Béa Applicator and Béa Cervical Cap Safety and Usability Study

NCT05129553 | Unknown FDA Device

• 1 other identifier: SOF63073301
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Safety and Usability

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (1)

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.

Device: Béa Applicator and Béa Cervical Cap Device

Interventions

Béa Applicator and Béa Cervical Cap Device DEVICE

Single-use of the investigational device

Single Use

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• StepOne Fertility: lead

Central Study Contacts

David G O'Rourke

CONTACT

0044 7445338259; david@beafertility.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: November 22, 2021
• Study Start: March 1, 2022
• Primary Completion: August 1, 2022
• Study Completion: September 30, 2022
• Last Updated: November 22, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share