A Prospective, 1-Arm, Open Label, Non-Randomized Study of the FERTI-LILY Conception Cup Device to Assess Label Comprehension, Device Usability and Safety in Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Safety of Device
研究概览
简要总结
The study is a prospective, 1-arm, open label, nonrandomized, single center study designed to evaluate label comprehension, device usability and safety of the FERTI·LILY Conception Cup. The primary safety endpoint will be an assessment of reported adverse events.
Subjects will be screened -10 (±3) days prior to the baseline visit. At baseline, 15-20 subjects meeting the inclusion/exclusion criteria will be provided with a FERTI·LILY Conception Cup device and instructions for using the device. Subjects will participate in a label comprehension protocol that includes the physician confirmation that they have adequate comprehension to enroll. If not, a screen failure form is completed.
Subjects will agree to try and use the device within 2 weeks of disposition therefore at baseline a two-week visit is scheduled. In the event they do not use the device within the two-week period the follow up visit can be rescheduled based on the visit window of +14 days. If it is not used within 4 weeks, the PI will have the subject return to the site to authorize another two-week period that will be captured as unscheduled follow up visit. The subject should complete the Device Experience Survey after each device use. The Device Experience Survey will be returned at this time, and adverse events will be assessed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Subject is a female volunteer, age ≥ 18 years.
- •Subject is willing and able to provide written informed consent for study participation.
- •Subject agrees to use the FCC device as directed.
- •Subject agrees to complete all study-related assessments.
- •Subject agrees to try to use the cup within two weeks of disposition.
- •PI confirms that the subject had the adequate label comprehension to enroll in the study.
排除标准
- •Subject has a medical condition or other factor that, in the opinion of the investigator, would contraindicate participation in the study.
- •Subject has active bacterial vaginosis infection or vaginismus.
- •Subject has an abnormal clinically significant Pap Smear diagnosis.
- •Subject has a history of endometriosis.
- •Subject has any contraindications with the Instructions for Use.
- •Subject has an allergy to silicone.
- •Subject is pregnant or lactating.
结局指标
主要结局
Safety of Device
时间窗: 6 weeks
Occurrence of device-related adverse events.
次要结局
- Label Comprehension Assessment Protocol(6 weeks)
- Device Usability(6 weeks)