CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 8 enrolled
Drug / intervention
Spartan FRX CYP2C19 Test Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01676298
NCT01676298N/ACompleted
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Study of the Analytical Reproducibility of the Spartan FRX CYP2C19 *2,*3 and *17 Genotyping System.

Spartan Bioscience Inc.·observational·Posted Aug 30, 2012·Updated Jan 7, 2013

In Brief

An observational study evaluating Spartan FRX CYP2C19 Test System for Analytical Reproducibility of a Medical Device. Completed, enrolled 8 participants across 3 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsAnalytical Reproducibility of a Medical Device
CountriesCanada
CollaboratorsChildren's Hospital of Eastern Ontario, Ottawa Hospital Research Institute, Mount Sinai Hospital, Canada

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 30, 2012
Enrollment StartAug 1, 2012
Primary CompletionSep 1, 2012
Study CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 13.8 years ago

Interventions

Spartan FRX CYP2C19 Test Systemdevice