TARGET Post-Approval Study (NCT02800863) | Clinical Trial Compass
CompletedNot Applicable
TARGET Post-Approval Study
United States426 participantsStarted 2016-08-23
Plain-language 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) stimulation. The primary endpoint is the 12-month serious adverse event rate for permanent implants.
Who can participate
Age range22 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 investig…