Summary

for people ages 22-75 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
Lawrence Poree

Description

Summary

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.

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

Details

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.

Keywords

Complex Regional Pain Syndrome (CRPS) Complex Regional Pain Syndromes Reflex Sympathetic Dystrophy Dorsal Root Ganglion (DRG) Stimulation (Axium™ Neurostimulator System) Dorsal Root Ganglion (DRG) Stimulation

Eligibility

You can join if…

Open to people ages 22-75

  • 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.

You CAN'T join if...

  • 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.

Locations

  • University of California - San Francisco accepting new patients
    San Francisco California 94143 United States
  • Summit Pain Alliance Inc. accepting new patients
    Santa Rosa California 95401 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
St. Jude Medical
ID
NCT02800863
Lead Scientist
Lawrence Poree
Study Type
Observational
Last Updated
September 7, 2018