NCT01735812撤回不适用
Cryoablation of Symptomatic Uterine Fibroids Using the IceSense3™ System in a Percutaneous Laparoscopic-assisted Approach
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Incidence, subsequent interventions and procedure-related adverse events
研究概览
简要总结
The goal of this study is to evaluate the safety & efficacy of cryoablation using IceCure medical's IceSense3™ device for the treatment of symptomatic uterine fibroids in a percutaneous lap-assisted approach.
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
- •Pre-menopausal woman between the ages of 30 and 50 (inclusive)
- •Patient had completed her family planning and does not desire future childbearing.
- •Patient is suffering from menorrhagia as a result of symptomatic uterine fibroids.
- •Patient's uterus size is smaller than 18 gestational weeks.
- •Patient wishes to preserve her uterus and avoid hysterectomy.
- •Patient has 1-3 treatable uterine fibroids in size of up to 10cm measured by US/MRI.
- •Overall treated fibroid volume is ≤ 3,138cm3 (width x length x height x 0.523)
- •Patient has clinical menorrhagia as indicated by menstrual blood loss of ≥160 ml during one baseline cycle prior to treatment.
- •Patient is able to visit the clinic as needed during the 1 year follow-up period following the treatment.
- •The patient has been informed of the study and agrees to its provisions, and has signed an IRB approved written informed consent, including data privacy authorization.
排除标准
- •Patient had not finished her family planning
- •Patient was already treated for uterine fibroids in the past (UAE, myomectomy, HIFU,...) or undergone endometrial ablation.
- •Patient had been treated with GnRH over the last 3 months.
- •Patient has known symptomatic endometriosis that cannot be completely removed during laparoscopic procedure.
- •Patient has known or suspected adenomyosis
- •Patient had any active abdominal/pelvic inflammatory disease.
- •Patient has known or suspected gynecologic malignancy.
- •Patient with submucosal fibroids type "zero"
- •Patient with undiagnosed vaginal bleeding
- •Patient with blood clotting disorders
- •Patients carrying contagious diseases such as Tuberculosis Hepatitis or AIDS.
- •Patient participating in other trials using drugs or devices.
- •Patient is unable to commit all study requirements including follow-up visits and questionnaires.
- •Patient has any contraindication for laparoscopic surgery
结局指标
主要结局
Incidence, subsequent interventions and procedure-related adverse events
时间窗: 12 months
To evaluate procedural safety by monitoring incidence, subsequent interventions and procedure-related adverse events within 12 months of treatment
Improvement in patient's fibroid-related quality of life
时间窗: 12 months
To evaluate procedural efficacy by the improvement in patient's fibroid-related quality of life as assessed in scores of symptom severity subscale questionnaire (SSS-UFS-QOL) at 12 months post-treatment comparing to baseline score.
次要结局
- Improvement in menstrual bleeding(12 months)
- Improvement in patient's fibroid-related quality of life(6 months)
- Reduction in fibroid volume(12 months)
研究者
研究点 (2)
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