MRI-guided High Intensity Focused Ultrasound Ablation of Leiomyomas. Single Arm, Feasibility Study Using the Symphony - MRI Guided Focused Ultrasound System for the Treatment of Leiomyomas
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- The ability to ablate fibroid tissue measured by temperature elevation
研究概览
简要总结
Single arm, first-in human feasibility study using the Symphony - MRI guided focused ultrasound system for the treatment of leiomyomas. The study is expected to accrue over 12 months. This study will help determine the feasibility to ablate leiomyomas, as measured by MR thermometry and contrast enhanced imaging. In addition, the study will look at the efficacy and safety of the treatment, as measured by the reduction in fibroid size and reduction in symptom severity score and adverse events. This study will help develop future pivotal trials using the same device.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •MR-HFU device accessibility to fibroids that at least 50% of fibroid volume can be treated
- •Fibroids selected for treatment meet the following criteria
- •Total planned ablation volume of all fibroids should not exceed 500 ml AND
- •Completely non-enhancing fibroids should not be treated
- •Transformed SSS score >= 40
- •Pre- or peri-menopausal, as indicated by clinical evaluation
- •Weight < 140 kg or 310 lbs
- •Willing and able to attend all study visits
- •Willing and able to use reliable contraception methods
- •Uterine size < 24 weeks
- •Cervical cell assessment by PAP: normal, LOW Grade SIL, Low risk HPV or ASCUS subtypes of cervical tissue
- •Waist circumference <110cm or 43 inches
排除标准
- •Other Pelvic Disease (Other mass, endometriosis, ovarian tumor, acute pelvic disease, significant adenomyosis, prolonged bleeding requiring further evaluation as determined by patient's gynecologist)
- •Positive pregnancy test
- •Extensive scarring along anterior lower - abdominal wall (>50% of area)
- •Surgical clips in the potential path of the HIFU beam
- •Tattoos in the potential path of the HIFU beam
- •MRI contraindicated
- •MRI contrast agent contraindicated (including renal insufficiency)
- •Calcification around or throughout uterine tissue that may affect treatment
- •Communication barrier
- •Fibroids not quantifiable on MRI (e.g., multi-fibroid cases where volume measurements are not feasible)
- •Pedunculated fibroids
- •Bowel loops int he ultrasound beam path
- •Patients with inability to tolerate prolonged prone position for up to 3 hours
- •Patient with unstable medical conditions
- •Patients with coagulopathy or under current anti-coagulation therapy
结局指标
主要结局
The ability to ablate fibroid tissue measured by temperature elevation
时间窗: 1 year
Measured by MRI thermometry
The ability to ablate fibroid tissue indicated by Non-Perfused Volume (NPV)
时间窗: 1 year
Measure by contrast enhanced imaging
Safety of the system measured by collection of adverse events related to potential damage to tissue outside the treatment zone
时间窗: 1 year
Safety will be measured by collection of adverse events related to potential damage to tissue outside the treatment zone.
Safety of the system based on damage to skin measured by collection of adverse events related to potential damage to skin over the treatment volume
时间窗: 1 year
Safety will be measured by collection of adverse events related to potential damage to skin over the treatment volume.
次要结局
- Treatment efficacy to reduce symptom severity by Symptom Severity Scores (SSS)(1 year)
- Treatment efficacy to reduce fibroid size(1 year)
- Treatment efficacy to reduce fibroid size by NPV(1 year)
研究者
Dr. Elizabeth David
Affiliate scientist, Interventional Radiologist and Assistant Professor
Sunnybrook Health Sciences Centre