Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07392333
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT07392333
Study Brief:
Protocol Section:
NCT07392333