NCT02023801已完成不适用
A Single Arm Clinical Study of the Safety and Efficacy of the AURORA™ Endometrial Ablation System
Minerva Surgical, Inc.2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2011年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Reduction in Menstrual Blood Loss to Normal Levels at 12 Months
研究概览
简要总结
This is a clinical study without a formal hypothesis. The primary objective of the study is to evaluate the use of the Aurora Endometrial Ablation System in achieving a return to normal menstrual blood loss at 12 months post-treatment, in premenopausal women with menorrhagia due to benign causes for whom childbearing is complete or no longer wish to retain fertility.
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
- 25 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Refractory menorrhagia with no definable organic cause
- •Female subject from age 25 to 50 years
- •Uterine sound measurement of 6.0cm to 10.0cm (external os to internal fundus)
- •One of the following criteria:
- •A. Documented history of menorrhagia secondary to dysfunctional uterine bleeding (DUB).
- •B. If a pictorial blood loss assessment chart (PBLAC) scoring systems is used; a minimum PBLAC score of ≥150 for 3 months prior to study enrollment; OR, A minimum PBLAC score ≥150 for one month for women who either i. had at least 3 prior months documented failed medical therapy; or ii. had a contraindication to medical therapy; or iii. refused medical therapy
- •Premenopausal at enrollment as determined by FSH measurement ≤ 40 IU/ml
- •Not pregnant and no desire to be pregnant in the future
- •Patient agrees not to use hormonal contraception or any other medical intervention for bleeding during the study
- •Able to provide written informed consent using a form that has been approved by the reviewing IRB/EC
- •Subject agrees to follow-up exams and data collection, including ability to accurately use menstrual diaries
- •Subject who is literate or demonstrates an understanding on how to use menstrual diaries or how to collect and provide used sanitary products
排除标准
- •Pregnancy or subject with a desire to conceive
- •Endometrial hyperplasia as confirmed by histology
- •Presence of active endometritis
- •Active pelvic inflammatory disease
- •Active sexually transmitted disease (STD), at the time of ablation. Note: Treatment of STD documented in the chart serves as sufficient evidence of infection resolution. Patient may be considered for study enrollment.
- •Presence of bacteremia, sepsis, or other active systemic infection
- •Active infection of the genitals, vagina, cervix, uterus or urinary tract at the time of the procedure
- •Known/suspected gynecological malignancy within the past 5 years
- •Known clotting defects or bleeding disorders
- •Untreated/unevaluated cervical dysplasia (except CIN I)
- •Known/suspected abdominal/pelvic cancer
- •Prior uterine surgery (except low segment cesarean section) that interrupts the integrity of the uterine wall (e.g., myomectomy or classical cesarean section)
- •Previous endometrial ablation procedure
- •Currently on medications that could thin the myometrial muscle, such as long-term steroid use (except inhaler or nasal therapy for asthma)
- •Currently on anticoagulants
- •Abnormal or obstructed cavity as confirmed by hysteroscopy or SIS, specifically:
- •Septate or bicornuate uterus or other congenital malformation of the uterine cavity
- •Pedunculated or submucosal myomas distorting the uterine cavity
- •Polyps likely to be the cause of the subject's menorrhagia
- •Intramural or subserosal myomas that distort the uterine cavity
- •Presence of an intrauterine device (IUD) which the patient is unwilling to have removed at the time of the operative visit
- •Presence of an implantable contraceptive device (e.g. Essure or Adiana).
- •Subject currently on hormonal birth control therapy or unwilling to use a non-hormonal birth control post-ablation (including a Mirena device).
- •Subject who is within 6-weeks post partum.
- •Any general health condition which, in the opinion of the Investigator, could represent an increased risk for the subject
- •Any subject who is currently participating or considers future participation in any other research of an investigational drug or device.
结局指标
主要结局
Reduction in Menstrual Blood Loss to Normal Levels at 12 Months
时间窗: 12 Months
Number of subjects in whom menstrual blood loss was reduced to normal or below normal levels at 12 months, as measured by a pictorial blood loss assessment chart (PBLAC) score of \<=75.
次要结局
- Procedure Time(< 1 hour)
研究者
研究点 (2)
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