Last updated on July 2019

TARGET Post-Approval Study


Brief description of study

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

Detailed Study Description

A maximum of 376 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 Neurostimulator System across 40 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.

Clinical Study Identifier: NCT02800863

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Center for Clinical Research, LLC

Winston-Salem, NC United States
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Front Range Pain Medicine

Fort Collins, CO United States
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Vertex Spine and Pain

Franklin, TN United States
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NeuroSpine Institute

Eugene, OR United States
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Advanced Pain Management

Greenfield, WI United States
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Florida Pain Institute

Merritt Island, FL United States
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Holy Cross Hospital

Fort Lauderdale, FL United States
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Summit Pain Alliance Inc.

Santa Rosa, CA United States
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VA Loma Linda Healthcare System

Loma Linda, CA United States
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Premier Pain Solutions

Asheville, NC United States
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Rhode Island Hospital

Providence, RI United States
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Advanced Pain Care

Henderson, NV United States
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Arizona Pain Specialists

Scottsdale, AZ United States
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Spinal Diagnostics

Tualatin, OR United States
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Shannon Clinic

San Angelo, TX United States
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DNA Advanced Pain Treatment

Pittsburgh, PA United States
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Ochsner Medical Center

New Orleans, LA United States
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Advanced Pain Solutions

Mesquite, TX United States
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Goodman Campbell Brain & Spine

Indianapolis, IN United States
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Ioannis Skaribas, MD

Katy, TX United States
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Loma Linda University Hospital

Loma Linda, CA United States
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Orthopedic Pain Specialists

Santa Monica, CA United States
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Jason Edward Pope, MD LLC

Santa Rosa, CA United States
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Kansas University Medical Center

Kansas City, KS United States
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Peter Staats, MD

Shrewsbury, NJ United States
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Adena Bone and Joint Center

Chillicothe, OH United States
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Dr. Jeffery James Rowe

King Of Prussia, PA United States
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El Paso Pain Center

El Paso, TX United States
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