A Prospective Cohort Study of Basivertebral Nerve Ablation Using the Stryker OptaBlate BVN System for the Treatment of Vertebrogenic Low Back Pain

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age22+
SponsorStryker Instruments

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Basivertebral nerve ablation

Treatment groups

25 Participants
are divided into 1 treatment group

Sponsors and collaborators