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

Axon srl

Status: Completed

Conditions: Vertebral Metastasis

Treatments: Device: Spinery System

Study type: Interventional

Funder types: Industry

Identifiers

NCT05467540

Protocol #2020-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

Spinery® RF Ablation System Arm

Experimental group

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.

Treatment:

Device: Spinery System