Béa Applicator and Béa Cervical Cap Safety and Usability Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Single Use 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
Single-use of the investigational device
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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People who are able to and for whom it is medically safe to conceive
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Heterosexual couples and individuals, of any race or ethnicity, who are sexually active
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18 - 40 years of age
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Trying to conceive
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Signed Informed Consent
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Approximately nineteen per cent (19%) of participants will present with a retroverted uterus as found in the general female population.
Exclusion Criteria:
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Vaginal prolapse (female)
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Hysterectomy (female)
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Erectile dysfunction (male)
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Diagnosis and/or treatment of vaginitis or sexually transmitted infection (STI) within the last month
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Colposcopy with biopsy surgery within the last three (3) months (female)
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Treatment for dysplasia surgery within the previous three (3) months (female)
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Vaginal/cervical surgery within the last three (3) months (female)
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Current pregnancy (female)
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Unable to read and understand English, as assessed by REALM
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Presence of noticeable lesions, open sores, viral warts, and any other genital abnormalities (female & male)
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- StepOne Fertility
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SOF63073301