Ignite Creation Date:
2024-05-06 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 2:18 PM
Study NCT ID:
NCT05129553
Status:
UNKNOWN
Last Update Posted:
2021-11-22
First Post:
2021-11-10
Brief Title:
Béa Applicator and Béa Cervical Cap Safety and Usability Study
Sponsor:
StepOne Fertility
Organization:
StepOne Fertility
Study Overview
Official Title:
Béa Applicator and Béa Cervical Cap Usability Study
Status:
UNKNOWN
Status Verified Date:
2021-11
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None