Recruiting

Stryker OptaBlate

Sponsor:

Stryker Instruments

Code:

NCT07392333

Conditions

Verteborgenic Low Back Pain

Back Pain Lower Back

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Basivertebral nerve ablation

Study Details

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.

Conditions

Verteborgenic Low Back Pain

Back Pain Lower Back

Study ID

NCT07392333

Start date

Jun 2, 2026

Status verified date

Jun, 2026

Completion date

Nov 30, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

25 participants

Anticipated

Interventions and Outcome Measures

Arms

OptaBate BVN cohort

Interventions

Basivertebral nerve ablation

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.

Primary outcome measure

  • Change in functional disability, assessed by the mean improvement in Oswestry Disability Index (ODI) score [ Time Frame: 3 months post-procedure ]
  • Incidence and severity of adverse events related to the procedure and/or device. [ Time Frame: 12 months post-procedure ]

Central Contacts and Locations

Locations

Cantor Spine Center

Recruiting

Fort Lauderdale, Florida, United States, 33306

Contacts

Anthony Giuffrida, MD

954-567-1332info@cantorspinecenter.com

More Information

Sponsor

Stryker Instruments

Last update posted

Jun 18, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Stryker Instruments on 2026-06-18.