Status:
COMPLETED
TARGET Post-Approval Study
Lead Sponsor:
Abbott Medical Devices
Conditions:
Complex Regional Pain Syndrome (CRPS)
Eligibility:
All Genders
22-75 years
Brief 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) stimulat...
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 ac...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 23 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 23 2021
Estimated Enrollment :
426 Patients enrolled
Trial Details
Trial ID
NCT02800863
Start Date
August 23 2016
End Date
September 23 2021
Last Update
July 8 2024
Active Locations (44)
Enter a location and click search to find clinical trials sorted by distance.
1
Arizona Pain Specialists
Scottsdale, Arizona, United States, 85258
2
Spanish Hills Interventional Pain Specialists
Camarillo, California, United States, 93010
3
California Orthopedics & Spine
Larkspur, California, United States, 94939
4
Loma Linda University Hospital
Loma Linda, California, United States, 92354