A Phase IV Clinical Study To Evaluate the Safety of MR-Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication Techniques
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- InSightec
- 入组人数
- 121
- 试验地点
- 16
- 主要终点
- Percent Occurrence of Chronic Leg Pain
研究概览
简要总结
The objective of this Phase IV study is to evaluate the safety of the ExAblate treatment of uterine fibroids using the enhanced sonication techniques, based on the current commercially-approved treatment guidelines. Treatment may include up to 100% of individual fibroid volume, within established serosal and sacral treatment margins.
The Enhanced sonication is one of the various sonication modes that may lead to increased thermal dose volume of each sonication without additional safety risks. This is an additional treatment tool available in the ExAblate system for the treatment of uterine fibroids.
The safety profile of the Enhanced Sonication was investigated under an FDA-regulated IDE study. FDA granted approval of Enhanced Sonication with the requirement to perform a post-approval study to collect additional safety data when treating up to 100% of individual fibroid volume.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women age 18 or older
- •Symptomatic uterine fibroids, defined as those resulting in scores of 21 or higher, based on patient responses to questions 1-8 of the Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL)
- •Women who have given written informed consent
- •Women who are able and willing to attend all study visits.
- •Patient is pre or peri-menopausal (within 12 months of last menstrual period).
- •Patient should be family complete.
- •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.
- •Fibroid enhances on MR contrast imaging.
排除标准
- •Women who are pregnant, as confirmed by serum/urine test at time of screening, or urine pregnancy test on the day of treatment.
- •Patients who are breast-feeding.
- •Patients with active pelvic inflammatory disease (PID).
- •Patients with active local or systemic infection.
- •Patients experiencing chronic leg or lower back pain within the last 6 months.
- •Contraindication for MRI Scan:
- •Severe claustrophobia that would prevent completion of procedure in the MR unit
- •Weight greater than 250 lbs (113Kg)
- •Implanted ferromagnetic materials and/or devices contraindicated for MR scan
- •Known intolerance to MRI contrast agent (e.g. Gadolinium or Magnevist)
- •Any other contraindication for MRI Scan
- •Extensive abdominal scarring in the beam path (that cannot be avoided by redirection of the beam).
- •Dermoid cyst of the ovary anywhere in the treatment path.
- •Known or suspected pelvic carcinoma or pre-malignant conditions, including sarcoma and adenomatous hyperplasia.
- •Intrauterine device (IUD) anywhere in the treatment path.
- •Undiagnosed vaginal bleeding.
- •Pedunculated fibroids.
- •Uterine size >24 weeks.
研究组 & 干预措施
ExAblate treatment
干预措施: ExAblate (Device)
结局指标
主要结局
Percent Occurrence of Chronic Leg Pain
时间窗: From treatment to 1-month post-treatment
The hypothesis was that over 90% of subjects would not experience chronic leg pain. A lower 95% Confidence Limit \> 0.90 was considered statistically successful.
次要结局
未报告次要终点