Ignite Creation Date:
2024-05-06 @ 12:51 PM
Last Modification Date:
2024-10-26 @ 1:05 PM
Study NCT ID:
NCT03865901
Status:
WITHDRAWN
Last Update Posted:
2019-09-17
First Post:
2019-03-05
Brief Title:
Protocol to Validate the Performance of the Mellitus Glycated CD59 ELISA for Gestational Diabetes Screening
Sponsor:
Mellitus LLC
Organization:
Mellitus LLC
Study Overview
Official Title:
Subject Enrollment and Specimen Collection Protocol to Validate the Performance of the Mellitus GCD59 ELISA for Gestational Diabetes Screening
Status:
WITHDRAWN
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Further product development is needed prior to clinical study testing
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Demonstrate effective performance of the Mellitus GCD59 Test an ELISA in screening for gestational diabetes mellitus GDM
Detailed Description:
Validate the performance of the Mellitus GCD59 ELISA as a screening test for GDM by evaluating its negative predictive value NPV and positive predictive value PPV to identify pregnant women at risk for GDM Sensitivity and specificity of the Mellitus GCD59 ELISA will also be evaluated
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