Breath Samples Collection Clinical Trial, for Development of the TERA BioStation T101, Intended for CoV-19 Exhalation Products Detection.

A Single Center, Two Arms, Non-interventional, Breath Samples Collection Clinical Trial, for Development of the TERA Bio Station T101, Intended for SARS-CoV-2 Exhalation Products Detection.

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05162495

Enrollment

500

Registered

2021-12-17

Start date

2022-01-01

Completion date

2022-08-01

Last updated

2022-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Brief summary

The Sponsor has developed a rapid screening tool intended to determine if the subject tested has COVID-19.

Detailed description

According to recent scientific literature, the virus infection occurs mainly through the nasal cavity, and therefore, samples of nasal and pharyngeal fluids are expected to be high viral load samples. The proposed clinical trial is to test the mentioned for potential dominant virus particles absorbance frequencies according to which, it will be possible to perform a statistical analysis of spectral data of infected subjects' samples compared to healthy ones and to examine whether a statistical significance between 'Infected' and 'Healthy' can be demonstrated in terms spectroscopic measurements. Indication for Use: Rapid detection of the novel SARS-CoV-2 (COVID-19) virus in breath samples. The study is aimed to collect data in order to assess whether a patient's COVID -19 status can be identified by a unique spectrophotometric pattern.

Interventions

DEVICEBioStation T101 and TeraTube

Rapid detection of the novel SARS-CoV-2 (COVID-19) virus in breath samples.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention model description

The participant's breath sample is taken by blowing preferably three times into a disposable TeraTube. Thereafter, the tube is sealed, sterilized, and scanned by the BioSafety Station for analysis of its bio-chemical spectral signature. This will take place once during the study.

Eligibility

Sex/Gender

ALL

Age

18 Years to 120 Years

Healthy volunteers

Yes

Inclusion criteria

General: 1. Male or female subject aged 18 years and above 2. Subject is able and willing to provide informed consent 3. Subject is able to complete the breath test. Arm A: 4. Requiring a diagnostic or screening RT-PCR test for COVID-19. Arm B: 5. Positive to COVID-19 in RT-PCR test performed up to 48 hours before screening.

Exclusion criteria

1. Male of female subject under the age of 18. 2. Subject is unable to provide and informed consent, for any reason.

Design outcomes

Primary

Measure	Time frame	Description
Primary Outcome Measure	The collection of an additional samples requiring COVID 19 diagnostic evaluation will take approximately 1 minute from initial collection of the sample	Rate of positive and negative cases in collected breath samples using breath analyzer test compare to PCR results.

Contacts

Primary ContactYebgeny Marzon, MD

emarzon@leumit.co.il+972 50 764 3281

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026