Basivertebral nerve ablation for vertebrogenic low back pain using the OptaBlate BVN system

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational study of patients undergoing basivertebral nerve ablation with the Stryker OptaBlate BVN system as part of routine care. Participants are followed for 12 months after the procedure to observe outcomes. Eligible patients must be treated according to the device’s instructions for use and provide informed consent. The study aims to document real-world outcomes in a single center and does not assign treatments beyond standard clinical practice. Exclusion criteria include contraindications in the IFU, prior vertebral surgeries or procedures at target levels, obesity, malignancy, recent spine interventions, and other conditions that could affect safety or outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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's running

• Cantor Spine Center
  Fort Lauderdale, Florida, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.