Béa Applicator and Béa Cervical Cap Safety and Usability Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Béa Applicator and Béa Cervical Cap Usability Study

Conditions
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Safety and Usability

Intervention / Treatment
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* Device: Béa Applicator and Béa Cervical Cap Device


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Use<br>The participants will then be given the Béa Applicator and Béa Cervical Cap with accompanying instructions for single-use in a home use environment. | Device: Béa Applicator and Béa Cervical Cap Device<br>* Single-use of the investigational device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 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 |