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

Conditions

• Back Pain Lower Back
• Verteborgenic Low Back Pain

Eligibility Criteria

Sex

ALL

Age

22 Years - N/A

Healthy Volunteers

Not accepted

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.

Study Details

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.

Key Dates

First listed

Feb 6, 2026

Start date

Jun 2, 2026

Status verified

Jun 2026

Primary completion

Jan 31, 2027

Completion

Nov 30, 2027

Study Design

Enrollment

25 participants (estimated)

Arms

• Arm: OptaBate BVN cohort

Primary Outcome Measure

Change in functional disability, assessed by the mean improvement in Oswestry Disability Index (ODI) score [ Time Frame: 3 months post-procedure ]

Locations (1)

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