A Prospective Trial to Assess the Safety and Performance of the Spinal Modulation Neurostimulator System in the Treatment of Chronic Pain

Spinal Modulation0 sites30 target enrollmentDecember 2, 2010

Overview

No summary available.

Registry

who.int

Start Date

December 2, 2010

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

Spinal Modulation

•1\) Male or female \>\= 18 years old
•2\) Chronic, intractable pain in the thoracic, lumbar, and/or sacral distributions(s) for at least 6 months
•3\) Failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy, and interventional pain procedures for chronic pain
•4\) Minimum baseline pain rating of 60 mm on the VAS
•5\) Stable pain medication dosage for at least 30 days
•6\) Stable neurologic function in the past 30 days

•1\) Female subject of childbearing potential is pregnant/nursing, plans to become pregnant or is unwilling to use approved birth control
•2\) Escalating or changing pain condition within the past month as evidenced by investigator examination
•3\) Subject is currently involved in medically related litigation
•4\) Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator or intrathecal drug pump
•5\) Subject currently has an active infection
•6\) Subject has, in the opinion of the investigator, a medical comorbidity that contraindicates placement of an active medical device
•7\) Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation
•8\) Imaging (MRI, CT, x\-ray) findings within the last 12 months that, in the investigator’s opinion, contraindicates lead placement