Collecting Respiratory Sound Samples From Corona Patients to Extend the Diagnostic Capability of VOQX Electronic Stethoscope to Diagnose COVID-19 Patients
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Hadas Sapir
- Número de teléfono: 972 54 7826543
- Correo electrónico: shadas@gsap.co.il
Ubicaciones de estudio
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Ashkelon, Israel, 7830604
- Reclutamiento
- Barzilai Medical Center
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Hadera, Israel, 38100
- Reclutamiento
- Hille Yaffe Medical Center
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Zrifin, Israel, 703000
- Reclutamiento
- Shamir Medical Center (Assaf Harofah)
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Poner en pantalla
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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. |
Electronic stethoscope
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Performance outcome
Periodo de tiempo: 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
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Through study completion, an average of 1 year
|
|
Performance outcome
Periodo de tiempo: through study completion, an average of 1 year
|
Use machine learning technologies to identify the above sound patterns and corresponding pathologies
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through study completion, an average of 1 year
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: David Linhard, Sanolla
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Infecciones por coronavirus
- Infecciones por coronaviridae
- Infecciones por Nidovirales
- Infecciones por virus de ARN
- Enfermedades virales
- Infecciones
- Infecciones del Tracto Respiratorio
- Enfermedades de las vías respiratorias
- Neumonía Viral
- Neumonía
- Enfermedades pulmonares
- Signos y Síntomas Respiratorios
- COVID-19
- Sonidos Respiratorios
Otros números de identificación del estudio
- VOQX
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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