Verteborgenic Low Back PainOptaBlate BVNNCT07392333
A Prospective Cohort Study of Basivertebral Nerve Ablation Using the Stryker OptaBlate BVN System for the Treatment of Vertebrogenic Low Back Pain
An observational study of Verteborgenic Low Back Pain and Back Pain Lower Back, run by Stryker Instruments at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Verteborgenic Low Back Pain, Back Pain Lower Back
- What is being tested?
- Basivertebral nerve ablation
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2026to 30 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic low back pain of at least 6 months' duration that has not responded to at least 6 months of conservative treatment and who demonstrate Type 1 or Type 2 Modic changes on MRI consistent with vertebrogenic pain.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cantor Spine Center
Fort Lauderdale, Florida, 33306
Anthony Giuffrida, MD, 954-567-1332, info@cantorspinecenter.com
About this study
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
- Being tested
- Basivertebral nerve ablation
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basivertebral nerve ablationDevice
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 group | Role | What they receive |
|---|---|---|
| OptaBate BVN cohort | Not described Receives: Device: Basivertebral nerve ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in functional disability, assessed by the mean improvement in Oswestry Disability Index (ODI) score
Measured: 3 months post-procedure
Incidence and severity of adverse events related to the procedure and/or device.
Measured: 12 months post-procedure
Secondary outcomes (9)
Change in Oswestry Disability Index (ODI) score
Measured: 6 and 12 months post-procedure
Change in Visual Analogue Score (VAS)
Measured: 3, 6 and 12 months post-procedure
Rate of patients achieving clinical success at 3 months, defined as Oswestry Disability Index (ODI) score improvement ≥10 points and VAS reduction ≥2 cm
Measured: 3 months post-procedure
Change in health-related quality of life (36-item Short Form Survey Instrument (SF-36))
Measured: 3, 6, and 12 months post-procedure
Change in Pain Medication Dosage for Low Back Pain as Measured by Prescription Dosage Records
Measured: 3, 6 and 12 months post-procedure
Rate of additional procedures (lumbar transforaminal epidural steroid injections, lumbar interlaminar steroid injections, radiofrequency ablations etc.)
Measured: 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
Measured: 6 weeks post-procedure
Change in health-related quality of life (European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L))
Measured: 3, 6 and 12 months post-procedure
Assessment of global patient satisfaction through completion of a brief, non-validated, rating-scale questionnaire.
Non-validated, rating-scale questionnaire to assess perceived satisfaction with the treatment received, willingness to undergo the same treatment again for a comparable outcome, and willingness to recommend the treatment to an individual with the same medical condition
Measured: 3, 6 and 12 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start2 Jun 2026
- Primary completion31 Jan 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Verteborgenic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stryker Instruments
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07392333
- Sponsor's protocol ID
- SISBVN12025US
- Acronym
- OptaBlate BVN
- Status last verified
- Jun 2026
- First submitted
- 26 Jan 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data will not be shared to protect patient confidentiality and because data sharing is not included in the informed consent or study protocol
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study of Basivertebral Nerve Ablation Using the Stryker OptaBlate BVN System for the Treatment of Vertebrogenic Low Back Pain
- ClinicalTrials.gov ID
- NCT07392333
- Acronym / sponsor ID
- OptaBlate BVN / SISBVN12025US
- Conditions
- Verteborgenic Low Back Pain, Back Pain Lower Back
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Stryker InstrumentsIndustry (pharma, biotech, devices)
- Study start
- 2 Jun 2026 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OptaBate BVN cohort | – | Device: Basivertebral nerve ablation |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic low back pain of at least 6 months' duration that has not responded to at least 6 months of conservative treatment and who demonstrate Type 1 or Type 2 Modic changes on MRI consistent with vertebrogenic pain.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Basivertebral nerve ablationThe 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. | Device | OptaBate BVN cohort |
Primary outcome
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
9 secondary outcomes
Change in Oswestry Disability Index (ODI) score
Time frame: 6 and 12 months post-procedure
Change in Visual Analogue Score (VAS)
Time frame: 3, 6 and 12 months post-procedure
Rate of patients achieving clinical success at 3 months, defined as Oswestry Disability Index (ODI) score improvement ≥10 points and VAS reduction ≥2 cm
Time frame: 3 months post-procedure
Change in health-related quality of life (36-item Short Form Survey Instrument (SF-36))
Time frame: 3, 6, and 12 months post-procedure
Change in Pain Medication Dosage for Low Back Pain as Measured by Prescription Dosage Records
Time frame: 3, 6 and 12 months post-procedure
Rate of additional procedures (lumbar transforaminal epidural steroid injections, lumbar interlaminar steroid injections, radiofrequency ablations etc.)
Time frame: 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
Time frame: 6 weeks post-procedure
Change in health-related quality of life (European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L))
Time frame: 3, 6 and 12 months post-procedure
Assessment of global patient satisfaction through completion of a brief, non-validated, rating-scale questionnaire.
Time frame: 3, 6 and 12 months post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect patient confidentiality and because data sharing is not included in the informed consent or study protocol
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Verteborgenic Low Back Pain and Back Pain Lower Back, run by Stryker Instruments at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in functional disability, assessed by the mean improvement in Oswestry Disability Index (ODI) score (time frame: 3 months post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.