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NCT04497610 Clinical Trial

SARS-CoV-2 (COVID-19) Detection Using the Breath Analizer TeraSystem

COVID19 Clinical Trial

Official title:
SARS-CoV-2 (COVID-19) Detection Using the Breath Analizer TeraSystem

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT04497610
Other study ID # Tera-CR-1
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date November 2022
Est. completion date November 2022

Study information
Verified date November 2022
Source Instituto Costarricense de Investigaciones Clínicas ICIC
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The purpose of the study is to verify the sensibility and accuracy of a rapid detection test for SARS-CoV-2 in breath samples analyzed by the breath detector analyzer TeraSystem, comparing with PCR tests.

Description:

BioSafety Technologies has developed a rapid detection test to clear people of COVID-19. A person can undergo an easy non-invasive test, to determine if they are: COVID-19 Clear (Negative) or Infected (Positive). The user-friendly process does not involve medically trained personnel. The study will compare TeraSystem test results against PCR test results. Persons participating will be persons having a PCR test as part of the Health System and consenting to participate.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date November 2022
Est. primary completion date November 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 7 Years and older
Eligibility Inclusion Criteria: Older than 7 years odf age Able to provide informed consent Able to take the breath test Exclusion Criteria: Younger than 7 years of age Unable to provide informed consent Unable to take the breath test

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Breath sample
Patient will blow into a tube 5 times.

Locations
Country Name City State
Costa Rica Instituto Costarricense de Investigaciones Clínicas San José

Sponsors (1)
Lead Sponsor Collaborator
Instituto Costarricense de Investigaciones Clínicas ICIC

Country where clinical trial is conducted

Costa Rica, 

Outcome
Type Measure Description Time frame Safety issue
Primary Presence of disease Established diagnosis 1 minute
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