Ignite Creation Date:
2024-05-06 @ 12:23 AM
Last Modification Date:
2024-10-26 @ 10:49 AM
Study NCT ID:
NCT01564940
Status:
COMPLETED
Last Update Posted:
2012-03-28
First Post:
2012-03-25
Brief Title:
Human Factors Usability Study of Ib2C Conception System
Sponsor:
Rinovum Womens Health Inc
Organization:
Rinovum Womens Health Inc
Study Overview
Official Title:
Human Factors Usability Study of Abbreviated Functional Use of the Intimate Bridge 2 Conception Inc Conception System
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
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:
The purpose of this study is to obtain subjective feedback in a home use environment regarding usability and ease of use of the applicator and conception cap and the instructions for use Data will be collected and evaluation to determine if the usability requirements of the conception system as determined by the usability specification have been met The study will not involve sexual intercourse or delivery of any fluids to the cervix The study will only involve use of the applicator to insert the cervical cap into the vagina track it to the cervix and prepare and release the cervical cap with removal string attached onto the cervix The conception cap will remain in place for no more than 6 hours
Detailed Description:
The purpose of this study is to obtain subjective feedback in a home use environment regarding usability and ease of use of the applicator and conception cap and the instructions for use Data will be collected and evaluation to determine if the usability requirements of the conception system as determined by the usability specification have been met The study will not involve sexual intercourse or delivery of any fluids to the cervix The study will only involve use of the applicator to insert the cervical cap into the vagina track it to the cervix and prepare and release the cervical cap with removal string attached onto the cervix The conception cap will remain in place for no more than 6 hours
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None