Spartan COVID-19 System: Evaluation of Clinical Sample Collection
NCT ID: NCT04473248
Last Updated: 2020-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
27 participants
INTERVENTIONAL
2020-06-28
2020-08-30
Brief Summary
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Detailed Description
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The lab-based predicate test will be taken at the same time, with results reported back to Spartan to be compared with results obtained from the Spartan COVID-19 System.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
SINGLE
Study Groups
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Method 1- Nasopharyngeal Swab in transfer liquid
A nasopharyngeal swab will inoculate a proprietary solution which will be transferred to the Spartan COVID-19 System for analysis
Spartan COVID-19 System
PCR analysis of patient samples using the Spartan COVID-19 System
Method 2- Dipping of specialized swab in VTM
A nasopharyngeal swab will inoculate VTM solution. A modified traditional Spartan Swab will be dipped into the inoculated VTM solution and then transferred to the Spartan COVID-19 System for analysis.
Spartan COVID-19 System
PCR analysis of patient samples using the Spartan COVID-19 System
Method 3: Direct input of VTM
Using the VTM from Method 2, pipette 10uL of VTM, inoculated with sample, into the Spartan COVID-19 System for analysis.
Spartan COVID-19 System
PCR analysis of patient samples using the Spartan COVID-19 System
Method 4: Collection of nasal sample.
Using a modified tip of the Spartan swab, a nasal sample will be taken from the patient and directly placed into the Spartan COVID-19 System for analysis.
Spartan COVID-19 System
PCR analysis of patient samples using the Spartan COVID-19 System
Interventions
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Spartan COVID-19 System
PCR analysis of patient samples using the Spartan COVID-19 System
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Humber River Hospital
OTHER
The Ottawa Hospital
OTHER
Spartan Bioscience Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Tara Linseman, MSc
Role: STUDY_DIRECTOR
Spartan Bioscience Inc.
Locations
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Humber River Hospital
North York, Ontario, Canada
The Univeristy of Ottawa Heart Institute
Ottawa, Ontario, Canada
Countries
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Other Identifiers
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VNV-00552
Identifier Type: -
Identifier Source: org_study_id