A Prospective, Multicenter, Randomized Double-blind Study Examining the Safety and Efficacy of Using the Evoke™ Spinal Cord Stimulator (SCS) System With Feedback to Treat Patients With Chronic Pain of the Trunk and/or Limbs.
Phase: NA
Conditions: Chronic Pain, Back Pain, Pain
Sponsor: Saluda Medical Americas, Inc.



Study: SCLSH1503 
 
Evoke Clinical Study Protocol 
 
Page 2 of 59 
 
Saluda Medical Americas, Inc. 
-CONFIDENTIAL- 
Rev. 4.00, 06Aug2018 
CLIN-PCL-002065 
TABLE OF CONTENTS 
1 
CLINICAL PROTOCOL SUMMARY ............................................................................................... 6 
2 
BACKGROUND .............................................................................................................................. 9 
2.1 
Disease and Current Treatment ............................................................................................. 9 
2.2 
Summary of Prior Preclinical and Clinical Experience.......................................................... 10 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2.3 
Rationale for the Clinical Study ............................................................................................. 13 
3 
DEVICE DESCRIPTION AND INDICATION FOR USE ............................................................... 14 
3.1 
Device Description ................................................................................................................ 14 
3.1.1 
Investigational Device ................................................................................................... 14 
3.1.2 
Control Device .............................................................................................................. 14 
3.2 
Target Indication for Use ...................................................................................................... 15 
4 
STUDY PURPOSE AND OBJECTIVES ....................................................................................... 15 
4.1 
Study Purpose ...................................................................................................................... 15 
4.2 
Primary Objective ................................................................................................................. 15 
4.3 
Secondary Objectives ........................................................................................................... 15 
5 
STUDY DESIGN ........................................................................................................................... 15 
5.1 
Overview ............................................................................................................................... 15 
5.2 
Randomization ...................................................................................................................... 16 
5.3 
Blinding ................................................................................................................................. 16 
5.4 
Minimization of Bias .............................................................................................................. 17 
6 
STUDY POPULATION ................................................................................................................. 17 
6.1 
Study Sites ............................................................................................................................ 17 
6.2 
Inclusion Criteria ................................................................................................................... 17 
6.3 
Exclusion Criteria .................................................................................................................. 18 
7 
STUDY ASSESSMENTS .............................................................................................................. 19 
 
 
 
 

Study: SCLSH1503 
 
Evoke Clinical Study Protocol 
 
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Saluda Medical Americas, Inc. 
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CLIN-PCL-002065 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
8 
STUDY PROCEDURES ............................................................................................................... 21 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
9 
ADVERSE EVENTS ..................................................................................................................... 28 
9.1 
Adverse Event Definitions ..................................................................................................... 28 
9.1.1 
Adverse Event ............................................................................................................... 28 
9.1.2 
Serious Adverse Event ................................................................................................. 28 
9.1.3 
Unanticipated Adverse Device Effects.......................................................................... 28 
9.2 
Adverse Event Recording and Reporting ............................................................................. 29 
9.2.1 
Adverse Event Recording ............................................................................................. 29 
9.2.2 
Adverse Event Reporting .............................................................................................. 29 
9.3 
Independent Adjudication Committee ................................................................................... 29 
10 
DEVICE DEFICIENCIES .............................................................................................................. 30 
10.1 
Device Deficiency Definitions ............................................................................................... 30 
10.2 
Device Deficiency Reporting ................................................................................................. 30 
11 
STATISTICAL ANALYSIS ............................................................................................................ 30 
11.1 
Timing of Analyses ............................................................................................................... 30 
11.2 
Study Endpoints .................................................................................................................... 30 
11.2.1 
Primary Composite Endpoint ........................................................................................ 30 
11.2.2 
Secondary Endpoints for Hierarchical Testing ............................................................. 31 
11.2.3 
Additional Secondary Endpoints ................................................................................... 31 

Study: SCLSH1503 
 
Evoke Clinical Study Protocol 
 
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Saluda Medical Americas, Inc. 
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11.3 
Sample Size .......................................................................................................................... 31 
11.3.1 
Calculation .................................................................................................................... 31 
11.4 
General Statistical Procedures ............................................................................................. 32 
11.4.1 
Assessment of Baseline Characteristics ...................................................................... 32 
11.4.2 
Assessment of Poolability ............................................................................................. 32 
11.4.3 
Analysis Populations ..................................................................................................... 33 
11.4.4 
Handling of Missing Data in Primary and Hierarchical Analyses .................................. 33 
11.5 
Analysis of Study Endpoints ................................................................................................. 34 
11.5.1 
Primary Composite Endpoint ........................................................................................ 34 
11.5.2 
Hierarchical Secondary Endpoints................................................................................ 34 
11.5.3 
Other Secondary Effectiveness Endpoints ................................................................... 35 
11.5.4 
Adverse Events ............................................................................................................. 35 
12 
RISK ANALYSIS ........................................................................................................................... 35 
12.1 
Potential Risks ...................................................................................................................... 35 
12.2 
Minimization of Risks ............................................................................................................ 35 
12.3 
Potential Benefits .................................................................................................................. 36 
12.4 
Benefit-Risk Conclusions ...................................................................................................... 36 
13 
STUDY ADMINISTRATION .......................................................................................................... 36 
13.1 
Study Materials ..................................................................................................................... 36 
13.1.1 
Packaging and Labeling ............................................................................................... 36 
13.1.2 
Handling and Storage ................................................................................................... 36 
13.1.3 
Product Administration .................................................................................................. 36 
13.1.4 
Product Accountability .................................................................................................. 37 
13.2 
Ethics .................................................................................................................................... 37 
13.2.1 
Institutional Review Board Approval ............................................................................. 37 
13.2.2 
Informed Consent ......................................................................................................... 37 
13.2.3 
Subject Confidentiality .................................................................................................. 37 
13.3 
Data and Quality Management ............................................................................................. 37 
13.3.1 
Data Collection and Management ................................................................................ 38 
13.3.2 
Monitoring ..................................................................................................................... 38 
13.3.3 
Audits/Inspections ......................................................................................................... 38 
13.4 
Access to Study Records ...................................................................................................... 38 
13.5 
Study Site Training ............................................................................................................... 38 
13.6 
Investigator Responsibilities ................................................................................................. 38 
13.7 
Investigator Agreement and Financial Disclosure ................................................................ 38 
13.7.1 
Investigator Records ..................................................................................................... 39 
13.7.2 
Investigator Reports ...................................................................................................... 39 
13.8 
Sponsor Responsibilities ...................................................................................................... 40 
13.8.1 
Sponsor Representatives ............................................................................................. 40 
13.9 
Deviations to the Protocol ..................................................................................................... 40 

Study: SCLSH1503 
 
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Saluda Medical Americas, Inc. 
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CLIN-PCL-002065 
13.10 Amendments to the Protocol ................................................................................................ 41 
13.11 Completion, Early Termination, or Suspension of the Study ................................................ 41 
13.12 Record Retention .................................................................................................................. 41 
13.13 Clinical Trials Registry/Database (ClinicalTrials.gov) ........................................................... 41 
13.14 Publication ............................................................................................................................ 41 
REVISION HISTORY ............................................................................................................................ 42 
ABBREVIATIONS AND ACRONYMS .................................................................................................. 43 
BIBLIOGRAPHY ................................................................................................................................... 44 
APPENDIX A: 
 ............................................................ 45 
 
 
 
 

Study: SCLSH1503 
 
Evoke Clinical Study Protocol 
 
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Saluda Medical Americas, Inc. 
-CONFIDENTIAL- 
 
CLIN-PCL-002065 
Inclusion Criteria 
Subjects enrolled in this study must meet the following inclusion criteria, as 
determined by the Investigator: 
1. 
Subject is male or female between the ages of 18 and 80 years. 
2. 
Have been diagnosed with chronic, intractable pain of the trunk and/or 
limbs, which has been refractory to conservative therapy for a minimum of 
6 months. 
3. 
VAS leg pain score ≥ 6 cm. 
4. 
VAS back pain score ≥ 6 cm. 
5. 
VAS overall trunk and limb pain score ≥ 6 cm. 
6. 
Be an appropriate candidate for an SCS trial and the surgical procedures 
required in this study based on the clinical judgment of the Investigator. 
7. 
Prescribed pain medications have been stable for at least 30 days prior to 
the baseline evaluation. 
8. 
ODI score of 41-80 (severely disabled or crippled) out of 100 at the 
baseline evaluation. 
9. 
Be willing and capable of giving informed consent and able to comply with 
study-related requirements, procedures, and visits.   
10. The subject’s primary back pain is located such that lead placement will 
be in the thoracolumbar region. 
Exclusion Criteria 
Subjects enrolled in this study must not meet the following exclusion criteria, as 
determined by the Investigator: 
1. 
Have a medical condition or pain in other area(s), not intended to be treated 
with SCS, that could interfere with study procedures, accurate pain 
reporting, and/or confound evaluation of study endpoints, as determined by 
the Investigator. 
2. 
Have evidence of an active disruptive psychological or psychiatric disorder 
or other known condition significant enough to impact perception of pain, 
compliance of intervention, and/or ability to evaluate treatment outcomes. 
3. 
Are not a surgical candidate due to a diagnosis of an uncontrolled 
coagulation disorder, bleeding diathesis, progressive peripheral vascular 
disease, uncontrolled diabetes mellitus, or morbid obesity. 
4. 
Have an existing drug pump and/or SCS system or another active 
implantable device such as a pacemaker, deep brain stimulator (DBS), or 
sacral nerve stimulator (SNS). 
5. 
Have prior experience with SCS. 
6. 
Have a condition currently requiring or likely to require the use of MRI or 
diathermy. 
7. 
Have a life expectancy of less than 1 year. 
8. 
Have an active systemic infection or local infection in the area of the 
surgical site. 
9. 
Be allergic, or have shown hypersensitivity, to any materials of the 
neurostimulation system which come in contact with the body. 
10. Be pregnant or nursing (if female and sexually active, subject must be using 
a reliable form of birth control, be surgically sterile, or be at least 2 years 
post-menopausal). 
11. Have a documented history of substance abuse (narcotics, alcohol, etc.) or 
substance dependency in the 6 months prior to the baseline evaluation. 
12. Be concomitantly participating in another clinical study. 
13. Be involved in an injury claim under current litigation or have 
pending/approved worker’s compensation claim. 

Study: SCLSH1503 
 
Evoke Clinical Study Protocol 
 
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Saluda Medical Americas, Inc. 
-CONFIDENTIAL- 
 
CLIN-PCL-002065 
3.2 
Target Indication for Use 
 
 
 
4 
STUDY PURPOSE AND OBJECTIVES 
4.1 
Study Purpose 
 
 
 
4.2 
Primary Objective 
 
 
 
   
4.3 
Secondary Objectives 
 
 
 
 
 
  
 
 
 
• 
 
 
 
 
 
 
 
 
  
 
 
 
  
 
 
5 
STUDY DESIGN 
5.1 
Overview 
 
 
   
 
 
 
 
 
  
 
 

Study: SCLSH1503 
 
Evoke Clinical Study Protocol 
 
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Saluda Medical Americas, Inc. 
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CLIN-PCL-002065 
 
   
 
 
 
 
    
5.4 
Minimization of Bias 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
   
 
 
 
6 
STUDY POPULATION 
6.1 
Study Sites 
Study subjects will be enrolled at up to 20 US sites. 
6.2 
Inclusion Criteria 
Subjects enrolled in this study must meet the following inclusion criteria, as determined by the 
Investigator: 

Study: SCLSH1503 
 
Evoke Clinical Study Protocol 
 
Page 18 of 59 
 
Saluda Medical Americas, Inc. 
-CONFIDENTIAL- 
 
CLIN-PCL-002065 
 
1. Subject is male or female between the ages of 18 and 80 years. 
 
2. Have been diagnosed with chronic, intractable pain of the trunk and/or limbs, which has been 
refractory to conservative therapy for a minimum of 6 months. 
 
3. VAS leg pain score ≥ 6 cm. 
 
4. VAS back pain score ≥ 6 cm. 
 
5. VAS overall trunk and limb pain score ≥ 6 cm. 
 
6. Be an appropriate candidate for an SCS trial and the surgical procedures required in this study 
based on the clinical judgment of the Investigator. 
 
7. Prescribed pain medications have been stable for at least 30 days prior to the baseline 
evaluation. 
 
8. ODI score of 41-80 (severely disabled or crippled) out of 100 at the baseline evaluation. 
 
9. Be willing and capable of giving informed consent and able to comply with study-related 
requirements, procedures, and visits.   
 
10. The subject’s primary back pain is located such that lead placement will be in the thoracolumbar 
region. 
6.3 
Exclusion Criteria 
Subjects enrolled in this study must not meet the following exclusion criteria, as determined by the 
Investigator: 
 
1. Have a medical condition or pain in other area(s), not intended to be treated with SCS, that 
could interfere with study procedures, accurate pain reporting, and/or confound evaluation of 
study endpoints, as determined by the Investigator. 
 
2. Have evidence of an active disruptive psychological or psychiatric disorder or other known 
condition significant enough to impact perception of pain, compliance of intervention, and/or 
ability to evaluate treatment outcomes. 
 
3. Are not a surgical candidate due to a diagnosis of an uncontrolled coagulation disorder, 
bleeding diathesis, progressive peripheral vascular disease, uncontrolled diabetes mellitus, or 
morbid obesity. 
 
4. Have an existing drug pump and/or SCS system or another active implantable device such as 
a pacemaker, deep brain stimulator (DBS), or sacral nerve stimulator (SNS). 
 
5. Have prior experience with SCS. 
 
6. Have a condition currently requiring or likely to require the use of MRI or diathermy. 
 
7. Have a life expectancy of less than 1 year. 
 
8. Have an active systemic infection or local infection in the area of the surgical site. 
 
9. Be allergic, or have shown hypersensitivity, to any materials of the neurostimulation system 
which come in contact with the body. 
 

Study: SCLSH1503 
 
Evoke Clinical Study Protocol 
 
Page 21 of 59 
 
Saluda Medical Americas, Inc. 
-CONFIDENTIAL- 
 
CLIN-PCL-002065 
 
 
 
 
 
  
8 
STUDY PROCEDURES 

Study: SCLSH1503 
 
Evoke Clinical Study Protocol 
 
Page 35 of 59 
 
Saluda Medical Americas, Inc. 
-CONFIDENTIAL- 
Rev. 
 
CLIN-PCL-002065 
11.5.3 Other Secondary Effectiveness Endpoints 
11.5.4 Adverse Events 
12 RISK ANALYSIS 
12.2  Minimization of Risks 

Study: SCLSH1503 
 
Evoke Clinical Study Protocol 
 
Page 36 of 59 
 
Saluda Medical Americas, Inc. 
-CONFIDENTIAL- 
Rev. 
 
CLIN-PCL-002065 
12.3  Potential Benefits 
12.4 Benefit-Risk Conclusions 
13 STUDY ADMINISTRATION 
13.1 Study Materials 
13.1.2 Handling and Storage 
13.1.3 Product Administration 

Study: SCLSH1503 
 
Evoke Clinical Study Protocol 
 
Page 37 of 59 
 
Saluda Medical Americas, Inc. 
-CONFIDENTIAL- 
Rev. 
 
CLIN-PCL-002065 
13.1.4 Product Accountability 
13.2 Ethics 
13.2.1 Institutional Review Board Approval 
13.2.2 Informed Consent 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
13.2.3 Subject Confidentiality 
 
 
 
  
 
13.3 Data and Quality Management 
 
 
 

Study: SCLSH1503 
 
Evoke Clinical Study Protocol 
 
Page 41 of 59 
 
Saluda Medical Americas, Inc. 
-CONFIDENTIAL- 
Rev. 4.00, 06Aug2018 
CLIN-PCL-002065 
13.10 Amendments to the Protocol 
 
 
13.11 Completion, Early Termination, or Suspension of the Study 
 
 
 
 
 
 
 
 
 
 
 
 
 
13.12 Record Retention 
 
 
 
 
 
 
   
13.13 Clinical Trials Registry/Database (ClinicalTrials.gov) 
This clinical study will be registered on www.ClinicalTrials.gov. Study results will be submitted as 
required. Per the requirements of 21 CFR Part 50, the ICF will contain a statement that clinical trial 
information will be entered into this clinical trials registry/database.     
13.14 Publication 
 
 
 
 
 
 
 

Study: SCLSH1503 
 
Evoke Clinical Study Protocol 
 
Page 43 of 59 
 
Saluda Medical Americas, Inc. 
-CONFIDENTIAL- 
Rev. 
 
CLIN-PCL-002065 
ABBREVIATIONS AND ACRONYMS 

Study: SCLSH1503 
 
Evoke Clinical Study Protocol 
 
Page 45 of 59 
 
Saluda Medical Americas, Inc. 
-CONFIDENTIAL- 
Rev. 
 
CLIN-PCL-002065 
APPENDIX A: