COVID-19NCT04910191
Collecting Respiratory Sound Samples From Corona Patients to Extend the Diagnostic Capability of VOQX Electronic Stethoscope to Diagnose COVID-19 Patients
A study testing Electronic stethoscope in people with COVID-19, run by Sanolla at 3 sites in Israel.
Trial summary
Technological developments in the recent decades has enabled the integration of electronic and digital components in the stethoscope design, in an attempt to improve auditory performance and, moreover, to assist in improving user's diagnostic accuracy by incorporating computerized, digital technologies, artificial… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Electronic stethoscope
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesIsrael
- Study dates
- 27 May 2020to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients over the age of 18 years
- RT-PCR positive for COVID 19
- Patients diagnosed with the following pulmonary pathology:
- Pneumonia
- Pulmonary edema
- Bronchitis
Show all 15Show fewer
- Acute asthmatic attack
- Emphysema
- Or Normal (e.g. asymptomatic patients)
- The diagnosis is confirmed if possible, by:
- Anamnesis
- Physical examination
- X-ray
- Suggestive blood test - CBC
- Pulse oximetry
Who cannot join
- Pregnant women
- Chest malformation
- Unconsciousness
- Subject that need a guardian
- Weigh above 150 Kg.
- Patients with current shortness of breath
- Patients currently assisted by breathing machine such as CPAP or other
Trial locations and contacts
3 sites in 1 country.
Israel3 sites, 3 recruiting
- Recruiting
Barzilai Medical Center
Ashkelon, 7830604
- Recruiting
Hille Yaffe Medical Center
Hadera, 38100
- Recruiting
Shamir Medical Center (Assaf Harofah)
Zrifin, 703000
About this study
Technological developments in the recent decades has enabled the integration of electronic and digital components in the stethoscope design, in an attempt to improve auditory performance and, moreover, to assist in improving user's diagnostic accuracy by incorporating computerized, digital technologies, artificial intelligence capabilities and deep-learning-based algorithms enhancing these devices.
We believe that these technologies can be used to significantly improve the diagnostic performance in the primary care phase, by means of a sophisticated stethoscope that enables auscultation to sounds and signals typically found in the sub-sound frequency level. Their transformation into the sound range, and the use of artificial intelligence and machine learning techniques to characterize sound patterns that correspond to specific problems or diseases can substantially enhance the physician's or other care giver's performance to the benefit of the patients.
At this stage, the software in development does not purport to make diagnostic decisions, but only to provide information that will enhance decision and diagnosis making process, therefore enable a more accurate and definitive diagnostic decision and perhaps decrease the number of additional diagnostic tests requested.
Read the detailed description
Up to 200 patients will participate in an open, prospective and multi-center study.
Patients diagnosed as positive to COVID-19 will be referred to a VOQX examination. All patients will receive detailed explanation about the purpose of the examination, its impact and will provide their consent prior to the examination. The VOQX device output will have no influence on the decision-making process of the physicians and care givers. The VOQX Stethoscope membrane will be put on the patient's chest area in predefined anterior and posterior points. The data collected in the form of breath sound signals in particular infra-sound will be transferred to an external computer and processed by machine learning algorithm developed by the company. The algorithm will seek patterns typical for the diagnosed disease for each corresponding case diagnosed.
- Conditions
- COVID-19
- Being tested
- Electronic stethoscope
- Keywords
- COVID-19, Diagnostic, Viral infection disease, Electronic stethoscope
- Medical subject headings
- COVID-19, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic stethoscopeDiagnostic test
Also called VOQX
Electronic stethoscope
| Study group | Role | What they receive |
|---|---|---|
| Open Label | Experimental | Up to 200 patients will participate in this open study. Before each examination with the study device, data from each patient (Current medical condition, medical history and demographic data) will be inserted to a computer and added to the database of the study for further processing in conjunction with the study device results.
The study device electronic stethoscope membrane will be put on the patient's chest area in predefined anterior and posterior points. At the end of each examination the data will be transferred to a computer and stored in the patient's file. Each patient will be requested to attend the examination once. Receives: Diagnostic Test: Electronic stethoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance outcome
Detection and identification of pulmonary sound signals ranging from infra-sound to auditory sound which are typical to specific pathologies of COVID-19
Measured: Through study completion, an average of 1 year
Performance outcome
Use machine learning technologies to identify the above sound patterns and corresponding pathologies
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start27 May 2020
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanolla
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Linhard, Study director, Sanolla
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04910191
- Sponsor's protocol ID
- VOQX
- Status last verified
- Feb 2021
- First submitted
- 23 Feb 2021
- Last updated
- 2 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collecting Respiratory Sound Samples From Corona Patients to Extend the Diagnostic Capability of VOQX Electronic Stethoscope to Diagnose COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04910191
- Acronym / sponsor ID
- VOQX
- Conditions
- COVID-19
- Keywords
- COVID-19, Diagnostic, Viral infection disease, Electronic stethoscope
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- SanollaIndustry (pharma, biotech, devices)
- Study start
- 27 May 2020 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 2 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Technological developments in the recent decades has enabled the integration of electronic and digital components in the stethoscope design, in an attempt to improve auditory performance and, moreover, to assist in improving user's diagnostic accuracy by incorporating computerized, digital technologies, artificial intelligence capabilities and deep-learning-based algorithms enhancing these devices.
We believe that these technologies can be used to significantly improve the diagnostic performance in the primary care phase, by means of a sophisticated stethoscope that enables auscultation to sounds and signals typically found in the sub-sound frequency level. Their transformation into the sound range, and the use of artificial intelligence and machine learning techniques to characterize sound patterns that correspond to specific problems or diseases can substantially enhance the physician's or other care giver's performance to the benefit of the patients.
At this stage, the software in development does not purport to make diagnostic decisions, but only to provide information that will enhance decision and diagnosis making process, therefore enable a more accurate and definitive diagnostic decision and perhaps decrease the number of additional diagnostic tests requested.
Detailed description
Up to 200 patients will participate in an open, prospective and multi-center study.
Patients diagnosed as positive to COVID-19 will be referred to a VOQX examination. All patients will receive detailed explanation about the purpose of the examination, its impact and will provide their consent prior to the examination. The VOQX device output will have no influence on the decision-making process of the physicians and care givers. The VOQX Stethoscope membrane will be put on the patient's chest area in predefined anterior and posterior points. The data collected in the form of breath sound signals in particular infra-sound will be transferred to an external computer and processed by machine learning algorithm developed by the company. The algorithm will seek patterns typical for the diagnosed disease for each corresponding case diagnosed.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Label | Experimental | Diagnostic Test: Electronic stethoscopeUp to 200 patients will participate in this open study. Before each examination with the study device, data from each patient (Current medical condition, medical history and demographic data) will be inserted to a computer and added to the database of the study for further processing in conjunction with the study device results. The study device electronic stethoscope membrane will be put on the patient's chest area in predefined anterior and posterior points. At the end of each examination the data will be transferred to a computer and stored in the patient's file. Each patient will be requested to attend the examination once. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients over the age of 18 years
- RT-PCR positive for COVID 19
- Patients diagnosed with the following pulmonary pathology:
- The diagnosis is confirmed if possible, by:
Key exclusion criteria (7 listed)
- Pregnant women
- Chest malformation
- Unconsciousness
- Subject that need a guardian
- Weigh above 150 Kg.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic stethoscopeAlso: VOQXElectronic stethoscope | Diagnostic test | Open Label |
Primary outcome
Performance outcome
Time frame: Through study completion, an average of 1 year
Detection and identification of pulmonary sound signals ranging from infra-sound to auditory sound which are typical to specific pathologies of COVID-19
Performance outcome
Time frame: through study completion, an average of 1 year
Use machine learning technologies to identify the above sound patterns and corresponding pathologies
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Linhard study director
Sanolla
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic stethoscope in people with COVID-19, run by Sanolla at 3 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hadas Sapir (972 54 7826543, shadas@gsap.co.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance outcome (time frame: Through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2021.