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Spartan Cube CYP2C19 Inter Laboratory Reproducibilty Study

NCT04473573 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2020-07-16

No results posted yet for this study

Summary

The study verifies that the Spartan Cube CYP2C19 System generates reproducible results under multi-variant conditions including test site (three different test sites), operators (two operators per site), testing days (five non-consecutive days per site), and test kit lot (three different lots).

Conditions

  • Genotyping Techniques

Interventions

DEVICE

Spartan Cube CYP2C19 System

Using buccal material, determine the genotype of the \*2, \*3 and \*17 SNPs of the CYP2C19 gene on the Spartan Cube CYP2C19 System.

Sponsors & Collaborators

  • Children's Hospital of Eastern Ontario

    collaborator OTHER

  • The Ottawa Hospital

    collaborator OTHER

  • The University of Ottawa Heart Institute

    collaborator UNKNOWN

  • Spartan Bioscience Inc.

    lead INDUSTRY

Principal Investigators

  • Shaimaa Ahmed, PhD · Spartan Bioscience

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-31
Primary Completion
2020-03-17
Completion
2020-03-17

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 NCT04473573 on ClinicalTrials.gov