Last updated on September 2018

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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Ioannis Skaribas, MD

Ioannis Skaribas, MD
Katy, TX United States
6.18miles
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