NCT07392333 A Prospective Cohort Study of Basivertebral Nerve Ablation Using the Stryker OptaBlate BVN System for the Treatment of Vertebrogenic Low Back Pain
| NCT ID | NCT07392333 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Stryker Instruments |
| Condition | Verteborgenic Low Back Pain |
| Study Type | OBSERVATIONAL |
| Enrollment | 25 participants |
| Start Date | 2026-06-02 |
| Primary Completion | 2027-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 25 participants in total. It began in 2026-06-02 with a primary completion date of 2027-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Frequently Asked Questions
Who can join the NCT07392333 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, studying Verteborgenic Low Back Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07392333 currently recruiting?
Yes, NCT07392333 is actively recruiting participants. Visit ClinicalTrials.gov or contact Stryker Instruments to inquire about joining.
Where is the NCT07392333 trial being conducted?
This trial is being conducted at Fort Lauderdale, United States.
Who is sponsoring the NCT07392333 clinical trial?
NCT07392333 is sponsored by Stryker Instruments. The trial plans to enroll 25 participants.