a percutaneous trial with a commercially available SCS trial system.   
 
 

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2.0 
STUDY OBJECTIVES 
 
2.1 
Primary Objectives  
• Effectiveness: To assess the performance of the DISCSS™ device in 
achieving back pain reduction as compared to baseline by patient report using 
a Numeric Rating Scale (NRS) and Anatomical Pain Maps in a cohort of 
patients with chronic back pain during a three -four day trial of the  SCS 
DISCSS™ system. 
• Safety: To evaluate the safety of the DISCSS™ device by reviewing adverse 
events and serious adverse events in trial participants. 
 
2.2 
Secondary Objective 
• To describe patients’ experience and perceptions with the use of the 
DISCSS™ device for management of chronic back pain through analysis of 
their responses to a subjective evaluation questionnaire.  
 
3.0 
STUDY DESIGN 
3.1 
Description of Study Design 
This investigation will be performed as a prospective, multicenter, open-label 
feasibility study. Thirty (30) patients with back pain greater than leg pain who 
were candidates for Spinal Cord Stimulation (SCS) and have successfully 
completed a percutaneous trial with a commercially available SCS system will be 
trialed with a 3-4 day exposure to the investigational DISCSS™ device.  The trial 
will be conducted at 5-7 U.S. centers. The percutaneous trial leads from the 
commercial system will be connected to the External Pulse Generator of the 
DISCSS™ Trial System and the patients will be trialed for an additional three-
four days. 
 
The investigational product for this feasibility trial will be the DISCSS™ system, 
not the commercially available trial SCS system. Exposure to the commercially 
available trial SCS system will be considered background therapy. The purpose of 
the background therapy phase is to establish baseline pain levels and determine 
patients’ eligibility to continue to the investigational phase of the trial using the 
DISCSS™ SCS phase of the trial. Pain assessment and complications data from 
the commercial spinal stimulation system will be collected during the background 
therapy phase. The pain and complications data from the background therapy 
phase will not be analyzed in terms of the study endpoints.     
 
Commercial device selection will be left to the discretion of the Investigator.  
Some of the frequently used commercially available trial SCS systems include 
Prodigy Neurostimulation System (St. Jude Medical (ABBOTT)), Medtronic 
SCS, the Senza System (Nevro Corporation), and the Precision Plus (Boston 

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Scientific). The Sponsor will not be responsible for the cost or complications that 
occur during the use of the commercial trial system.   
 
3.2 
Primary Endpoints  
The primary effectiveness endpoints for this study will include:  
• Pain intensity ratings on a Numeric Rating Scale (NRS); and  
• Anatomical Pain Maps demonstrating location of Back Pain, Leg Pain and 
Overall Pain 
The primary safety endpoints for this study will include: 
• Incidence of adverse events arising from the DISCSSTM treatment phase 
• Incidence of serious adverse events arising from the DISCSSTM treatment 
phase 
 
3.3 
Secondary Endpoints  
The secondary endpoint for this study will include:    
• Patient descriptions of device efficacy and device stimulation sensation as 
captured on a study-specific questionnaire  
 
4.0 
STUDY ENROLLMENT AND WITHDRAWAL 
 
4.1 
Inclusion Criteria 
In order to be eligible to participate in this study, an individual must meet all of 
the following criteria:   
 
a) Age greater than 21 years and less than 80 years  
b) Has a diagnosis of chronic neuropathic pain of trunk and limbs  
c) Is eligible for a spinal cord stimulation trial of a commercially available SCS 
trial system.  Subjects will be evaluated at the end of the background 
Commercial SCS Device phase for complications and appropriateness to 
continue to the investigational phase with the DISCSS™ system.  
Complications from the background phase with the commercial SCS device 
may include, but are not limited to unusual pain or discomfort during the trial 
stimulation, local skin reactions or infection at the implant site.  
d) Has a Back Pain Score of minimum intensity 5.0 on a Numeric Rating Scale 
(NRS)  
e) Has an NRS Back Pain Score that is greater than both Leg Pain Scores  
f) Is not a candidate for revision surgery 
g) Has completed a minimum of 6 weeks of conservative therapy (physical 
therapy, anti-inflammatory medications, or similar therapies) with limited or 
no reduction in back pain 
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i) Is willing to halt and/or modify the use of all prescription and over-the-
counter analgesics per the Investigator’s direction during study participation 
j) Is capable of providing written informed consent  
k) Is able to comply with the requirements of study visits, follow-up phone visits 
and self-assessment questionnaires 
l) If existing permanent implanted leads are in place, the patient must be 
undergoing a paradigm shift in treatment (e.g. Conventional Sensory SCS to Sub-
Perception SCS) that necessitates trialing of the new commercial SCS device. 
 
 
4.2 
Exclusion Criteria 
An individual who meets any of the following exclusion criteria at screening will 
be excluded from participation: 
 
a) 
Is a poor surgical candidate by determination of the Investigator  
b) 
Is unable to operate or understand the use of the commercial or 
investigational Spinal Cord Stimulator systems 
c) 
Has an active systemic infection 
d) 
Has exposure to shortwave, microwave or ultrasound diathermy at home 
or at work 
e) 
Has occupational exposure to high levels of non-ionizing radiation such as 
radio or cell phone transmission stations, facilities using radiofrequency 
heat sealers or induction heaters, or electric power infrastructure 
controlled environments 
f) 
Has an implanted cardiac system (e.g. pacemakers) 
g) 
Is currently participating in another clinical study 
h) 
Is currently pregnant or lactating, or not using adequate birth control 
i) 
Has any untreated major psychiatric comorbidity 
j) 
Has serious drug-related behavioral issues per Investigator’s assessment 
k) 
Has a bleeding complication or coagulopathy 
l) 
Requires concurrent use of anticoagulant therapy such as heparin, 
warfarin, rivaroxaban, dabigatran, apixaban, edoxaban, enoxaparin, 
fondaparinux 
m) 
Is immunocompromised and at risk for infection 
n) 
Has insulin-dependent diabetes not controlled through diet and/or 
medication 
o) 
Has chronic pain related to malignancy 
p) 
Has used a commercially available SCS device within the last 14 days 
q) 
Is otherwise determined, based on the opinion of the Investigator to be an 
unsuitable candidate for this study 
 
4.3 
Early Discontinuation 

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The participant may withdraw participation in the trial for any reason.  Possible 
reasons for early discontinuation by the participant include: 
• Consent withdrawal 
• Inability to tolerate the background SCS trial phase with the commercially 
approved device 
• Occurrence of a clinical adverse event or development of a medical condition 
such that continued participation in the study would not be in the best interest 
of the participant 
 
The Investigator may also discontinue a patient from the study in the event of: 
• The participant meets an exclusion criterion (either newly developed or not 
previously recognized) that precludes further study participation 
• Any medical event/condition that presents a health or safety risk and prevents 
the participant from continuing in the study  
• Participant’s failure to comply with protocol requirements 
• Administrative reasons (e.g. Sponsor’s decision to stop the study) 
• Device complication 
 
At the time of early discontinuation, the SCS device will be removed.  
Percutaneous trial leads will be removed, if applicable.  All end of study 
evaluations will be completed, and study completion source documents and case 
report forms will be completed.  All adverse events will be followed by the 
Investigator until resolution. 
 
4.4 
Missed Visits  
Contact information for the participant and an alternate contact (i.e. a friend, 
relative, etc.) will be collected at Visit 1 and documented in the records. Any 
participant who misses one scheduled appointment will be contacted the same day 
by study site personnel. Telephone contact will be repeated at least daily for 3 
days.  A certified letter (or its equivalent) will be sent to the participant’s last 
known address. All attempts will be made to arrange an appointment to remove 
the device and leads as well as collect any end of study evaluations, as applicable.  
Participants who are determined to be lost to follow up after 3 phone contacts and 
a certified letter cannot be considered for re-enrollment.  
 
4.5 
Use of Data from Early Discontinuation Cases  
Study data collected previously for patients who are discontinued from the study 
by the Investigator or lost to follow-up may still be included and used for the 
study unless the patient presents written notification of withdrawal of consent to 
the Investigator. In the event that a patient withdraws consent to participate in the 
study, data previously collected for the patient may not be included or used for the 
study. 
 

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4.6 
Treatment for Early Discontinuation Cases 
Patients who withdraw voluntarily or are discontinued by the Investigator will 
remain eligible for Standard of Care treatment by the Investigator and study staff. 
5.0 
STUDY SCHEMA 
Screening 
Background Phase  
Commerical SCS Device 
Washout 
Investigation Study Phase 
DISCSSTM SCS Device 
Day 0 
Duration 3-5 days 
Duration 1-
2 days 
Duration 3-4 days 
Visit 1 
Visit 2 
Visit 3 
Visit 4 
Visit 5 
*Please note that the Screening Visit (Visit 1, Day 0) may be combined with Visit 2
(Initiation of the Background Phase with Commercial SCS Device) upon Principal
Investigator discretion and participant agreement.  Combining Visit 1 and Visit 2 is
contingent on successful verification of eligibility, completion of all screening
evaluations, including meeting informed consent requirements.
6.0 
STUDY PROCEDURES 
6.1 
Screening (Visit 1) 
Potential participants will be identified from the patient population at the 
investigative sites.  The following procedures will be conducted at Screening: 
•
Informed Consent:  Only patients who sign the IRB-approved informed
consent form will be permitted to participate in the clinical study.  Participants
who do not speak English must be provided a copy of an IRB-approved
informed consent form in their native language.  The original signed copy of
the informed consent will be retained in each participant’s study file and a
copy will be given to the patient to take home for their records.  No study-
specific procedures will be done prior to the patient providing informed
consent.
•
Physical Exam
•
Medical History
•
Conservative Therapy History
•
Medication History
•
Urine Pregnancy Test (for female participants only)
•
NRS Pain Assessments (back, bilateral lower extremities, and overall pain)
•
Anatomical Pain Maps (back, bilateral lower extremities, and overall pain)
•
Inclusion and Exclusion Criteria Evaluation

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At the completion of the screening exam, the Investigator will evaluate the patient 
for eligibility.  If eligible, the patient can be enrolled.  Please note that Visit 1 and 
Visit 2 may be combined if eligibility is verified and all screening evaluations are 
completed prior to initiating Visit 2 activities. 
 
6.2 
Initiation of Background Commercial Trial SCS Device Phase (Visit 2) 
During this visit, the following will occur: 
• NRS Pain Assessments (back, bilateral lower extremities, and overall pain) 
• Anatomical Pain Maps (back, bilateral lower extremities, and overall pain) 
• Concomitant Medication Review 
• Percutaneous lead implantation under fluoroscopic guidance, per 
Manufacturer instructions, if applicable.  Note:  If the subject has existing 
permanent implanted leads in place, the permanent leads may be used if the 
subject is undergoing a paradigm shift in treatment that necessitates trialing of 
the commercial SCS device. In this case the trial leads will not be used. 
• Radiographic Imaging of implanted percutaneous trial leads as described in 
Section 16.4.  
• Connection of the external trial leads to the commercial External Pulse 
Generator (EPG) system per Manufacturer instructions.   
• Programming and adjustment of settings for the commercially available trial 
SCS system per Manufacturer instructions.   
• Assessment of Complications, including but not limited to unusual pain or 
discomfort during the trial stimulation, local skin reactions at the implant site, 
and complications related to implantation of percutaneous trial leads  
• Review of device use instructions during patient’s home use, including all 
pertinent warnings   
 
The duration of the Background Commercial Trial SCS Device Phase is 3-5 days. 
At the end of the visit they will be scheduled for Visit 3, the planned termination 
of the Background Commercial Trial SCS Device Phase. 
 
6.3 
Completion of Background Trial Commercial SCS Device Phase (Visit 3) 
During this visit, the following will occur: 
• NRS Pain Assessments (back, bilateral lower extremities, and overall pain) 
• Anatomical Pain Maps (back, bilateral lower extremities, and overall pain) 
• Assessment of Complications, including but not limited to unusual pain or 
discomfort during the trial stimulation, local skin reactions or infection at the 
implant site  
• Concomitant Medication Review 
• Disconnection of commercial External Pulse Generator (EPG) (note: the 
percutaneous trial leads are to remain for the DISCSSTM treatment phase).  
 

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Participants who are determined by the Investigator to have successfully 
completed the background therapy with the commercially available SCS and are 
willing to participate in the investigational trial phase will return to the clinic after 
a 24-48 hour washout period to receive the investigational DISCSS™ SCS device 
and begin the Investigational Study Phase.  
 
6.4 
Washout Period 
Participants will spend 24-48 hours undergoing a “washout period” between study 
phases.  
During this period, they will be reminded not to increase the usual dosages of any 
of their prescribed medications, including pain medications. However, they may 
decrease their pain medications, if desired. All other prescribed medications (i.e., 
antihypertensives, hypoglycemics, cardiovascular medications, cardiopulmonary 
medications, membrane stabilizers, etc.) are to continue as usual.  
 
6.5 
Initiation of Investigational Study Phase with DISCSS™ SCS Device (Visit 4)  
Participants will return to the clinic at Visit 4 for initiation of a 3-4 day trial 
period with the investigational DISCSS™ device. During this visit, the following 
will occur: 
• Investigator confirmation of patient eligibility to start the Investigational 
Study Phase with the DISCSS™ SCS Device  
• NRS Pain Assessments (back, bilateral lower extremities, and overall pain) 
• Anatomical Pain Maps (back, bilateral lower extremities, and overall pain) 
• Concomitant Medication Review 
• Assessment of adverse events 
• Radiographic Imaging of implanted percutaneous trial leads.  
 
o If migration of implanted percutaneous leads has occurred, 
modification of placement by guided fluoroscopy is performed, 
followed by radiographic confirmation of location of trial implanted 
leads  
o Note:  Percutaneous lead modification of placement is conducted per 
the package instructions of the percutaneous trial leads in use. 
• Connection of the DISCSS External Pulse Generator (EPG) to the 
percutaneous trial leads following the instructions in Appendix III: DISCSS™ 
Stimulator System Clinician Use Guide  
• Investigator programming of settings for the investigational DISCSSTM SCS 
device per the instructions provided in Appendix III: DISCSS™ Stimulator 
System Clinician Use Guide 
 
The subject will be instructed to contact the Investigator in the event of any 
adverse events with the DISCSS™ SCS device and/or the percutaneous trial 
leads.  The subject will be trained on the information included in Appendix II: 

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DISCSS™ Patient User Manual and provided a copy of this document.  If device 
complications occur between Visit 4 and Visit 5, the Investigator will follow the 
instructions provided in Section 8.9. The subject will return to the clinic for an 
unscheduled visit as described in Section 6.7, and the device complications and/or 
adverse events will be addressed clinically and per the procedures outlined in the 
protocol and the DISCSS™ Stimulator System Clinician Use Guide.  If indicated, 
the Investigator will adjust the settings on the DISCSS™ Stimulator System or, if 
necessary replace the DISCSS™ Stimulator System Clinician Use Guide as 
outlined in Section 8.9.  If the complication cannot be resolved, the subject will be 
discontinued from the study as described in Section 4.6. 
 
At the end of the visit they will be scheduled for Visit 5, the completion of the 
Investigational Study Phase and reminded to return to the clinic at this time to 
complete the trial.  
 
6.6 
Completion of Experimental Study Phase with DISCSS™ SCS Device (Visit 
5) 
Participants will return to the clinic 3-4 days later for Visit 5. During this visit, the 
following will occur: 
• NRS Pain Assessments (back, bilateral lower extremities, and overall pain) 
• Anatomical Pain Maps (back, bilateral lower extremities, and overall pain) 
• Patient Subjective Evaluation Questionnaire 
• Concomitant Medication Review 
• Radiographic documentation and archiving of location of implanted 
percutaneous leads as described in Section 16.4 
• Disconnection of investigational DISCSSTM External Pulse Generator (EPG) 
SCS device as described in Appendix III: DISCSS™ Stimulator System 
Clinician Use Guide 
• Percutaneous lead removal per Manufacturer instructions, if applicable.  Note:  
If the subject has existing permanent implanted leads in place, the permanent 
leads may remain in place.    
• Assessment of adverse events 
• Return of device as described in Section 9.0 
 
6.7 
Unscheduled Visits 
Participants may be seen for unscheduled visits as needed. Any adverse events, device 
complications and concomitant medication changes that are reported at unscheduled 
visits should be documented in the study records and entered in the EDC. Adverse event 
follow up should be completed per Section 10.0 (Safety Reporting).  
6.8 
Study Completion 

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The final study visit occurs at Visit 5 of the Investigational Study Phase with DISCSS™ 
SCS Device. Participants who undergo early discontinuation from the study will have 
final data collection on the date of withdrawal.   
 
 

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7.0 
SCHEDULE OF EVALUATIONS 
 
Screening 
 
Background Phase with 
Commercial SCS Device 
 
Duration:  3-5 days 
Washout 
24-48 
hours 
Investigational Phase 
with DISCSS™ 
 
Duration:  3-4 Days 
 
 
Day 0 
Start of 
Commercial 
SCS Device 
Phase 
End of 
Commercial 
SCS Device 
Phase 
 
Start of 
DISCSS™ 
Device 
Phase 
End of 
DISCSS™ 
Device 
Phase 
 
Visit 1a 
Visit 2a 
Visit 3 
 
Visit 4 
Visit 5 
Informed Consent 
X 
 
 
 
 
 
Inclusion/Exclusion 
Criteria 
Xb 
 
 
 
 
 
Eligibility  
Re-assessment 
 
 
 
 
Xb 
 
Demographics 
X 
 
 
 
 
 
Physical Exam, 
Medical History 
and Conservative 
Therapy History 
X 
 
 
 
 
 
Urine Pregnancy 
Test (females only) 
X 
 
 
 
 
 
NRS Pain 
Assessment 
X 
X 
X 
 
X 
X 
Anatomical Pain 
Maps 
X 
X 
X 
 
X 
X 
Concomitant 
Medication Review 
X 
X 
X 
 
X 
X 
Patient Subjective 
Evaluation 
Questionnaire 
 
 
 
 
 
X 
Percutaneous Trial 
Lead 
Implantatione, 
Adjustment & 
Removal (under 
guided 
fluoroscopy) 
 
Xc, e 
 
 
Xc, e 
Xc, e 
Radiographic 
Imaging of 
Implanted 
Percutaneous Trial 
Leads 
 
Xd 
 
 
 
 
 
Xd 
Xd 

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Screening 
 
Background Phase with 
Commercial SCS Device 
 
Duration:  3-5 days 
Washout 
24-48 
hours 
Investigational Phase 
with DISCSS™ 
 
Duration:  3-4 Days 
 
 
Day 0 
Start of 
Commercial 
SCS Device 
Phase 
End of 
Commercial 
SCS Device 
Phase 
 
Start of 
DISCSS™ 
Device 
Phase 
End of 
DISCSS™ 
Device 
Phase 
 
Visit 1a 
Visit 2a 
Visit 3 
 
Visit 4 
Visit 5 
Device Use 
Initiation & 
Programming, and 
adjustment of 
External Pulse 
Generator (EPG) 
Settings 
 
X 
 
 
X 
 
EPG Removale  
 
 
X 
 
 
X 
Commercial Device 
Complications 
Evaluation 
 
X 
X 
 
X 
 
Adverse Event 
Review  
 
 
 
 
X 
X 
Study Completion 
and Device Return 
 
 
 
 
 
X 
a Visit 1 and Visit 2 may be combined if eligibility is verified and all screening evaluations are completed 
prior to initiating Visit 2 activities.   
b Eligibility criteria will be reviewed by the PI during Screening at Visit 1.  PI will re-assess eligibility to 
continue participation in the Investigational Phase with the DISCSS™ SCS device at the start of Visit 4.  
c Leads will be implanted percutaneously at Visit 2. At Visit 4 their positioning may be modified, if 
required. At Visit 5 they will be removed after the DISCSS™ EPG device is disconnected.  Removal of 
percutaneous trial leads is not done under guided fluoroscopy.   
d Radiographic imaging will be performed to document lead positions at Visit 2 once the leads have been 
implanted. At Visit 4 & 5 radiographic imaging will be performed to confirm that migration has not 
occurred. 
e If applicable.  Note:  If the subject has existing permanent implanted leads in place, the permanent leads 
will be used, and the trial leads will not be implanted or removed.   
 
 
 

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8.0 
INVESTIGATIONAL PRODUCT 
8.1 
Description of Investigational Product 
The Meagan Medical, Inc. DISCSS™ System is comprised of the following 
components: 
• Clinician programmer (Programmer) 
• Patient remote (Remote) 
• External feasibility neurostimulator (Stimulator)  
• Patch cable 
 
 
 
The stimulator applies electrical stimulation to the patient via a patch cable to 
implanted leads. The clinician programmer connects wirelessly to the stimulator 
to configure stimulation settings and provide stimulation to the patient. The 
patient remote connects wirelessly to the stimulator to activate stimulation, using 
only settings previously configured by the clinician programmer. 
 
Stimulation consists of multiple sinusoidal waveforms driven to trial implanted 
lead electrodes positioned around the spinal column. Programmed stimulation 
parameters define the amplitude, frequency, phase, and duty cycle of the 
waveforms generated by the stimulator. Stimulation parameters also define the 
mapping of the generated waveforms to the lead set contacts. 
 
A single sinusoidal waveform is referred to as a channel, which consists of both a 
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referred to as clusters. The first channel of a cluster is driven at a base frequency 
and the second channel at a beat frequency.  
 
8.2 
Risk Analysis 
Based on pre-clinical testing, Adverse Events that may be associated with the 
investigational DISCSSTM device include the following: 
• Skin infection 
• Spinal infection 
• Allergic reaction 
• Nerve damage 
• Tissue inflammation 
• Patient discomfort 
• Electric shock 
• Major tissue damage 
Risks associated with the use of the investigational device and commercial device are 
expected to be comparable.  
 
8.3 
Methods to Minimize Risk 
Adequate measures have been taken to minimize all of the above risks prior to initiation of 
a U.S. feasibility clinical study, including proper design specification and review, and 
preclinical testing.  
The study Sponsor will provide appropriate training to each Investigator prior to each site’s 
respective study initiation. Medical professionals will be trained on the selection criteria 
and protocol for the clinical study prior to their first use of the investigational device. The 
training will address topics such as the indications and contraindications for the use of the 
device, management of adverse events, and follow-up care. 
Investigators will assess the possible presence of the risks associated with each device 
during the study treatment and at each follow-up visit by physical examination and 
participant interview as applicable. 
8.4 
Rationale for the Investigation 
Although many of these risks are significant in nature, they are infrequent.  The probability 
of incidence for any given event is extremely rare.  Moreover, if use of the DISCSS™ 
system produces a successful result, it may reduce the participant’s symptoms of pain and 
dysfunction. Based on these potential benefits, and the anticipated risks, Meagan Medical 
believes this study is justified. 
8.5 
Instructions for Use and Administration 

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Instructions for use of the DISCSS™ System are provided in the DISCSS™ Clinician 
Use Manual, which will be provided to each Principal Investigator during device use 
training, and retained in the site’s regulatory files for reference during the study. 
 
8.6 
Packaging and Labeling 
In accordance with federal regulations set forth in 21 CFR 812.5, the DISCSS™ System 
and User Manual will be labeled with the following statement: 
‘CAUTION – Investigational Device.  Limited by Federal (or United States) law to 
investigational use.’ 
 
8.7 
Investigational Product Accountability 
The investigational device may only be used in the treatment of participants enrolled in 
the study. Investigators are responsible for the documented accountability for every 
investigational device. This includes maintaining the security of device inventory and 
keeping accurate records of device receipt, usage, and disposition.  Each Investigator 
must adhere to the following: 
• Each DISCSS™ trial system will be identified with a unique serial number and 
assigned to one patient on the trial. Following completion of Visit 5, each device will 
be returned to Meagan Medical. 
• The investigational device may be only administered to patients under the 
Investigator’s personal supervision and treatment, or under the supervision of an 
authorized sub-Investigator as designated in the Investigator’s Agreement and the 
Delegation of Authority Log. 
• The receipt, use, and disposition of the investigational device must be recorded in the 
Device Accountability Log.  
• Complete and accurate accountability records must be kept, which document the 
receipt and transfer or return of all investigational devices for this study, including 
number of devices, catalogue part numbers, lot numbers, and names of all site 
personnel who received, used, transferred or returned the device(s) and associated 
dates.  
 
The DISCSS™ trial system serial number will be linked to each patient’s Subject ID 
in the EDC.  The Subject Identification Number is the only Subject information 
entered into the DISCSS™ System during device calibration at Visit 4. Each 
DISCSS™ System used in this trial is designed to be used with one subject and 
returned to Meagan Medical upon study completion, unless the system is replaced for 
any reason during use as described in Section 8.9 Device Complications.  In the event 
of device replacement, the serial number of the replacement device will be recorded 
on CRFs and entered into the EDC. 
 

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8.8 
Return of Investigational DISCSS™ Device 
As described above, the DISCSS™ System will be returned to Meagan Medical after 
study completion for each subject for download of the device use log output as described 
in Appendix III: DISCSS™ Stimulator System Clinician Use Guide “Download Logs.”  
An electronic copy of the device use log output identified by device serial number and 
subject identification number will be transmitted to the Investigator site for storage with 
the Subject’s records.  The device use logs will be uploaded to the database at Meagan 
Medical for analysis and storage. 
 
8.9 
Device Complications 
In the event of a device malfunction or complication, subjects will be advised to return to 
the clinic for evaluation as described in Section 6.7 Unscheduled Visits.  The device 
complications and/or adverse events will be addressed clinically and per the procedures 
outlined in the protocol Study Procedures Section 6.0, Safety Reporting Section 10.0 and 
the DISCSS™ Stimulator System Clinician Use Guide.  If indicated, the Investigator will 
adjust the settings on the DISCSS™ Stimulator System or, if necessary replace the 
DISCSS™ Stimulator System according to the Clinician Use Guide as outlined in 
Section 8.9.  If the complication cannot be resolved, the subject will be discontinued from 
the study as described in Section 4.6. 
 
All information regarding the adverse event, device malfunction or complication and 
replacement, as applicable will be captured in the medical records, Case Report Forms 
and entered into the clinical database.  The malfunctioning device will be returned to 
Meagan Medical where the device use logs will be downloaded and analyzed. 
9.0 
CONCOMITANT MEDICATIONS/THERAPIES 
Study participants will be counseled to stop the use of the following medications 
throughout the duration of their study participation: warfarin, rivaroxaban, dabigatran, 
apixaban, edoxaban, enoxaparin, fondaparinux, and aspirin. 
 
10.0 
SAFETY REPORTING 
10.1 
Overview and Definitions 
All adverse events associated with the DISCSS™ will be recorded and analyzed. 
Regulations contained in the FDA and ICH Guidelines will be followed in the 
identification, reporting and analysis of adverse events. 
 
Adverse Event: An adverse event (AE) is any untoward medical occurrence, disease, 
injury, or untoward clinical signs (including abnormal laboratory findings, surgical 
complications, etc.), whether related or unrelated to the investigational device or its use. 
 
Anticipated Adverse Device Effect: Any adverse effect related to the device, which is 
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Serious Adverse Event (SAE):  A Serious Adverse Event is an adverse event which: 
• Led to a death, 
• Resulted in life threatening illness or injury* 
• Resulted in patient hospitalization or prolongation of existing hospitalization, 
• Resulted in patient disability or permanent damage or required intervention to prevent 
permanent impairment/damage 
• Led to a congenital abnormality or birth defect 
* NOTE: the term “life-threatening” refers to an event in which the patient was at a risk 
of death at the time of the event; it does not refer to an event which hypothetically might 
have caused death if it were more severe. 
 
Unanticipated Adverse Device Effects (UADE): An Unanticipated Adverse Device 
Effect is: 
1. 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 is not 
identified in nature, severity, or degree of incidence in this protocol; or  
2. Any other unanticipated serious problem associated with a device that relates to the 
rights, safety, or welfare of the patients. 
 
10.2 
Safety Monitoring 
The Sponsor/designee will monitor all adverse event reports to identify and trend all 
events that would require temporary discontinuation of study enrollment, to fully 
characterize device safety, to modify the study protocol, or to terminate the study. 
 
10.3 
Reporting Procedures for All Adverse Events 
All adverse events occurring during the study, whether or not attributed to the DISCSS™ 
treatment, observed by the Investigator or reported by the participant, will be recorded on 
the Adverse Event CRF. After review with the participant by the study site personnel, all 
adverse events will be documented in the participant’s source document and on the 
appropriate CRF pages. The following information must be collected: 
• Description of event 
• Date of onset 
• Date of resolution 
• Duration 
• Severity 
• Relationship to the study device  
• Action(s) taken 
• Outcome(s) 
 
The Sponsor will make the determination of whether event is anticipated or 
unanticipated. 
 

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The participant should be given appropriate care under medical supervision until 
symptoms resolve. If the adverse event is of such severity in the Investigator’s judgment 
that it warrants withdrawal from the study, the participant should be withdrawn from 
treatment and the end of study evaluations should be completed and recorded on Case 
Report Forms.  
 
10.4 
Adverse Event Severity Assessment 
Adverse events are described as mild, moderate or severe. The severity of adverse events 
will be assessed on the following severity index scale: 
 
Mild:  The adverse event is transient, requires no treatment, and does not interfere with 
the participant’s daily activity. 
 
Moderate:  The adverse event introduces a low level of inconvenience or concern to the 
participant and may interfere with daily activities, but is usually ameliorated by simple 
therapeutic measures. 
 
Severe:  The adverse event interrupts the participant’s usual daily activity and requires 
systematic therapy or other treatment. 
 
10.5 
Relationship to Device or Procedure 
The relationship of an adverse event to the study will be graded as follows: 
 
None:  The adverse event is not associated with the study device use. 
 
Remote:  The temporal association is such that the study device is not likely to have had 
an association with the observed adverse event. 
 
Possible:  This causal relationship is assigned when the adverse event: 
a) Follows a reasonable temporal sequence from device use, but 
b) Could have been produced by the study participant’s clinical state or other modes 
of therapy administered to the study participant. 
 
Probable:  This causal relationship is assigned when the adverse event: 
a) Follows a reasonable temporal sequence from device use; 
b) Abates upon discontinuation of the treatment; 
c) Cannot be reasonably explained by known characteristics of the participant’s 
clinical state. 
 
Definite:  This causal relationship is assigned when the adverse event: 
a) Follows a reasonable temporal sequence from device use; 
b) Abates upon discontinuation of the treatment; and 
c) Is confirmed by the reappearance of the adverse event on repeat exposure. 
 
10.6 
Timelines for Adverse Event Reporting 

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Adverse events shall be recorded in the patient’s study records and in the EDC on the 
Adverse Event eCRF within 72 hours of the site becoming aware of the event. The study 
database will be configured to notify the Sponsor of all adverse events that are indicated 
to be ‘serious’. Serious adverse events (SAEs) will trigger the database to send an email 
notification to the Sponsor using the contact information provided below. 
 
Sponsor Contact: Bill Carroll 
E-mail: BCarroll@RSMedical.com 
E-mail: tyearwood@nopaindr.com 
 
The Investigator should provide additional information on the SAE by updating the 
information on the Adverse Event eCRF as updates become available. The Sponsor may 
also ask for additional clinical reports including redacted source documents to be 
provided by the Investigator to assist in the assessment of the event.  Significant new 
information and updates should continue to be submitted promptly to the Sponsor and 
entered on the Adverse Event eCRF as they become available, and the Investigator 
should follow the SAE until it is resolved or no further improvement is expected. 
The Sponsor shall ensure that the Investigator submits safety event notifications to the 
governing Investigational Review Board (IRB) within the timeframe specified by the 
IRB, when applicable.  Acceptable means of confirming that the IRB requirements have 
been met include forwarding a copy of the written, signed report that was sent to the IRB 
to the Sponsor.  Copies of this report should be filed in the Investigator’s site files and the 
Sponsor’s clinical investigation files. 
 
10.7 
Determination and Reporting of Unanticipated Adverse Device Effects  
The Sponsor shall review all reported SAEs to evaluate whether they meet the criteria for 
an Unanticipated Adverse Device Effect. For adverse events that are determined to be 
UADEs, the Sponsor will submit an expedited safety report to the FDA’s Center for 
Devices and Radiological Health (CDRH).  The expedited safety report will consist of a 
completed Form FDA 3500A and a cover letter analyzing the significance of the event. 
The expedited safety report will be submitted to the FDA as soon as possible and, in no 
event, later than 10 working days after the Sponsor first receives notice of the UADE. A 
copy of this safety report will be provided to all participating study Investigators.   
If, following receipt and investigation of follow-up information regarding an adverse 
event that was previously determined not to be a UADE, the Sponsor determines that the 
event does meet the requirements for expedited reporting, the Sponsor will submit a 
completed Form FDA 3500A and cover letter as soon as possible, but in no event later 
than 10 working days after this is determined. 
 

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10.8 
Study Termination  
The Sponsor, in consultation with the Investigators, shall determine if the reported event 
presents an unreasonable risk to study patients.  If the event is determined to pose an 
unreasonable risk, the Sponsor shall develop procedures to terminate the study within 5 
working days. 
 
10.9 
Treatment of Adverse Events  
Adverse events that occur during the study shall be handled by established standards of 
care to protect the health and safety of the patient.  Necessary care shall be provided by 
the Investigator or designee. 
 
11.0 
Protocol Deviations 
 
A protocol deviation is any noncompliance with the clinical protocol or Good Clinical 
Practice Guidelines.  The noncompliance may be either on the part of the participant, the 
Investigator, or the study site staff.  The site must record all protocol deviations with an 
explanation for the deviation on the appropriate study forms.  If required, deviations will 
be reported to the IRB per the IRB’s guidelines.   
 
Minor Deviations: A minor deviation does not impact the participants’ rights, safety, or 
well-being, or the completeness, accuracy or reliability of the study data.  Minor 
deviations shall be documented in the study database along with a full description of the 
event and outcome.  The Sponsor will analyze these deviations and assess their 
significance.  Minor deviations should be reported to the reviewing IRB if required by the 
IRB’s deviation reporting guidelines. 
 
Major deviations: A major deviation is a deviation from the protocol that may impact the 
participants’ rights, safety, or well-being, or the completeness, accuracy or reliability of 
the study data, or a deviation from FDA regulations or IRB guidelines. Major deviations 
should be reported to the Sponsor within 24 hours of site awareness of the event and must 
be documented in the study database along with a full description of the event and 
outcome. The Sponsor will analyze these deviations and assess their significance. Major 
deviations should be reported to the reviewing IRB per the IRB’s deviation reporting 
guidelines. 
 
12.0 
STATISTICAL CONSIDERATIONS 
For this feasibility study, descriptive statistics will be utilized to describe the data for each 
endpoint. For continuous variables, this include the mean value, change from baseline, 
standard deviation, and 95% confidence interval. For categorical variables, the rate and a 
95% confidence interval will be presented. As there is no comparator group for this clinical 
study, no hypothesis-based statistical testing is planned. For adverse event information, the 

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number of events, the number of subjects experiencing events, and the rate of subjects 
experiencing an event will be presented. 
 
13.0 
ETHICS & PROTECTION OF HUMAN SUBJECTS 
13.1 
Ethical Review  
Prior to the start of the study the Investigator will provide the Sponsor or its designee 
with documentation that the IRB/EC has reviewed and approved the protocol and the 
Informed Consent Form. Additional documentation may be submitted pending applicable 
local requirements. Each Investigator must provide at least the following documentation: 
• The IRB/EC approval of the protocol. 
• The IRB/EC approval of the Informed Consent Form. 
• The IRB/EC annual (or any other frequency when applicable – i.e. quarterly, 
semiannually according to the local IRB standard operating procedure) renewed 
approval of the protocol. 
• The IRB/EC approval of any revisions to the Informed Consent Form or 
amendments to the protocol. 
 
13.2 
Regulatory Considerations 
This study will be conducted in accordance with the Good Clinical Practice (GCP) 
guidelines and applicable regulatory requirements (FR, ICH, E3-E6 ISO14155) including 
but not limited to: 
• The Food and Drug Administration (FDA) Regulations on Investigational Device 
Exemption (21 CFR 812), 
• The FDA Regulations on research with human beings (21 CFR 50 and 56), 
• The Health and Human Services (DHHS) Regulations on research with human 
beings (45 CFR 46 Subparts A, B, C, and D) and 
• The International Conference on Harmonization (ICH) "Guidance for Industry-E6 
Good Clinical Practice: Consolidated Guideline." 
 
13.3 
Informed Consent    
The Informed Consent Form (ICF) for this study will be prepared in accordance with 
FDA 21 CFR Part 50. The ICF will be used to explain the possible risks and benefits to 
the patient in simple terms before the patient is entered into the study. The ICF will 
contain a statement that the consent is freely given, that the patient is aware of the risks 
and benefits of entering the study, and that the patient is free to withdraw from the study 
at any time. The ICF will need to be reviewed and approved by the Sponsor or its 
designee prior to the IRB/EC submission. All appropriate bills/ legislative actions are to 
be considered and the ICF amended, as appropriate (e.g. California Bill of Rights is to be 
on the forefront of the ICF if study conducted in California).  
 
Prior to a patient’s participation in the study, the written ICF will be signed and 
personally dated by the patient or by the patient’s legally acceptable representative, and 
witnessed by the person who conducted the informed consent discussion.  If a patient is 
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witness will be present during the entire consent discussion. After the written ICF and 
any other written information to be provided to the patient is read and explained to the 
patient or legal representative, and oral consent to the patient’s participation in the study 
has been given by the patient, the witness will sign and date the ICF.  
 
The Investigator must document acquisition of patient consent in the patient’s medical 
records, and the patient or legal representative must be given a copy of the ICF document 
prior to enrollment into the study. 
 
The Investigator is required to report any failure to obtain patient consent to the IRB/EC 
and the Sponsor or its designee, within 24 hours of learning of such an event.  
 
13.4 
Participant and Data Confidentiality 
The study will be conducted in accordance with the Privacy Rule (45 CFR Parts 160 and 
164) of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). 
 
Participating Investigators, their staff, the sponsor(s) and their agents will extend all 
efforts to maintain participant confidentiality. The study protocol, documentation, data, 
and all other information generated for the study will be held in strict confidence.  No 
information concerning the study or the data will be released to any unauthorized third 
party without prior written approval of the Sponsor.  The study monitor, other authorized 
representatives of the sponsor, representatives of the IRB may inspect all documents and 
records required to be maintained by the Investigator, including but not limited to 
medical records and study documentation for the participants in this study.  The clinical 
study site will permit access to such records.   
 
The study participant’s contact information will be securely stored at each clinical site for 
internal use during the study.  At the end of the study, all records will continue to be kept 
in a secure location for as long as dictated by the IRB and for at 2 years following the 
date a marketing application is approved for the device for the indication for which it is 
being investigated; or, if no application is to be filed or if the application is not approved 
for such indication, until 2 years after the investigation is discontinued and FDA is 
notified. 
 
All participant data will be identified by Participant Identification Numbers. Participant 
Identification Numbers will be assigned in a XX-YYY format, where XX = a unique site 
identification number and YYY = a unique patient identification number. 
 
The only information entered into the DISCSS™system is the Subject Identification 
Number, which is linked to the serial number of the device by a Study-specific log and 
entered into the EDC. 
 
14.0 
CLINICAL MONITORING 

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The Sponsor's Clinical designee (the CRO) will perform the clinical study monitoring. 
The CRO’s staff will be trained and have the scientific and clinical knowledge needed to 
monitor the study appropriately. 
 
Monitoring will include pre-investigational site Visits (Site Qualification Visit and Site 
Initiation Visit), Interim Monitoring Visits and a Close-out Visit. Monitoring will occur 
as frequently as needed to assure proper conduct of the protocol.   
 
Interim Monitoring visits will be performed as frequently as needed in order to assure 
appropriate study implementation. Monitoring visits will be documented on monitoring 
visit reports, and will aim to verify that:  
• Compliance with the clinical protocol and applicable regulations is being 
maintained 
• Only authorized site individuals are participating in study activities  
• The investigational device is being used according to the protocol and instructions 
for use 
• Adequacy of staffing and facilities 
• Adequate access of site to eligible patients 
• Signed and dated informed consent forms have been obtained from each patient 
• eCRFs and queries are complete 
• Source data is verified and signed-off upon as accurate 
• Patient files are accurate and complete 
• All adverse events are reported to the Sponsor 
• All serious and unanticipated adverse device events are reported to the Sponsor 
and the IRB/EC 
• All other required reports, notifications, applications, submissions, and 
correspondence are maintained in the Investigator’s files and are accurate 
• Maintenance and calibration of equipment relevant to clinical assessments is 
appropriately performed and documented 
• Patient withdrawal has been documented (if applicable) 
• Patient non-compliance has been documented (if applicable) 
• The Investigator and site staff are informed and knowledgeable of all relevant 
document updates concerning the clinical investigation 
• Corrective and preventive actions have been implemented (if applicable) 
 
Each site’s Investigator will allocate adequate time for monitoring activities.  The 
Investigator will also ensure that the monitor or other compliance or quality assurance 
reviewer is given access to the study-related documents and study related facilities, and 
has adequate space to conduct the monitoring visit. 
 
15.0 
STUDY TRAINING 
Training of study site personnel will be initiated prior to the protocol being implemented. 
All participating Investigators and coordinators will under a comprehensive training with 
the DISCSS™ device and trained on its components. Training will consist of both lecture 
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his/her designee following formal device training by the Sponsor or the Sponsor’s 
designee.  Training materials for the Clinician and for the Subject will be provided by 
Meagan Medical. 
 
16.0 
DATA HANDLING AND RECORDKEEPING 
16.1 
Source Documents 
Each participating site will maintain appropriate medical and research records for this 
trial, in compliance with ICH E6 and regulatory and institutional requirements for the 
protection of confidentiality of participants.   
 
Source data include all information, original records of clinical findings, observations, or 
other activities in a clinical trial necessary for the reconstruction and evaluation of the 
trial.  Examples of these original documents and data records include, but are not limited 
to hospital records, clinical and office charts, device logs, memoranda, recorded data 
from automated instruments, study-specific source worksheets, and copies or 
transcriptions certified after verification as being accurate and complete.   
 
16.2 
Data Collection and Management Responsibilities 
Source documents and electronic Case Report Forms (eCRFs) will be completed in a 21 
CFR Part 11 compliant electronic data capture (EDC) system for each patient enrolled 
into the clinical study.  The Study Coordinator will review and sign off on completed 
eCRFs to attest that all data entered on the eCRFs are complete and accurate after the 
monitor finishes the source document verification process.  The Investigator will sign off 
on the Eligibility Criteria, all Adverse Event, and Protocol Deviation and Study 
Completion eCRFs and will sign each patient’s casebook once the patient completes the 
study to attest that all data entered on the eCRFs are complete and accurate.  All of the 
above signatures will be completed digitally within the EDC system using the system’s 
Part 11 compliant digital signature system function. 
 
Any required data clarifications will be handled within the EDC system’s query 
management system.  The EDC will be programmed to automatically issue data 
clarification queries on missing values and values out of acceptable ranges.  Study 
monitors and data managers will also be able to add data clarification queries to data 
points within the system.  Study coordinators will have the opportunity to correct data 
and/or respond to the query for review by monitors and data managers. 
 
16.3 
Study Records Retention 
The Investigator and Sponsor will maintain records in accordance with 21 CFR 812, 
Subpart G, to include: 
• Current and past versions of the IRB-approved clinical protocol and corresponding 
IRB-approved consent form(s) and, if applicable, patient recruitment 
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• FDA correspondence related to the IDE application; including supplemental IDE 
applications, current Investigator lists, progress reports 
• IRB correspondence (including approval notifications)including safety and 
protocol deviation reports, and annual or interim reports 
• Signed Investigator Agreements and financial disclosure forms for participating 
Investigators 
• Curriculum vitae (Investigator and Sub-Investigators) 
• Certificates of required training for Investigators and Sub-Investigators, including 
human subject protection and Good Clinical Practice 
• Instructions for handling the investigational device and other study-related 
materials  
• Signed Informed Consent Forms 
• Source Documents  
• Monitoring visit reports 
• Copies of relevant Sponsor-Investigator correspondence, including notifications of 
adverse event information 
• Screening and Enrollment Log 
• Final clinical study report 
 
The sponsor and study Investigators will retain all study records and reports for up to two 
years after the marketing application is approved for the investigational device; or, if a 
marketing application is not submitted or approved for the investigational device, until 
two years after investigations under the IDE have been discontinued and the FDA so 
notified. 
 
16.4 
Collection, Transfer and Archiving of Radiographic Imaging Data 
Radiographic imaging will be taken to confirm the location of implanted percutaneous 
trial leads during Visit 2 when the percutaneous trial leads are implanted,  Visit 4 at the 
initiation of the investigational study phase with the DISCSS™ device, and Visit 5 to 
confirm lead placement and successful percutaneous trial lead removal.  A radiograph of 
the marked insertion point will be taken.  Documentation of the lead placement will be 
generated and maintained with the subject’s records on site.  At Visit 4, any lead 
migration or abnormalities will be noted on the radiology report.  The de-identified image 
will be saved electronically (via DICOM files or equivalent) for transfer to Meagan 
Medical at the conclusion of the study.  All imaging data will also be maintained at the 
clinical site.  
 
16.5 
Transfer and Storage of Device Use Log 
The Investigator will return each device to Meagan Medical after study completion for 
each subject.  Only one device will be used per subject per site.  The devices are uniquely 
identified by serial number.  Both Subject ID and Serial Number will be recorded on 
Case Report Forms and entered into the clinical database.  Meagan Medical will 
download a copy of the Device Use Log and upload the logs into the clinical database.  

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An electronic copy identified by Subject Identification Number and Device Serial 
Number will be provided to the investigative site for their records.   
 
16.6 
Publication and Data Sharing Policy 
Any Investigator involved with this study is obligated to provide the Sponsor with 
complete test results and all data derived from the study.  Investigators are not permitted 
to publish or share the results or any part of the results of this study, nor any of the 
information provided by the Sponsor for the purposes of performing the study, to any 
third party without the consent of Meagan Medical, Inc.   
 
17.0 
AUDITS AND INSPECTIONS 
Sites may be audited by the Sponsor or Sponsor designee, by IRBs, the Office of Human 
Research Protection or FDA during this trial.  The investigational site will provide direct 
access to all trial related files, source documents, and reports for the purpose of 
monitoring and auditing by the sponsor and inspection by local and regulatory 
authorities.  
 
18.0 
PUBLICATION PLAN 
The study will be registered on Clinicaltrials.gov in compliance with 42 CFR Part 11. 
Results of the study, including negative outcomes or an unanticipated early termination 
of the trial, will be posted to the Clinicaltrials.gov database at the conclusion of the study. 
In the event that the study is terminated early, the posting of these results will be 
completed within 30 days of completion of data analysis. 
 
 
 
 

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19.0 
LITERATURE REFERENCES 
1. Melzack R, Wall PD. Pain mechanisms: a new theory. Science. 1965; 150:971-979.  
2. Shealy CN, Mortimer JT, Reswick JB. Electrical inhibition of pain by stimulation  of 
the dorsal columns: preliminary clinical report. Anesth Analg 1967; 46: 489-491. 
3. Kapural L, Yearwood TL, et al. Novel 10-kHz High-frequency Therapy (HF10 
Therapy) Is Superior to Traditional Low-frequency Spinal Cord Stimulation for the 
Treatment of Chronic Back and Leg Pain. Anesthesiology. 2015; 123: 851-860. 
4. Kapural L, Yearwood TL, et al. Comparison of 10-kHz High-Frequency and 
Traditional Low-Frequency Spinal Cord Stimulation for the Treatment of Chronic 
Back and Leg Pain: 24-Month Results From a Multicenter, Randomized, Controlled 
Pivotal Trial. Neurosurgery. 2016; 79: 667-677. 
 
5. North RB, Wetzel FT. Spinal Cord Stimulation for Chronic Pain of Spinal Origin: A 
Valuable Long-Term Solution. Spine. 2002; 27: 2584-2591. 
6. Taylor RS, Van Buyten JP, Buchser E. Spinal cord stimulation for chronic back and 
leg pain and failed back surgery syndrome: a systematic review and analysis of 
prognostic factors. Spine. 2005; 30: 152-160. 
7. Kumar K, Taylor R, Jacques L, et al. Spinal cord stimulation versus conventional 
medical management for neuropathic pain: a multicenter randomized controlled trial 
in patients with failed back surgery syndrome. Pain 2007; 132: 179-188. 
 
20.0 
APPENDICES 
Appendix I: Informed Consent Form 
Appendix II: DISCSS™ Stimulator System User Guide 
Appendix III: DISCSS™ Stimulator System Clinician Use Guide