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WithdrawnNCT04497610Updated Nov 29, 2022

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

An observational study in COVID19, sponsored by Instituto Costarricense de Investigaciones Clínicas ICIC. Withdrawn at 1 site in Costa Rica. Open to participants aged 7 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-29.

Sponsored by Instituto Costarricense de Investigaciones Clínicas ICIC · Observational

Why this study was withdrawn
Study was not initiated
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
7 Years and older
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • COVID19

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Keywords

  • SARS-CoV-2, coronavirus testing
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

Browse COVID-19 studies →

Lead sponsor

This is the only study on the registry with Instituto Costarricense de Investigaciones Clínicas ICIC as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Population under Country's screening program and known positive cases.

Inclusion criteria

Older than 7 years odf age Able to provide informed consent Able to take the breath test

Exclusion criteria

Exclusion Criteria:

Younger than 7 years of age Unable to provide informed consent Unable to take the breath test

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Target follow-up
1 Day
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • Positive TeraSystem test

    Patients having positive PCR tests will undergo TeraSystem test

    Diagnostic Test: Breath sample

  • Negative TeraSystem test

    Patients having negative PCR tests will undergo TeraSystem test

    Diagnostic Test: Breath sample

Interventions

  • Diagnostic testBreath sample

    Patient will blow into a tube 5 times.

06

What researchers measure

Primary outcomes

  1. Presence of disease

    Established diagnosis

    Time frame: 1 minute

07

Study locations

1 site
  • Instituto Costarricense de Investigaciones Clínicas
    San José, Costa Rica
08

References and documents

Individual participant data

Plan to share: No — Personal data will be coded. No identifying information will be shared. Only demographic, and breath tests results will be shared.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04497610
Lead sponsor
Instituto Costarricense de Investigaciones Clínicas ICIC
Responsible party
Dr. Guillermo Rodríguez Gómez (Founder, Instituto Costarricense de Investigaciones Clínicas ICIC) — Principal investigator
First posted
Aug 4, 2020
Start date
Nov 2022 (estimated)
Primary completion
Nov 2022 (estimated)
Completion
Nov 2022 (estimated)
Last update
Nov 29, 2022

Study contacts

Guillermo Rodríguez Gómez, MD
principal investigator · Founder and Investigator

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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