Evaluation of Sonalleve MR-HIFU for Non-invasive Thermal Therapy of Facet-Joint Syndrome: Feasibility and Safety Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Feasibility: planned temperature (57°C) achieved at target area of sonication
研究概览
简要总结
Patients suffering from facet-joint-syndrome associated with lower-back pain will be treated with MRI-guided High Intensity Focused Ultrasound thermal therapy for pain relief.
详细描述
Patients with diagnosed facet-joint-syndrome are suffering from severe pain in the respective regions, mainly lower-back pain. Eligible patients will be treated with High Intensity Focused Ultrasound (HIFU) under MRI control. The control by MRI assures on the one hand the correct selection of area to be sonicated and monitors in parallel the temperature, reached in the target area. The aim is to thermally ablate facet joint and/or medial branch nerves at lumbar spine. Ablation is deemed to be feasible and successful if temperatures of at least 57°C are reached at the target. The entire procedure will be done under anaesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •chronic low back pain
- •clinical diagnosis of Lumbar Facet Joint Syndrome
- •eligible for MRI and MR-HIFU session
- •eligible for general anaesthesia
- •intact skin and soft tissue over treatment zone
- •facet joint anatomy clearly identifiable
- •patients must be able to discontinue all pain relief medication for a minimum of 48 hours prior to baseline assessment
- •patients able to provide consent for the study
排除标准
- •spinal implants
- •treatment target zone < 10 mm from the skin
- •pregnant female patients
- •breastfeeding female patients
- •body weight > 140 kg
- •systemic and/or local infections
- •moderate to high grade of spinal instability
- •MRI contrast agent contraindication
- •any MRI-unsafe implant or pacemaker
- •facet joint anatomy which is not targetable or reachable due to scars, surgical clips, implants, or prosthesis in the planned beam path of the ultrasound beam
结局指标
主要结局
Feasibility: planned temperature (57°C) achieved at target area of sonication
时间窗: treatment day (4 hours)
Temperatures achieved at the intended treatment location during MR-HIFU treatments
次要结局
- safety of entire procedure(180 days)
- Pain reduction after study treatment(180 days)
- change in Quality of Life (QoL) assessed via Quality of Life Questionnaire(180 days)
- comparison of contrast in MRI before and after treatment(180 days)