Home Usage of Conception Kit Instructions
试验速览
- 阶段
- 不适用
- 发起方
- Conceivex
- 入组人数
- 60
- 试验地点
- 2
研究概览
简要总结
Patients will use the Conception Kit in their home and fill out a 22 question questionnaire in order to demonstrate their knowledge of the method of usage as described in the instructions and on the website: www.conceptionkit.com.
详细描述
Patients will be given a Conception Kit and take the Kit home and read the instructions and if needed consult the website. The patient will then complete a 22 question questionnaire in order to demonstrate their knowledge of the method of use.
All Components have 510K clearance. This study is a validation of the instructions for use (IFU) only.
OPK Class I Device 21CFR 862.1485, Conception Cap K993953, Pregnancy Test Kit K974059, Semen Collection Device K902936 (21CFR 884.5300),
Conception Kit has CE Marked by GMED. (Certificate 2037)
Conceivex is an ISO 13485: 2003 company
研究设计
- 研究类型
- Observational
- 观察模型
- Natural History
- 时间视角
- Other
入排标准
- 年龄范围
- 16 Years 至 55 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women who are actively trying to become pregnant
排除标准
- •Women who are contraindicated for a pregnancy