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

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.

Study Overview

• Status: Recruiting
• Conditions: Back Pain Lower Back; Verteborgenic Low Back Pain
• Intervention / Treatment: Device: Basivertebral nerve ablation

• Study Type: Observational
• Enrollment (Estimated): 25

Contacts and Locations

Study Locations

• United States
  • Florida
    • Fort Lauderdale, Florida, United States, 33306
      • Recruiting
      • Cantor Spine Center
      • Contact: Anthony Giuffrida, MD; Phone Number: 954-567-1332; Email: info@cantorspinecenter.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with chronic low back pain of at least 6 months' duration that has not responded to at least 6 months of conservative treatment and who demonstrate Type 1 or Type 2 Modic changes on MRI consistent with vertebrogenic pain.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
OptaBate BVN cohort	Device: Basivertebral nerve ablation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in functional disability, assessed by the mean improvement in Oswestry Disability Index (ODI) score	3 months post-procedure
Incidence and severity of adverse events related to the procedure and/or device.	12 months post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Visual Analogue Score (VAS)		3, 6 and 12 months post-procedure
Change in health-related quality of life (36-item Short Form Survey Instrument (SF-36))		3, 6, and 12 months post-procedure
Change in Pain Medication Dosage for Low Back Pain as Measured by Prescription Dosage Records		3, 6 and 12 months post-procedure
Rate of additional procedures (lumbar transforaminal epidural steroid injections, lumbar interlaminar steroid injections, radiofrequency ablations etc.)		12 months post-procedure
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		6 weeks post-procedure
Change in health-related quality of life (European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L))		3, 6 and 12 months post-procedure
Change in Oswestry Disability Index (ODI) score		6 and 12 months post-procedure
Rate of patients achieving clinical success at 3 months, defined as Oswestry Disability Index (ODI) score improvement ≥10 points and VAS reduction ≥2 cm		3 months post-procedure
Assessment of global patient satisfaction through completion of a brief, non-validated, rating-scale questionnaire.	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	3, 6 and 12 months post-procedure

Collaborators and Investigators

• Sponsor: Stryker Instruments

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: January 26, 2026
• First Submitted That Met QC Criteria: February 4, 2026
• First Posted (Actual): February 6, 2026

Study Record Updates

• Last Update Posted (Actual): June 18, 2026
• Last Update Submitted That Met QC Criteria: June 16, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Low Back Pain
• Other Study ID Numbers: SISBVN12025US

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared to protect patient confidentiality and because data sharing is not included in the informed consent or study protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No