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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Use | Experimental | The participants will then be given the Béa Applicator and Béa Cervical Cap with accompanying instructions for single-use in a home use environment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Béa Applicator and Béa Cervical Cap Device | Device | Single-use of the investigational device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Correctly place semen in the device | Participants indicate an ability to collect and transfer semen into the device in the intended use environment (at-home). | 0.5 hrs |
| Correctly inserting the device into the vagina | Participants indicate an ability to insert the device into the vagina, in the intended use environment (at-home). | 1 hrs |
| Correctly positioning of the device over the cervical os | A clinical examination by a physician to confirm the device is positioned over the cervical os. | 4-6 hrs |
| Correctly withdraw the device from the vagina | Participants indicate an ability to withdraw the device from the vagina with the use of the removal string. | 4-6 hrs |
| The device causes trauma or harm | 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. | 4-6 hrs |
| Presence of semen in the cap | After the device is removed from the vagina, a physician assesses the presence of semen remaining in the cervical cap. | 4-6 hrs |
| Correctly dispose of the used device after use | Participants indicate an ability to dispose of the device after use. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David G O'Rourke | Contact | 0044 7445338259 | david@beafertility.com |
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Participant data will not be shared with researchers outside the study.
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| 4-6 hrs |
| Correctly avoid sexual activity while the device is in place | Participants indicate an ability to avoid sexual activity while the device is on the cervical os. | 4-6 hrs |