Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in the USA / NCT07392333
Recruiting Observational

A Prospective Cohort Study of Basivertebral Nerve Ablation Using the Stryker OptaBlate BVN System for the Treatment of Vertebrogenic Low Back Pain

NCT07392333 · tracked via the Priya Life Science USA tracker
Sponsor
Stryker Instruments
Phase
Observational
Started
2026-06-02
Last updated
2026-06-18

Condition(s) studied

Verteborgenic Low Back PainBack Pain Lower Back

Investigational drug(s) / intervention(s)

Basivertebral nerve ablation

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.

Study 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

Sex
ALL
Min age
22 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

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

Trial sites (1)

FacilityCityRegionStatus
Cantor Spine Center Fort Lauderdale Florida Recruiting

More Stryker Instruments trials in the USA

MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07392333 on ClinicalTrials.gov ↗ ← All trials in the USA