NCT06153667招募中不适用
Prospective, Multi-Center Study Using Bearing nsPVA Embolization Particles for the Treatment of uTErine fibRoids With Uterine Artery Embolization
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 5
- 主要终点
- Primary Effectiveness
研究概览
简要总结
This is a prospective, multicenter, observational, post-market clinical follow-up study in subjects treated with Bearing nsPVA Embolization Particles for uterine fibroid embolization. Data collection will include safety and performance outcome relating to the use of Bearing nsPVA, through 6 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult women ≥ 18 years old at the time of enrollment.
- •Subject has symptomatic uterine fibroid(s), suitable to embolization.
- •Subject provides written informed consent.
排除标准
- •Subject is pregnant.
- •Subject has suspected pelvic inflammatory disease or any other pelvic infection.
- •Subject has any malignancy of the pelvic region, (e.g., endometrial neoplasia).
结局指标
主要结局
Primary Effectiveness
时间窗: 6 months
The primary effectiveness endpoint will be clinical success defined as ≥ 50% improvement in the Uterine Fibroid Symptom and Quality of Life (UFS-QoL) Symptom Severity subscale at 6 months as compared to baseline.
Primary Safety
时间窗: 30 days
The primary safety endpoint will be the absence of serious device-related adverse events (AEs) through 30 days.
次要结局
未报告次要终点
研究者
研究点 (5)
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