Post Approval Study: MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- InSightec
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Number and Type of Adverse Events
研究概览
简要总结
The goal of this study is to develop additional long term data to evaluate the safety and effectiveness of this treatment.
Indications for use for this system is: '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.'
详细描述
Background
General:
Uterine leiomyoma (fibroids) are the most common neoplasms of the female pelvis. These benign tumors are generally oval in shape, and often highly vascular. On T2 weighted MR imaging exams, or T1 exams with contrast, uterine fibroids are easily identifiable. They occur in 20-25% of women of reproductive age and can cause a variety of problems generally described as either bleeding or mass effects from the fibroid. In general, these symptoms can be classified into two categories:
- heavy menstrual bleeding, defined as bleeding on heavy days requiring a change of sanitary wear every 2 hours or less, significant clot passage, flooding, substantial prolongation of menstrual periods compared with the patient's prior experience, or anemia.
- pelvic pain or pressure, heaviness or discomfort, or similar symptoms in the back, flank or leg attributable to the bulk of the fibroid, urinary frequency, increase in nocturia, difficulty voiding or compression of the ureters with hydronephrosis.
Measures of the clinical success of patients who elect treatment of fibroids are generally subjective, and evaluated by the patient in terms of improvement in the initial symptoms that caused her to seek treatment (decrease in pain, bladder or bowel symptoms, or reduction in vaginal bleeding), while experiencing a minimum of co-morbidities from the treatment itself.
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
- 性别
- Female
- 接受健康志愿者
- 否
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 magnetic resonance imaging (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
- •Women 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
Number and Type of Adverse Events
时间窗: 36 months
Adverse events outcomes are reported in the adverse events module.
次要结局
未报告次要终点