NCT02520414已完成不适用
A Pilot Study to Assess the Feasibility of the Symphion® Bipolar Hysteroscopic Tissue Resection System in an Office Environment
Minerva Surgical, Inc.2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2014年11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
- 10
- 试验地点
- 2
- 主要终点
- Safety Profile of the Symphion® Bipolar Hysteroscopic Tissue Resection System When Used in the Office Setting for the Removal of Intracavitary Polyps and Myomas.
研究概览
简要总结
The purpose of this study is to determine the safety and feasibility of using the Symphion system in an office setting.
详细描述
The purpose is to determine the safety and feasibility of using an intrauterine tissue resection system in the office setting, as well as to expand the national discussion regarding in-office hysteroscopic procedures as it relates to the highest standards of care and cost containment.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet the approved Instructions for Use for the Symphion® bipolar hysteroscopic tissue resection system
- •Confirmation hysteroscopic evaluation to access appropriate pathology type and size meets the Protocol guidelines for inclusion
- •Subject has signed written Informed Consent
排除标准
- •Subjects who are pregnant
- •Subjects who have an active genital tract infection (as assessed by the physician)
- •Subjects who have cervical malignancies
- •Subjects who have previously been diagnosed with endometrial cancer
- •Subjects who have Type 2 intracavitary myomas
- •Type 0 or 1 intracavitary myoma greater than 3.0 cm
结局指标
主要结局
Safety Profile of the Symphion® Bipolar Hysteroscopic Tissue Resection System When Used in the Office Setting for the Removal of Intracavitary Polyps and Myomas.
时间窗: 2 weeks
Absence of device related adverse events, or death.
次要结局
未报告次要终点
研究者
研究点 (2)
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