| NCT ID | NCT06611397 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Columbia University |
| Condition | Disc Herniation |
| Study Type | INTERVENTIONAL |
| Enrollment | 5 participants |
| Start Date | 2025-03-15 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 5 participants in total. It began in 2025-03-15 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will be a double-blinded, two-arm, prospective, randomized controlled pilot feasibility study in 40 evaluable subjects (20 in each arm) at one study site within the United States. Subjects in Arm 1 will receive unilateral Discogen treatment; subjects in Arm 2 will receive unilateral sham treatment (control). Treatment in both arms can include medications, e.g. NSAIDs or muscle relaxants for axial or radicular pain.
Eligibility Criteria
Inclusion Criteria The subject may be included in the study if the following conditions are met: 1. Adult (\> 21 y.o.) males and females legally able and willing to participate and provide consent in the study and attend follow-up visits 2. Able and willing to complete study forms and communicate with the investigator 3. Presenting with unilateral radicular leg pain with or without axial back pain of \>1 month duration 4. No epidural injections at treatment site within the last three months 5. Leg NPS pain score of 4 - 9 in the last month (on a scale of 0 to 10) 6. Clinical presentation of sensory radiculopathy referable to single-level disc disease/herniation at L3-4, L4-5 or L5-S1 7. MRI lumbar spine negative for extruded disc herniation, tumor, or bleeding, but positive for disc disease/herniation at L3-4, L4-5 or L5-S1 with mild to moderate foraminal or spinal stenosis (less than 50%). Exclusion Criteria: 1. Pregnant or breastfeeding patient 2. Younger than 21 or older than 75 years 3. Presenting with motor deficits 4. Presenting with a baseline Oswestry Disability Index ≥ 41% (severe disability or worse) 5. Presence of metal hardware within the lumbosacral spine 6. History of spine surgery at the level of treatment. 7. Lumbar spine pathology that may increase procedural risk and/or influence symptoms and/or generate unrelated adverse events (per the discretion of the study PI) 8. Severe lumbar central canal stenosis (greater than 50%) 9. Severe lumbar foraminal stenosis (greater than 50%) 10. Severe herniated lumbar disc 4(Grade 2 and above) 11. Lumbar instability on flexion/extension plain films, greater the Grade 1 spondylolisthesis 12. Unable to understand and complete research questionnaires 13. Any severe medical condition preventing the patient from safely and effectively being treated in the study or reporting study outcomes. 14. BMI greater than 30 15. Implanted spinal stimulators 16. Epidural injections at treatment site within the last three months
Contact & Investigator
Clark Smith, MD, PhD
PRINCIPAL INVESTIGATOR
Columbia University
Frequently Asked Questions
Who can join the NCT06611397 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 75 Years, studying Disc Herniation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06611397 currently recruiting?
Yes, NCT06611397 is actively recruiting participants. Contact the research team at cs3028@cumc.columbia.edu for enrollment information.
Where is the NCT06611397 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06611397 clinical trial?
NCT06611397 is sponsored by Columbia University. The principal investigator is Clark Smith, MD, PhD at Columbia University. The trial plans to enroll 5 participants.