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 @ 1:47 PM
Ignite Modification Date:
2025-12-24 @ 1:47 PM
NCT ID:
NCT05349695
Eligibility Criteria:
Inclusion Criteria:
* Male/female over 18 years old.
* Chronic intractable back and/or leg pain (PSPS T2), refractory to conservative treatment measures.
* Positive recommendation after multidisciplinary assessment including psychiatric assessment.
* Patients are capable of giving written informed consent.
Exclusion Criteria:
* Negative recommendation after multidisciplinary assessment (ex. psychiatric disorders).
* Insufficient improvement during trial period.
* Previous SCS implantation.
* Removal due to complication (infection, loss of function,...)
* Surgical contraindication (infection of surgical site, coagulation disorders,..)
* Pregnancy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05349695
Study Brief:
Protocol Section:
NCT05349695