Ignite Creation Date:
2024-05-06 @ 12:29 AM
Last Modification Date:
2024-10-26 @ 10:50 AM
Study NCT ID:
NCT01585012
Status:
COMPLETED
Last Update Posted:
2015-05-06
First Post:
2012-04-23
Brief Title:
Usability Study of the Focus Touch Conception System Semen Collection
Sponsor:
Rinovum Womens Health Inc
Organization:
Rinovum Womens Health Inc
Study Overview
Official Title:
Phase 2 Human Factors Usability Study of the Focus Touch Conception System Semen Collection
Status:
COMPLETED
Status Verified Date:
2015-05
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:
Ib2C
Brief Summary:
This is a human factors usability study designed to validated usability by obtaining feedback in a home use environment regarding ease of use of the Focus Touch Conception System Conceptacle when used to collect semen and the instructions for use The investigators will collect data to demonstrate that the usability requirements of the conception system as collection device as determined by Usability Specification Focus Touch Conception System ER-000001 have been met The ability of the device to be used during sexual intercourse without discomfort or injury to the female participants vaginalcervical tissues shall also be taken into account Participating couples will be asked to use the Focus Touch Conception System Conceptacle in condom form using the Instructions For Use to collect semen during sexual intercourse in a home use environment This study will involve sexual intercourse between monogamous heterosexual couples who are trying to conceive or are on a non-vaginal birth control with which they do not normally use condoms Participants will be asked to complete the study and the questionnaire within 3 days of receiving the study packet Contact information shall be collected but participants will only be contacted if they fail to return the questionnaire within the requested timeframe
Detailed Description:
None
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