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BASILEA
Clinical Study of a RadioFrequency Basivertebral Nerve Ablation Device (Spinery® RF Generator and Its Sterile Single-use Accessories - the Spinery® Kit and the Spinery® Cooling Connection) for Chronic Low Back Pain (CLBP) Treatments
Sponsor study identifier
interventional
69
1 country
3
Study Start
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
January 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The goal of this clinical trial is to learn whether the Spinery® RF Generator and its sterile single-use accessories can safely lower disability and pain in adults with long-term low back pain that is thought to come from changes inside the vertebral bones of the lower spine. This type of pain is called vertebrogenic chronic low back pain. The study will include adults whose low back pain has lasted for at least 6 months and has not improved enough with non-surgical care. Participants must also have specific changes on spine magnetic resonance imaging (MRI), called Modic type 1 changes or selected Modic type 2 changes, at one or more levels between L3 and S1. The main questions this study aims to answer are:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2, 2026
Actual (reported)July 10, 2026
Actual (reported)September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
March 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Mean Change in Oswestry Disability Index Score From Baseline to 3 Months
The Oswestry Disability Index is used to assess disability related to low back pain. The score ranges from 0 to 100, where 0 represents no disability and 100 represents maximum disability. Higher scores indicate worse disability. The change will be calculated as the Oswestry Disability Index score at 3 months minus the Oswestry Disability Index score at baseline. A negative change indicates improvement, while a positive change indicates worsening.
Baseline and 3 months after treatment
Completion of the Ablation Procedure Without Device-Related Adverse Events
This outcome evaluates whether the ablation procedure is completed without adverse events related to the investigational device. Device-related adverse events will be assessed by the investigator according to the protocol.
During the procedure and through completion of the post-procedure assessment on the day of treatment
Participants assigned to this arm will receive active treatment using the Spinery® RF Generator and its sterile single-use accessories with the single bipolar ablation modality. In this approach, one cooled bipolar radiofrequency probe is introduced percutaneously into the target vertebral body under imaging guidance, such as fluoroscopy and/or CT, according to the protocol-defined procedure. Radiofrequency energy is delivered by the Spinery® RF Generator through the dedicated sterile single-use accessories to treat the intended basivertebral nerve target region. The number of treated vertebral bodies is determined according to the protocol-defined affected level(s), from L3 to S1. Participants will undergo the same post-treatment assessments as the other study arms, including MRI at approximately 6 weeks and clinical follow-up at 3 and 6 months.
Participants assigned to this arm will receive active treatment with the Spinery® RF Generator and its sterile single-use accessorie using the double parallel bipolar ablation modality. In this approach, two cooled bipolar radiofrequency probes are introduced percutaneously into the target vertebral body under imaging guidance, such as fluoroscopy and/or CT, and positioned according to the protocol-defined parallel configuration. Radiofrequency energy is delivered by the Spinery® RF Generator through the dedicated sterile single-use accessories to treat the intended basivertebral nerve target region. The number of treated vertebral bodies is determined according to the protocol-defined affected level(s), from L3 to S1. Participants will undergo the same post-treatment assessments as the other study arms, including MRI at approximately 6 weeks and clinical follow-up at 3 and 6 months.
Single bipolar ablation is performed using the Spinery® RF Generator and its dedicated sterile single-use accessories, including the Spinery® Kit and the Spinery® Cooling Connection. In this modality, one cooled bipolar radiofrequency probe is introduced percutaneously into the target vertebral body under imaging guidance, such as fluoroscopy and/or CT. Controlled bipolar radiofrequency energy is delivered to the intended basivertebral nerve target region according to the protocol-defined parameters.
Ospedale Santissima Trinità
Cagliari, Italy
Azienda Ospedaliera di Cosenza
Cosenza, Italy
Azienda Ospedaliera Antonio Cardarelli - U.O.C. Neuroradiologia
Naples, 80131, Italy
Mario Muto, MD
Azienda Ospedaliera Antonio Cardarelli
Pierluca Rocca, MD
Azienda Ospedaliera di Cosenza
Emanuele Piras, MD
Ospedale Santissima Trinità
First Submitted
July 2, 2026
First Posted
July 10, 2026
Mean Change in Oswestry Disability Index Score From Baseline to 6 Months
Baseline and 6 months after treatment
Mean Change in Visual Analogue Scale Pain Score From Baseline to 3 and 6 Months
Baseline, 3 months, and 6 months after treatment
Mean Change in EQ-5D-5L Index Score From Baseline to 3 and 6 Months
Baseline, 3 months, and 6 months after treatment
Technical Success of the Ablation Procedure
During the procedure
Targeting Success Confirmed by 6-Week MRI
6 weeks after treatment
Participants assigned to this arm will receive active treatment with the Spinery® RF Generator and its sterile single-use accessorie using the double cross bipolar ablation modality. In this approach, two cooled bipolar radiofrequency probes are introduced percutaneously into the target vertebral body under imaging guidance, such as fluoroscopy and/or CT, and positioned according to the protocol-defined cross configuration. Radiofrequency energy is delivered by the Spinery® RF Generator through the dedicated sterile single-use accessories to treat the intended basivertebral nerve target region. The number of treated vertebral bodies is determined according to the protocol-defined affected level(s), from L3 to S1. Participants will undergo the same post-treatment assessments as the other study arms, including MRI at approximately 6 weeks and clinical follow-up at 3 and 6 months.
Double parallel bipolar ablation is performed using the Spinery® RF Generator and its dedicated sterile single-use accessories, including the Spinery® Kit and the Spinery® Cooling Connection. In this modality, two cooled bipolar radiofrequency probes are introduced percutaneously into the target vertebral body under imaging guidance, such as fluoroscopy and/or CT, and positioned according to the protocol-defined parallel configuration. Controlled bipolar radiofrequency energy is delivered to the intended basivertebral nerve target region.
Double cross bipolar ablation is performed using the Spinery® RF Generator and its dedicated sterile single-use accessories, including the Spinery® Kit and the Spinery® Cooling Connection. In this modality, two cooled bipolar radiofrequency probes are introduced percutaneously into the target vertebral body under imaging guidance, such as fluoroscopy and/or CT, and positioned according to the protocol-defined cross configuration. Controlled bipolar radiofrequency energy is delivered to the intended basivertebral nerve target region.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Study Start
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
January 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 10, 2026
Record last verified: 2026-07
Individual participant data will not be shared. Aggregate study results may be reported in scientific publications, regulatory submissions, and public registry updates.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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