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NCT Number: NCT07392333

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

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.

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Key information

Conditions

Verteborgenic Low Back Pain Back Pain Back Pain Lower Back Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cantor Spine Center

Fort Lauderdale, Florida, 33306, United States

Location status: Recruiting

Location contact

Anthony Giuffrida, MD

CONTACT

[email protected]

954-567-1332

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Basivertebral nerve ablation

Device

The basivertebral nerve ablation is a minimally invasive, image-guided procedure in which radiofrequency energy is used to ablate the basivertebral nerve within the vertebral body, interrupting pain signals associated with vertebrogenic low back pain.

Primary outcomes

  1. Change in functional disability, assessed by the mean improvement in Oswestry Disability Index (ODI) score

    Time frame: 3 months post-procedure

  2. Incidence and severity of adverse events related to the procedure and/or device.

    Time frame: 12 months post-procedure

Secondary outcomes

  1. Change in Oswestry Disability Index (ODI) score

    Time frame: 6 and 12 months post-procedure

  2. Change in Visual Analogue Score (VAS)

    Time frame: 3, 6 and 12 months post-procedure

  3. Rate of patients achieving clinical success at 3 months, defined as Oswestry Disability Index (ODI) score improvement ≥10 points and VAS reduction ≥2 cm

    Time frame: 3 months post-procedure

  4. Change in health-related quality of life (36-item Short Form Survey Instrument (SF-36))

    Time frame: 3, 6, and 12 months post-procedure

  5. Change in Pain Medication Dosage for Low Back Pain as Measured by Prescription Dosage Records

    Time frame: 3, 6 and 12 months post-procedure

  6. Rate of additional procedures (lumbar transforaminal epidural steroid injections, lumbar interlaminar steroid injections, radiofrequency ablations etc.)

    Time frame: 12 months post-procedure

  7. Imaging assessment - Magnetic Resonance Imaging (MRI) including Mean size of the lesion Rate of subjects with radiographic evidence of targeting success based on lesion location on MRI

    Time frame: 6 weeks post-procedure

  8. Change in health-related quality of life (European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L))

    Time frame: 3, 6 and 12 months post-procedure

  9. Assessment of global patient satisfaction through completion of a brief, non-validated, rating-scale questionnaire.

    Time frame: 3, 6 and 12 months post-procedure

    Non-validated, rating-scale questionnaire to assess perceived satisfaction with the treatment received, willingness to undergo the same treatment again for a comparable outcome, and willingness to recommend the treatment to an individual with the same medical condition

Sponsors and collaborators

Lead sponsor

Stryker Instruments

Industry

Registry information

Acronym: OptaBlate BVN

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 6, 2026
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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