Béa Applicator and Béa Cervical Cap Usability Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 主要终点
- The device causes trauma or harm
研究概览
简要总结
This is a Clinical Study Designed to Validate the Usability and Safety of the Over-the-counter (OTC) Béa Applicator and Béa Cervical Cap Device in a Home Use Environment.
详细描述
Female participants will undergo a baseline physical assessment performed by a physician at the study site. The participants will then be given the Béa Applicator and Béa Cervical Cap device with accompanying instructions and a semen collection pot. The participants will return home to use the device as per the Instruction for Use (IFU). The Béa Cervical Cap will remain in place for a minimum of 4 hours and a maximum of 6 hours. At the follow-up assessment, the investigator will investigate all primary objectives via a physical exam or via questioning the participant.
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •People who are able to and for whom it is medically safe to conceive
- •Heterosexual couples and individuals, of any race or ethnicity, who are sexually active
- •18 - 40 years of age
- •Trying to conceive
- •Signed Informed Consent
- •Approximately nineteen per cent (19%) of participants will present with a retroverted uterus as found in the general female population.
排除标准
- •Vaginal prolapse (female)
- •Hysterectomy (female)
- •Erectile dysfunction (male)
- •Diagnosis and/or treatment of vaginitis or sexually transmitted infection (STI) within the last month
- •Colposcopy with biopsy surgery within the last three (3) months (female)
- •Treatment for dysplasia surgery within the previous three (3) months (female)
- •Vaginal/cervical surgery within the last three (3) months (female)
- •Current pregnancy (female)
- •Unable to read and understand English, as assessed by REALM
- •Presence of noticeable lesions, open sores, viral warts, and any other genital abnormalities (female & male)
结局指标
主要结局
The device causes trauma or harm
时间窗: 4-6 hrs
After the device is removed from the vagina, a physician assessment via a speculum examination to determine if the device caused trauma or harm to the vaginal epithelium or cervix.
Presence of semen in the cap
时间窗: 4-6 hrs
After the device is removed from the vagina, a physician assesses the presence of semen remaining in the cervical cap.
Correctly dispose of the used device after use
时间窗: 4-6 hrs
Participants indicate an ability to dispose of the device after use.
Correctly place semen in the device
时间窗: 0.5 hrs
Participants indicate an ability to collect and transfer semen into the device in the intended use environment (at-home).
Correctly inserting the device into the vagina
时间窗: 1 hrs
Participants indicate an ability to insert the device into the vagina, in the intended use environment (at-home).
Correctly positioning of the device over the cervical os
时间窗: 4-6 hrs
A clinical examination by a physician to confirm the device is positioned over the cervical os.
Correctly withdraw the device from the vagina
时间窗: 4-6 hrs
Participants indicate an ability to withdraw the device from the vagina with the use of the removal string.
Correctly avoid sexual activity while the device is in place
时间窗: 4-6 hrs
Participants indicate an ability to avoid sexual activity while the device is on the cervical os.
次要结局
未报告次要终点