TARGET Post-Approval Study (TARGET PAS)

Abbott

Status

Completed

Conditions

Complex Regional Pain Syndrome (CRPS)

Treatments

Device: Dorsal Root Ganglion (DRG) Stimulation (Proclaim™ Neurostimulator System)

Device: Dorsal Root Ganglion (DRG) Stimulation (Axium™ Neurostimulator System)

Study type

Observational

Funder types

Industry

Identifiers

NCT02800863

SJM-CIP-10113

Details and patient eligibility

About

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.

Full 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.

Enrollment

426 patients

Sex

All

Ages

22 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 Visual Analogue Scale (VAS) 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.

Exclusion criteria

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.