Prospective Study of Basivertebral Nerve Ablation With the OptaBlate BVN System for Vertebrogenic Low Back Pain
Part of paid clinical trials in Fort Lauderdale, Florida.
- Sponsor
- Stryker Instruments
- Study ID
- NCT07392333
- Status
- Not Yet Recruiting
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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 — DEVICEThe 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
- Start date
- Mar 31, 2026
- Status verified
- Feb 2026
- Primary completion
- Dec 31, 2026
- 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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Cantor Spine Center | Fort Lauderdale | Florida | 33306 |