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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04910191
• Other study ID #: VOQX
• Status: Recruiting
• Phase: N/A
• Start date: May 27, 2020
• Est. completion date: December 2021

Study information

• Verified date: February 2021
• Source: Sanolla
• Contact: Hadas Sapir
• Phone: 972 54 7826543
• Email: shadas[@]gsap.co.il
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Respiratory Sounds

Intervention

Diagnostic Test:
• Electronic stethoscope
Electronic stethoscope

Locations

Country	Name	City	State
Israel	Barzilai Medical Center	Ashkelon
Israel	Hille Yaffe Medical Center	Hadera
Israel	Shamir Medical Center (Assaf Harofah)	Zrifin

Sponsors (1)

Lead Sponsor	Collaborator
Sanolla

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Performance outcome	Use machine learning technologies to identify the above sound patterns and corresponding pathologies	through study completion, an average of 1 year