OsteoCool Tumor Ablation Post-Market Study (OPuS One)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 218
- 试验地点
- 31
- 主要终点
- Change of Worst Pain Score: Thoracic/Lumbar Spine RF Ablation
研究概览
简要总结
This study evaluates the effectiveness of the Medtronic OsteoCool™ RF Ablation System.
详细描述
The OsteoCool™ RF Ablation system has 510k regulatory clearance in the United States, Conformité Européene (CE) mark in Europe, and Health Canada Licence in Canada. The goal of this study is to collect real-world outcomes among a cohort of patients in the US, EUR and CAN with metastatic malignant lesions in a vertebral body, painful metastatic lesions involving bone (in the US, patients with metastatic lesions involving the bone must have failed or were not candidates for standard therapy), and benign bone tumors such as osteoid osteoma who receive treatment with the OsteoCool™ RF Ablation system. Additionally, the study will collect device, procedure and/or therapy related adverse events and device deficiencies. Lastly, subject outcomes (such as pain relief, quality of life, and function) will be evaluated using validated assessment measures.
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
- •Candidate for OsteoCool RF ablation per the labeled indication applicable in their respective country/region
- •A. Metastatic lesions targeted for treatment must be located in the thoracic and/or lumbar vertebral body(ies), periacetabulum, iliac crest, and/or sacrum OR benign bone tumors - no restrictions on location of lesion
- •Report worst pain score ≥4/10 at the target treatment site within the past 24 hours
- •Localized pain resulting from no more than two sites total of metastatic disease
- •Have Karnofsky score ≥40 at enrollment (not applicable for subjects with benign bone tumors)
- •Willing and able to provide a signed and dated informed consent, comply with the study plan, follow up visits and phone calls
- •At least 18 years old at the time of informed consent
排除标准
- •A. Implanted with heart pacemaker or other implanted electronic device (Europe and Canada only)
- •Use of OsteoCool 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 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
- •Subjects in concurrent studies can only be enrolled with permission from Medtronic. Please contact Medtronic's study manager to determine if the subject can be enrolled in both studies.
结局指标
主要结局
Change of Worst Pain Score: Thoracic/Lumbar Spine RF Ablation
时间窗: From Baseline to 3 months post RF ablation
Demonstrate an improvement of worst pain score (WPS) at the target treatment site in the previous 24 hours for subjects with metastatic lesions in only the thoracic and/or lumbar vertebral body(ies) as collected using the Brief Pain Inventory (BPI). The WPS is a single question from the BPI (scored from 0-10; 0=NO PAIN and 10=PAIN AS BAD AS YOU CAN IMAGINE). Lower scores indicate less pain.
次要结局
- Change in Worst Pain Score: Periacetabulum, Iliac Crest, and/or Sacrum RF Ablation(From Baseline to 3 months post RF ablation)