Safety and Efficacy of Embozene Microspheres for Uterine Fibroid Embolization Compared to Embosphere for Symptomatic Relief From Uterine Fibroids
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Primary Endpoint
研究概览
简要总结
This is a randomized, prospective, multi-center study of 225 female subjects age 30-50 years with symptoms from uterine fibroids. All subjects will be followed for a total of thirty-six (36) months following uterine fibroid embolization.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject is able to provide informed consent and must sign the Institutional Review Board approved Informed Consent Form.
- •Pre-menopausal women age 30-50 years at time of enrollment
- •Have been selected forUterine Fibroid Embolization (UFE) prior to entry to the study.
排除标准
- •Patient has a history of pelvic malignancy
- •Patient has an abnormal Pap smear within 12 months of the planned Uterine Fibroid Embolization procedure
- •Patient with coexisting condition that might explain abnormal bleeding (including endometrial hyperplasia and adenomyosis) or pelvic pain (including endometriosis and ovarian cysts).
- •Is at substantial risk for the need of organ transplantation, such as renal insufficiency.
- •Patient has evidence of current or recent pelvic inflammatory disease or uterine infection.
- •Patient with a severe contrast allergy or renal insufficiency that would represent a contradiction to the administration of iodine-based contrast agents.
- •Patients unable to comply with the follow-up requirements of the study.
研究组 & 干预措施
Embozene® Microspheres
Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.
干预措施: Embozene® Microspheres (Device)
Embosphere®
Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.
干预措施: Embosphere® (Device)
结局指标
主要结局
Primary Endpoint
时间窗: 12 Months post study procedure
The primary effectiveness endpoint for this clinical trial is the proportion of subjects who have success, defined as 50% menstrual blood loss (MBL) reduction or less than 80 ml of MBL per cycle, evaluated by the Alkaline Hematin (AH) method, at 12 months.
次要结局
未报告次要终点