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Collecting Respiratory Sound Samples From Corona Patients to Extend the Diagnostic Capability of VOQX Electronic Stethoscope to Diagnose COVID-19 Patients

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ClinicalTrials.gov Identifier: NCT04910191
Recruitment Status : Unknown
Verified February 2021 by Sanolla.
Recruitment status was:  Recruiting
First Posted : June 2, 2021
Last Update Posted : June 2, 2021
Sponsor:
Information provided by (Responsible Party):
Sanolla

Study Description
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Brief 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 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.


Condition or disease Intervention/treatment Phase
COVID-19 Diagnostic Test: Electronic stethoscope Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Collecting Respiratory Sound Samples From Corona Patients to Extend the Diagnostic Capability of VOQX Electronic Stethoscope to Diagnose COVID-19 Patients
Actual Study Start Date : May 27, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Open Label

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.

 Diagnostic Test: Electronic stethoscope
Electronic stethoscope
Other Name: VOQX


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients over the age of 18 years
  • RT-PCR positive for COVID 19

  • Patients diagnosed with the following pulmonary pathology:

    • Pneumonia
    • Pulmonary edema
    • Bronchitis
    • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04910191


Contacts
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Contact: Hadas Sapir 972 54 7826543 shadas@gsap.co.il

Locations
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Israel
Barzilai Medical Center Recruiting
Ashkelon, Israel, 7830604
Hille Yaffe Medical Center Recruiting
Hadera, Israel, 38100
Shamir Medical Center (Assaf Harofah) Recruiting
Zrifin, Israel, 703000
Sponsors and Collaborators
Sanolla
Investigators
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Study Director: David Linhard Sanolla
More Information
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Responsible Party: Sanolla
ClinicalTrials.gov Identifier: NCT04910191    
Other Study ID Numbers: VOQX
First Posted: June 2, 2021    Key Record Dates
Last Update Posted: June 2, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Sanolla:
COVID-19
Diagnostic
Viral infection disease
Electronic stethoscope
Additional relevant MeSH terms:
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COVID-19
Respiratory Sounds
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Signs and Symptoms, Respiratory