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Spartan FRX Project Reproducibility Study

NCT01676298 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 8

Last updated 2013-01-07

Study results available
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Summary

The Spartan FRX CYP2C19 Test System (hereafter referred to as the 'FRX System') is a qualitative in vitro diagnostic test for the identification of a patient's CYP2C19 \*2, \*3 and \*17 genotypes from genomic DNA obtained from buccal swab samples. The objective of the study is to evaluate the performance of the FRX System under multivariate conditions including different days, sites, operators and systems.

Conditions

  • Analytical Reproducibility of a Medical Device

Interventions

DEVICE

Spartan FRX CYP2C19 Test System

Sponsors & Collaborators

  • Children's Hospital of Eastern Ontario

    collaborator OTHER

  • Ottawa Hospital Research Institute

    collaborator OTHER

  • Mount Sinai Hospital, Canada

    collaborator OTHER

  • Spartan Bioscience Inc.

    lead INDUSTRY

Principal Investigators

  • Chris JE Harder, PhD · Spartan Bioscience

  • Azar Azad, PhD · MOUNT SINAI HOSPITAL

  • Marc Desjardins, PhD · Ottawa Hosptial Research Institute

  • Jean McGowan-Jordan, PhD · Children's Hospital of Eastern Ontario

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2012-09-30
Completion
2012-11-30

Countries

  • Canada

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 NCT01676298 on ClinicalTrials.gov