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 SystemDevice

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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;

Sponsors & Collaborators

Axon srl
Industrylead

Study Sites (5)

Ospedale Santissima Trinità

Cagliari, Italy

Istituto Oncologico del Mediterraneo IOM

Catania, Italy

Azienda Ospedaliera di Cosenza

Cosenza, Italy

Azienda Ospedaliera Antonio Cardarelli

Naples, Italy

Azienda Ospedaliera Universitaria Senese

Siena, Italy

Results Point of Contact

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

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

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Study Arms (1)

Spinery® RF Ablation System Arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (5)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Study Arms (1)

Spinery® RF Ablation System Arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (5)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations