MyoSure Hysteroscopic Tissue Removal System Registry Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 290
- 试验地点
- 2
- 主要终点
- Procedure Efficacy
研究概览
简要总结
The objective of this study is to demonstrate the safety and effectiveness of community gynecologist initiated treatment of intra-uterine polyps and submucosal fibroids with the MyoSure Hysteroscopic Tissue Removal System in a significantly sized patient population.
详细描述
Between 500 and 600 subjects will be enrolled in a prospective, multi-center registry study. Approximately 100 of these cases will be completed in an office setting, with the remaining 400-500 cases completed in a hospital outpatient or ambulatory surgery center. Subjects will undergo a hysteroscopic tissue removal procedure to remove intrauterine polyps and submucosal fibroids.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy female between 18 and 65 years of age
- •Subject must be able to understand, read and sign the study specific informed consent forms after the nature of the study has been fully explained to her
- •Subject is indicated for myomectomy or polypectomy
- •Subject exhibits intrauterine polyps and/or submucous myomas which meet one of the following criteria. In cases of subjects with multiple intrauterine pathology, classification is based as follows:
- •All polyps
- •All Type 0, Type 1 or Type 2 myomas ≤ 6 cm in diameter
- •Polyps plus Type 0, Type 1 or Type 2 myomas ≤6 cm in diameter
排除标准
- •Subject is pregnant
- •Subject has an Intrauterine Device (IUD) at the time of the procedure. A subject may be enrolled in the study if the IUD is removed prior to the treatment procedure
- •Subject is taking an anticoagulant or antiplatelet medication other than low dose aspirin
- •Active pelvic inflammatory disease or pelvic/vaginal infection
- •Subject has a known or suspected coagulopathy or bleeding disorder
- •Subject has a history of disease which increases the risk for fluid overload (i.e. significant cardiac, hepatic, or renal dysfunction)
- •Subject has other co-morbid condition(s) that, in the opinion of the Investigator, could limit the subject's ability to participate in the study or impact the scientific integrity of the study
研究组 & 干预措施
Intrauterine pathology, myomectomy
Subjects with intrauterine fibroids and/or polyps will undergo intrauterine pathology removal using the MyoSure Tissue Removal System; myomectomy procedure.
干预措施: MyoSure Tissue Removal System (Device)
结局指标
主要结局
Procedure Efficacy
时间窗: 1 hour post treatment
Mean percent of pathology removed, based on hysteroscopic assessment immediately following completion of the treatment procedure
次要结局
- Percentage of Subjects That Achieve 100% Removal of Target Pathology(1 hour post treatment)