Clinical Study of a Focused Ultrasound Device for Treating Uterine Fibroids and Menorrhagia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 3
- 主要终点
- Evaluation of All Adverse Events Encountered
研究概览
简要总结
The Mirabilis High-Intensity Focused Ultrasound (HIFU) Treatment System delivers therapeutic focused ultrasound energy to the uterus under integrated ultrasound imaging guidance to offer non-invasive treatment for uterine fibroids. The purpose of this clinical study is to assess the initial safety and performance of the Mirabilis HIFU Treatment System for transabdominal treatment of uterine fibroids in eligible women who are scheduled to undergo hysterectomy following treatment with the device or who are seeking relief from fibroid-related symptoms.
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 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18-55 years
- •Patients seeking relief from uterine fibroid related symptoms, including those scheduled to undergo abdominal hysterectomy due to benign pathology
- •Patients able and willing to provide informed consent
排除标准
- •Visible scar within the HIFU beam path that cannot be avoided
- •Known or suspected abdominal adhesions between the anterior uterine serosa and the abdominal wall
- •Currently pregnant or desire to become pregnant in the future
- •Pelvic malignancy
- •Pelvic congenital malformation
- •Acute pelvic infection
- •Otherwise determined by a physician to be inappropriate for the study
结局指标
主要结局
Evaluation of All Adverse Events Encountered
时间窗: Adverse Events were monitored until the patient's exit from the study (up to 6 months post-treatment).
Safety of the treatment was determined by evaluating the incidence of Adverse Events and Adverse Device Effects. Adverse Device Effects are Adverse Events that are related to treatment with the device. Relatedness of an Adverse Event to the treatment was determined on a case-by-case basis by the investigator. The average number of Serious Adverse Device Effects per patient and the average number of Non-Serious Adverse Device Effects per patient are reported to provide numeric outcomes of this evaluation.
次要结局
- HIFU-related Non-Perfused Volume (NPV)(The NPV was measured between 0 and 7 days post-treatment.)