NCT00215618已完成3 期
Clinical Evaluation of Uterine Balloon Therapy System for Menorrhagia
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 250
- 主要终点
- Incidence of post-procedure amenorrhea in women treated with uterine balloon therapy.
研究概览
简要总结
The purpose of this research is to determine the proportion of women who achieve permanent cessation of bleeding after Uterine Balloon Therapy (UBT) for the treatment of heavy uterine bleeding.
详细描述
This study was also designed to determine the effect of a post procedure curettage on bleeding patterns and post-operative discharge and pain.
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
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female at least 30 years of age who is premenopausal and for whom childbearing is complete.
- •Excessive menstrual bleeding documented by a diary score of at least
- •Have documented 3 months failed medical therapy or either a) contraindicated for or b) refused medical therapy.
- •Have an anatomically normal uterine cavity sounding at least 4cm, but not greater than 12cm.
- •Have a normal pap smear and no unexplained abnormal pap smears within 1 year of the procedure.
- •Agree not to switch from hormonal to non-hormonal contraception or vice versa during or just prior to the study.
- •Agree to use reliable contraception throughout the study.
- •Freely agree to participate in the study, including all study related procedures and evaluations, and document this agreement by signing informed consent documentation.
排除标准
- •Active pelvic inflammatory disease (PID) or recurrent chronic PID.
- •Active genital or urinary tract infection at the time of the procedure.
- •History of malignancy of the reproductive system within 5 years of the procedure or have ever had malignancy of the endometrium.
- •Endometrial neoplasia, determined by endometrial biopsy taken within 6 months of procedure.
- •Cavity distorting submucous myoma(s) determined by preoperative hysterogram, hysteroscopy, or transvaginal sonography within 6 months of the procedure.
- •Previous endometrial ablation procedure.
- •Previous uterine surgeries (such as full thickness myomectomy, subserosal myomectomy, uterine reconstruction, or any surgery in which thinning of the uterine musculature could occur) except for low transverse caesarean section.
- •Pregnant or desirous of future pregnancy.
- •Taken endometrial suppression medication, except for oral contraceptives, within 3 months of the procedure.
- •Concurrent open or laparoscopic surgery.
结局指标
主要结局
Incidence of post-procedure amenorrhea in women treated with uterine balloon therapy.
时间窗: 6 and 12 mo
次要结局
- Post-procedure bleeding levels(2 and 3 yrs)
- Effect of post-procedure curettage on bleeding patterns, post-operative discharge and post-operative pain.(2 and 3 yrs)
- System utility as indicated by equipment events that require intervention.(perioperative)
研究者
相似试验
已完成
3 期
LCS12 vs. ENG Subdermal Implant (Nexplanon) Discontinuation Rate StudyContraceptionNCT01397097Bayer766
已完成
不适用
Safety Study of ExAblate for the Treatment of Uterine FibroidsUterine FibroidsNCT01142791InSightec121
已完成
不适用
Radiologic Evaluation and Breast Density (READ)Breast CancerNCT00117663Kaiser Permanente1,704
已完成
不适用
Suspension of the Pelvic and Abdominal Organs During Minimally Invasive SurgeryPelvic ProlapseEndometrium CancerEndometriosisNCT06187558University of Cagliari330
已完成
不适用
Introduction of UBT for PPH Management in Three CountriesPostpartum HemorrhageNCT02910310Gynuity Health Projects60,105