A Prospective Cohort Study of Basivertebral Nerve Ablation Using the Stryker OptaBlate BVN System for the Treatment of Vertebrogenic Low Back Pain
Recruiting
Observational Study
Verteborgenic Low Back PainBack Pain Lower Back
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
22 and older
Sex
Any
Study type
Observational
Participants needed
25 (estimated)
Sponsor
Stryker Instruments · Industry
Who this trial is looking for
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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.
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Status
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 writt…
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
Contacts
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