NCT02873611Unknown不适用
Estimation of the Localization Accuracy of the Genicular Ablation Procedure Applied for Chronic Pain Suppression
TPM Medical Systems Ltd.0 个研究点目标入组 30 人开始时间: 2016年8月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 主要终点
- Location and orientation of the relevant genicular nerves based on eye-balling inspection of MRI images by a radiologist
研究概览
简要总结
Estimation of the localization accuracy of the genicular ablation procedure applied for chronic pain suppression
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years and older.
- •Diagnosed with primary degenerative osteoarthritis.
- •Complaining of knee pains
- •Patients clinically eligible for genicular nerve ablation procedure non-electively based on physical examination
- •Patient signed ICF
排除标准
- •Co-morbidities: patient suffers from neuropathy, bony tumors, traumatic fractures and DM.
- •Claustrophobic or failing cooperativity assessment of laying still during long MRI scans
- •Pregnancy or pregnancy suspicion
- •Enrolled in concurrent studies that may confound the results of this study
- •Clinical condition that in the investigator's opinion would not allow the subject to complete the study, e.g., tremor, extreme obesity, mental disorders.
研究组 & 干预措施
MRI scanning and the genicular ablation
Experimental
patients undergoing both MRI scanning and the genicular ablation procedure. additional MRI testing of apprx. 0.5-1 hour
干预措施: MRI (Device)
MRI scanning and the genicular ablation
Experimental
patients undergoing both MRI scanning and the genicular ablation procedure. additional MRI testing of apprx. 0.5-1 hour
干预措施: genicular ablation procedure (Procedure)
结局指标
主要结局
Location and orientation of the relevant genicular nerves based on eye-balling inspection of MRI images by a radiologist
时间窗: 6 months
次要结局
未报告次要终点
研究者
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