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

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

ArmDescriptionAssigned Intervention
Dorsal Root Ganglion (DRG) Stimulation
  • Device: Dorsal Root Ganglion (DRG) Stimulation (Axium™ Neurostimulator System)
    Electrical stimulation of the DRG using the Axium™ Neurostimulator System
  • Device: Dorsal Root Ganglion (DRG) Stimulation (Proclaim™ Neurostimulator System)
    Electrical Stimulation of the DRG using the Proclaim™ Neurostimulator System.

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.