Safety and UsabilityNCT05129553
Béa Applicator and Béa Cervical Cap Safety and Usability Study
A study testing Béa Applicator and Béa Cervical Cap Device in people with Safety and Usability, run by StepOne Fertility.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety and Usability
- What is being tested?
- Béa Applicator and Béa Cervical Cap Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2022to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 10Show fewer
- 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)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Safety and Usability
- Being tested
- Béa Applicator and Béa Cervical Cap Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Béa Applicator and Béa Cervical Cap DeviceDevice
Single-use of the investigational device
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Béa Applicator and Béa Cervical Cap Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4-6 hrs
Correctly dispose of the used device after use
Participants indicate an ability to dispose of the device after use.
Measured: 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.
Measured: 4-6 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start1 Mar 2022 (estimated)
- Primary completion1 Aug 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety and UsabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- StepOne Fertility
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05129553
- Sponsor's protocol ID
- SOF63073301
- Status last verified
- Nov 2021
- First submitted
- 10 Nov 2021
- Last updated
- 22 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Participant data will not be shared with researchers outside the study.
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Béa Applicator and Béa Cervical Cap Usability Study
- ClinicalTrials.gov ID
- NCT05129553
- Acronym / sponsor ID
- SOF63073301
- Conditions
- Safety and Usability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- StepOne FertilityIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2022 (estimated)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 22 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Use | Experimental | Device: Béa Applicator and Béa Cervical Cap DeviceThe participants will then be given the Béa Applicator and Béa Cervical Cap with accompanying instructions for single-use in a home use environment. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Béa Applicator and Béa Cervical Cap DeviceSingle-use of the investigational device | Device | Single Use |
Primary outcome
Correctly place semen in the device
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 4-6 hrs
Participants indicate an ability to dispose of the device after use.
Correctly avoid sexual activity while the device is in place
Time frame: 4-6 hrs
Participants indicate an ability to avoid sexual activity while the device is on the cervical os.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
- Individual participant dataSharing planned: No. Participant data will not be shared with researchers outside the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Béa Applicator and Béa Cervical Cap Device in people with Safety and Usability, run by StepOne Fertility.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David G O'Rourke (0044 7445338259, david@beafertility.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correctly place semen in the device (time frame: 0.5 hrs). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2021.