Safety and Usability
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEBéa Applicator and Béa Cervical Cap Device
Single-use of the investigational device
Sponsors
StepOne Fertility
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correctly place semen in the device | 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 | 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 | 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 | 4-6 hrs | Participants indicate an ability to withdraw the device from the vagina with the use of the removal string. |
| The device causes trauma or harm | 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 | 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 | 4-6 hrs | Participants indicate an ability to dispose of the device after use. |
| Correctly avoid sexual activity while the device is in place | 4-6 hrs | Participants indicate an ability to avoid sexual activity while the device is on the cervical os. |
Contacts
Primary ContactDavid G O'Rourke
Outcome results
None listed