NCT00159328已完成4 期
Phase 4 Study of Magnetic Resonance Guided Focused Ultrasound Surgery Following Gonadotrophin Releasing Hormone Agonist Treatment for Symptomatic Uterine Fibroids
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Symptom improvement as judged by validated disease specific questionnaire
研究概览
简要总结
The purpose of this study is to determine whether ablation of uterine fibroids with MR guided focused ultrasound following 3 months pre-treatment with Gonadotrophin releasing analogues will allow the effective use of this therapy in women with larger fibroids.
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
- Diagnostic
- 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
- •Subject has given consent
- •Willing and able to attend all visits
- •Minimum age 18 with no desire for future fertility
- •Uterine fibroid > 300 cc on MRI
- •Normal cervical smear
- •Screening symptom score >21
- •Pre or peri-menopausal
- •Fibroids being device accessible
排除标准
- •Pregnancy
- •Previous GNRH treatment
- •Hormonal Contraception
- •Patient on dialysis
- •Haematocrit <25
- •ASA score > 2
- •Severe cerebrovascular disease
- •Anticoagulated
- •Active pelvic infection or history of PID
- •Weight> 250 lbs
- •Any contra-indication to MR imaging
- •Intolerance to MRI contrast agent
- •Unable to remain in prone positions for 3hours
- •Abdominal scarring in beam pathway
- •Breast feeding
- •Non-perfused fibroid on contrast enhanced images
结局指标
主要结局
Symptom improvement as judged by validated disease specific questionnaire
次要结局
- Change in fibroid and uterine volume.
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
A Clinical Study to Evaluate Safety of the ExAblate 2100 UF V2 System in the Treatment of Symptomatic Uterine FibroidsUterine FibroidsBleedingPainNCT01092988InSightec40
撤回
3 期
Treatment of Uterine Fibroids With Magnetic Resonance Guided High Intensity Focused UltrasoundUterine LeiomyomaNCT02736435Thunder Bay Regional Health Research Institute
已完成
不适用
Factors Influencing Volumetric MR-HIFU Ablation of Uterine FibroidsUterine FibroidNCT02386137University Hospital, Bordeaux40
已完成
不适用
Focal MR-Guided Focused Ultrasound Treatment of Localized Intermediate Risk Prostate LesionsLocalized Intermediate Risk Prostate LesionsNCT01657942InSightec101
已完成
不适用
Tailored Radiofrequency Ablation of Uterine MyomasUterine FibroidsNCT04091529International Evangelical Hospital54