Study of Gemini Rechargeable Spinal Cord Stimulation (SCS) System

Study Overview
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Brief Summary
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The aim of this pre-market, prospective, single-arm, non-randomized, open-label, multi-center clinical study is to collect confirmatory data to show that the Gemini SCS neurostimulation system functions as intended in a clinical setting.

Official Title
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Study of Gemini Rechargeable Spinal Cord Stimulation System

Conditions
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Chronic Pain

Intervention / Treatment
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* Device: Gemini SCS neuromodulation system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is indicated for an SCS system, or has an implanted SCS system and is scheduled to receive an IPG replacement. 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. 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. Subject must provide written informed consent prior to any clinical investigation-related procedure. Subject is at least 18 years at the time of enrollment. Subject is capable and willing to recharge an implanted IPG. Exclusion Criteria: Subject's SCS trial was unsuccessful. Subject is currently participating, or intends to participate, in another clinical investigation that may confound the results of this study, as determined by Abbott. Subject has or will receive more than one IPG. Subject is pregnant or breastfeeding or plans to become pregnant during the clinical investigation follow-up period. 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. Subject has or is scheduled to receive an intrathecal pump. Subject is part of a vulnerable population.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gemini rechargeable Spinal Cord Stimulation (SCS) System<br>Patients will be implanted with the Gemini rechargeable SCS System | Device: Gemini SCS neuromodulation system<br>* 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: failed back surgery syndrome, intractable low back and leg pain, angina pectoris and peripheral vascular disease.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confirmatory Safety Endpoint: The Rate of Serious Adverse Events Related to the Investigational IPG and/or Charging System | The rate of serious adverse events adjudicated as related to the investigational IPG and/or charging system will be assessed. | At 6 weeks (30-45 days) follow-up post implant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gemini rechargeable SCS System, ABT-CIP-10407, IPG