Béa Applicator and Béa Cervical Cap Safety and Usability Study

Béa Applicator and Béa Cervical Cap Usability Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Safety and Usability
• Intervention / Treatment: Device: Béa Applicator and Béa Cervical Cap Device

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David G O'Rourke; Phone Number: 0044 7445338259; Email: david@beafertility.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: StepOne Fertility

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2022
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): September 30, 2022

Study Registration Dates

• First Submitted: November 10, 2021
• First Submitted That Met QC Criteria: November 10, 2021
• First Posted (Actual): November 22, 2021

Study Record Updates

• Last Update Posted (Actual): November 22, 2021
• Last Update Submitted That Met QC Criteria: November 10, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: SOF63073301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Participant data will not be shared with researchers outside the study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No