NCT05332132Unknown不适用
Evaluation of the Heracure Device for Hysterectomy
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Device or procedure related Adverse Event (AE)
研究概览
简要总结
Safety and performance evaluation of the Heracure Device for intra-uterine morcellation after vaginal or laparoscopic hysterectomy.
详细描述
The purpose of this clinical investigation is to evaluate the safety and efficacy of the Heracure Device for intra-uterine morcellation after vaginal or laparoscopic hysterectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subject is undergoing hysterectomy due to benign gynecologic disease
排除标准
- •Subject is not suspected of malignancy
结局指标
主要结局
Device or procedure related Adverse Event (AE)
时间窗: Intra-operation
Adverse Event defined as uterine perforation at the end of procedure, assessed by inflating the uterus with saline.
次要结局
- Device Success(Intra-operation)
研究者
研究点 (1)
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