Validate the Efficacy and the Safety of the Keikku Electronic Stethoscope for Its Indication and Intended Purpose, Under the Intended Conditions of Use. (KCI-1)

Prospective, Controlled, Open-label Study Evaluating the Keikku Electronic Stethoscope

This study is testing a digital stethoscope called the Keikku electronic stethoscope. Doctors use stethoscopes to listen to the heart, and this new device records heart sounds using a smartphone app. The purpose of the study is to check how well this new device works and whether it is safe to use.

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Murmurs; Wheezing
• Intervention / Treatment: Device: Digital stethoscope using MEMS sensor and mobile application for cardiac auscultation

Detailed Description

This clinical study is designed to evaluate the performance and safety of the Keikku electronic stethoscope, an innovative medical device developed by Lapsi Health Holding BV. The Keikku device combines a micro-electromechanical system (MEMS) sensor with a Bluetooth-enabled smartphone application, allowing physicians to capture and review heart sounds in real-time or via secure cloud storage.

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.

• Study Type: Observational
• Enrollment (Estimated): 149

Contacts and Locations

• Study Contact: Name: Alfredo Gilberto Guerreros Benavides; Phone Number: +51 1 6196161; Email: alfgb@yahoo.es

Study Locations

• Peru
  • Lima, Peru, 15036
    • Recruiting
    • Clinica Internacional San Borja

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study will enroll 149 pediatric and adult male and non-pregnant female individuals, from birth to (and including) 99 years of age.

Description

Inclusion Criteria:

• Pediatric, including newborn (from birth to 1 month of age), or adult (aged 99 or below) individuals.

• 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:

pregnant female individuals

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: 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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Agreement in murmur detection between digital and conventional stethoscopes	Overall agreement (in percent) between the Keikku electronic stethoscope and a conventional analog stethoscope in identifying the presence or absence of a heart murmur.	Day 0 (Single visit)

Collaborators and Investigators

• Sponsor: Lapsi Health Holding B.V.
• Collaborators: Clínica Internacional

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2025
• Primary Completion (Estimated): September 15, 2025
• Study Completion (Estimated): October 15, 2025

Study Registration Dates

• First Submitted: June 23, 2025
• First Submitted That Met QC Criteria: June 23, 2025
• First Posted (Actual): June 29, 2025

Study Record Updates

• Last Update Posted (Actual): June 29, 2025
• Last Update Submitted That Met QC Criteria: June 23, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Telemedicine; Prospective Studies; Pediatric Cardiology; Diagnostic Techniques and Procedures; Electronic Health Records; Safety Assessment; Heart Murmurs; Stethoscopes; Cardiac Auscultation; Medical Device Evaluation; Sound Recording and Reproduction; Adult Cardiology; Signal Processing, Computer-Assisted; Clinical Accuracy
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Respiratory Sounds; Heart Murmurs
• Other Study ID Numbers: D087

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No