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:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT02403518
Eligibility Criteria:
Inclusion Criteria:
* Appropriate Freedom SCS candidate as affirmed by study investigator
* Candidate has a stable spine not suitable for further surgery as confirmed by physician
* 18 years of age or older (no upper age limit)
* Diagnosis of failed back surgery syndrome (FBSS) characterized by chronic, intractable pain of the legs, back, or both legs and back
* At least 6 months since last surgical procedure on the spine
* Average score of 60mm or greater on a VAS scale (Scale of 0 to 100, where 0 equals no pain and 100 equals worst possible pain)
* Pain duration of at least 6 months
* Expected lifespan of at least two years
* Able to comply with study requirements
* Gives informed consent for study participation
Exclusion Criteria:
* A consistent VAS score of 100 over the past 24 hours as established at Visit 1
* A co-existing condition that could increase the risk of SCS implantation (e.g., severe cardiac or respiratory disorders, coagulation disorder) or planned surgery within the study duration that could be compromised by SCS (e.g., diathermy)
* Pregnant or planning to become pregnant
* Known or suspected substance abuse within the last 2 years
* Major psychiatric disorder (untreated or refractory to treatment) in the investigators opinion
* Cognitive and/or behavioral issues that could impair study participation, (e.g., unreliability; defective memory; noncompliance in taking medications or keeping appointments; or impaired orientation to time, place, and events)
* Documented allergy to Freedom SCS material components
* Co-existing pain condition or participation in another clinical study that could confound the results of this study
* History of another implanted medical device (e.g., explanted spinal cord stimulator, peripheral nerve stimulation, sacral nerve stimulator, pacemaker, or intrathecal drug delivery)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02403518
Study Brief:
Protocol Section:
NCT02403518