NCT05467540

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Axon srl · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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.

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: 1. To evaluate short-term pain reduction at 3 months following treatment, as measured by changes in the BPI "worst pain" score. 2. 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

Interventions

Type	Name	Description
DEVICE	Spinery System	Radiofrequency ablation of bone metastases performed with the Spinery System, a radiofrequency generator with dedicated sterile, single-use accessories (electrode kit and cooling connection).

Timeline

• Start date: 2022-07-11
• Primary completion: 2024-02-15
• Completion: 2024-11-30
• First posted: 2022-07-20
• Last updated: 2025-11-28
• Results posted: 2025-11-28

Locations

5 sites across 1 country: Italy