Vertebral MetastasisSPARTANCT05467540

Spinery® A Novel Radio-Frequency Tumor Ablation Device for Spine Metastatic Tumors

A study testing Spinery System in people with Vertebral Metastasis, run by Axon srl at 5 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The SPARTA study (Spinery® Radiofrequency Ablation Device Study) is a prospective, multicenter, single-arm clinical investigation designed to evaluate the safety, performance, and efficacy of the Spinery® RF Generator and its sterile single-use accessories for the palliative treatment of painful bone metastases. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Vertebral Metastasis
What is being tested?: Spinery System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 52 participants
Where: 5 sitesItaly
Study dates: 11 Jul 2022to 30 Nov 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with painful metastatic malignant lesions involving bone;
Patients, candidates to standard therapy, in which the RF ablation can be performed in combination with the Standard Therapy in accordance with the Investigator's indications;
Patients who have failed, not candidates or refuse Standard Therapy (chemotherapy or radiotherapy);
Patients with metastatic tumor size compatible with the expected ablation dimensions as reported for SPINERY devices in the IFU;
Patients with localized pain resulting from not more than two sites of symptomatic metastatic disease
Patients that do not have evidence of impending fracture

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Patients with metastatic lesions targeted for treatment located in the thoracic and/or lumbar vertebral body(ies), peri-acetabulum, iliac crest, and/or sacrum - no restrictions on location of lesion;
Patients with BPI-Report worst pain score ≥4/10 at the target treatment site within the past 24 hours
Patients with Karnofsky score ≥ 40 at enrollment
Patients willing and able to provide a signed and dated informed consent, comply with the study plan, follow up visits and phone calls
Patients at least 18 years old at the time of informed consent

Who cannot join

Patients implanted with heart pacemaker or other implanted electronic device
Patients with previous mechanical bone stabilization in the vertebral body to be treated
Use of SPINERY in vertebral body levels C1-C7
Multiple myeloma, solitary plasmacytoma, or primary malignant lesions in the index vertebra or bone.
Active or incompletely treated local infection at the planned treatment site(s) and/or systemic infection.
Planned treatment site(s) accompanied by objective evidence of secondary radiculopathy or neurologic compromise.

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Planned treatment site(s) associated with spinal cord compression or canal compromise requiring decompression.
Fractures due to prostatic cancer or other osteoblastic metastases to the spine. Metastatic lesions originating in the prostate that are osteolytic or of mixed origin are eligible for the study.
Pregnant, breastfeeding, or plan to become pregnant during the study duration.
Concurrent participation in another clinical study that may add additional safety risks and/or confound study results.
Any condition that would interfere with the subject's ability to comply with study instructions or might confound the study interpretation.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Italy5 sites

Ospedale Santissima Trinità
Cagliari
Istituto Oncologico del Mediterraneo IOM
Catania
Azienda Ospedaliera di Cosenza
Cosenza
Azienda Ospedaliera Antonio Cardarelli
Naples
Azienda Ospedaliera Universitaria Senese
Siena

Other trials in Italy

About this study

Official title: Clinical Study of Spinery® A Novel Radio-Frequency Tumor Ablation Device for Spine Metastatic Tumors

Adult patients with metastatic lesions involving the vertebral bodies, sacrum, iliac crest, or peri-acetabulum who were not candidates for, or had failed, standard therapies underwent percutaneous radiofrequency ablation with the investigational device.

A total of 52 participants were enrolled across five Italian centers and were assessed at baseline, post-procedure, and during follow-up visits at 1, 3, and 12 months.

Endpoints include evaluation of pain reduction, quality of life, usability, and procedural safety.

Read the detailed description

Bone metastases are a frequent cause of pain and disability in patients with advanced cancer, often leading to impaired mobility and reduced quality of life. Conventional treatments such as systemic analgesics, radiotherapy, or chemotherapy may not always achieve adequate symptom control, particularly in patients with recurrent or resistant disease.

Radiofrequency (RF) ablation has emerged as a minimally invasive, image-guided procedure that induces controlled thermal necrosis within metastatic lesions, potentially reducing pain by interrupting nociceptive pathways and stabilizing the affected bone.

The SPARTA study was designed to collect clinical data on the Spinery® RF Generator and its sterile single-use accessories, a bipolar/monopolar RF ablation technology intended for percutaneous use in bone metastases.

This clinical investigation follows a prospective, multicenter, single-arm design without a control group; data are compared with published evidence available in the literature to contextualize safety and performance outcomes.

A total of 52 patients were enrolled across five Italian centers. Eligible participants were adults with painful metastatic bone tumors located in the thoracic or lumbar vertebrae, sacrum, iliac crest, or peri-acetabulum.

Following informed consent and baseline assessments, each patient underwent image-guided RF ablation using the Spinery® device. The procedure allowed the treating physician to select monopolar or bipolar cooled electrodes according to lesion size and location.

Participants were monitored within 24 hours post-procedure and followed at 1, 3, and 12 months after treatment.

Study assessments include:

Pain evaluation using the Brief Pain Inventory (BPI)
Quality of life assessment using the EQ-5D-5L questionnaire
Functional performance using the Karnofsky Performance Scale
Documentation of concomitant analgesic use and adverse events

The primary objectives are:

To evaluate short-term pain reduction at 3 months following treatment, as measured by changes in the BPI "worst pain" score.
To evaluate procedural safety, defined as the percentage of procedures completed without device-related adverse events, including nerve injury.

The secondary objectives are:

To assess long-term pain reduction at 12 months.
To evaluate usability and procedural performance (technical and procedural success without product-specialist intervention).
To monitor quality-of-life and functional outcomes over the follow-up period.

This clinical investigation is conducted in compliance with ethical principles of Good Clinical Practice and applicable regulatory requirements.

Conditions: Vertebral Metastasis
Being tested: Spinery System

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Spinery SystemDevice
Also called Spinery® RF Generator, the sterile single-use Spinery® Kit, and the sterile single-use Spinery® Cooling Connection
Radiofrequency ablation of bone metastases performed with the Spinery System, a radiofrequency generator with dedicated sterile, single-use accessories (electrode kit and cooling connection).

Study groups in NCT05467540
Study group	Role	What they receive
Spinery® RF Ablation System Arm	Experimental	Participants in this single-arm study underwent percutaneous radiofrequency ablation of painful bone metastases using the Spinery System, consisting of the Spinery® RF Generator, the sterile single-use Spinery® Kit, and the sterile single-use Spinery® Cooling Connection. The procedure was performed according to the study protocol, with follow-up visits scheduled at 1, 3, and 12 months to assess pain reduction, safety, usability, and quality of life. Receives: Device: Spinery System

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Worst Pain and Quality of Life Scores at 3 Months Using the Brief Pain Inventory (BPI) and EQ-5D-5L Questionnaires
Pain severity and health-related quality of life were evaluated using two validated questionnaires:
- Brief Pain Inventory (BPI): Participants rated their worst pain in the last 24 hours for each treated lesion site (thoracic, lumbar, peri-acetabulum, iliac crest, sacrum) on an 11-point numeric scale from 0 (no pain) to 10 (pain as bad as you can imagine).
Higher scores indicate worse pain. The change in BPI Worst Pain Score was calculated as the average reduction from baseline to the 3-month visit.
- EQ-5D-5L: Participants reported their overall health status across five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each rated on five levels of severity.
Responses were converted into a utility index ranging from -0.594 (worst health state) to 1.000 (best health state), where higher scores indicate better quality of life.
The EQ-5D-5L visual analogue scale (VAS) ranges from 0 (worst imaginable health) to 100 (best imaginable health).
Measured: Baseline and 3-month follow-up
Number and Percentage of Participants Who Successfully Completed the Spinery® RF Ablation Procedure
The number and percentage of participants who successfully completed the Spinery® RF ablation procedure per protocol.
Completion is defined as participants who underwent the full planned treatment without premature discontinuation or technical interruption.
Results are expressed as the count and percentage of the total number of treated participants.
Measured: Post-Procedure (primary evaluation point)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Jul 202230 Nov 2024

First posted20 Jul 2022
Study start11 Jul 2022
Primary completion15 Feb 2024
Study completion30 Nov 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Vertebral MetastasisStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Prospective, Multicenter, no control group
Masking: None (open label)
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05467540
Sponsor's protocol ID: Protocol #2020-01
Acronym: SPARTA
Status last verified: Nov 2025
First submitted: 13 Jul 2022
Last updated: 28 Nov 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Spine Metastases
Active, not recruitingPhase 2
Thermal Ablation and Spine Stereotactic Radiosurgery in Treating Patients With Spine Metastases at Risk for Compressing the Spinal Cord
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Active, not recruitingPhase 2
Cement Augmentation in Preventing Vertebral Body Compression Fracture Following Spine Stereotactic Radiosurgery in Patients With Solid Tumors and Spinal Metastases
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All Vertebral Metastasis trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Study of Spinery® A Novel Radio-Frequency Tumor Ablation Device for Spine Metastatic Tumors
ClinicalTrials.gov ID: NCT05467540
Acronym / sponsor ID: SPARTA / Protocol #2020-01
Conditions: Vertebral Metastasis
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: Axon srlIndustry (pharma, biotech, devices)
Study start: 11 Jul 2022 (actual)
Primary completion: 15 Feb 2024 (actual)
Study completion: 30 Nov 2024 (actual)
First posted: 20 Jul 2022 (actual)
Results: Posted 28 Nov 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A total of 52 participants were enrolled across five Italian centers and were assessed at baseline, post-procedure, and during follow-up visits at 1, 3, and 12 months.

Endpoints include evaluation of pain reduction, quality of life, usability, and procedural safety.

Detailed description

Participants were monitored within 24 hours post-procedure and followed at 1, 3, and 12 months after treatment.

Study assessments include:

Pain evaluation using the Brief Pain Inventory (BPI)
Quality of life assessment using the EQ-5D-5L questionnaire
Functional performance using the Karnofsky Performance Scale
Documentation of concomitant analgesic use and adverse events

The primary objectives are:

To evaluate short-term pain reduction at 3 months following treatment, as measured by changes in the BPI "worst pain" score.
To evaluate procedural safety, defined as the percentage of procedures completed without device-related adverse events, including nerve injury.

The secondary objectives are:

To assess long-term pain reduction at 12 months.
To evaluate usability and procedural performance (technical and procedural success without product-specialist intervention).
To monitor quality-of-life and functional outcomes over the follow-up period.

This clinical investigation is conducted in compliance with ethical principles of Good Clinical Practice and applicable regulatory requirements.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Prospective, Multicenter, no control group

Arm	Type	Receives
Spinery® RF Ablation System Arm	Experimental	Device: Spinery SystemParticipants in this single-arm study underwent percutaneous radiofrequency ablation of painful bone metastases using the Spinery System, consisting of the Spinery® RF Generator, the sterile single-use Spinery® Kit, and the sterile single-use Spinery® Cooling Connection. The procedure was performed according to the study protocol, with follow-up visits scheduled at 1, 3, and 12 months to assess pain reduction, safety, usability, and quality of life.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Patients with painful metastatic malignant lesions involving bone;
Patients, candidates to standard therapy, in which the RF ablation can be performed in combination with the Standard Therapy in accordance with the Investigator's indications;
Patients who have failed, not candidates or refuse Standard Therapy (chemotherapy or radiotherapy);
Patients with metastatic tumor size compatible with the expected ablation dimensions as reported for SPINERY devices in the IFU;
Patients with localized pain resulting from not more than two sites of symptomatic metastatic disease

Key exclusion criteria (11 listed)

Patients implanted with heart pacemaker or other implanted electronic device
Patients with previous mechanical bone stabilization in the vertebral body to be treated
Use of SPINERY in vertebral body levels C1-C7
Multiple myeloma, solitary plasmacytoma, or primary malignant lesions in the index vertebra or bone.
Active or incompletely treated local infection at the planned treatment site(s) and/or systemic infection.

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
Spinery SystemAlso: Spinery® RF Generator, the sterile single-use Spinery® Kit, and the sterile single-use Spinery® Cooling ConnectionRadiofrequency ablation of bone metastases performed with the Spinery System, a radiofrequency generator with dedicated sterile, single-use accessories (electrode kit and cooling connection).	Device	Spinery® RF Ablation System Arm

Primary outcome

Change From Baseline in Worst Pain and Quality of Life Scores at 3 Months Using the Brief Pain Inventory (BPI) and EQ-5D-5L Questionnaires
Time frame: Baseline and 3-month follow-up
Pain severity and health-related quality of life were evaluated using two validated questionnaires: * Brief Pain Inventory (BPI): Participants rated their worst pain in the last 24 hours for each treated lesion site (thoracic, lumbar, peri-acetabulum, iliac crest, sacrum) on an 11-point numeric scale from 0 (no pain) to 10 (pain as bad as you can imagine). Higher scores indicate worse pain. The change in BPI Worst Pain Score was calculated as the average reduction from baseline to the 3-month visit. * EQ-5D-5L: Participants reported their overall health status across five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each rated on five levels of severity. Responses were converted into a utility index ranging from -0.594 (worst health state) to 1.000 (best health state), where higher scores indicate better quality of life. The EQ-5D-5L visual analogue scale (VAS) ranges from 0 (worst imaginable health) to 100 (best imaginable health).
Number and Percentage of Participants Who Successfully Completed the Spinery® RF Ablation Procedure
Time frame: Post-Procedure (primary evaluation point)
The number and percentage of participants who successfully completed the Spinery® RF ablation procedure per protocol. Completion is defined as participants who underwent the full planned treatment without premature discontinuation or technical interruption. Results are expressed as the count and percentage of the total number of treated participants.

Results and safety

Results posted to the registry on 28 Nov 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Spinery RF Ablation Treatment Group	51	51

Primary outcome: Change From Baseline in Worst Pain and Quality of Life Scores at 3 Months Using the Brief Pain Inventory (BPI) and EQ-5D-5L Questionnaires

Time frame: Baseline and 3-month follow-up. Mean (Standard Deviation). Unit: points on a numeric scale

Measure	3-Months Follow-up n = 41
Change in Worst Pain Score (BPI, 0-10 scale; higher = worse pain)	3.4 (2.8)
Change in Quality of Life (EQ-5D-5L VAS, 0-100 scale; higher = better health status)	65.2 (19.0)

Population analysed: All participants who started treatment and completed the 3-month follow-up visit are included in this analysis.

Primary outcome: Number and Percentage of Participants Who Successfully Completed the Spinery® RF Ablation Procedure

Time frame: Post-Procedure (primary evaluation point). Count of participants. Unit: Participants

Measure	Post-Procedure n = 51
Value	51

Population analysed: All participants who started treatment and were evaluated for procedural completion.

Adverse events

Time frame: Serious and Other (Not Including Serious) Adverse Events were assessed from the day of the Spinery® RF Ablation procedure through the 3-month follow-up visit. All-Cause Mortality was assessed from the day of the procedure through the 12-month follow-up visit.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants	13 of 51 (25.5%)	1 of 51 (2%)	13 of 51

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Vertebral Metastasis

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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. This study is not recruiting at the moment.

Mario Muto, Prof, MD study director

Azienda Ospedaliera Antonio Cardarelli, Naples, Italy

Stefano Marini, MD principal investigator

Ospedale Santissima Trinità, Cagliari, Italy

Francesco Amato, MD principal investigator

Azienda Ospedaliera di Cosenza, Cosenza, Italy

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Spinery System in people with Vertebral Metastasis, run by Axon srl at 5 sites in Italy.

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 11 inclusion and 11 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: finished, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Italy. 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?

Yes. Results are posted in the registry (first posted 28 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Worst Pain and Quality of Life Scores at 3 Months Using the Brief Pain Inventory (BPI) and EQ-5D-5L Questionnaires (time frame: Baseline and 3-month follow-up). 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?

On the ClinicalTrials.gov record for NCT05467540.

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 28 Nov 2025.