NCT02542527已完成不适用
C88- Pilot Study A Prospective Case Series for Evaluation of the Functionality of a Fluid Filled Single Breast Pump Applied on a Lactating Breast
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Medela AG
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Breast pump vacuum (mmHg)
研究概览
简要总结
This study is an early (during the product development process) feasibility study. It shall evaluate the device design concept with respect to device functionality of a new fluid filled breast pump in a small number of subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 是
入选标准
- •Female over 18 years
- •Participant has an established milk flow, general rule: approx. 50 ml per breast per pumping session
- •The participant is pumping at least 2 times a week
- •The participant is 1-6 months after giving birth (postpartum) at the day of data assessment
- •The participant agrees to pump or feed the last time a minimum of 3 hours before the start of the pumping sessions
- •The participant agrees that the pumped breast milk cannot be fed to her infant (will be disposed)
- •The participant agrees to photograph and video record the breast and upper body (no face)
- •The participant agrees to the presence of up to 3 men in the room during the pumping session
排除标准
- •Participant or their baby is dependent on life-sustaining electric devices (e.g. heart pacemaker, insulin pump, etc.)
- •Participant has an medical condition of the breast
- •Participant is allergic to plastics or silicone
研究组 & 干预措施
Pumping with a fluid filled breast pump
Experimental
Participants pump (each breast 25 min) with the new fluid filled breast pump
干预措施: Fluid filled breast pump (Procedure)
结局指标
主要结局
Breast pump vacuum (mmHg)
时间窗: Measured during a single 25 minute pumping session
Vacuum will be continuously recorded during a single 25 Minute pumping session. The recorded units will be in mmHg. Each participants data will be assessed for the Minimum value, the Maximum value and the Mean value over 25 minutes.
次要结局
未报告次要终点
研究者
研究点 (1)
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