Ignite Creation Date:
2025-12-24 @ 1:16 PM
Ignite Modification Date:
2026-01-01 @ 7:12 PM
Study NCT ID:
NCT05162495
Status:
UNKNOWN
Last Update Posted:
2022-01-11
First Post:
2021-12-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Breath Samples Collection Clinical Trial, for Development of the TERA BioStation T101, Intended for CoV-19 Exhalation Products Detection.
Sponsor:
Tera Group
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2021-12
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: