Béa Applicator and Béa Cervical Cap Usability Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 40
- Primary Endpoint
- The device causes trauma or harm
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts 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)
Outcomes
Primary Outcomes
The device causes trauma or harm
Time Frame: 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
Time Frame: 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
Time Frame: 4-6 hrs
Participants indicate an ability to dispose of the device after use.
Correctly place semen in the device
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 4-6 hrs
Participants indicate an ability to avoid sexual activity while the device is on the cervical os.
Secondary Outcomes
No secondary outcomes reported