A Prospective, Randomized, Single-Center Study Comparing Contour SE™ Microspheres to Embosphere® Microspheres for Treating Symptomatic Uterine Fibroids With Uterine Fibroid Embolization (UFE)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Number of Participants With Fibroid Devascularization Measured by Contrast Enhanced Magnetic Resonance Imaging (MRI)
研究概览
简要总结
The purpose of this study is to demonstrate comparability between Contour SE™ Microspheres and Embosphere® Microspheres for achieving post UFE fibroid devascularization in women with symptomatic uterine fibroids.
详细描述
The purpose of this prospective randomized single-center study is to demonstrate comparability using Contour SE™ Microspheres (700-900µ and 900-1200µ) using a near stasis endpoint and Embosphere® Microspheres (500-700µ) using a "prune tree" endpoint for achieving post UFE fibroid devascularization in women with symptomatic uterine fibroids. The study will demonstrate (with the use of contrast enhanced Magnetic Resonance Imaging (MRI) at baseline and 24-hours post embolization) that uterine fibroids can successfully be devascularized using the embolization protocols. Contrast enhanced MRI will be performed at baseline, 24-hours, and 3-months post UFE. The subjects will be followed through 12-months post UFE and change from baseline in symptom severity (Quality of Life (QoL) Questionnaire) will be assessed at 3 months and 12 months.
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
- Single (Participant)
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
- •One or more of the following symptoms: abnormal menstrual bleeding, infertility related to fibroids, pelvic pain, and/or bulk/pressure related symptoms attributed to fibroids: i.e., pelvic pressure, abdominal enlargement, abdominal bloating, gastrointestinal pressure symptoms (backache, constipation), dysfunction of the urinary bladder (urinary frequency, urinary retention), vaginal pressure, and rectal pressure.
- •Severity of the symptom(s) warrants invasive treatment
- •Willing and able to complete the follow-up requirements outlined in the study design section of the protocol
- •Willing to sign a consent form
排除标准
- •Active pelvic inflammatory disease or infection
- •Any malignancy of the pelvic region
- •Endometrial neoplasia or hyperplasia
- •Presence of one or more submucosal fibroid(s) with more than 50% growth into the uterine cavity
- •Presence of pedunculated serosal fibroid as the dominant fibroid(s)
- •Fibroids with significant collateral feeding by vessels other than the uterine arteries
- •Presence of arteries supplying the fibroid are not large enough to accept 700-900 micron or 900-1200 micron microspheres
- •Coagulopathy
- •Atypical anatomy that will not allow for bilateral UFE
- •Subject with known severe contrast allergy
- •Subjects with known moderate to severe renal disease
研究组 & 干预措施
Arm 1
干预措施: Uterine Fibroid Embolization (UFE) (Procedure)
Arm 1
干预措施: Contour SE™ Microspheres (Device)
Arm 2
干预措施: Uterine Fibroid Embolization (UFE) (Procedure)
Arm 2
干预措施: Embosphere® Microspheres (Device)
结局指标
主要结局
Number of Participants With Fibroid Devascularization Measured by Contrast Enhanced Magnetic Resonance Imaging (MRI)
时间窗: 24-hours post study procedure
MRI uses a large circular magnet and radio waves to generate signals from atoms in the body. These signals are used to construct images of internal structures. Injection of contrast through an IV is done during the test to enhance the view of the uterus. Contrast enhanced MRI was used as a test in this study to verify if blood supply to the fibroids was blocked or interrupted (devascularization).
次要结局
- Health Related Quality of Life (HRQL)Subscores(Baseline)
- Uterine Fibroid Symptom Quality of Life Questionaire (UFS-QOL) Score(12 months)
- Visual Analog Scale (VAS) Maximum Level of Pain(24 hours after study procedure)
- Procedure Time(During the study procedure (measured in minutes))
- Fluoroscopy Time(During the study procedure (measured in minutes))
- Visual Analog Scale (VAS) Maximum Level of Nausea(24 hours after study procedure)
- Any Adverse Events That the Participant Experienced(During the hospitalization stay post UFE)
- Health Related Quality of Life Subscores(12 months)