Clinical trial · Interventional
Spinery® A Novel Radio-Frequency Tumor Ablation Device for Spine Metastatic Tumors
Clinical Study of Spinery® A Novel Radio-Frequency Tumor Ablation Device for Spine Metastatic Tumors
NCT05467540CI-TRIAL-00098032SPARTAcompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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. 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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Vertebral Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Spinery System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Spinery® RF Ablation System Arm
- description
- 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.
- interventionNames
- Device: Spinery System
Primary outcomes (2)
- 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
- timeFrame
- Baseline and 3-month follow-up
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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. * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.