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Protocol to Validate the Performance of the Mellitus Glycated CD59 ELISA for Gestational Diabetes Screening

NCT03865901 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2019-09-17

No results posted yet for this study

Summary

Demonstrate effective performance of the Mellitus GCD59 Test (an ELISA) in screening for gestational diabetes mellitus (GDM)

Conditions

  • Gestational Diabetes

Interventions

DIAGNOSTIC_TEST

Mellitus GCD59 Test

An ELISA for screening for the risk of gestational diabetes

Sponsors & Collaborators

  • Regulatory and Clinical Research Institute Inc

    collaborator OTHER

  • Mellitus, LLC

    lead INDUSTRY

Principal Investigators

  • Joyce A Lonergan · Mellitus, LLC

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-31
Primary Completion
2020-05-31
Completion
2020-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03865901 on ClinicalTrials.gov