Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04746014
Status:
COMPLETED
Last Update Posted:
2021-08-06
First Post:
2021-02-04
Brief Title:
Clearblue Pregnancy Test Lay User Usage Study
Sponsor:
SPD Development Company Limited
Organization:
SPD Development Company Limited
Study Overview
Official Title:
Clearblue Pregnancy Test Lay User Usage Study
Status:
COMPLETED
Status Verified Date:
2021-08
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 Clearblue home pregnancy test HPT is an over the counter urine hCG human chorionic gonadotrophin visual pregnancy test which is intended for the detection of pregnancy This study will assess the performance of the HPT in the hands of the lay user by comparing their results when used according to the instructions for use IFU to i confirmed pregnancy status of the volunteers and ii to the results of trained study staff testing the same urine samples
Detailed Description:
The Clearblue HPT is an over the counter urine hCG visual-read test which is intended for the detection of pregnancy This study aims to demonstrate that the pregnancy test has the required performance characteristics in lay user testing The study will recruit a cross-section of the target pregnancy test user population that is women aged over 18 years representative of the intended user
A minimum of 300 women will be required to complete the study consisting of both pregnant and not pregnant volunteers Each volunteer will conduct the pregnancy test using their preferred sampling method either in-stream or dip Volunteers will be evaluated against confirmed pregnancy status Lay user comprehension of the device instructions and usability of the device will also be assessed
A minimum of 300 women will be required to complete the study consisting of both pregnant and not pregnant volunteers Each volunteer will conduct the pregnancy test using their preferred sampling method either in-stream or dip Volunteers will be evaluated against confirmed pregnancy status Lay user comprehension of the device instructions and usability of the device will also be assessed
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