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NCT05129553 | Unknown status | Safety and Usability


Béa Applicator and Béa Cervical Cap Safety and Usability Study
Sponsor:

StepOne Fertility

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

Safety and Usability

Intervention/treatment

Béa Applicator and Béa Cervical Cap Device

Phase

Not Applicable

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
Estimated Enrollment : 40 participants
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Béa Applicator and Béa Cervical Cap Usability Study
Actual Study Start Date : March 1, 2022
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : September 30, 2022
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

Ages Eligible for Study: 18 Years to 40 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
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)

Béa Applicator and Béa Cervical Cap Safety and Usability Study

Location Details


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Béa Applicator and Béa Cervical Cap Safety and Usability Study

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