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Clinical Trials/NCT07392333
NCT07392333RecruitingNot Applicable

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

Stryker Instruments1 site in 1 country25 target enrollmentStarted: June 2, 2026Last updated:
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Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
25
Locations
1
Primary Endpoint
Change in functional disability, assessed by the mean improvement in Oswestry Disability Index (ODI) score
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
22 Years to — (Adult, Older Adult)
Sex
All
Accepts 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

Arms & Interventions

OptaBate BVN cohort

Intervention: Basivertebral nerve ablation (Device)

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Change in ODI(6 and 12 months post-procedure)
  • Change in Visual Analogue Score (VAS)(3, 6 and 12 months post-procedure)
  • Rate of patients achieving clinical success at 3 months, defined as ODI improvement ≥10 points and VAS reduction ≥2 cm(3 months post-procedure)
  • Change in health-related quality of life (36-item Short Form Survey Instrument (SF-36))(3, 6, and 12 months post-procedure)
  • Change in Pain Medication Dosage for Low Back Pain as Measured by Prescription Dosage Records(3, 6 and 12 months post-procedure)
  • Rate of additional procedures (lumbar transforaminal epidural steroid injections, lumbar interlaminar steroid injections, radiofrequency ablations etc.)(12 months post-procedure)
  • Imaging assessment - Magnetic Resonance Imaging (MRI) including Mean size of the lesion Rate of subjects with radiographic evidence of targeting success based on lesion location on MRI(6 weeks post-procedure)
  • Change in health-related quality of life (European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L))(3, 6 and 12 months post-procedure)
  • Assessment of global patient satisfaction(3, 6 and 12 months post-procedure)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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