Engineering Evaluation of a Breast Pump Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Momtech Inc.
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Breast shield fit
研究概览
简要总结
This research involves feasibility testing of design concepts to support device development of an electric breast pump. The purpose is to evaluate a prototype device for feasibility purposes and not health outcomes.
详细描述
This engineering evaluation involves the voluntary participation of healthy adult lactating women for feasibility testing of breast shield designs. Participants will be asked to rate the breast shield design for fit, comfort, and the ease of use. In addition, participants will be asked to rate a comparison of the device relative to their experiences with their current commercial breast pump and breastfeeding their baby.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •History of good health
- •Currently lactating and planning to continue breastfeeding for the next 3 to 4 months
- •Currently using a commercial electric breast pump at least several times a week
- •Sufficient milk supply for one missed infant feeding per device testing visit
- •Willing to attend five device testing visits over 3 to 4 months
- •Willing to be video recorded during device testing
- •Willing to discard milk collected during testing
排除标准
- •No active breast or nipple injury, breast inflammation or infection, or nipple piercing
- •No prior history of breast implant, reduction or reconstruction surgery
- •Not currently pregnant
结局指标
主要结局
Breast shield fit
时间窗: 1 day (Single timepoint)
Rate fit of device by Questionnaire
Breast shield comfort
时间窗: 1 day (Single timepoint)
Rate comfort of device by Questionnaire
Breast shield ease of use
时间窗: 1 day (Single timepoint)
Rate ease of use of device by Questionnaire
次要结局
- Participant comparison of device to breastfeeding(1 day (single visit))
- Participant comparison of device to current commercial breast pump(1 day (single timepoint))
- Volume of milk expressed(1 day (Single Timepoint))