Pain Reduction and Ovarian Perfusion Following Uterine Fibroid Embolization Via Pressure-Enabled Drug Delivery With the TriNav Infusion System (PEDD-UFE)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 4
- 主要终点
- Pain Reduction
研究概览
简要总结
The goal of this study is to assess of Pressure-Enabled Drug Delivery on fibroid treatment in patients undergoing UFE.
详细描述
Uterine fibroids are the most common tumor type in women of reproductive age and may be associated with abnormal menstrual bleeding, pain, sub-fertility, and diminished quality of life. For women interested in uterine preservation who want to derive adequate relief from medical management, uterine fibroid embolization (UFE) is a treatment option. The goal of this study is to assess of Pressure-Enabled Drug Delivery on fibroid treatment in patients undergoing UFE.
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 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female, aged >18 years.
- •Prior clinical decision for treatment by UFE.
- •One or more enhancing intramural, submucosal or subserosal fibroids on MRI.
- •Having either bulk symptoms or menorrhagia.
排除标准
- •Absolute contraindication to contrast-enhanced MRI.
- •Current pregnancy.
- •Known history of adenomyosis.
- •Diagnosis of pelvic inflammatory disease.
- •Diagnosis of endometriosis.
- •Post-menopausal (no menses >12-months).
- •Diagnosed gynecologic malignancy.
- •Prior uterine fibroid embolization treatment.
- •>50% volume of non-enhancing fibroids.
- •Prior oophorectomy
- •GnRH agonist therapy within 6-months or GnRH antagonist therapy within 1-month prior to entering the study.
- •Target uterine vasculature not suitable for treatment with the TriNav Infusion System.
- •Allergy or intolerance to dilaudid.
- •Lack of ovarian perfusion on baseline MRI.
结局指标
主要结局
Pain Reduction
时间窗: 6 months
The Visual Analog Scale (VAS) Pain score will be used to assess pre- and post-procedural pain. The scale is from 1 to 10 with 1 indicating no pain and 10 indicating extreme pain.
次要结局
- ovarian perfusion(6 months)
研究者
Dania Daye, MD, PhD
Assistant Professor of Radiology
Massachusetts General Hospital