Trials / Withdrawn
WithdrawnNCT03865901
Protocol to Validate the Performance of the Mellitus Glycated CD59 ELISA for Gestational Diabetes Screening
Subject Enrollment and Specimen Collection Protocol to Validate the Performance of the Mellitus GCD59 ELISA for Gestational Diabetes Screening
- Status
- Withdrawn
- Phase
- —
- Study type
- Observational
- Enrollment
- 0 (actual)
- Sponsor
- Mellitus, LLC · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Mellitus GCD59 Test | An ELISA for screening for the risk of gestational diabetes |
Timeline
- Start date
- 2019-05-01
- Primary completion
- 2020-05-01
- Completion
- 2020-09-01
- First posted
- 2019-03-07
- Last updated
- 2019-09-17
Locations
19 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03865901. Inclusion in this directory is not an endorsement.