Prospective Study of Basivertebral Nerve Ablation With the OptaBlate BVN System for Vertebrogenic Low Back Pain

Stryker

Status: Not yet enrolling

Conditions: Back Pain Lower Back; Verteborgenic Low Back Pain

Treatments: Device: Basivertebral nerve ablation

Study type: Observational

Funder types: Industry

Identifiers

NCT07392333

SISBVN12025US

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

25 participants in 1 patient group

OptaBate BVN cohort

Treatment:

Device: Basivertebral nerve ablation