Safety and Efficacy of Embozene® Microspheres for Uterine Fibroid Embolization Compared to Embosphere® Microspheres for Symptomatic Relief From Uterine Fibroids
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 118
- 主要终点
- Fibroid Infarction Rate
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of Embozene Microspheres compared with Embosphere Microspheres for the treatment of symptomatic uterine fibroids. A total of 118 patents with symptomatic uterine fibroids will be enrolled at 6 sites. Symptom severity, health-related quality of life, and the appearance of the fibroids will be assessed prior to treatment. Patients will then undergo the uterine fibroid embolization procedure with either Embosphere Microspheres or Embozene Microspheres, which will be randomly assigned. Clinical outcomes will be assessed 1 month, 3 months, 6 months and 12 months after the procedure, and imaging outcomes will be obtained 3 months after the procedure.
详细描述
The uterine fibroid embolization (UFE) procedure is an accepted, minimally invasive treatment option for patients with symptomatic uterine fibroids. Studies evaluating the outcomes after this procedure have established that the use of polyvinyl alcohol particles and Embosphere Microspheres is associated with best clinical and imaging outcomes. Embozene Microspheres represent a new embolic agent that is being evaluated for use for the treatment of symptomatic fibroids. The purpose of this study is to evaluate the safety and effectiveness of Embozene Microspheres compared with Embosphere Microspheres for the treatment of symptomatic uterine fibroids.
A total of 118 patents with symptomatic uterine fibroids will be enrolled at 6 sites. A questionnaire designed to assess symptom severity and health-related quality of life in patients will be administered to patients at the time of enrollment. In addition, a contrast-enhanced magnetic resonance imaging (MRI) examination will be performed to confirm the diagnosis of fibroids. Patients will then undergo the uterine fibroid embolization procedure. The embolic agent used for the procedure (Embosphere Microspheres or Embozene Microspheres) will be randomly assigned. Patients will be seen 1 month, 3 months, and 6 months and contacted 12 months after the procedure so that the same questionnaire can be used to assess clinical outcomes. In addition, an MRI will be performed 3 months after the procedure to determine the imaging response to treatment.
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, Outcomes Assessor)
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
- •She is able to provide informed consent and sign the Institutional Review Board approved informed consent form.
- •She is pre-menopausal and 30-50 years of age at the time of enrollment.
- •She is not actively attempting to become pregnant for a minimum of 1 year after UFE, or practicing abstinence and willing to continue for a minimum of 1 year after UFE, or is surgically sterile.
- •She is suffering from clinically significant symptoms attributed to the presence of uterine fibroids including abnormal menstrual bleeding and/or bulk-related symptoms including pelvic pain/discomfort, abdominal distension, urinary symptoms (including but not limited to increased urinary frequency or urinary hesitancy), and/or dyspareunia.
排除标准
- •She has a history of pelvic malignancy.
- •She is pregnant or intends to become pregnant within 12 months of the planned UFE procedure.
- •She has had an abnormal PAP smear (anything other than normal or ASCUS - Atypical Squamous Cells of Unknown Significance) within 12 months of the planned UFE procedure.
- •She has a coexisting condition that might explain the presenting symptoms (including but not limited to adenomyosis, endometrial hyperplasia, endometriosis, and complex ovarian cysts).
- •She has evidence of current or recent pelvic inflammatory disease or uterine infection.
- •She has another serious medical condition that might preclude full participation in the study to the desired endpoint (e.g., uncontrolled diabetes, malignancy, chronic obstructive pulmonary disease, myocardial infarction, congestive heart failure, etc.)
- •She has a severe contrast allergy or renal insufficiency that would represent a contraindication to the administration of iodine-based or gadolinium-based contrast agents.
- •She has a contraindication to magnetic resonance imaging (MRI).
- •She has one or more MRI findings including a uterine size >20 cm in greatest length, a dominant fibroid with a greatest diameter >12 cm, an intracavitary submucosal fibroid, or non enhancing dominant fibroids.
- •In the judgment of the investigator, she is unable or unlikely to be able to comply with the study procedures and requirements.
结局指标
主要结局
Fibroid Infarction Rate
时间窗: 3 Months
The primary effectiveness endpoint for this study is the proportion of patients with a global rate of infarction for all fibroids present within the uterus that is \>90% as seen on contrast-enhanced MRI.
次要结局
- Symptom Severity(12 Months)
- Health-Related Quality of Life(12 Months)
- Uterine Volume(3 Months)
- Dominant Fibroid Volume(12 Months)
- Frequency of Adverse Events After Treatment(12 Months)
研究者
Gary Siskin, MD
Professor and Chairman, Department of Radiology, Albany Medical Center
Community Care Physicians, P.C.