TARGET Post-Approval Study

Study Overview
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Brief Summary
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The purpose of this prospective, multicenter, single arm post-approval study is to demonstrate continued safety of the Axium and Proclaim Neurostimulator System for dorsal root ganglion (DRG) stimulation. The primary endpoint is the 12-month serious adverse event rate for permanent implants.

Detailed Description
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A maximum of 426 adult subjects with moderate to severe chronic, intractable, pain of the lower limbs due to CRPS types I and II will undergo a trial of the Axium or Proclaim Neurostimulator System across up to 45 study sites in the United States. Only subjects who report a 50% or greater reduction in overall pain intensity through direct patient-reported percentage of pain relief will receive the permanent implant. Subjects will then return to the office for follow-up at 1, 3, 6 and 12 months post-permanent implant.

Official Title
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TARGET: A Post-Approval Study to Evaluate Targeted SCS Spinal Cord Stimulation (SCS) Dorsal Root Ganglion (DRG) Stimulation for the Management of Moderate to Severe Chronic, Intractable, Pain of the Lower Limbs Due to CRPS Types I and II

Conditions
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Complex Regional Pain Syndrome (CRPS)

Intervention / Treatment
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* Device: Dorsal Root Ganglion (DRG) Stimulation (Axium™ Neurostimulator System)
* Device: Dorsal Root Ganglion (DRG) Stimulation (Proclaim™ Neurostimulator System)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is male or female between 22 and 75 years of age. Subject has moderate to severe chronic intractable pain of the lower limbs resulting from Complex Regional Pain Syndrome (CRPS) types I or II. Subject has a baseline VAS score of > 60 mm for overall pain at the time of the baseline assessment. Subject is willing and able to comply with the study requirements. Subject is able to provide written informed consent. Exclusion Criteria: Subject has an active implantable medical device including but not limited to cardiac pacemakers and cardiac defibrillators. Subject is currently involved in medically related litigation, including workers compensation. Subject has a life expectancy of less than one year. Subject is pregnant or of child bearing potential and not using adequate contraception as determined by the investigator. Subject has, or plans to have, a spinal cord stimulation system or infusion pump system implanted. Subject has, or plans to have, a peripheral nerve stimulation system (PNS) or peripheral nerve field stimulation system (PNfS) implanted. Subject is considered to be a poor surgical or study candidate, which may include, but is not limited to the following: any medical, social, or psychological problem that could complicate the implant procedure and/or recovery from the implant procedure or could complicate the required procedures and evaluations of the study in the judgment of the investigator.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 75 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dorsal Root Ganglion (DRG) Stimulation<br> | Device: Dorsal Root Ganglion (DRG) Stimulation (Axium™ Neurostimulator System)<br>* Electrical stimulation of the DRG using the Axium™ Neurostimulator System<br>Device: Dorsal Root Ganglion (DRG) Stimulation (Proclaim™ Neurostimulator System)<br>* Electrical Stimulation of the DRG using the Proclaim™ Neurostimulator System.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Serious Adverse Events (SAEs) |  | throughout 12 month study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change from baseline to 12 months post-permanent implant for overall pain intensity measured using the Visual Analog Scale (VAS) |  | 12 months | 
| Change from baseline to 12 months post-permanent implant for physical function measured using the PROMIS Physical Function Scale |  | 12 months | 
| Change from baseline to 12 months post-permanent implant for quality of life measured using the PROMIS Global Health Scale |  | 12 months |