An interventional study of DiaNose in COVID-19, sponsored by Nanose Medical Ltd.. Status unknown. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-20.
Sponsored by Nanose Medical Ltd. · Not applicable, Interventional, and Other
The study aim is to collect and analyze data of potential Volatile Organic Compounds (VOCs) that could be used for discriminating between patients with and without COVID-19 or with high-risk for COVID-19 by DiaNose breath test.
up to 300 subjects will be enrolled to the study ( 200 COVID-19 suspected and 100 healthy volunteers in two clinical sites (1 in Israel and 1 in US).
DiaNose system is an electronic nose device that can "smell" diseases in the exhaled breath of patients in real time. This approach is non-invasive, simple and save.
The DiaNose prototype system consists the following elements:
A Soft Tube connected to a Sensors Chamber - The soft tube is made of medical grade silicon. The subject blows air into the tube for a few seconds and the exhaled air is directed through the sensors chamber. This unit is for single use.
This study is a prospective, multi-center research clinical study. The aim of this study is to collect and analyze data of potential Volatile Organic Compounds (VOCs) that could be used for discriminating between patients with and without COVID-19 or with high-risk for COVID-19 by DiaNose. The VOC profile of exhaled breath from subjects with COVID-19 infected suspected; and healthy volunteers, will be collected and analyzed to build and validate a predictive algorithmic model for diagnosing COVID 19.
Subjects which are COVID-19 infected suspected (Group 1); and healthy volunteers (Group 2), will be the study population. The study will encompass a total of up to 300 patients.
The COVID-19 infected suspected study group will be divided for the data analyzing and algorithm building into the following sub-groups (up to 200 subjects):
The patient will be asked to blow air into a disposable tube for a few seconds. Subject may be re-enrolled in case of need to perform additional PCR test and/or breath test with DiaNose according to standard of care or due to the study needs.
It is anticipated that it will require approximately 12 months to complete active enrollment.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 300 is above the median of 100 across 4,098 interventional studies indexed under COVID-19.
Browse COVID-19 studies →This is the only study on the registry with Nanose Medical Ltd. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Corona Suspected Subjects
Exclusion Criteria:
all subjects will be required to undergo the DiaNose exhalation test.
Device: DiaNose
DiaNose system is an electronic nose device that can "smell" diseases in the exhaled breath of patients in real time. The recognition of Volatile Organic Compounds (VOCs) in breath samples approach is non-invasive and for safe diagnosis of diseases. The DiaNose prototype system consists the following elements: * A Soft Tube connected to a Sensors Chamber - The soft tube is made of medical grade silicon. The subject blows air into the tube for a few seconds and the exhaled air is directed through the sensors chamber. This unit is for single use. * Sensors Reading Unit- a multi used unit for sensors signals measurement. The Sensor Reading Unit is connected to a Laptop either via a Data Acquisition Instrument - Commercial unit for resistance measurements (https://www.tek.com/keithley-switching-and-data-acquisition-systems/keithley-daq6510) (option A ) or directly by a USB cable (option B). * Laptop - Laptop is used to activate and save the test measurements.
collecting and analyzing of DiaNose sensors signals from potential VOC markers in the breath samples of all subjects to build and validate a predictive algorithmic model for diagnosing COVID 19.
Sensing Features (SFs) extracted from each of the sensors are used for statistical analysis by artificially intelligent/pattern recognition algorithm.
Time frame: 1 hour
No study locations are listed for this record.
This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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