TARGET Post-Approval Study — TARGET PAS  

Complex Regional Pain Syndrome (CRPS) Clinical Trial

Official title: 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

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Complex Regional Pain Syndrome (CRPS)
• Complex Regional Pain Syndromes
• Reflex Sympathetic Dystrophy

• NCT number: NCT02800863
• Study type: Observational
• Source: Abbott Medical Devices
• Status: Active, not recruiting
• Start date: August 23, 2016
• Completion date: July 2022