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A Prospective, Multi-center Observational Study With Blinded, Nested Case:Control Analyses to Evaluate the Performance of the Verinata Health Prenatal Aneuploidy Diagnostic Test
The primary objective of this study is to determine the performance characteristics (sensitivity and specificity) of the Verinata Health Test to detect fetal Trisomy 21 (T21) compared to karyotype results obtained by amniocentesis or chorionic villus sampling (CVS). Secondary objectives are to assess performance of the test to detect male gender (XY) and other less common aneuploidies (Trisomy 13 (T13), Trisomy 18 (T18), and Turner Syndrome (45, X)) compared to clinical fetal karyotype.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Center for Fetal Medicine
Los Angeles, California, United States
San Francisco Perinatal Associates
San Francisco, California, United States
Women's Clinic of Northern Colorado
Fort Collins, Colorado, United States
Visions Clinical Research
Boynton Beach, Florida, United States
OB/Gyn Specialists of the Palm Beaches
West Palm Beach, Florida, United States
New Mexico Consortium for Perinatal Research
Albuquerque, New Mexico, United States
Winthrop University Hospital
Mineola, New York, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
The Women's Hospital of Texas
Houston, Texas, United States
Start Date
June 1, 2010
Primary Completion Date
September 1, 2011
Completion Date
October 1, 2011
Last Updated
October 10, 2011
10,000
ESTIMATED participants
Lead Sponsor
Verinata Health, Inc.
NCT06976632
NCT06523543
NCT06357546
Data Source & Attribution
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