Feasibility Study of Hysteroscopic Cryoablation Treatment of Symptomatic Uterine Fibroids in Women Who do Not Desire Further Pregnancies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Number of Adverse Events
研究概览
简要总结
The purpose of the current study is to evaluate the technical success, safety and procedure feasibility of hysteroscopic cryoablation treatment of symptomatic uterine fibroids in women who do not desire further pregnancies using Galil Medical's 17-gauge 400mm Argon-based cryoablation needles
详细描述
Currently there are no optimal methods for treating symptomatic uterine fibroids. Existing therapeutic options are conservative (medications), invasive (e.g., hysterectomy, surgical myomectomy), or minimally invasive (uterine artery embolization, or myolysis).
Fibroid ablation using cryogenic energy, known as Cryoablation, offers a potential alternative method of fibroid treatment. Cryotherapy is a well-established technique for the treatment of various benign and malignant conditions. Cryoablation has been described for the treatment of prostate cancer, renal cell carcinoma, liver tumors and benign and malignant breast tumors.
Galil Medical's proposed feasibility study is looking to examine the technical success, safety and feasibility of a hysteroscopic approach for the treatment of symptomatic fibroids. This technique involves the insertion and placement of Galil Medical's 17-gauge cryoablation needle(s)guided by a hysteroscopic device. Ultrasound provides real-time monitoring of the needle insertion, placement and iceball propagation during the cryoablation procedure.
This treatment offers the patient to preserve her uterus by a minimally invasive procedure. The type of the fibroids intended for treatment (Type II submucous myomas)are often very difficult to completely and safely remove hysteroscopically and are often treated through an open or laparoscopic procedure. A hysteroscopic procedure does not involve intraperitoneal intervention and is therefore expected to be associated with less intra-operative and post-operative complications.
The recovery from hysteroscopic cryoablation is expected to be fast with only minimal self resolving discomfort. The patient should be able to return to her normal activity within 24-48 hours.
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
- 30 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Primary complaint is excessive bleeding
- •Subject is able to understand and give informed consent for participation in the study
- •Pre-menopausal woman between the ages of 30 and 50 (inclusive)
- •Has completed childbearing and not contemplating future fertility
- •Has symptomatic uterine fibroids
- •Fibroids type, size, location and number
- •1 submucosal fibroid
- •Type I and Type II fibroids
- •Using contraception to prevent pregnancy
排除标准
- •Any evidence of known or suspected infection or pre-malignancy/malignancy
- •Desire for future child bearing
- •Size > 4cm
- •2 or more submucosal fibroids
- •Fibroid distance from the serosa is less than 1 cm
结局指标
主要结局
Number of Adverse Events
时间窗: up to 4 weeks post procedure.
Safety of the procedure will be assessed by incidence and severity of intra and post procedure related adverse events (AEs)
次要结局
- Hysteroscopic Cryoablation Related Pain Will be Measured by Self Reported Pain Severity Visual Analogue Scale (VAS) Completed by the Patient(Prior to hospital discharge (less than 24 hours post-procedure))
- Number of Participants Discharged on Day of Cryoablation Procedure.(Post procedure)
- Time (in Days) to Return to Normal Activity(4 weeks post procedure)
- Evaluation of Length of an Average Cryoablation Procedure(Post procedure)
- Physician's Satisfaction From the Ease and Convenience of the Cryoablation Procedure(Post procedure)