Validate the Efficacy and the Safety of the Keikku Electronic Stethoscope for Its Indication and Intended Purpose, Under the Intended Conditions of Use.

NCT07044128 | Recruiting FDA Device

• 1 other identifier: D087
• Study Type: observational
• Target: 149
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Murmurs; Wheezing

Keywords

Stethoscopes; Heart Murmurs; Cardiac Auscultation; Diagnostic Techniques and Procedures; Medical Device Evaluation; Sound Recording and Reproduction; Pediatric Cardiology; Adult Cardiology; Telemedicine; Signal Processing, Computer-Assisted; Electronic Health Records; Clinical Accuracy; Safety Assessment; Prospective Studies

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

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

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

Interventions

Digital stethoscope using MEMS sensor and mobile application for cardiac auscultation DEVICE

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; Keikku Stethoscope Evaluation Group - Pediatric

Eligibility Criteria

• Age: Up to 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• pregnant female individuals

Sponsors & Collaborators

• Lapsi Health Holding B.V.: lead
• Clínica Internacional: collaborator

Study Sites (1)

Clinica Internacional San Borja

Lima, 15036, Peru

RECRUITING

MeSH Terms

Conditions

Heart Murmurs; Respiratory Sounds

Interventions

Heart Auscultation

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Auscultation; Physical Examination

Central Study Contacts

Alfredo Gilberto Guerreros Benavides

CONTACT

+51 1 6196161; alfgb@yahoo.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: June 29, 2025
• Study Start: July 15, 2025
• Primary Completion: September 15, 2025
• Study Completion: October 15, 2025
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

PE (1)