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

NCT04910191 | Unknown

• 1 other identifier: VOQX
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

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.

Conditions

COVID-19

Keywords

COVID-19; Diagnostic; Viral infection disease; Electronic stethoscope

Outcome Measures

Primary Outcomes (2)

• 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

  Through study completion, an average of 1 year

• Performance outcome

  Use machine learning technologies to identify the above sound patterns and corresponding pathologies

  through study completion, an average of 1 year

Study Arms (1)

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.

Diagnostic Test: Electronic stethoscope

Interventions

Electronic stethoscope DIAGNOSTIC_TEST

Electronic stethoscope

Also known as: VOQX

Open Label

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanolla: lead

Study Sites (3)

Barzilai Medical Center

Ashkelon, 7830604, Israel

RECRUITING

Hille Yaffe Medical Center

Hadera, 38100, Israel

RECRUITING

Shamir Medical Center (Assaf Harofah)

Zrifin, 703000, Israel

RECRUITING

MeSH Terms

Conditions

COVID-19; Disease

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David Linhard

  Sanolla

  STUDY DIRECTOR

Central Study Contacts

Hadas Sapir

CONTACT

972 54 7826543; shadas@gsap.co.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: June 2, 2021
• Study Start: May 27, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: June 2, 2021

Record last verified: 2021-02

Locations

IL (3)