Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06516211
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-10
Brief Title:
Predicate and Lay User-HCP Comparison Study of a Multi-Level Urine hCG Pregnancy Test
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Candidate - Predicate Comparison and Lay User-HCP Comparison Study of the ClaraTM Multi-Level Urine hCG Pregnancy Test
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Study volunteers will be required to conduct a home pregnancy test HPT at the trial center and provide a sample of urine from the same void for further testing
Volunteers will then complete a product usage questionnaire and leaflet comprehension questionnaire at site
Volunteers will then complete a product usage questionnaire and leaflet comprehension questionnaire at site
Detailed Description:
Eligible volunteers will be recruited into the study and provide informed consent
Volunteers will then test their urine sample with the investigational HPT according to the device Instructions For Use and their results will be recorded A sample of urine from the same void will be obtained for further testing by the healthcare provider HCP study technicians
The HCP technician will then test the volunteers sample with a second investigational HPT a professional use pregnancy test and a HPT the results of which will be used to provide the volunteer with her pregnancy test result During technician testing the volunteer will complete the device usability and leaflet comprehension questionnaires
True pregnancy status will be determined by laboratory tests and clinical information
Volunteers will then test their urine sample with the investigational HPT according to the device Instructions For Use and their results will be recorded A sample of urine from the same void will be obtained for further testing by the healthcare provider HCP study technicians
The HCP technician will then test the volunteers sample with a second investigational HPT a professional use pregnancy test and a HPT the results of which will be used to provide the volunteer with her pregnancy test result During technician testing the volunteer will complete the device usability and leaflet comprehension questionnaires
True pregnancy status will be determined by laboratory tests and clinical information
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