Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-24 @ 9:08 PM
NCT ID:
NCT01106404
Eligibility Criteria:
Inclusion Criteria:
* Meets the indications as an appropriate surgical candidate (after successful SCS screening trial) for implant of a neurostimulation system for spinal cord stimulation (SCS) treatment of trunk and/or limb pain, per labeled indications
* 18 years of age or older
* Willing and able to attend visits and comply with the study protocol
* Capable of using the patient programmer and recharging the neurostimulator (INS), able to read and answer questionnaires in English, without assistance of a caregiver
* Males and non-pregnant females
Exclusion Criteria:
* Has had a prior implantable SCS neurostimulation system
* Currently enrolled, or plans to enroll in another investigational device or drug trial during the study
* Has unresolved legal issues related to their pain condition for which they would be receiving neurostimulation
* Requires cervical placement of leads.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01106404
Study Brief:
Protocol Section:
NCT01106404