A Prospective Cohort Study of Basivertebral Nerve Ablation Using the Stryker OptaBlate BVN System for the Treatment of Vertebrogenic Low Back Pain
Recruiting now
Conditions studied: Verteborgenic Low Back Pain, Back Pain Lower Back
In brief
The goal of this observational study is to evaluate patient outcomes following treatment of vertebrogenic low back pain using the Stryker OptaBlate BVN System. Patients treated in accordance with the device IFU as part of routine clinical care and who consent to participate will be followed for 12 months after the procedure to assess treatment outcomes.
Key facts
- Study ID
- NCT07392333
- Run by
- Stryker Instruments
- People needed
- 25
- Starts
- 2026-06-02
- Expected to finish
- 2027-11-30
- Last updated by the study team
- 2026-06-18
Who can join
Age: 22 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patient scheduled for treatment with the OptaBlate BVN System in accordance with the device IFU and willing to participate in the clinical investigation, undergo study procedure, engage in follow-up, able to read, write, speak, and understand English, and able to provide written informed consent.
You may not qualify if…
- The patient meets one or more contraindications as defined in the locally applicable IFU
- Spinal fracture or history of spinal trauma at index levels
- Previous lumbar fusion at any level
- Prior basivertebral nerve ablation at the target levels
- Vertebral cancer, spinal metastasis or Tumor-related vertebral fractures
- History of Osteoporotic vertebral fractures
- Spine interventions, including epidural steroid injections within 30 days
- BMI > 40 kg/m²
- Symptomatic spinal stenosis
- Radicular pain or leg pain greater than back pain
- Pregnancy or planning pregnancy during study period
- Enrollment in another interventional clinical trial
- Contraindication to MRI
- Life expectancy of less than 12 months
Where it is running
- Cantor Spine Center — Fort Lauderdale, Florida, United States (enrolling)
Full record on ClinicalTrials.gov
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