Uterine Fibroid Embolization (UFE) for Symptomatic Fibroids: Comparison of Gel-Bead to Commonly Used Embolic Agents.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Degree of Fibroid Tissue Infarction at 3 months
研究概览
简要总结
The purpose of this post-market study is to evaluate UFE agents for the treatment of symptomatic uterine fibroids, using Gel-Bead compared to four other commonly used embolic agents.
详细描述
This single-center, prospective study will be conducted at one site in the United Kingdom. Up to 30 subjects will be enrolled and treated with Gel-Bead. Prospectively. Enrolled Gel-Bead subjects will be followed at 1-month and 3-months post-procedure.
Data from subjects treated with Gel-Bead will be compared to data from a previously unpublished, but widely presented, 100-patient cohort study at the University Hospital Southampton. This study evaluated 20 subjects in five different treatment groups for the treatment of symptomatic uterine fibroids. The five treatment groups include gelatin foam slurry, Embospheres, polyvinyl alcohol (PVA), Bead Block and Embozenes.
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
- •Female, age 18 years or older
- •Symptomatic uterine fibroid(s) requiring treatment per the investigators assessment
- •Negative serum pregnancy test at the Baseline visit and practicing effective contraception during the study
- •Willing to provide written informed consent prior to initiation of study procedures
- •Willing to comply with the specified study assessments and follow-up requirements
排除标准
- •Known hypersensitivity to porcine products or intravascular contrast material
- •Vascular anatomy or blood flow precluding correct catheter placement or embolic injection
- •Presence of collateral vessel pathways potentially endangering normal territories during embolization
研究组 & 干预措施
Gel-Beads arm
This group will undergo embolization of symptomatic uterine fibroids with Gel-Beads embolic agent
干预措施: Gel-Beads embolic material (Device)
结局指标
主要结局
Degree of Fibroid Tissue Infarction at 3 months
时间窗: 3 months
The primary endpoint is the degree of fibroid tissue infarction at 3 months post-procedure. Results for the total fibroid load and the dominant fibroid will be categorized as either 100% (Group A) ≥ 90-99% (Group B) or \<90% (Group C) infarcted. The degree of infarction will be visually estimated by the investigator.
Characterization of adverse events over 3 months
时间窗: 3 months
The primary safety endpoint is to characterize adverse events
次要结局
- Change in uterine and dominant fibroid volumes(3 months)