Ignite Creation Date:
2024-05-06 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05700370
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-01-26
First Post:
2023-01-17
Brief Title:
MyProstateScore Equivalency With and Without DRE
Sponsor:
LynxDx
Organization:
LynxDx
Study Overview
Official Title:
Equivalency of MyProstateScore MPS Results Between Urine Samples Collected With or Without a Preceding Digital Rectal Examination
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-01
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:
The purpose of the study is to quantify the concordance of MPS results between first-catch urine samples collected post-DRE and those collected without a DRE
Detailed Description:
The process for obtaining a urine sample for MPS currently requires a DRE within one hour prior to urine collection We aim to understand whether a DRE is a required step prior to urine collection for MPS and to explore alternative methods that may eliminate the need for a DRE In order to do so we will perform a crossover study in which each subject provides a sample under both conditions
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