Spinery® A Novel Radio-Frequency Tumor Ablation Device for Spine Metastatic Tumors (NCT05467540) | Clinical Trial Compass
CompletedNot Applicable
Spinery® A Novel Radio-Frequency Tumor Ablation Device for Spine Metastatic Tumors
Italy52 participantsStarted 2022-07-11
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 plasmacy…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
Timeframe: Baseline and 3-month follow-up
2
Number and Percentage of Participants Who Successfully Completed the Spinery® RF Ablation Procedure