NCT00295217已完成3 期
MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids: Clinical Study to Validate the Changes to ExAblate 2000 Device
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- InSightec
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- In this IDE for the 4.2 ExAblate system, the goal is evaluation of the new features to confirm that they do not introduce any new safety issues.
研究概览
简要总结
The goal of this study is to validate the new ExAblate Application software V4.2 by developing additional data that shows the safety of this treatment. The ExAblate is intended to ablate uterine fibroid tissue in pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure. Patients must have a uterine size of less than 24 weeks and not seeking treatment for reasons of improving fertility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- 是
入选标准
- •Women who present with symptomatic uterine fibroids and are not seeking treatment for the reason of improving fertility.
- •Able and willing to give consent and able to attend all study visits.
- •Patient is pre or peri-menopausal (within 12 months of last menstrual period).
- •Able to communicate sensations during the ExAblate procedure.
- •Uterine fibroids, which are device accessible (i.e., positioned in the uterus such that they can be accessed without being shielded by bowel or bone).
- •Fibroids(s) clearly visible on non-contrast MRI.
排除标准
- •Metallic implants that are incompatible with MRI
- •Sensitive to MRI contrast agents
- •Severe claustrophobia that would prevent completion of procedure in MR unit
- •Who are pregnant or desire to become pregnant in the future. Pregnancies following ExAblate treatment could be dangerous for both mother and fetus.
- •Pedunculated fibroids
- •Active pelvic inflammatory disease (PID)
- •Active local or systemic infection
- •Known or suspected pelvic carcinoma or pre-malignant conditions, including sarcoma and adenomatous hyperplasia
- •Intrauterine device (IUD) anywhere in the treatment path
- •Dermoid cyst of the ovary anywhere in the treatment path
- •Extensive abdominal scarring that cannot be avoided by redirection of the beam (e.g., due to Caesarean section or repeated abdominal surgeries)
- •Undiagnosed vaginal bleeding
结局指标
主要结局
In this IDE for the 4.2 ExAblate system, the goal is evaluation of the new features to confirm that they do not introduce any new safety issues.
次要结局
未报告次要终点
研究者
研究点 (4)
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