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Béa Applicator and Béa Cervical Cap Safety and Usability Study

NCT ID: NCT05129553

Last Updated: 2021-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2022-09-30

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.

Conditions

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Safety and Usability

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Béa Applicator and Béa Cervical Cap Device

Intervention Type DEVICE

Single-use of the investigational device

Interventions

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Béa Applicator and Béa Cervical Cap Device

Single-use of the investigational device

Intervention Type DEVICE

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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StepOne Fertility

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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David G O'Rourke

Role: CONTACT

Phone: 0044 7445338259

Email: [email protected]

Other Identifiers

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SOF63073301

Identifier Type: -

Identifier Source: org_study_id