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 @ 11:07 AM
Ignite Modification Date:
2025-12-26 @ 11:07 AM
NCT ID:
NCT01978912
Eligibility Criteria:
Inclusion Criteria:
* Subject has had a single contained or noncontained (extruded) lumbar disc herniation (L3-L4, L4-L5 or L5-S1) diagnosed by clinical symptoms and/or physical findings and confirmed by MRI.
* Subject has leg pain with a documented positive straight leg raise (SLR) test or femoral stretch test (FST).
* Subject has experiences herniated disc symptoms for at least 6 weeks prior to the study without relief with pain medications and other therapies.
* Subject has a BMI of 18 to 35 kg/m2
Exclusion Criteria:
* Subject has a sequestered lumbar disc herniation or intrathecal herniation confirmed by MRI
* Subject has two or more symptomatic lumbar disc herniations
* Previous intradiscal therapeutic intervention or has had any lumbar surgery
* Presence of lumbar spine disease and/or deformity other than a lumbar disc herniation
* Active smoker or is unable to abstain from tobacco use for 2 weeks prior to study injection
* Subject has a history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
70 Years
Study:
NCT01978912
Study Brief:
Protocol Section:
NCT01978912