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

NCT07392333 | Not Yet Recruiting FDA Device

• 1 other identifier: SISBVN12025US
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Verteborgenic Low Back Pain; Back Pain Lower Back

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Change in ODI

  6 and 12 months post-procedure

• Change in Visual Analogue Score (VAS)

  3, 6 and 12 months post-procedure

• Rate of patients achieving clinical success at 3 months, defined as ODI improvement ≥10 points and VAS reduction ≥2 cm

  3 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

Study Arms (1)

OptaBate BVN cohort

Device: Basivertebral nerve ablation

Interventions

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.

OptaBate BVN cohort

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Stryker Instruments: lead

Study Sites (1)

Cantor Spine Center

Fort Lauderdale, Florida, 33306, United States

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 6, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): November 30, 2027
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)