TARGET Post-Approval Study
Purpose
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.
Condition
- Complex Regional Pain Syndrome (CRPS)
Eligibility
- Eligible Ages
- Between 22 Years and 75 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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 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.
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.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Dorsal Root Ganglion (DRG) Stimulation |
|
More Details
- Status
- Active, not recruiting
- Sponsor
- Abbott Medical Devices
Study Contact
Detailed 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.