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:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2025-12-26 @ 12:18 PM
NCT ID:
NCT03727100
Eligibility Criteria:
Main Inclusion Criteria:
1. Be between 18 and 70 years of age (inclusive) at time the Informed Consent Form (ICF) is signed.
2. Diagnosis of unilateral radicular leg pain.
3. Women of childbearing potential must have a negative pregnancy test at Screening and within 24 hours prior to procedure and commit to adequate birth control during the the study.
4. Understands the purpose and any risks associated with the procedure required for the study and is willing to participate in the study.
5. Agrees to follow study-specific medication requirements.
6. Be able to read, write, understand, and complete study-related tasks, and adequately communicate in English.
7. Subject must have failed at least one conservative therapy in two different categories.
Main Exclusion Criteria:
1. Medical condition or radiographic evidence that, in the Investigator's opinion, could adversely impact study outcomes.
2. Received an lumbar epidural steroid injection, nerve block or similar procedure during the 4 weeks prior to Screening.
3. Female subjects who are pregnant or breastfeeding.
4. History of lumbar surgery.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03727100
Study Brief:
Protocol Section:
NCT03727100