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 @ 11:48 PM
Ignite Modification Date:
2025-12-24 @ 11:48 PM
NCT ID:
NCT03644251
Eligibility Criteria:
Inclusion Criteria:
* subject (male or female) is at least 18 to 70 years of age
* diagnosed with single level discogenic back pain confirmed by MRI and positive discography per Spine Interventional Society Guidelines
* Diagnosis of disc degeneration with Pfirrmann score of 1-3
* Subject has failed at least six months of conservative care
* Subject is symptomatic with axial lower back pain greater than lower limb pain at the intensity of \>6/10 concordant or partially concordant
* The subject is able to comply with all post-operative standard of care and follow instructions.
Exclusion Criteria:
* Subjects has significant disc protrusion, severe lumbar spinal stenosis, spine tumor, severe disc degeneration, or Sacroiliac (SI) joint syndrome
* Subject had previous surgery at the disc level
* Patient has previously received injection of FLO within 3 months of screening
* The subject is unable to comply with follow-up or not appropriate for inclusion based on investigator decision
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03644251
Study Brief:
Protocol Section:
NCT03644251