Clinical Study of Spinery® A Novel Radio-Frequency Tumor Ablation Device for Spine Metastatic Tumors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 5
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
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
时间窗: Baseline and 3-month follow-up
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).
Number and Percentage of Participants Who Successfully Completed the Spinery® RF Ablation Procedure
时间窗: Post-Procedure (primary evaluation point)
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.
次要结局
未报告次要终点