Treatment of Chronic Low Back or Leg Pain: BIOTRONIK Prospera Spinal Cord Stimulation Trial
Clinical Research Study Application
We are seeking individuals to participate in a clinical trial designed for those experiencing chronic low back pain and/or leg pain.
This trial involves the utilisation of the Biotronik Prospera system, an investigational Spinal Cord Stimulator (SCS), which requires a Day Surgery procedure with an overnight stay at Monash House Private Hospital.
If the temporary investigational device proves effective in relieving your pain, you may be eligible for a permanent implant, which is an additional procedure covered by the clinic with no ongoing costs. Moreover, there is no cost for the removal of the device during the trial, and the permanent device can also be removed at a later date if needed. By participating in this study, you will also be required to attend our clinic regularly for follow-up care provided by our medical team.
The objective of this clinical study is to assess whether a spinal cord stimulation system, such as the Biotronik Prospera device with remote monitoring and engagement capabilities, can have a positive impact on your daily pain levels. You will have the option to retain the device or have it removed.
It's important to note that the device you receive during the permanent implant will still allow you to undergo medical imaging procedures, including MRIs. There is no cost associated with participating in this study, as all procedures and equipment will be covered.
Study is approved by Bellberry Human Research Ethics Committee - Approval number 2021-01-044-A-13.