TARGET Post-Approval Study

  • STATUS
    Recruiting
  • participants needed
    426
  • sponsor
    Abbott Medical Devices
Updated on 4 August 2021
Investigator
Todd Stirman
Primary Contact
Summit Pain Alliance Inc. (2.2 mi away) Contact
+54 other location
pain disorder
ganglion

Summary

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.

Description

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.

Details
Condition Complex regional pain syndrome, Complex Regional Pain Syndrome- type 1 (CRPS-I)
Treatment Dorsal Root Ganglion (DRG) Stimulation (Axium™ Neurostimulator System), Dorsal Root Ganglion (DRG) Stimulation (Proclaim™ Neurostimulator System)
Clinical Study IdentifierNCT02800863
SponsorAbbott Medical Devices
Last Modified on4 August 2021

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