The aim of this pre-market, prospective, single-arm, non-randomized, open-label, multi-center clinical study is to collect confirmatory data to show that the Gemini SCS neurostimulation system functions as intended in a clinical setting.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
25
This neurostimulation system is indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain, angina pectoris and peripheral vascular disease.
QPain
Auchenflower, Australia
Metro Pain Group
Clayton, Australia
Sydney Spine & Pain
Hurstville, Australia
Sydney Pain Management Centre
Parramatta, Australia
Confirmatory Safety Endpoint: The Rate of Serious Adverse Events Related to the Investigational IPG and/or Charging System
The rate of serious adverse events adjudicated as related to the investigational IPG and/or charging system will be assessed.
Time frame: At 6 weeks (30-45 days) follow-up post implant
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Pain Care Perth
Perth, Australia
PainMedSA-Pain & Rehabilitation Specialists
Wayville, Australia