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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

Primary Purpose

COVID-19

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Electronic stethoscope
Sponsored by
Sanolla
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for COVID-19 focused on measuring COVID-19, Diagnostic, Viral infection disease, Electronic stethoscope

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Barzilai Medical CenterRecruiting
  • Hille Yaffe Medical CenterRecruiting
  • Shamir Medical Center (Assaf Harofah)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open Label

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 23, 2021
Last Updated
May 30, 2021
Sponsor
Sanolla
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1. Study Identification

Unique Protocol Identification Number
NCT04910191
Brief Title
Collecting Respiratory Sound Samples From Corona Patients to Extend the Diagnostic Capability of VOQX Electronic Stethoscope to Diagnose COVID-19 Patients
Official Title
Collecting Respiratory Sound Samples From Corona Patients to Extend the Diagnostic Capability of VOQX Electronic Stethoscope to Diagnose COVID-19 Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 27, 2020 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanolla

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19, Diagnostic, Viral infection disease, Electronic stethoscope

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Open Label
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Electronic stethoscope
Other Intervention Name(s)
VOQX
Intervention Description
Electronic stethoscope
Primary Outcome Measure Information:
Title
Performance outcome
Description
Detection and identification of pulmonary sound signals ranging from infra-sound to auditory sound which are typical to specific pathologies of COVID-19
Time Frame
Through study completion, an average of 1 year
Title
Performance outcome
Description
Use machine learning technologies to identify the above sound patterns and corresponding pathologies
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hadas Sapir
Phone
972 54 7826543
Email
shadas@gsap.co.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Linhard
Organizational Affiliation
Sanolla
Official's Role
Study Director
Facility Information:
Facility Name
Barzilai Medical Center
City
Ashkelon
ZIP/Postal Code
7830604
Country
Israel
Individual Site Status
Recruiting
Facility Name
Hille Yaffe Medical Center
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Individual Site Status
Recruiting
Facility Name
Shamir Medical Center (Assaf Harofah)
City
Zrifin
ZIP/Postal Code
703000
Country
Israel
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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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