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

NCT05467540 | Completed Results DMC

• 1 other identifier: Protocol #2020-01
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 5

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  Post-Procedure (primary evaluation point)

Study Arms (1)

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.

Device: Spinery System

Interventions

Spinery System DEVICE

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

Also known as: Spinery® RF Generator, the sterile single-use Spinery® Kit, and the sterile single-use Spinery® Cooling Connection

Spinery® RF Ablation System Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Axon srl: lead

Study Sites (5)

Ospedale Santissima Trinità

Cagliari, Italy

Location

Istituto Oncologico del Mediterraneo IOM

Catania, Italy

Location

Azienda Ospedaliera di Cosenza

Cosenza, Italy

Location

Azienda Ospedaliera Antonio Cardarelli

Naples, Italy

Location

Azienda Ospedaliera Universitaria Senese

Siena, Italy

Location

Results Point of Contact

• Title: Dr. Prof. Mario Muto
• Organization: AORN Cardarelli

mutomar2@gmail.com

+39800019774

Study Officials

• Mario Muto, Prof, MD

  Azienda Ospedaliera Antonio Cardarelli, Naples, Italy

  STUDY DIRECTOR

• Stefano Marini, MD

  Ospedale Santissima Trinità, Cagliari, Italy

  PRINCIPAL INVESTIGATOR

• Francesco Amato, MD

  Azienda Ospedaliera di Cosenza, Cosenza, Italy

  PRINCIPAL INVESTIGATOR

• Luigi Manfrè, MD

  Istituto Oncologico del Mediterraneo, Catania, Italy

  PRINCIPAL INVESTIGATOR

• Matteo Bellini, MD

  Azienda Ospedaliera Universitaria Senese, Siena, Italy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, Multicenter, no control group

Study Record Dates

• First Submitted: July 13, 2022
• First Posted: July 20, 2022
• Study Start: July 11, 2022
• Primary Completion: February 15, 2024
• Study Completion: November 30, 2024
• Last Updated: November 28, 2025
• Results First Posted: November 28, 2025

Record last verified: 2025-11

Locations

IT (5)