Validate the Efficacy and the Safety of the Keikku Electronic Stethoscope for Its Indication and Intended Purpose, Under the Intended Conditions of Use.
NCT ID: NCT07044128
Last Updated: 2025-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
149 participants
OBSERVATIONAL
2025-07-15
2025-10-15
Brief Summary
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The study will include 149 participants of all ages (from birth to 99 years), who are undergoing routine (non-urgent) heart checks. After giving consent, each participant will have their heart sounds listened to twice: once with the Keikku electronic stethoscope and once with a regular stethoscope. Two different doctors will do the listening, and they won't share information with each other. The doctors will record whether they hear a heart murmur and how clear the sounds were.
The study will compare the findings from the new device to those from the regular stethoscope. Researchers will also check for any device problems or side effects. The study takes place at a single site in Peru and will take about one day for each participant.
The goal is to find out if the Keikku electronic stethoscope is accurate and safe for doctors to use in real medical settings.
Detailed Description
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The Keikku electronic stethoscope differs from traditional stethoscopes in that it digitally records and transmits auscultation sounds without interpreting them. Physicians use the Keikku Mobile Application to listen, annotate, and share these sounds. This study assesses whether such a device can match the diagnostic capabilities of conventional analog stethoscopes, particularly in detecting heart murmurs.
This is a prospective, open-label, controlled clinical investigation involving 149 pediatric and adult participants (from birth to age 99) in non-urgent cardiac evaluations. Each participant undergoes two sequential heart sound assessments at four standard precordial chest locations (mitral, tricuspid, aortic, and pulmonary):
Keikku electronic stethoscope: used by a physician listening via Bluetooth headphones.
Conventional stethoscope: used by a second, blinded physician.
Each device's use is independently evaluated using predefined clinical report forms. Physicians record whether a murmur is present and rate the acoustic quality of the auscultation on a 5-point Likert scale.
To ensure objectivity, physicians do not communicate their findings, and the second physician has no access to the recordings or results obtained by the first. All recordings (both digital and analog) are stored on GDPR-compliant cloud servers. Final clinical decisions about patient care are based only on the findings of the conventional stethoscope, not the investigational device.
The study's primary endpoint is the agreement percentage between the Keikku and conventional stethoscopes in murmur detection. Secondary and exploratory endpoints include the incidence of device-related adverse events, the sensitivity and specificity of murmur detection, user-reported sound quality, and any technical issues (device deficiencies) encountered.
Participation in this study lasts only one day and involves no follow-up visits. No treatment decisions are made based on the investigational device. The research is conducted at a single site in Peru, and the data will contribute to a broader understanding of digital stethoscope performance in clinical environments.
By validating the diagnostic capabilities of the Keikku electronic stethoscope, this study aims to support the safe integration of digital auscultation technology into everyday clinical care and remote telemedicine applications.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Keikku Stethoscope Evaluation Group - Pediatric
This group includes pediatric participants undergoing non-urgent cardiac evaluation. Each participant receives heart sound assessments using both the investigational Keikku electronic stethoscope and a conventional analog stethoscope. The primary aim is to compare the accuracy of murmur detection between the two devices. Evaluations are performed by two separate physicians to ensure independent assessment.
Digital stethoscope using MEMS sensor and mobile application for cardiac auscultation
The intervention is a digital stethoscope system comprising a handheld device with a micro-electromechanical system (MEMS) sensor and a Bluetooth Low Energy (BLE) connection to a mobile application (Keikku Mobile App) installed on an iOS or Android smartphone. The device captures auscultation sounds from standard precordial locations (mitral, tricuspid, aortic, and pulmonary), transmits them in real time to the mobile application, and stores the recordings on a secure, GDPR-compliant cloud server. The device does not interpret sounds. Each auscultation lasts 15 seconds per site. Physicians use Bluetooth headphones to listen during recording. The application allows for annotation and review of sound data. The intervention is administered once per participant during a single study visit, immediately followed by a comparator auscultation using a conventional analog stethoscope by a second blinded physician.
Keikku Stethoscope Evaluation Group - Adults
This group includes adult participants undergoing non-urgent cardiac evaluation. Each participant receives heart sound assessments using both the investigational Keikku electronic stethoscope and a conventional analog stethoscope. The primary aim is to compare the accuracy of murmur detection between the two devices. Evaluations are performed by two separate physicians to ensure independent assessment.
Digital stethoscope using MEMS sensor and mobile application for cardiac auscultation
The intervention is a digital stethoscope system comprising a handheld device with a micro-electromechanical system (MEMS) sensor and a Bluetooth Low Energy (BLE) connection to a mobile application (Keikku Mobile App) installed on an iOS or Android smartphone. The device captures auscultation sounds from standard precordial locations (mitral, tricuspid, aortic, and pulmonary), transmits them in real time to the mobile application, and stores the recordings on a secure, GDPR-compliant cloud server. The device does not interpret sounds. Each auscultation lasts 15 seconds per site. Physicians use Bluetooth headphones to listen during recording. The application allows for annotation and review of sound data. The intervention is administered once per participant during a single study visit, immediately followed by a comparator auscultation using a conventional analog stethoscope by a second blinded physician.
Interventions
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Digital stethoscope using MEMS sensor and mobile application for cardiac auscultation
The intervention is a digital stethoscope system comprising a handheld device with a micro-electromechanical system (MEMS) sensor and a Bluetooth Low Energy (BLE) connection to a mobile application (Keikku Mobile App) installed on an iOS or Android smartphone. The device captures auscultation sounds from standard precordial locations (mitral, tricuspid, aortic, and pulmonary), transmits them in real time to the mobile application, and stores the recordings on a secure, GDPR-compliant cloud server. The device does not interpret sounds. Each auscultation lasts 15 seconds per site. Physicians use Bluetooth headphones to listen during recording. The application allows for annotation and review of sound data. The intervention is administered once per participant during a single study visit, immediately followed by a comparator auscultation using a conventional analog stethoscope by a second blinded physician.
Eligibility Criteria
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Inclusion Criteria
* Individuals who are either:
* presenting for initial, non-urgent outpatient evaluation of a cardiac murmur or for non-urgent cardiac clearance; or
* presenting for return, non-urgent outpatient evaluation of a cardiac murmur; or
* undergoing initial or recurrent, non-urgent evaluation of a cardiac murmur in inpatient setting; or
* undergoing non-urgent cardiac clearance in inpatient setting.
Exclusion Criteria
99 Years
ALL
Yes
Sponsors
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Clínica Internacional
OTHER
Lapsi Health Holding B.V.
INDUSTRY
Responsible Party
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Locations
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Clinica Internacional San Borja
Lima, , Peru
Countries
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Central Contacts
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Other Identifiers
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D087
Identifier Type: -
Identifier Source: org_study_id