Targeting the Conus Medullaris With ECAP-Controlled Closed-Loop SCS for Treatment of Chronic Pelvic Pain: HOPE Trial

Exclusion Criteria14

• Subject is pregnant or nursing.
• Subject is involved in a malignancy or injury claim under current litigation or has pending/approved worker's compensation claim.
• Subject's mechanism of pain is unknown.
• Suspected cause and onset of pain are more than 30 days apart.
• Subject has history of small fiber neuropathy, mitochondrial disease, fibromyalgia, addiction, CRPS in secondary pain area, and/or atypical facial pain.
• Subject has been diagnosed with Crohn's Disease, Irritable Bowel Syndrome, ulcerous colitis, or any other inflammatory disease that is ongoing.
• Subject has a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, as determined by the Investigator.
• Subject has a history of sexual abuse and/or sexual trauma.
• Subject has a history of unmanaged depression or anxiety that pre-dates the onset of symptoms.
• Subject is using greater than 100 MME (morphine milligram equivalents) of opioids at baseline.
• Subject shows evidence of an active, disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention, and/or ability to evaluate treatment outcomes.
• Subject has previous neuromodulation experience including SCS (Spinal Cord Stimulator) and/or DRG (Dorsal Root Ganglion).
• Subject has an existing drug pump and/or SCS system, or another active implantable device such as a pacemaker, deep brain stimulator, or sacral nerve stimulator.
• Subject is concomitantly participating in another clinical study.