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 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 12:13 AM
NCT ID:
NCT03876158
Eligibility Criteria:
Inclusion Criteria:
1. Be male or female between the ages of 22 and 85 years
2. Be capable of giving informed consent and completing assessments required by the study
3. Have pain intensity of greater than 5 out of 10 as measured by VAS
4. Have an active existing peristaltic intrathecal drug delivery system
5. Have stable drug dosage for at least 6 weeks prior to valve-gated pump implant
6. Be an appropriate candidate for surgery
7. Be able to comply with required study visits and assessments including English proficiency
Exclusion Criteria:
1. Have a significant pain disorder not intended to be treated with the test device or comparator
2. Be terminally ill and/or have a life expectancy of less than 6 months
3. Be a pregnant/lactating woman or a woman of child-bearing potential
4. Have a systemic or local infection (contraindicated for pump implantation)
5. Have history/evidence of an active disruptive psychiatric disorder or other known condition with potential to impact compliance with study visits and assessments
6. Have an underlying condition increasing susceptibility to infection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Maximum Age:
85 Years
Study:
NCT03876158
Study Brief:
Protocol Section:
NCT03876158