N/A
N=8
Spartan FRX Project Reproducibility Study
Analytical Reproducibility of a Medical Device
Bottom Line
View on ClinicalTrials.gov: NCT01676298 ↗Enrolled (actual)
8
Serious AEs
—
Results posted
Jan 2013
Primary outcome: Primary: Percentage of Correct Calls to Assess Reproducibility of the Spartan FRX CYP2C19 System. — 98.3; 100; 97.5; 99.2 Percentage of Correct Calls
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Spartan FRX CYP2C19 Test System (Device)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- Spartan Bioscience Inc.
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Correct Calls to Assess Reproducibility of the Spartan FRX CYP2C19 System. |
98.3; 100; 97.5; 99.2; 100; 99.2 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Above 16 years of age
- Must have required genotype
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT01676298). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.