A Randomized Study to Evaluate the Safety and Effectiveness of MRgFUS Procedure Compared With Myomectomy for the Treatment of Uterine Fibroids
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- InSightec
- 试验地点
- 2
- 主要终点
- Safety
研究概览
简要总结
The objective of this trial is to evaluate the safety and efficacy of ExAblate for the treatment of uterine fibroids.
Women, seeking treatment for symptomatic uterine leiomyomata will be eligible for the study.Women who agree to participate will sign an informed consent and will be randomized to ExAblate treatment or myomectomy.
All patients will be followed through the 36 month visit. Follow-up visits/telephone calls will be completed at 1 week, 2 weeks, 6 weeks, 3 months, 6, 12, 18, 24 and 36 months post treatment.
Patients will be evaluated by assessing their overall physical and mental health as well as for device/procedure related adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（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 (raw score) 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)
- •Able to communicate sensations during the ExAblate procedure
- •Uterine fibroids, which are device accessible
- •Fibroid(s) clearly visible on non-contrast MRI.
- •Fibroid(s) enhances on MR contrast imaging
排除标准
- •Women currently pregnant
- •Uterine size > 24 cm W/O the cervix
- •More than 4 clinically significant fibroids (per MRI)
- •Prior myomectomy, UAE
- •Allergy to either gadolinium or iodinated contrast
- •Implanted metallic device prohibiting MRI
- •Severe claustrophobia
- •Active pelvic infection
- •Current use of intrauterine contraceptive device
- •Unstable medical conditions requiring additional monitoring during the procedure
- •Bleeding diathesis requiring medical treatment
- •Imaging suggestive of malignant disease of uterus, ovary, or cervix
- •Imaging and suggestive of adenomyosis.
- •Pedunculated submucosal or pedunculated subserosal myoma
- •Size and weight which prohibits subject from fitting in MRI device
- •Unavoidable, scarring, skin folds or irregularity, bowel, pubic bone, IUD, surgical clips or hard implants in the beam path.
- •Hyper intense fibroid relatively to the uterus muscle
- •Women with ovarian dermoid cyst anywhere in the treatment path
研究组 & 干预措施
Treatment
MR guided Focused Ultrasound
干预措施: Exablate 2100 (Device)
Surgery
Myomectomy
干预措施: Myomectomy (Procedure)
结局指标
主要结局
Safety
时间窗: 36 months post treatment
Safety will be evaluated by recording and assessing the incidence and severity of major adverse events from treatment through the 3 years follow-up period.
Efficacy
时间窗: 36 months post treatment
Comparison between ExAblate treatment and non-Hysteroscopic Myomectomy in terms of treated patients who did not undergo another interventional treatment for recurrence of uterine fibroid symptoms at up to 36 months (3 years).
次要结局
- Efficacy(36 months post treatment)