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

NCT05467540 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-11-28

Study results available
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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.

Conditions

  • Vertebral Metastasis

Interventions

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).

Sponsors & Collaborators

  • Axon srl

    lead INDUSTRY

Principal Investigators

  • Mario Muto, Prof, MD · Azienda Ospedaliera Antonio Cardarelli, Naples, Italy

  • Stefano Marini, MD · Ospedale Santissima Trinità, Cagliari, Italy

  • Francesco Amato, MD · Azienda Ospedaliera di Cosenza, Cosenza, Italy

  • Luigi Manfrè, MD · Istituto Oncologico del Mediterraneo, Catania, Italy

  • Matteo Bellini, MD · Azienda Ospedaliera Universitaria Senese, Siena, Italy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-11
Primary Completion
2024-02-15
Completion
2024-11-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05467540 on ClinicalTrials.gov