NL-OMON36763
Completed
Not Applicable
A Prospective Trial to Assess the Safety and Performance of the Spinal Modulation Neurostimulator System in the Treatment of Chronic Pain - Neurostimulation
Spinal Modulation0 sites35 target enrollmentTBD
ConditionsChronic intractable pain
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic intractable pain
- Sponsor
- Spinal Modulation
- Enrollment
- 35
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Male or female \* 18 years old
- •2\.Subject is able and willing to comply with the follow\-up schedule and protocol
- •3\.Chronic, intractable pain in the thoracic, lumbar, and/or sacral distribution(s) for at least 6 months
- •4\.Failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy and interventional pain procedures for chronic pain
- •5\.Minimum baseline pain rating of 60 mm on the VAS
- •6\.Stable pain medication dosage for at least 30 days
- •7\.Stable neurologic function in the past 30 days as assessed by investigator examination
- •8\.In the opinion of the investigator, the subject is psychologically appropriate for the implantation for an active implantable medical device
- •9\.Subject is able to provide written informed consent
- •10\.Subject speaks Dutch or English
Exclusion Criteria
- •1\.Female subject 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 has had corticosteroid therapy at an intended site of stimulation within the past 30 days
- •5\.Subject has had radiofrequency treatment of an intended target DRG(s) within the past 3 months
- •6\.Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator or intrathecal drug pump
- •7\.Subject is unable to operate the device
- •8\.Subjects with indwelling devices that may pose an increased risk of infection
- •9\.Subjects currently has an active infection
- •10\.Subject has, in the opinion of the investigator, a medical comorbidity that contraindicates placement of an active medical device
Outcomes
Primary Outcomes
Not specified
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