Status:

TERMINATED

Clinical Performance of the MaterniT21 PLUS LDT in Multiple Gestation Pregnancies

Lead Sponsor:

Sequenom, Inc.

Collaborating Sponsors:

Friends Research Institute, Inc.

Conditions:

Down Syndrome

Edwards Syndrome

Eligibility:

FEMALE

18+ years

Brief Summary

This study will evaluate the clinical performance of massively parallel sequencing (MPS) using the MaterniT21 PLUS LDT in the detection of fetal aneuploidy in circulating cfDNA extracted from a matern...

Eligibility Criteria

Inclusion

  • Subject was pregnant with a multiple gestation and received NIPT with the MaterniT21 PLUS LDT and a valid test result is available;
  • Subject was 18 years of age or older at the time of NIPT;
  • Subject provides signed and dated informed consent in English;

Exclusion

  • Subjects' treating physician is not located in the United States.

Key Trial Info

Start Date :

August 1 2014

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

September 1 2015

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT02226315

Start Date

August 1 2014

End Date

September 1 2015

Last Update

September 17 2015

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Presbyterian/St. Luke's Medical Center

Denver, Colorado, United States, 80218