NCT03427671已完成不适用
An Open Label, Single Center Study to Evaluate the Safety and Effectiveness of OCL 500 Embolization Microspheres (OCL 500) in Uterine Artery Embolization for the Treatment of Premenopausal Women With Symptomatic Uterine Fibroids
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Fibroid volume
研究概览
简要总结
This is a prospective, open-label, single-arm, safety and effectiveness study of Occlusin 500 microspheres in women with symptomatic uterine fibroids.
详细描述
Prior to entering the study, all patients will undergo pre-study assessments including compliance with inclusion and exclusion criteria, laboratory assessments, pelvic examination, and imaging of the pelvis. Following conventional catheter angiography to confirm catheter placement and the uterine vasculature, each patient will undergo transarterial embolization with Occlusin 500 microspheres.
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
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Premenopausal women with symptomatic uterine fibroids
- •Willing and able to provide informed consent
- •Fibroids visible by ultrasound or non-contrast magnetic resonance imaging
- •Fibroids with a minimum diameter of 4cm for a single fibroid or 3cm where there are 2 or more fibroids; minimum total fibroid burden 33cc
- •Documented ovulation by Luteinizing Hormone (LH) testing
- •Follicle Stimulating Hormone (FSH) value >40 IU/L within 3 months prior to procedure
- •Pelvic examination within 6 months prior to procedure
- •Normal Pap smear
排除标准
- •Positive pregnancy test
- •Uterine size > 20 weeks gestation
- •Fibroids that are more than 50% submucosal
- •Individual fibroids > 12cm in diameter, or total fibroid burden > 905cc
- •Pedunculated subserosal fibroids with an attachment to the uterus less than 50% of the greatest diameter of the fibroid
- •Fibroids situated in the cervix
- •Abnormally large ovarian arteries
- •Uterine pathology other than fibroids
- •History of gynecologic malignancy
- •Active pelvic infection or history of pelvic inflammatory disease
- •Undiagnosed pelvic mass outside the uterus
- •History of chemotherapy or radiation to the abdomen or pelvis
- •Intra-Uterine Device (IUD) in position
- •History of, or ongoing, hemolytic anemia
- •Severe cerebrovascular disease defined by a cerebrovascular accident within 6 months of treatment
- •Anticoagulant therapy or known bleeding disorder
- •Treatment with Gonadotropin Releasing Hormone (GnRH) agonists within the previous 6 weeks
- •Received another investigational agent within past 12 weeks
- •Compromised hematopoietic function
- •Compromised hepatic function
- •Compromised renal function
- •BMI > 38
- •Claustrophobia
- •Contraindication to angiography
- •Contraindication to magnetic resonance imaging (MRI) or MRI contrast agents
- •Allergy to contrast agents
- •Allergy to bovine collagen
- •Patient desires to become pregnant, or does not agree to contraception during study
研究组 & 干预措施
Occlusin 500 microspheres
Experimental
Uterine fibroid embolization
干预措施: Occlusin 500 Microspheres (Device)
结局指标
主要结局
Fibroid volume
时间窗: 6 months post-embolization
Magnetic Resonance Imaging-determined fibroid volume
次要结局
- Quality of Life Assessment(6 month post-embolization)
- Uterine volume(6 months post-embolization)
- Fibroid volume(1 month post-embolization)
研究者
研究点 (2)
Loading locations...
相似试验
招募中
2 期
Adjuvant Adebrelimab Plus Apatinib for Participants With HCC at High-risk of Recurrence After Curative ResectionCarcinoma, HepatocellularNCT06454578Qilu Hospital of Shandong University30
招募中
1 期
U87 CAR-T in Patients With Advanced Head and Neck TumorsNasopharynx CancerHead and Neck CancerNCT06614686Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd20
终止
4 期
Effects of Riociguat on RIght VEntricular Size and Function in PAH and CTEPHPrimary Pulmonary Arterial HypertensionChronic Thromboembolic Pulmonary HypertensionNCT04954742Heidelberg University30
招募中
1 期
A Single-arm, Open-label Clinical Study to Evaluate the Efficacy and Safety of VRT106 in Combination With Chemotherapy for Resectable Pancreatic CancerPancreatic CancerNCT06758544Guangdong Provincial People's Hospital18
进行中（未招募）
2 期
Fruquintinib Combined With Tislelizumab and HAIC in Patients With Advanced Colorectal Liver Metastases Cancer Who Failed Standard TherapyColorectal CancerNCT05435313Fudan University39