Study of Gemini Rechargeable Spinal Cord Stimulation System
Phase: NA
Conditions: Chronic Pain
Sponsor: Abbott Medical Devices

 
Clinical Investigation Plan Cover Page 
 
 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
87173 CIP Posting Cover Page Ver C 
Template 
 
NCT Number: NCT05590000 
GEMINI 
Study of Gemini Rechargeable Spinal Cord Stimulation (SCS) System 
Study Document No: ABT-CIP-10485 
Version A 
Date: 11-FEB-2022 
 
 
Sponsor  
 
 
Abbott 
        
 
 
 
6901 Preston Rd 
      
  
 
 
Plano, TX 75024 
        
 
 
 
United States 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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ABT-CIP-10407 
CRD 1030  
 
Study of Gemini Rechargeable Spinal Cord Stimulation (SCS) System 
 
 
Version Number 
B 
Date 
February 11, 2022 
Planned Number of Sites and 
Region(s) 
Up to 8 sites in Australia 
Clinical Investigation Type 
Pre-market, prospective, single-arm, non-randomized, open-label, 
multi-center clinical study. 
Abbott Medical Expert 
XXXXXXXXXXXXXXXXX 
Sponsor 
Abbott Neuromodulation 
6901 Preston Rd 
Plano, TX 75024 
Electronic Data Capture Software 
Oracle Clinical 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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ABT-CIP-10407 
CRD 1030  
 
Study of Gemini Rechargeable Spinal Cord Stimulation (SCS) System 
 
 
SITE PRINCIPAL INVESTIGATOR SIGNATURE PAGE 
 
 
I have read and agree to adhere to the clinical investigation plan and all regulatory requirements 
applicable in conducting this clinical investigation. 
 
 
Site Principal Investigator 
 
Printed name: 
Signature: 
Date: 
 
 
 
 

 
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TABLE OF CONTENTS 
 
1. 
INTRODUCTION ................................................................................................... 9 
1.1. 
Background and Rationale ............................................................................................. 9 
1.1.1. 
Background ................................................................................................................. 9 
1.1.2. 
Rationale for Conducting this Clinical Investigation .................................................. 10 
2. 
CLINICAL INVESTIGATION OVERVIEW ........................................................... 11 
2.1. 
Clinical Investigation Objective ..................................................................................... 11 
2.1.1. 
Primary Objective ..................................................................................................... 11 
2.2. 
Devices Used in the Clinical Investigation .................................................................... 11 
2.2.1. 
Name of the Devices
 ................................................................ 11 
2.2.2. 
Indication for Use ...................................................................................................... 11 
2.2.3. 
Description of the Devices
 ........................................................ 12 
2.2.4. 
Summary of Preclinical Studies ................................................................................ 12 
3. 
CLINICAL INVESTIGATION DESIGN ................................................................. 12 
3.1. 
Clinical Investigation Procedures and Follow-up Schedule .......................................... 12 
3.2. 
Measures Taken to Avoid and Minimize Bias .............................................................. 14 
3.3. 
Suspension or Early Termination of the Clinical Investigation ..................................... 14 
4. 
ENDPOINTS ........................................................................................................ 14 
4.1. 
Confirmatory Safety Endpoint ...................................................................................... 14 
4.2. 
Additional Endpoints ..................................................................................................... 14 
5. 
SUBJECT SELECTION AND WITHDRAWAL ..................................................... 15 
5.1. 
Subject Population ....................................................................................................... 15 
5.2. 
Subject Recruitment/Screening and Informed Consent ............................................... 15 
5.2.1. 
Subject Recruitment and Screening ......................................................................... 15 
5.2.2. 
Informed Consent ..................................................................................................... 15 
5.2.2.1. 
Special Circumstances for Informed Consent ................................................ 16 
5.3. 
Eligibility Criteria ........................................................................................................... 17 
5.3.1. 
General Eligibility Criteria ......................................................................................... 17 
5.3.2. 
 ....................................................................................................... 17 
5.3.3. 
 ...................................................................................................... 17 
5.4. 
Subject Enrollment ....................................................................................................... 17 
5.5. 
Subject Withdrawal and Discontinuation ...................................................................... 18 
5.6. 
Number of Subjects ...................................................................................................... 19 

 
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5.7. 
Total Expected Duration of the Clinical Investigation ................................................... 19 
6. 
TREATMENT AND EVALUATION OF ENDPOINTS ........................................... 19 
6.1. 
Baseline/Pre-procedure ................................................................................................ 19 
6.1.1. 
Baseline Assessments .............................................................................................. 19 
6.2. 
 .......................................................................................... 19 
6.3. 
Follow-up Assessments ............................................................................................... 20 
6.3.1. 
2-
eek Follow-up (
 or Telehealth Visit) ................................ 20 
6.3.2. 
6-
eek Follow-up (
Visit) .......................................................................... 20 
6.3.3. 
Patient Reported Outcome (PRO) Measures (if applicable) ..................................... 21 
 
 .............................................................. 21 
6.3.3.2. 
Patient-Reported Outcome Measure Information System (PROMIS-29) ...... 21 
6.3.4. 
Unscheduled Visits ................................................................................................... 22 
6.3.5. 
Schedule of Events ................................................................................................... 22 
7. 
Adverse Events ................................................................................................... 24 
7.1. 
Definition ...................................................................................................................... 24 
7.1.1. 
Adverse Event .......................................................................................................... 24 
7.1.2. 
Serious Adverse Event ............................................................................................. 24 
7.1.3. 
Device Deficiency/Device Malfunction (if applicable) ............................................... 24 
7.2. 
Device Relationship ...................................................................................................... 26 
7.2.1. 
Unanticipated (Serious) Adverse Device Effect [U(S)ADE] ...................................... 26 
7.3. 
Adverse Event and Device Deficiency/Device Malfunction Reporting ......................... 26 
7.3.1. 
Adverse Event Reporting .......................................................................................... 26 
7.3.2. 
Unanticipated Serious Adverse Device Effect Reporting to Sponsor and IRB (if 
applicable) ............................................................................................................................... 27 
7.3.3. 
Device Deficiency/Malfunction Reporting (if applicable) ........................................... 27 
7.3.4. 
Adverse Event Reporting to Country Regulatory Authorities by the Sponsor ........... 28 
8. 
STATISTICAL CONSIDERATIONS ..................................................................... 28 
8.1. 
Analysis Populations .................................................................................................... 28 
8.2. 
Statistical Analyses ...................................................................................................... 28 
8.2.1. 
Confirmatory Safety Endpoint ................................................................................... 28 
8.2.2. 
Additional Endpoints ................................................................................................. 28 
8.3. 
Sample Size Calculation .............................................................................................. 29 
8.4. 
Timing of Analysis ........................................................................................................ 29 
8.5. 
Planned Interim Analysis .............................................................................................. 29 

 
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8.6. 
Withdrawal from the study ............................................................................................ 29 
8.7. 
Deviations from Statistical Plan .................................................................................... 29 
9. 
DIRECT ACCESS TO SOURCE DATA/DOCUMENTS ....................................... 29 
10. 
QUALITY CONTROL AND QUALITY ASSURANCE ........................................... 29 
10.1. Selection of Clinical Sites and Investigators ................................................................. 29 
10.2. Clinical Investigation Finances and Agreements .......................................................... 30 
10.3. CIP Amendments ......................................................................................................... 30 
10.4. Training ........................................................................................................................ 30 
10.4.1. 
 .......................................................................................................... 30 
10.5. Monitoring ..................................................................................................................... 30 
10.6. Deviations from CIP ..................................................................................................... 31 
10.7. Quality Assurance Audit ............................................................................................... 31 
10.8. Sponsor Auditing .......................................................................................................... 32 
10.9. Committees (add as applicable for clinical investigation) ............................................. 32 
10.9.1. 
Clinical Events Committee (CEC) ......................................................................... 32 
11. 
DATA HANDLING AND RECORD KEEPING...................................................... 33 
11.1. Protection of Personally Identifiable Information .......................................................... 33 
11.2. 
 ................................................................................................ 34 
11.3. Source Documentation ................................................................................................. 34 
11.4. Case Report Form Completion ..................................................................................... 34 
11.5. Record Retention ......................................................................................................... 35 
11.6. Investigational Devices Accountability ......................................................................... 35 
12. 
 ............................................................................... 35 
12.1. Ethics Committee Review and Approval ...................................................................... 35 
13. 
CLINICAL INVESTIGATION CONCLUSION ....................................................... 36 
14. 
PUBLICATION POLICY ...................................................................................... 36 
15. 
RISK ANALYSIS .................................................................................................. 37 
15.1. Anticipated Clinical Benefits ......................................................................................... 37 
15.2. Foreseeable Adverse Events and Anticipated Adverse Device Effects ....................... 37 
15.3. Residual Risks Associated with the Device Under Investigation, as Identified in the 
Risk Management Report / Risk Analysis Report ................................................................... 38 
15.4. Risks Associated with Participation in this Clinical Investigation .................................. 38 
15.5. Steps Taken to Control or Mitigate Risks ..................................................................... 38 
15.6. Risk to Benefit 
 .............................................................................................. 39 

 
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15.7. References ................................................................................................................... 39 
 
 

 
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COMPLIANCE STATEMENT:  
 
This clinical investigation will be conducted in accordance with this Clinical Investigation Plan, 
the Declaration of Helsinki, ISO 14155:2020 standard and the appropriate local legislation(s). 
The most stringent requirements, guidelines or regulations must always be followed. The 
conduct of the clinical investigation will be approved by the appropriate Ethics Committee (EC) 
of the respective clinical site and as specified by local regulations. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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1. 
INTRODUCTION 
Spinal cord stimulation (SCS) is a well-established treatment for chronic intractable pain. The 
purpose of this study is to collect confirmatory data to show that the Gemini Spinal Cord 
Stimulation neuromodulation system functions as intended in a clinical setting. 
The clinical investigation will be conducted in accordance with this CIP. All investigators 
involved in the conduct of the clinical investigation will be qualified by education, training, or 
experience to perform their tasks, and training will be documented appropriately. 
1.1. 
Background and Rationale 
1.1.1. Background 
It is estimated that 20.4% (50 million) of US adults suffer from chronic pain and 8% of adults 
have high-impact chronic pain [1]. The economic burden of chronic pain is high worldwide, with 
annual costs estimated as high as $635 billion dollars in the US [2]. Chronic pain has been 
linked to loss of mobility, opioid dependence, anxiety, and depression, leading to an overall 
decrease in quality of life [1]. Additionally, up to 15% of all chronic pain patients are 
unresponsive to standard medical therapy, and therefore, seek alternative options [2]. 
Considering the long-term detrimental effects of opioid use and its societal impact [3] , it is 
imperative to explore alternative strategies for handling long-term pain management. 
SCS is a commonly utilized form of neurostimulation developed by Abbott and other companies 
over the past four decades to address chronic pain. It is a minimally invasive and reversible 
procedure in which leads are placed into the epidural space. When an electrical current is 
applied to the leads, large myelinated fibers of the dorsal column are stimulated, mitigating pain. 
Abbott is an established manufacturer of neurostimulation systems, including spinal cord 
stimulators that can deliver tonic stimulation and the BurstDRTM waveform [4-6]. Tonic 
stimulation delivers impulses at a consistent amplitude, frequency, and pulse width, and 
typically produces paresthesia over the patient’s area of pain. In contrast, BurstDRTM stimulation 
delivers impulses in rapid succession, known as a burst train, followed by a short silent phase. 
Programmable parameters include the amplitude of the burst train, the time from onset of one 
burst train to the onset of the next burst train (burst rate), and the rate of pulses within each train 
(intra-burst rate). Amplitudes programmed for burst are typically lower than those traditionally 
used for tonic stimulation, typically resulting in pain suppression without paresthesia.  
Abbott has produced both rechargeable and non-rechargeable (primary cell) systems. Primary 
cell systems contain an implanted battery of sufficient size to power the implant for its expected 
lifetime and are surgically replaced upon battery depletion. Rechargeable systems utilize a 
wireless power transfer system to allow patients to recharge the batteries of the implanted 
system. Rechargeable systems allow for longer useful life of implanted systems, especially in 
cases where higher power stimulation settings are desired. Rechargeable systems also allow 
for smaller implanted devices, as the battery does not need to be large enough to support the 
entire implant lifetime. 
The investigational device for this study is the new Gemini rechargeable SCS system, including 
IPG, charger, and supporting programmer and controller. The investigational system is 
compatible with Abbott’s existing on-market SCS leads, extensions and adapters. 
XXXXXXXXXXXXXXXXX. The investigational system also leverages Abbott’s iPad clinician 
programmer app and iPhone patient controller app to provide clinician and patient control of the 
implanted device. 

 
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1.1.2. Rationale for Conducting this Clinical Investigation 
The benefits of SCS and BurstDR therapy are well established. The Gemini SCS system 
introduces a novel IPG, charger, and supporting applications. Extensive testing has been 
performed to demonstrate safety, functionality, usability, and efficacy of these devices and this 
study is designed to further support those data with clinical experience. Many facets of the 
system leverage Abbott’s existing on-market technologies such as approved leads, iOS patient 
controller and clinician programmer applications, patient contacting materials etc., which have 
been demonstrated as safe through previous testing and field experience. The study focuses on 
safety events that could be attributed to the new charging system and is designed to detect any 
serious effects caused by the new component of the system. The study further supports the 
Gemini SCS system under the European Medical Devices Regulation (EU MDR) which requires 
the manufacturer to generate sufficient clinical evidence on the device for CE-Mark. This 
standard is internationally recognized, XXXXXXXXXXXXXXXXX. 
 
 
 

 
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2. 
CLINICAL INVESTIGATION OVERVIEW 
2.1. 
Clinical Investigation Objective 
2.1.1. Primary Objective 
The objective of this study is to collect confirmatory data to show that the Gemini SCS 
neuromodulation system functions as intended in a clinical setting.  
2.2. 
Devices Used in the Clinical Investigation 
2.2.1. Name of the Devices Under Investigation 
The following investigational components of the Gemini SCS neuromodulation system will be 
used in this clinical investigation: 
 
Device name 
Model 
Manufacturer 
Region 
Investigational or 
Market Released 
Gemini SCS IPG 
32400 
Abbott 
Australia, Europe 
 
 
 
 
 
 
 
 
 
 
 
 
Investigational 
 
 
 
 
 
 
 
 
 
 
 
 
Gemini Wireless 
Charger 
16000 
Gemini Clinician 
Programmer App  
55600 
Gemini Patient 
Controller App  
55500 
IPG Pocket Sizer 12720 
IPG Port Plug 
12710 
Charger AC 
Adapter 
16720 
Charging 
Apparel, SCS 
(reusable) 
16750 
Gemini Charging 
Cable 
16710 
 
 
These investigational components are used with on-market leads and accessories 
(CL1014851).  
2.2.2. Indication for Use 
This neurostimulation system is indicated as an aid in the management of chronic, intractable 
pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: 

 
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failed back surgery syndrome, intractable low back and leg pain, angina pectoris and peripheral 
vascular disease. 
2.2.3. Description of the Devices Under Investigation 
The Gemini SCS IPG is a 16-channel, rechargeable electronic device designed to be connected 
to one or more leads with up to 16 total electrodes. The IPG is powered by a hermetically 
sealed rechargeable battery within a titanium case and uses microelectronic circuitry to 
generate constant-current electrical stimulation to nerve structures. A wireless charger placed 
over the IPG recharges the battery of the implanted device. The IPG and wireless charger 
communicate via Bluetooth with an external programmer and a patient control device. The 
external programmer enables the clinicians to adjust and fine-tune the low intensity pulses of 
current that stimulate the nerve structures. Patients are provided with a controller to further 
control and assess the status of the system.  
 
Additional information and details on the components of the Gemini rechargeable SCS system 
are available in the Investigator Brochure. 
2.2.4. Summary of Preclinical Studies 
The Gemini Investigator Brochure contains details of bench testing and preclinical studies 
conducted with the Gemini rechargeable SCS system.   
3. 
CLINICAL INVESTIGATION DESIGN 
This is a pre-market, prospective, single-arm, non-randomized, open-label multi-center clinical 
study designed to show that the Gemini SCS neurostimulation system functions as intended in 
a clinical setting. 
 
The study is designed to report on 20 subjects who receive a Gemini SCS implant and complete 
follow-up. XXXXXXXXXXXXXXXXX. The clinical investigation will be conducted at up to 8 
centers in Australia. 
 
The Sponsor has designed this clinical investigation to involve as little pain, discomfort, fear, 
and any other foreseeable risk as possible for subjects. Refer to the Risks Analysis section of 
this clinical investigation plan for details.  
3.1. 
Clinical Investigation Procedures and Follow-up Schedule 
The flowchart and the follow-up requirements of this clinical investigation are described below. 
Enrollment, baseline and permanent implant can occur on the same day. 
 
 
 
 

 
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Figure 1: Clinical Investigation Flowchart 
 
 
 
Enrollment 
Baseline (0-15 days post 
enrollment)  
Permanent implant visit 
(following baseline and within 
60 days of enrollment) 
 
2 week follow-up visit (10-14 
days post implant) 
 
6 week follow-up visit (30-45 
days post implant)  

 
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3.2. 
Measures Taken to Avoid and Minimize Bias 
An independent Clinical Events Committee (CEC) will adjudicate all serious adverse events, 
including all deaths, and all non-serious device- and procedure-related adverse events. 
3.3. 
Suspension or Early Termination of the Clinical Investigation 
While no formal statistical rule for early termination of the clinical investigation for insufficient 
effectiveness of the device under investigation is defined, the Sponsor reserves the right to 
discontinue the clinical investigation at any stage or reduce the follow-up period with suitable 
written notice to the investigator. Possible reason(s) may include, but are not limited to: 
• Unanticipated adverse device effect (e.g., UADE) occurs and it presents an unreasonable 
risk to the participating subjects 
• Further product development is cancelled 
 
If the Sponsor discontinues the clinical investigation, sites will follow subjects per routine 
hospital practice with device-related AEs reported to the Sponsor as per vigilance/commercial 
reporting requirements. The investigator shall return all clinical investigation materials (including 
devices that are not currently implanted) to the Sponsor and provide a written statement to the 
EC (if applicable). All applicable clinical investigation documents shall be subject to the same 
retention policy as detailed in Section 11.5 of the CIP.  
 
If the Sponsor suspends or prematurely terminates the clinical investigation at an individual site 
in the interest of safety, the Sponsor will inform all other Principal Investigators. 
 
If suspension or premature termination occurs, the Sponsor will remain responsible for providing 
resources to fulfill the obligations from the CIP and existing agreements for following the 
subjects enrolled in the clinical investigation, and the Principal Investigator or authorized 
designee will promptly inform the enrolled subjects at his/her site, if appropriate. 
 
A Principal Investigator, EC, or regulatory authority may also suspend or prematurely terminate 
participation in the clinical investigation at the investigational site for which they are responsible. 
The investigators will follow the requirements specified in the Clinical Trial Agreement.  
 
If a suspended investigation is to be resumed, a prior approval should be obtained from the EC 
and a notification should be sent to the regulatory bodies. 
4. 
ENDPOINTS  
4.1. 
Confirmatory Safety Endpoint 
The confirmatory safety endpoint is the rate of serious adverse events adjudicated as related to 
the investigational IPG and/or charging system. No formal hypothesis test will be evaluated, but 
data for the endpoint will be used to confirm whether Gemini SCS system functions as intended. 
4.2. 
Additional Endpoints 
Additional endpoints are reported using descriptive statistics, without hypothesis testing: 

 
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• All serious adverse events 
• Non-serious adverse events related to device, procedure, stimulation, charging, or MRI 
(investigational device and on-market devices) 
 
Additional data collected: 
 
• Patient satisfaction 
• Patient experience with charging 
• NRS score change 
• PROMIS-29 change  
• Charging history 
• Stimulation programs used 
• Stimulation programs available 
 
5. 
SUBJECT SELECTION AND WITHDRAWAL  
5.1. 
Subject Population 
This clinical investigation will enroll subjects scheduled to receive a Gemini SCS implant for an 
approved chronic pain indication. Patients must meet all general eligibility criteria and provide 
written informed consent prior to sites conducting any investigation-specific procedures not 
considered standard of care.  
5.2. 
Subject Recruitment/Screening and Informed Consent 
5.2.1. Subject Recruitment and Screening 
A member of the site’s clinical investigation team previously trained to the CIP must evaluate 
patients for the general clinical investigation eligibility criteria, and if applicable, will enter the 
patients into a site-specific screening log.  A patient who does not satisfy all general eligibility 
criteria prior to informed consent is considered a screen failure and should not be enrolled in the 
clinical investigation. 
 
Sites will ask patients meeting all inclusion criteria and no exclusion criteria to sign an Informed 
Consent form following the established Informed Consent process (described in Section 5.2.2) 
to participate in the clinical investigation. Sites will enter these patients into the screening log. 
Once a duly dated and signed Informed Consent form is obtained, the clinical investigation-
specific procedures may begin. 
5.2.2. Informed Consent 
The Investigator or an authorized designee (if applicable) will conduct the Informed Consent 
process, as required by applicable regulations and the center’s EC. This process will include a 
verbal discussion with the patient on all aspects of the clinical investigation that are relevant to 
the patient’s decision to participate, such as details of clinical investigation procedures, 

 
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anticipated benefits, and potential risks of clinical investigation participation. Sites must inform 
patients about the right to withdraw from the clinical investigation at any time and for any reason 
without sanction, penalty, or loss of benefits to which the patient is otherwise entitled. 
Withdrawal from the clinical investigation will not jeopardize future medical care or relationship 
with the investigator.  
 
During the discussion, the Principal Investigator or an authorized designee will avoid any 
improper influence on the patient and will respect patient’s legal rights. Financial incentives will 
not be given to patients. Patients may be compensated for time and travel directly related to the 
participation in the clinical investigation. The site shall provide the patient with the Informed 
Consent form written in a language that is understandable to the patient and that has been 
approved by the center’s EC. The patient shall have adequate time to review, ask questions, 
and consider participation. The Principal Investigator or an authorized designee will make 
efforts to ensure that the patient understands the information provided. If the patient agrees to 
participate, the patient must sign and date the Informed Consent form, along with the person 
obtaining the consent prior to any clinical investigation-specific procedures. The site will file the 
signed original in the patient’s hospital or research charts and provide a copy to the patient. All 
serious adverse events and any device-related adverse events as defined in Section 7.1 are 
reportable once a subject has signed and dated the ICF. 
 
Sites will report any failure to obtain informed consent from a patient to the Sponsor within 5 
working days and to the reviewing center’s EC according to the EC’s reporting requirements. 
 
If, during the clinical investigation, new information becomes available that can significantly 
affect a subject's future health and medical care, the Principal Investigator or authorized 
designee (if applicable) will provide this information to the subject. If relevant, sites will ask the 
subject to confirm their continuing informed consent in writing. 
5.2.2.1. Special Circumstances for Informed Consent  
This clinical investigation excludes individuals unable to make the decision to participate in a 
clinical investigation on their own or who are unable to fully understand all aspects of the 
investigation that are relevant to the decision to participate, or who could be manipulated or 
unduly influenced as a result of a compromised position, expectation of benefits or fear of 
retaliatory response. This clinical investigation excludes individuals under the age of 18 or age 
of legal consent from the clinical investigation population. The clinical investigation excludes 
Individuals unable to read or write. The clinical investigation excludes pregnant or breastfeeding 
women.  
 
 
 
 

 
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5.3. 
Eligibility Criteria 
5.3.1. General Eligibility Criteria 
Assessment for general eligibility criteria is based on medical records of the site and interview 
with a candidate patient. Patients must meet all inclusion criteria to participate in the clinical 
investigation. If any exclusion criteria are met, the patient is excluded from the clinical 
investigation and cannot be enrolled (screen failure). 
 
If any clinical and/or laboratory tests are required for patient screening and are not included in a 
site’s standard tests, they must be completed after written informed consent is obtained.  
5.3.2. Inclusion Criteria 
1. Subject is indicated for an SCS system, or has an implanted SCS system and is 
scheduled to receive an IPG replacement.  
2. Subject is scheduled to receive a new IPG permanent implant and has completed a 
successful SCS trial in the last 6-months, OR subject is scheduled to undergo an all-in-
one procedure OR has an implanted SCS system for an approved chronic pain 
indication. 
3. Subject has a documented NRS pain score of ≥ 6 after at least 5 days without 
stimulation OR has an implanted functioning SCS system with NRS pain score of ≤ 4.  
4. Subject must provide written informed consent prior to any clinical investigation-related 
procedure. 
5. Subject is at least 18 years at the time of enrollment. 
6. Subject is capable and willing to recharge an implanted IPG.   
5.3.3. Exclusion Criteria 
1. Subject’s SCS trial was unsuccessful. 
2. Subject is currently participating, or intends to participate, in another clinical investigation 
that may confound the results of this study, as determined by Abbott. 
3. Subject has or will receive more than one IPG. 
4. Subject is pregnant or breastfeeding or plans to become pregnant during the clinical 
investigation follow-up period. 
5. Subject has other anatomic or comorbid conditions, or other medical, social, or 
psychological conditions that, in the investigator’s assessment, could limit the subject’s 
ability to participate in the clinical investigation. 
 
6. Subject has or is scheduled to receive an intrathecal pump. 
7. Subject is part of a vulnerable population (section 5.2.2 of the clinical 
investigational plan). 
5.4. 
Subject Enrollment 
A subject is considered enrolled in the study when the following conditions are met: 
1. Subject has provided written informed consent, and 
2. Subject has been determined to meet all inclusion/exclusion criteria. 

 
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5.5. 
Subject Withdrawal and Discontinuation 
Each subject meeting all eligibility criteria shall remain in the clinical investigation until 
completion of the required follow-up period; however, a subject’s participation in any clinical 
investigation is voluntary. The subject has the right to withdraw at any time without penalty or 
loss of benefit. Conceivable reasons for discontinuation may include the following: 
 
• Subject does not have the Gemini neurostimulation system implanted within 60 days of 
enrollment 
• Subject death 
• Subject voluntary withdrawal  
• Subject is lost to follow-up as described below  
• Subject’s follow-up is terminated according to Section 3.3 
• Subject’s Gemini rechargeable SCS system has been explanted 
• Subject’s trial was unsuccessful (for ‘all-in-one’ procedures) 
 
Sites must notify the Sponsor of the reason for subject discontinuation. Investigators must also 
report this to their respective EC as defined by their institution’s procedures.  
 
No additional follow-up is required or data recorded from subjects once withdrawn from the 
clinical investigation. 
 
However, if a subject withdraws from the investigation due to problems related to the safety or 
performance of the device under investigation, the investigator shall ask for the subject's 
permission to follow the subject’s condition outside of the clinical investigation. 
 
 
Lost to Follow-up 
 
If the subject misses the scheduled 6-week follow-up visit and the attempts at contacting the 
subject detailed below are unsuccessful, then the subject is considered lost to follow-up. Site 
personnel shall make all reasonable efforts to locate and communicate with the subject (and 
document these efforts in the source documents), including the following: 
• A minimum of two telephone calls or electronic communications on different days over the 
specified follow-up window to contact the subject should be recorded in the source 
documentation, including date, time and initials of site personnel trying to make contact. 
• If these attempts are unsuccessful, the site should send a letter (certified if applicable) to 
the subject. 
 
Note: Telephone contact with a General Practitioner, another physician or a relative without the 
presence of the subject, as well as indirect documentation obtained via discharge letters, will 
not be considered as subject contact. 
 
 

 
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5.6. 
Number of Subjects  
The study is designed to report on 20 subjects who receive a Gemini SCS implant and complete 
follow-up. XXXXXXXXXXXXXXXXX. 
5.7. 
Total Expected Duration of the Clinical Investigation 
Subjects participating in this clinical investigation will be followed for approximately 6 weeks 
after the permanent implant procedure. XXXXXXXXXXXXXXXXX. 
6. 
TREATMENT AND EVALUATION OF ENDPOINTS 
6.1. 
Baseline/Pre-procedure 
6.1.1. Baseline Assessments 
Baseline visit should occur no more than 15 days after enrollment. If an SCS trial was 
performed, baseline pain and functional assessments should be made after at least 5 days 
without stimulation. If it is not possible to have stimulation off for at least 5 days, baseline data 
may be obtained from medical records from the last 6 months. The baseline pain score reported 
should be the score used to evaluate the inclusion and exclusion criteria (no stimulation NRS ≥ 
6, stimulation NRS ≤ 4). The following baseline data will be collected: 
 
• 
Patient demographics 
• 
Pain diagnosis (specifically the subject's primary indication for neuromodulation) and 
pain location 
• 
Pain history (time with chronic pain, previous treatment) 
• 
Prior interventions (e.g. physical therapy, injections, surgeries) to treat the presenting 
condition 
• 
Numeric Rating Scale (NRS) for pain intensity  
• 
PROMIS-29   
• 
Adverse events (if applicable) 
6.2. 
Permanent System Implant 
Implantation of the neurostimulation system will be performed according to the sites standard 
operating procedures and should be consistent with instructions in the IFU. It should be performed 
after the baseline assessments and no later than 60 days from the enrollment visit. If it has not 
occurred within 60 days after Enrollment, the subject will be withdrawn (Section 5.5). Following 
system implantation, the stimulator will be activated and programmed by trained personnel either 
during post-operative recovery or at an office visit in accordance with the physician’s and 
hospital’s standard operating procedures. The subject’s spinal cord stimulator will be programmed 
according to the most recent Abbott programming guidance. After programming, the subject will 
receive a patient programmer and will be instructed on how to use the system to relieve their pain. 
 
The investigator or delegate will instruct the subject on use of the charger, including weekly 
charging after the initial wound healing period. 

 
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A charging plan for the patient should satisfy the following criteria: 
• 
First battery charge prior to attending the 2-week follow up visit 
• 
Weekly battery charge after 2 weeks 
 
The following information will be collected at the permanent system implant:  
 
• 
Neurostimulation system device information 
• 
Lead type(s) and location 
• 
Programming parameters subject is using at the end of device activation 
• 
All serious adverse events including deaths (if applicable) 
• 
Non-serious adverse events related to device, procedure, stimulation, charging, or MRI (if 
applicable) 
• 
Withdrawal (if applicable) 
• 
Device deficiency (if applicable) 
• 
Additional Surgery (if applicable) 
6.3. 
Follow-up Assessments  
6.3.1. 2-Week Follow-up (In-Person, Phone Call or Telehealth Visit) 
A 2-week follow-up visit, which may occur in person, by telephone or as a telehealth visit, will 
occur 10-14 days after permanent implant. The 2-week follow-up visit provides an opportunity 
for the site to confirm that the patient understands the charging plan and has the opportunity to 
report any adverse events. If the clinician programmer is connected to the subject’s IPG all 
reports will be downloaded. The following data will be collected: 
 
• 
All serious adverse events including deaths (if applicable) 
• 
Non-serious adverse events related to device/procedure/stimulation/charging/MRI (if 
applicable) 
• 
Charging history (if applicable)  
• 
Stimulation programs used since permanent implant (if applicable)  
• 
Stimulation programs available at the end of the visit (if applicable)  
• 
Withdrawal (if applicable) 
• 
Device Deficiency (if applicable) 
• 
Additional Surgery (if applicable) 
6.3.2. 6-Week Follow-up (In-Person Visit) 
Subjects will be followed at a 6-week follow-up visit that will occur 30-45 days after permanent 
implant. The following data will be collected: 
 
• 
All serious adverse events including deaths (if applicable)  
• 
Non-serious adverse events related to device, procedure, stimulation, charging, or MRI (if 
applicable)  

 
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• 
NRS  
• 
PROMIS-29  
• 
Patient satisfaction 
• 
Patient charging experience 
• 
Charging history 
• 
Stimulation programs used since permanent implant 
• 
Stimulation programs available at the end of the visit 
• 
Withdrawal (if applicable) 
• 
Device Deficiency (if applicable) 
• 
Additional Surgery (if applicable)  
 
During the 6-week follow-up visit, site personnel will connect to the subject’s IPG using the CP. 
Site personnel will use the CP to collect the charging history, programming and program use 
details as PDF files. 
6.3.3. Patient Reported Outcome (PRO) Measures  
The Coordinator or designee will administer the patient-reported outcome questionnaires, via 
paper for later transcription to EDC. It is important the subject understands the meaning of all 
words and instructions in the questionnaires. The subject should be instructed to ask any 
questions about the questionnaires if further explanation is needed. Once the questionnaires 
are completed, the Coordinator or designee will review for completeness to verify that all 
questions have been answered according to the directions provided. 
 
The following validated PRO measures will be collected: 
• 
NRS for pain intensity  
• 
PROMIS-29  
The pain NRS consists of 1 question that will be asked by interviewing the subjects. Patients will 
be asked to rate, from 0 (no pain) to 10 (worst imaginable pain), their pain at the time of study 
visit specific to the area(s) of chronic pain being treated. A higher score indicates greater pain 
intensity. 
6.3.3.2. Patient-Reported Outcome Measure Information System (PROMIS-29)  
The PROMIS-29 is an adult scale developed in partnership with the National Institutes of Health 
(NIH) in the United States to estimate overall quality of life by assessing the following domains 
known to impact activities of daily living: physical function, sleep disturbance, depression, 
anxiety, fatigue, pain interference, pain intensity, and social role satisfaction. The scale requires 
subjects to rate the frequency and/or severity of symptoms and experiences related to each of 
these domains. A total score is calculated and transformed against normative data into a t score 
indicating global quality of life in relation to population norms. Subscales are defined by each 
domain described above and can be examined separately to parse separate symptoms or 
deficiencies in quality of life. The final item is an 11-point pain intensity numerical rating scale 
(NRS) by which the subject rates their average pain over the past 7 days. Subjects should read 
each item and check the one box that most closely represents their response. 

 
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6.3.4. Unscheduled Visits 
An unscheduled visit is defined as a visit that occurs between the required follow-up visits for 
non-standard of care issues, such as a potential or actual adverse event. If the clinician 
programmer is connected to the subject’s IPG all reports will be downloaded. Any data collected 
related to the clinical study endpoint should be documented by completing the appropriate CRF 
(see schedule of events table).  
Following an unscheduled visit, the subject will be seen for the next scheduled study visit within 
window. 
 
6.3.5. Schedule of Events 
 
 

 
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CIP Activity 
Enrollment 
Baseline 
Permanent 
Implant 
Procedure 
Follow-up visits 
2-week (10-14 
days post 
implant) 
Follow-up visits 
6-week (30-45 
days post 
implant) 
Unscheduled visit 
Subject evaluated for 
eligibility 
X 
 
 
 
 
 
Informed Consent 
Process 
X 
 
 
 
 
 
Demographics 
 
X 
 
 
 
 
Medical History  
 
X 
 
 
 
 
Pain diagnosis and pain 
location 
 
X 
 
 
 
 
NRS for pain intensity 
 
X 
 
 
X 
 
PROMIS-29 
 
X 
 
 
X 
 
Patient charging 
experience  
 
 
 
 
X 
 
Patient Satisfaction 
 
 
 
 
X 
 
Implant procedure and 
system data 
 
 
X 
 
 
 
Device Programming  
 
 
X 
(X) 
X 
(X) 
Charging History 
 
 
 
(X) 
X 
(X) 
Stimulation programs 
used  
 
 
 
(X) 
X 
(X) 
Stimulation programs 
available 
 
 
X 
(X) 
X 
(X) 
Device deficiency 
 
 
(X) 
(X) 
(X) 
(X) 
Additional surgery 
(System revision, 
Replacement/Explant) 
 
 
 
(X) 
(X) 
(X) 
Serious adverse events 
 
(X) 
(X) 
(X) 
(X) 
(X) 
Procedure- Device- 
charger- stimulation- MRI- 
related Adverse Events 
 
 
(X) 
(X) 
(X) 
(X) 
Withdrawal 
 
(X) 
(X) 
(X) 
(X) 
(X) 
(X)-Indicates event may occur at visit 
 

 
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7. 
Adverse Events 
To comply with worldwide standards and guidelines on clinical investigation adverse event 
reporting, the Sponsor has adopted uniform and worldwide applicable standard definitions and 
reporting timelines to be used and adhered to by the investigators.  
7.1. 
Definition 
7.1.1. Adverse Event 
An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (including abnormal laboratory findings) in subjects, users or other 
persons, whether or not related to the medical device under investigation. 
 
As part of ISO14155 Section 3.2, the Adverse Event definition has the following notes: 
 
Note 1: This definition includes events related to the medical device under investigation or the 
comparator. 
Note 2: This definition includes events related to the procedures involved. 
Note 3: For users or other persons, this definition is restricted to events related to medical 
devices under investigation. 
7.1.2. Serious Adverse Event 
If the AE meets any of the criteria below, it is regarded as a serious adverse event (SAE).  
 
a) Led to a death, 
b) Led to a serious deterioration in health of the subject, that either resulted in  
1. a life-threatening illness or injury, or 
2. a permanent impairment of a body structure or a body function, or 
3. in-patient hospitalization or prolongation of existing hospitalization, or 
4. medical or surgical intervention to prevent life threatening illness or injury or 
permanent impairment to a body structure or a body function. 
5. chronic disease  
c) Led to fetal distress, fetal death or a congenital abnormality or birth defect. 
 
Note: A planned hospitalization for a pre-existing condition, or a procedure required by the CIP 
without a serious deterioration in health, is not considered to be an SAE. 
 
7.1.3. Device Deficiency/Device Malfunction (if applicable) 
 
Device deficiency is defined as an inadequacy of a medical device related to its identity, quality, 
durability, reliability, safety or performance, such as malfunction, misuse or use error and 
inadequate labeling. This includes the failure of the device to meet its performance 

 
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specifications or otherwise perform as intended. Note: performance specifications include all 
claims made in the labeling of the device. 
 
A device malfunction is the failure of a device to meet its performance specifications or 
otherwise perform as intended, when used in accordance with the instructions for use or CIP. 
 
 
 

 
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7.2. 
Device Relationship 
Determination of whether there is a reasonable possibility that an investigational product or 
device under investigation caused or contributed to an AE is to be determined by the 
Investigator and recorded on the appropriate CRF form. Determination should be based on the 
assessment of temporal relationships, evidence of alternative etiology, medical/biologic 
plausibility and patient condition (pre-existing condition). 
7.2.1. Unanticipated (Serious) Adverse Device Effect [U(S)ADE] 
Unanticipated serious adverse device effect (USADE) refers to any serious adverse effect on 
health or safety or any life-threatening problem or death caused by, or associated with, a 
device, if that effect, problem or death was not previously identified in nature, severity, or 
degree of incidence in the investigational plan or application (including a supplementary plan or 
application), or any other unanticipated serious problem associated with a device that relates to 
the rights, safety, or welfare of subjects. 
7.3. 
Adverse Event and Device Deficiency/Device Malfunction Reporting 
7.3.1. Adverse Event Reporting 
Safety surveillance and reporting starts as soon as the patient completes the ICF. All serious 
adverse events and any device-related adverse events, including those observed during the 
implant procedures and all-in-one/ on-table trials, will be reported. 
 
Safety surveillance and reporting will continue until the subject performs the last follow-up visit, 
the subject is deceased, the subject concludes participation in the clinical investigation, or the 
subject withdraws from the clinical investigation.  All serious and non-serious procedure- and 
device-related adverse event data, including deaths and device deficiency data, will be collected 
throughout the life of the study and will be reported to the Sponsor on a CRF. Additional 
information with regards to a procedure- and device-related adverse event should be updated 
within the appropriate CRF. 
 
Unchanged, chronic, non-worsening or pre-existing conditions are not AEs and should not be 
reported.  
 
The Sponsor will provide an offline form to allow the investigator to report SAEs in the event the 
entry cannot be made in the EDC. This does not replace the EDC reporting system. Sites must 
still enter all information in the EDC system as soon as feasible. 
 
SAE Reporting 
The investigator must report all SAEs to the Sponsor as soon as possible but no later than 
outlined below.  
 
Clinical Site 
Reporting timelines 
All Sites 
Sites must report SAEs to the Sponsor no later than 3 calendar days 
from the day the site personnel became aware of the event or as per 

 
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the investigative site’s local requirements, if the requirement is more 
stringent than those outlined. 
 
 
Sites must record the date the site staff became aware that the event met the criteria of an SAE 
in the source document.  The Investigator will further report the SAE to the local EC according 
to the institution’s EC reporting requirements. 
 
The following adverse events will be collected in this study for investigational devices as well as 
the approved devices: 
• 
All serious adverse events including deaths 
• 
Non-serious adverse events related to device/procedure/stimulation/Charging/MRI 
• 
USADE 
• 
DD 
7.3.2. Unanticipated Serious Adverse Device Effect Reporting to Sponsor and IRB (if 
applicable) 
The Sponsor requires the Investigator to report any USADE to the Sponsor within 3 calendar 
days of the investigator’s knowledge of the event, unless local requirements are more stringent, 
and to the EC per EC requirements.  
7.3.3. Device Deficiency/Malfunction Reporting (if applicable) 
Sites should report all device deficiencies/malfunctions on the appropriate CRF form.  
 
The investigator must report all device deficiencies/malfunctions to the Sponsor as soon as 
possible but no later than outlined below.  
Clinical Sites 
Reporting timelines 
All Sites 
Sites must report device deficiencies/malfunctions to the Sponsor no later 
than 3 calendar days from the day the site personnel became aware of the 
event or as per the investigative site’s local requirements, if the requirement 
is more stringent than those outlined. 
 
Sites must report device deficiencies/malfunctions to the EC per the investigative site’s local 
requirements. 
 
In the event of a device deficiency/malfunction and the investigational device is not implanted, 
sites should return the device to the Sponsor.   
 
If investigational devices are explanted for any reason, the investigator should arrange for the 
device to be returned to the Sponsor. See appendix VII for additional details. 
 
All investigational device explant procedures shall be performed at the discretion of the study 
investigator, and should follow the specific processes of the participating site. 

 
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Sites will have access to an offline form to allow the investigator to report device 
deficiencies/malfunctions if sites cannot enter the information in the EDC system. This does not 
replace the EDC reporting system. Sites must still enter all information in the EDC system as 
soon as feasible.  
Sites should report all device deficiencies/malfunctions to the Sponsor’s Customer Service 
Department. 
7.3.4. Adverse Event Reporting to Country Regulatory Authorities by the Sponsor  
The Sponsor will report SAEs and reportable device deficiencies/malfunctions to the country 
regulatory authority, per local requirements.  
 
Note: Reportable device deficiencies/malfunctions include device deficiencies/malfunctions that 
might have led to an SAE if a) suitable action had not been taken or b) intervention had not 
been made or c) if circumstances had been less fortunate. These are handled under the SAE 
reporting system. 
8. 
STATISTICAL CONSIDERATIONS 
The following section describes the statistical methods for the clinical investigation. A separate 
Statistical Analysis Plan (SAP) will provide additional details on statistical analyses. 
8.1. 
Analysis Populations 
1. 
The following populations will be used in the analyses for this study.  
1. XXXXXXXXXXXXXXXXX. 
2. XXXXXXXXXXXXXXXXX. 
8.2. 
Statistical Analyses  
This section describes the analysis for the confirmatory safety endpoint and additional 
endpoints. Further details are provided in the Statistical Analysis Plan.  
8.2.1. Confirmatory Safety Endpoint  
The confirmatory safety endpoint for this study is the rate of SAEs related to the IPG and/or 
charging system. 
 
The confirmatory endpoint will be summarized as the number and percentage of subjects with 
IPG and/or charging system related SAEs, along with exact 95% Clopper-Pearson confidence 
intervals.   
8.2.2. Additional Endpoints 
Descriptive summary statistics will be presented for additional endpoints. Continuous variables 
will be summarized using mean and standard deviation. Categorical variables will be 
summarized using counts and percentages. The 95% confidence intervals for each type of data 
will be provided as appropriate. 

 
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8.3. 
Sample Size Calculation  
[5, 7-9] XXXXXXXXXXXXXXXXX 
8.4. 
 Timing of Analysis 
The analysis will be performed after all enrolled subjects have completed their 6-week visits or 
withdrawn from study. 
8.5. 
Planned Interim Analysis 
XXXXXXXXXXXXXXXXX. 
8.6. 
Withdrawal from the study 
If a subject withdraws from the study prior to the permanent IPG implant procedure, that subject 
shall be reported, excluded from analysis of endpoints except for a serious adverse event. If a 
subject withdraws after permanent implant procedure has begun, that subject shall be reported 
and included in the analysis of endpoints for the available data. 
8.7. 
Deviations from Statistical Plan 
The Sponsor will document any major changes in an amendment to the protocol or statistical 
analysis plan (SAP), and any minor changes to the planned analysis in the final report.  
9. 
DIRECT ACCESS TO SOURCE DATA/DOCUMENTS 
 
The investigator/institution will permit direct access to source data/documents for performing 
clinical investigation-related monitoring, audits, EC review and regulatory inspections. 
 
Subjects providing informed consent are agreeing to allow clinical investigation monitors or 
regulatory authorities, including foreign countries, to review in confidence any records 
identifying the subjects in this clinical investigation. This information may be shared with 
regulatory agencies; however, the Sponsor undertakes not to otherwise release the subject's 
personal and private information. 
10. 
QUALITY CONTROL AND QUALITY ASSURANCE 
10.1. Selection of Clinical Sites and Investigators 
The Sponsor will select investigators qualified by training and experience to participate in the 
clinical investigation. Sites will be selected based upon review of a recent site assessment, if 
applicable, and the qualifications of the investigators who will participate in the clinical 
investigation.  

 
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10.2. Clinical Investigation Finances and Agreements 
Abbott will finance the clinical investigation and will compensate investigational sites for 
participation in the clinical investigation per the conditions of agreement between Abbott and the 
investigational site. 
10.3. CIP Amendments  
The Sponsor will provide approved CIP amendments to the Investigators prior to implementing 
the amendment. The Principal Investigator is responsible for notifying the EC or equivalent 
committee of the CIP amendment (administrative changes) or obtaining EC’s approval of the 
CIP amendment (changes in subject care or safety), according to the instructions provided by 
the Sponsor with the CIP amendment.   
 
Sites must document in writing acknowledgement/approval of the CIP amendment by the EC 
prior to implementation of the CIP amendment. Sites must also provide copies of this 
documentation to the Sponsor. 
10.4. Training 
10.4.1. Site Training 
All Investigators and clinical investigation personnel are required to attend Sponsor training 
sessions, which may be conducted at an Investigator's meeting, a site initiation visit, or other 
appropriate training sessions. Over-the-phone or self-training may take place as required. 
Training of Investigators and clinical investigation personnel will include, but is not limited to, the 
CIP requirements, investigational device usage, electronic case report form completion, and 
clinical investigation personnel responsibilities. All Investigators and clinical investigation 
personnel that are trained must sign a training log (or an equivalent) upon completion of the 
training. Prior to signing the training log, Investigators and clinical investigation personnel must 
not perform any CIP-related activities that are not considered standard of care at the site.  
10.5. Monitoring  
Sponsor and/or designee will monitor the clinical investigation over its duration according to the 
CIP-specific monitoring plan which will include the planned extent of source data verification.  
 
Prior to initiating any procedure, the Sponsor monitor (or delegate) will ensure that the following 
criteria are met:  
 
• 
The investigator understands and accepts the obligation to conduct the clinical 
investigation according to the CIP and applicable regulations and has signed the Clinical 
Trial Agreement. 
• 
The Investigator and his/her staff should have sufficient time and facilities to conduct the 
clinical investigation and should have access to an adequate number of appropriate 
subjects to conduct the clinical investigation.  
• 
Sites must have source documentation (including original medical records) to 
substantiate proper informed consent procedures, adherence to CIP procedures, 

 
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adequate reporting and follow-up of adverse events, accuracy of data collected on case 
report forms, and device information.  
• 
The Investigator/site will permit access to such records and will maintain a monitoring 
visit sign-in log at the site. The Investigator will agree to dedicate an adequate amount of 
time to the monitoring process. The Investigator and/or research coordinator will be 
available for monitoring visits. It is expected that the Investigator will provide the monitor 
with a suitable working environment for review of clinical investigation-related 
documents. 
10.6. Deviations from CIP 
The Investigator should not deviate from the CIP for any reason except in cases of medical 
emergencies when the deviation is necessary to protect the rights, safety, and well-being of the 
subject, or to eliminate an apparent immediate hazard to the subject. In that event, the 
Investigator will notify Sponsor immediately by phone or in writing.  
 
The Sponsor will not grant any waivers for CIP deviations.  Sites must report all deviations to 
the Sponsor using the Deviation CRF. The Sponsor will monitor the occurrence of CIP for 
evaluation of investigator compliance to the CIP and regulatory requirements and handle 
according to written procedures. Investigators will inform their EC or equivalent committee of all 
CIP deviations in accordance with their specific EC or equivalent committee reporting policies 
and procedures.  
 
In the event of repeated non-compliance, as determined by the Sponsor, a Sponsor’s monitor or 
company representative will attempt to secure compliance by one or more of the following (and 
not limited to):  
• Visiting the investigator and/or delegate 
• Telephoning the investigator and/or delegate 
• Corresponding with the investigator and/or delegate 
 
Repeated non-compliance with the signed agreement, the CIP, or any other conditions of the 
clinical investigation may result in further escalation in accordance with the Sponsor’s written 
procedures, including securing compliance or, at its sole discretion, the Sponsor may terminate 
the investigator's participation in the clinical investigation.  
10.7. Quality Assurance Audit 
A Sponsor representative or designee may request access to all clinical investigation records, 
including source documentation, for inspection during a Quality Assurance audit.  
 
If an investigator is contacted by a Regulatory Agency in relation to this clinical investigation, the 
Investigator will notify Sponsor immediately. The Investigator and Research Coordinator must 
be available to respond to reasonable requests and audit queries made during the audit 
process. The Investigator must provide the Sponsor with copies of all correspondence that may 
affect the review of the current clinical investigation (e.g., Form FDA 483, Inspectional 
Observations, Warning Letters, Inspection Reports, etc.). The Sponsor may provide any needed 
assistance in responding to regulatory audits. 

 
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10.8. Sponsor Auditing 
1. The Sponsor shall prepare an audit plan as well as the operating procedures for the 
related duties and conduct audits in accordance with the audit plan and the operating 
procedures. 
2. Individuals engaged in auditing (hereinafter referred to as "auditor") shall be different 
than those in charge of medical device development or monitoring. 
3. The auditor shall prepare an audit report documenting the matters confirmed in the audit 
to certify and verify that the audit has been conducted and submit them to the Sponsor. 
10.9. Committees (add as applicable for clinical investigation) 
10.9.1. Clinical Events Committee (CEC) 
The CEC is an independent adjudication body comprised of qualified physicians who are not 
participants in the clinical investigation. The CEC will review and adjudicate pre-specified events 
reported by investigators or identified by Safety personnel for the clinical investigation as 
defined in the CEC charter and according to definitions provided in this CIP.   
 
 

 
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11. 
DATA HANDLING AND RECORD KEEPING 
Sponsor and/or its affiliates will maintain documentation of the systems and procedures used in 
data collection for the duration of the clinical investigation.  
 
CRF data collection will be performed through a secure web portal and only authorized 
personnel will access the EDC system using a unique username and password to enter, review 
or correct data. Passwords and electronic signatures will be strictly confidential.   
 
The data will be subjected to consistency and validation checks within the EDC system and 
supplemental review by the Sponsor.    
 
At the end of the clinical investigation, completed CRF images with the date-and-time stamped 
electronic audit trail indicating the user, the data entered, and any reason for change (if 
applicable) will be provided to the investigational sites, if requested.  
 
For the duration of the clinical investigation, the Investigator will maintain complete and accurate 
documentation including, but not limited to, medical records, clinical investigation progress 
records, laboratory reports, CRFs, signed ICFs, device accountability records (if applicable), 
correspondence with the EC and clinical investigation monitor/Sponsor, adverse event reports, 
and information regarding subject discontinuation or completion of the clinical investigation. 
11.1. Protection of Personally Identifiable Information 
The Sponsor respects and protects personally identifiable information collected or maintained 
for this clinical investigation.  
 
The Sponsor implements technical and physical access controls to ensure that Personal 
Information is accessible only to and processed only on a ‘need to know ’basis, including 
periodic review of access rights, and revocation of access when an individual’s employment is 
terminated or the individual transitions to a role that does not require access to Personal 
Information, and appropriate restrictions on physical access to premises, facilities, equipment, 
and records containing Personal Information. 
 
The Sponsor requires the investigational sites to enter only pseudonymous Personal 
Information (key-coded) necessary to conduct the clinical investigation, such as the patient’s 
medical condition, treatment, dates of treatment, etc., into Sponsor’s data management 
systems. The Sponsor discloses as part of the clinical investigation informed consent process 
that some Sponsor representatives still may see Personal Information at the participating sites 
for technical support of the participating physicians on the device implant or procedures, 
monitoring and quality control purposes. All parties will observe confidentiality of Personal 
Information always throughout the clinical investigation. All reports and data publications will 
preserve the privacy of each subject and confidentiality of his/her information. 
 
The Sponsor data management systems and processes were designed, developed, and tested 
according to industry standards to appropriately safeguard Confidential Information (including 
any Personal Information) against unauthorized access and/or interference by third parties, 
intrusion, theft, destruction, loss or alteration. Clinical Investigation data are encrypted in transit 
and at rest.  

 
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The Sponsor maintains a Privacy Incident procedure that complies in all respects with 
Applicable Law and industry best practices. 
11.2. Data Management Plan 
A Data Management Plan (DMP) will describe procedures used for data review, data cleaning, 
and issuing and resolving data discrepancies. If appropriate, the Sponsor may update the DMP 
throughout the duration of the clinical investigation. The Sponsor will track and document 
control all revisions. 
11.3. Source Documentation  
Regulations and GCP require the Investigator to maintain information in the subject’s original 
medical records that corroborates data collected on the CRFs. To comply with these regulatory 
requirements/GCP, sites should include the following information in the subject record at a 
minimum and if applicable to the clinical investigation: 
• Medical history/physical condition of the subject before involvement in the clinical 
investigation sufficient to verify CIP entry criteria 
• Dated and signed notes on the day of entry into the clinical investigation referencing the 
Sponsor, CIP number, subject ID number, and a statement that informed consent was 
obtained 
• Dated and signed notes from each subject visit (for specific results of procedures and 
exams) 
• AEs reported and their resolution, including supporting documents, such as discharge 
summaries, operative notes, follow-up clinic notes, and lab results including 
documentation of site awareness of SAEs and of investigator assessment of device 
relationship for SAEs. 
• Subject’s condition upon completion of or withdrawal from the clinical investigation 
• Any other data required to substantiate data entered into the CRF 
• Patient reported outcome measures may be completed using CRF worksheets. This 
serves as source documentation. 
11.4. Case Report Form Completion  
Site research personnel trained on the CIP and CRF completion will perform the primary data 
collection clearly and accurately based on source-documented hospital and/or clinic chart 
reviews. The investigator will ensure accuracy, completeness, legibility, and timeliness of the 
data reported to the Sponsor on the CRFs and in all required reports. 
 
Sites will collect data on all subjects enrolled into the clinical investigation.   
 
Only authorized site personnel will be permitted to enter the CRF data through the EDC system 
deployed by the Sponsor. The Sponsor will use an electronic audit trail to track any subsequent 
changes of the entered data. 

 
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11.5. Record Retention 
The Sponsor and Investigator/Site will archive and retain all documents pertaining to the clinical 
investigation as per the applicable regulatory record retention requirements. The Investigator 
must obtain permission from Sponsor in writing before destroying or transferring control of any 
clinical investigation records. 
11.6. Investigational Devices Accountability 
The Sponsor ships investigational products only to the Principal Investigator (the responsible 
leader of the investigational site) or his/her legal designee of each site, after sites receive 
documentation of site activation and shipping authorization is complete.   
 
The Investigator or an authorized designee must maintain adequate records of the receipt and 
disposition of each investigational device, including part number, batch/lot number, and serial 
number (if applicable), date used, subject identification, and treating physician. 
 
Storage locations for the devices at investigational sites must be locked with access restricted 
only to investigators and authorized personnel.  
 
Sites must return all investigational devices associated with a device failure or device 
deficiency, that are not implanted, to the Sponsor.  
 
If investigational devices are explanted for any reason, the investigator should arrange for the 
device to be returned to the Sponsor. See Appendix VII for additional details. 
 
All investigational device explant procedures shall be performed at the discretion of the study 
investigator, and should follow the specific processes of the participating site. 
 
Sites must return unused investigational devices to the Sponsor.  
 
The clinical investigation will use an Inventory Accountability Log supplied by the Sponsor for 
device accountability. The Inventory Accountability Log must document the disposition of all 
investigational devices including those that have been returned to Sponsor. 
 
12. 
ETHICAL CONSIDERATION 
12.1. Ethics Committee Review and Approval 
The Principal Investigator at each investigational site will obtain EC approval for the CIP and 
ICF/other written information provided to the patient prior to consenting and enrolling patients in 
this clinical investigation. The site must receive the approval letter prior to the start of this clinical 
investigation and provide a copy to the Sponsor.  
 
Sites will submit any amendments to the CIP as well as associated ICF changes to the EC and 
written approval obtained prior to implementation, according to each institution’s EC 
requirements.  
 

 
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No changes will be made to the CIP or ICF or other written information provided to the patient 
without appropriate approvals, including EC, the Sponsor, and the regulatory agencies (if 
applicable).  
 
Until the clinical investigation is completed, the Investigator will advise his/her EC of the 
progress of this clinical investigation, per EC requirements. Written approval must be obtained 
from the EC yearly to continue the clinical investigation, or according to each institution’s EC 
requirements.  
 
Sites will not perform any investigative procedures, other than those defined in this CIP, on the 
enrolled subjects without the written agreement of the EC and the Sponsor. 
13. 
CLINICAL INVESTIGATION CONCLUSION 
The clinical investigation will be concluded when: 
• 
All sites are closed AND 
• 
The final report has been provided to investigators or the Sponsor has provided formal 
documentation of clinical investigation closure. 
The Sponsor will submit the clinical investigation report within one year of the end of the 
investigation to the investigational sites, competent authorities and reviewing IRBs and ECs. 
14. 
PUBLICATION POLICY 
The data and results from the clinical investigation are the sole property of the Sponsor. The 
Sponsor shall have the right to access and use all data and results generated during the clinical 
investigation. The Investigators will not use this clinical investigation-related data without the 
written consent of the Sponsor for any purpose other than for clinical investigation completion or 
for generation of publication materials, as referenced in the Clinical Trial Agreement. Single-
center results are not allowed to be published or presented before the multi-center results. The 
Sponsor must review and approve any proposals for publications or presentations by the 
investigators in a timely manner in compliance with the Sponsor’s publication policy set forth in 
the Clinical Trial Agreement. 
 
 
 
 
 

 
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15. 
RISK ANALYSIS 
15.1. Anticipated Clinical Benefits 
 
While there are no guaranteed clinical benefits associated with participation in this clinical study, 
it is expected that patients implanted with a Gemini SCS system will experience similar 
improvements in symptoms relating to chronic pain as patients implanted with other 
commercially available SCS neurostimulation systems such as reduction in perceived pain. 
 
XXXXXXXXXXXXXXXXX.  
 
15.2. Foreseeable Adverse Events and Anticipated Adverse Device Effects 
Risks associated with the specified device and procedure, together with their likely incidence, 
are described in the IB/IFU.  There may be risks related to the device under investigation that 
are unknown at present.  Likewise, the exact frequency of the risk is unknown. 
 
The use of a neurostimulation system involves risks. In addition to the risks commonly associated 
with surgery, below are listed the anticipated potential adverse effects with the use of a 
neurostimulation system: 
 
• 
Unpleasant sensations or motor disturbances, including involuntary movement, caused 
by stimulation at high outputs (if either occurs, turn off your EPG/IPG immediately) 
• 
Undesirable changes in stimulation, which may be related to cellular changes in tissue 
around the electrodes, or changes in electrode position relative to the spinal cord 
• 
Changes in stimulation or reduced pain relief due to lose electrical connections   
• 
Changes in stimulation or reduced pain relief due to lead failure. 
• 
Stimulation in unwanted places such as the ribs or chest  
• 
Changes in stimulation or reduced pain relief due to lead migration 
• 
Epidural hemorrhage  
• 
Hematoma  
• 
Infection  
• 
Spinal cord compression  
• 
Paralysis from placement of a lead in the epidural space 
• 
Cerebrospinal fluid (CSF) leakage 
• 
Paralysis below the level of implant 
• 
Weakness below the level of implant  
• 
Clumsiness below the level of implant  
• 
Numbness below the level of implant  
• 
Pain below the level of implant 
• 
Persistent pain at the lead site 
• 
Persistent pain at the IPG site 
• 
Seroma (mass or swelling) at the IPG site 
• 
Seroma at the lead incision site 
• 
Allergic or rejection response to device/implant materials 
• 
Implant migration  

 
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• 
Skin erosion around the implant 
• 
Loss of stimulation due to premature battery depletion or battery failure 
 
The following potential adverse events may be associated with charging the system and are listed 
as warnings or precautions in the IFU: 
 
• 
Heating or discomfort at surgical staples while recharging. Charging should not be carried 
out while staples are in place 
• 
Heating or discomfort at the pocket while recharging 
• 
Interference with another implanted medical device 
 
The following potential adverse events may occur in the MRI environment:  
 
• 
Lead electrode heating resulting in tissue damage or serious patient injury  
• 
IPG heating resulting in tissue damage in the implant pocket or patient discomfort or both  
• 
Induced currents on leads resulting in overstimulation or shocking sensations  
• 
Damage to the IPG or leads causing the system to fail to deliver stimulation or causing 
the system to deliver overstimulation  
• 
Damage to the functionality or mechanical integrity of the IPG resulting in the inability to 
communicate with the IPG  
• 
Movement or vibration of the IPG or leads  
 
15.3. Residual Risks Associated with the Device Under Investigation, as 
Identified in the Risk Management Report / Risk Analysis Report 
All risks have identified risks have been mitigated as far as possible through application of 
appropriate controls and inspections and determined to be within acceptable levels.   
Residual risks are disclosed in the IFU in the form of clear instructions of what actions to take or 
to avoid, to avoid a hazardous situation of harm from occurring (contra-indications, warnings, 
and precautions). The anticipated AEs disclosed in the IFU (and CIP Appendix V) provide 
further information to enable the user, and potentially the patient, to make an informed decision 
that weighs the residual risk against the benefit of using the device. 
A detailed description of the risk analysis process, residual risks, and associated mitigations is 
presented in the Investigators Brochure (CL1014827).  
15.4. Risks Associated with Participation in this Clinical Investigation 
The risks involved with this study are comparable to those associated with the implant of any 
other commercially available neurostimulation system. Risks specific to Abbott 
neurostimulation systems are outlined in the associated IFU, and these disclosed risks are 
not modified by participation in this study. 
 
15.5. Steps Taken to Control or Mitigate Risks 
The Sponsor will employ measures throughout the course of this study to minimize these risks 
such as clearly defined inclusion and exclusion criteria, proper consenting process, selection of 
investigational sites that have a sufficient level of clinical expertise, investigator selection, and 

 
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appropriate training for all involved in the study activities. In-depth recommendations, special 
precautions and instructions regarding patient selection, device handling, device placement and 
system removal are included in IFU documents of all devices included in this study. All device-
related adverse events and device deficiencies will be reported to the Sponsor and will be 
monitored internally for safety surveillance purposes. 
15.6. Risk to Benefit Rationale 
The risks associated with Abbott’s neurostimulation systems are anticipated to be comparable 
to those associated with the use of other commercially available neurostimulation systems. The 
patients participating in this study are indicated for using a neurostimulation system as part of 
their standard medical management and are subject to the risks associated with these devices. 
Refer to the Investigational Brochure for details.  
 
15.7. References 
 
1. 
Dahlhamer, J., et al., Prevalence of Chronic Pain and High-Impact Chronic Pain Among 
Adults - United States, 2016. MMWR Morb Mortal Wkly Rep, 2018. 67(36): p. 1001-
1006. 
2. 
Gaskin, D.J. and P. Richard, The economic costs of pain in the United States. J Pain, 
2012. 13(8): p. 715-24. 
3. 
Rudd, R.A., et al., Increases in Drug and Opioid-Involved Overdose Deaths - United 
States, 2010-2015. MMWR Morb Mortal Wkly Rep, 2016. 65(50-51): p. 1445-1452. 
4. 
Deer, T., et al., Success Using Neuromodulation With BURST (SUNBURST) Study: 
Results From a Prospective, Randomized Controlled Trial Using a Novel Burst 
Waveform. Neuromodulation, 2018. 21(1): p. 56-66. 
5. 
Falowski, S.M., et al., Improved Psychosocial and Functional Outcomes and Reduced 
Opioid Usage Following Burst Spinal Cord Stimulation. Neuromodulation, 2020. 
6. 
Deer, T.R., et al., Novel Intermittent Dosing Burst Paradigm in Spinal Cord Stimulation. 
Neuromodulation, 2020. 
7. 
XXXXXXXXXXXXXXXXX 
8. 
XXXXXXXXXXXXXXXXX 
9. 
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APPENDIX I: ABBREVIATIONS AND ACRONYMS 
AE 
Adverse Event 
CEC 
Clinical Events Committee 
CIP 
Clinical Investigation Plan 
CP 
Clinician Programmer 
CRF 
Case Report Form 
DD 
Device Deficiency 
DMP 
Data Management Plan 
EC 
Ethics Committee 
EDC 
Electronic Data Capture 
FAS 
Full Analysis Set 
GCP 
Good Clinical Practice 
IB 
Investigator Brochure 
ICF 
Informed Consent Form 
IFU 
Instructions for Use 
IPG 
Implantable Pulse Generator 
MRI 
Magnetic Resonance Imaging 
NRS 
Numerical Rating Scale 
PRO 
Patient Reported Outcome 
PROMIS Patient-Reported Outcomes Measurement Information System 
SAE  
Serious Adverse Event 
SCS 
Spinal Cord Stimulation 
SD 
Standard Deviation 
UADE 
Unanticipated Adverse Device Effect 
USADE 
Unanticipated Serious Adverse Device Effect 
 
 
 
 

 
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APPENDIX II: SITE CONTACT INFORMATION 
Contact information for each participating clinical site is available under a separate 
cover by contacting the Sponsor at: 
 
Abbott 
6901 Preston Rd 
Plano, TX 75024 
 

 
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APPENDIX III: LABELS 
IFU documents will be kept under a separate cover and are available upon request.  
 
 

 
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APPENDIX IV: CASE REPORT FORMS 
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APPENDIX V: INFORMED CONSENT FORM 
The study specific sample Informed Consent Form will be kept under a separate cover and is 
available upon request. 
 
 
 
 

 
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APPENDIX VI: MONITORING PLAN 
A copy of the Monitoring Plan can be obtained upon request from the Sponsor Clinical Project 
Manager for the clinical investigation. 
 
 

 
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APPENDIX VII: EXPLANT, RETURN AND ANALYSIS OF THE IPG 
The disposition of explanted Gemini SCS IPGs warrants special consideration, as their proper 
return will allow for analysis, providing valuable information on performance and possible failure 
modes. 
 
Clinical study sites’ responsibilities for explant and return of the device: Abbott requests 
that all Gemini SCS IPGs which are explanted by the investigators, or are explanted at other 
sites and recoverable by the investigators, be returned to Abbott as follows: 
• 
Contact the Abbott clinical manager(s) for the study as soon as it is learned that the IPG 
will be (or has been) explanted. The clinical manager(s) will provide shipping instructions 
to ensure the IPG is delivered to Abbott Neuromodulation’s Product Performance group 
for failure analysis. Note: Device(s) shall be shipped to the return address as soon as 
possible and no later than 15 calendar days. 
• 
Used devices may present a health hazard.  All possible safety measures shall be taken 
when handling used or explanted products to reduce the potential for staff to come into 
physical contact with potentially contaminated devices.  Ensure that the device is free of 
gross contamination.  If necessary, remove moisture by wiping with a dry cloth or towel.  
Note: Do not sterilize or sanitize the device. 
• 
Place the device in a leakproof biohazard container or bag, and seal. 
• 
Place the biohazard container or bag into a Device Return Kit. Include sufficient packing 
materials so that the biohazard container or bag is packed snugly.  The outer packaging 
must be clearly labelled as “Biohazard”. 
• 
If the explant is associated with any alleged device deficiency, include a description of 
the deficiency.  Clearly print the Return number and/or Product Event Record (PER) 
number on the outside of the sealed box. 
• 
Follow all instructions of the Abbott clinical manager in shipping the explanted device to: 
 
Attn: Abbott Returns Department 
6901 Preston Road 
Plano TX, 75024   USA 
 
Abbott responsibilities for the analysis of an explanted and returned device: Gemini SCS 
IPGs that are explanted and returned will, upon receipt at Abbott, be evaluated according to 
Abbott’s normal failure analysis practice for returned product. 
 

 
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APPENDIX VIII: REVISION HISTORY 
 
Amendment 
Number 
Version 
Date 
Details 
Rationale 
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XXXXXX 
XXXXXX
XXXXXX
XXXXX 
XXXXXXXXXX
XXXXXXX 
XXXXXXXXXXXXXXXXX 
XXXXXXXXXXXXXXX
XX 
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XXXXXX 
XXXXXX
XXXXXX
XXXXX 
XXXXXXXXXX
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XXXXXXXXXXXXXXXXX 
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XX 
 
 
 
 

 
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APPENDIX IX: CIP SUMMARY 
Clinical 
Investigation 
Name and Number 
CRD_1030 Gemini 
Title 
Study of Gemini Rechargeable Spinal Cord Stimulation (SCS) System 
Objective(s) 
The objective of this study is to collect confirmatory data to show that the Gemini 
Spinal Cord Stimulation neuromodulation system functions as intended in a 
clinical setting.  
Device Under 
Investigation 
Gemini rechargeable Spinal Cord Stimulation (SCS) System  
Number of 
Subjects Required 
for Inclusion in 
Clinical 
Investigation 
The study is designed to report on 20 subjects who receive a Gemini SCS 
implant and complete follow-up. XXXXXXXXXXXXXXXXX. 
Clinical 
Investigation 
Design 
Prospective, pre-market, non-randomized, multi-center, single-arm study 
Confirmatory 
Safety Endpoint 
The rate of serious adverse events adjudicated as related to the IPG and/or 
charging system.  
Subject Follow-up 
• 
Enrollment/Baseline 
• 
Permanent Implant 
• 
2-week (10-14 days) follow-up post implant (in office, phone call, telemedicine) 
• 
6-week (30-45 days) follow-up post implant (in office) 
Inclusion Criteria 
1. Subject is indicated for an SCS system, or has an implanted SCS system 
and is scheduled to receive an IPG replacement.  
2. Subject is scheduled to receive a new IPG permanent implant and has 
completed a successful SCS trial in the last 6-months, OR subject is 
scheduled to undergo an all-in-one procedure OR has an implanted SCS 
system for an approved chronic pain indication. 
3. Subject has a documented NRS pain score of ≥ 6 after at least 5 days 
without stimulation OR has an implanted functioning SCS system with NRS 
pain score of ≤ 4.  
4. Subject must provide written informed consent prior to any clinical 
investigation-related procedure. 
5. Subject is at least 18 years at the time of enrollment. 
6. Subject is capable and willing to recharge an implanted IPG.   

 
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Exclusion Criteria 
1. Subject’s SCS trial was unsuccessful. 
2. Subject is currently participating, or intends to participate, in another 
clinical investigation that may confound the results of this study, as 
determined by Abbott. 
3. Subject has or will receive more than one IPG. 
4. Subject is pregnant or breastfeeding or plans to become pregnant during 
the clinical investigation follow-up period. 
5. Subject has other anatomic or comorbid conditions, or other medical, 
social, or psychological conditions that, in the investigator’s assessment, 
could limit the subject’s ability to participate in the clinical investigation. 
6. Subject has or is scheduled to receive an intrathecal pump. 
7. Subject is part of a vulnerable population (section 5.2.2 of the 
clinical investigational plan).