Ignite Creation Date:
2024-05-06 @ 2:24 AM
Last Modification Date:
2024-10-26 @ 11:18 AM
Study NCT ID:
NCT02038322
Status:
COMPLETED
Last Update Posted:
2014-01-16
First Post:
2013-10-28
Brief Title:
The Stork OTC Collection Placement Delivery
Sponsor:
Rinovum Womens Health Inc
Organization:
Rinovum Womens Health Inc
Study Overview
Official Title:
The Stork Conception System OTC Clinical Trial Semen Collection Placement and Delivery
Status:
COMPLETED
Status Verified Date:
2014-01
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:
This is a clinical study designed to validate the usability and safety of the over-the-counter OTC device by obtaining feedback in a home use environment regarding ease of use of The Stork Conception System and the instructions for use In addition to usability results for safety including vaginal
Detailed Description:
Female participants will undergo a baseline pelvic examination Participating couples will be given The Stork Conception System OTC including Instructions for Use the questionnaire and two ziplock bags The device will be used in accordance with the instructions for use Participants will use the Conceptacle as a collection condom during sexual intercourse Participants will remove the Cervical Cap from the Sheath of the Conceptacle and discard the Sheath Participants will then load the Cervical Cap into the Applicator for insertion placement and deployment of the device Participants will wash the applicator with soap and water and place it in the double zip lock bags During the time the cervical cap is inserted normal activity will be recommended with the exception of having intercourse The female participants will leave the conception cap inserted for a period of time between 4 and 12 hours return to the investigators office for examination remove the Cervical Cap and undergo a follow up pelvic examination Participants will be asked to complete the study and the questionnaire within 3 days of receiving the study packet As a result this study could take up to 4 days to complete per enrolled couple
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