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

Launched by LAPSI HEALTH HOLDING B.V. · Jun 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new digital stethoscope called the Keikku electronic stethoscope. A stethoscope is a tool doctors use to listen to heart sounds, and this new device records those sounds through a smartphone app. The goal of the study is to see if the Keikku stethoscope works as well as a regular stethoscope and if it is safe to use when checking for heart murmurs or wheezing.

The trial is open to people of all ages, from newborns to adults up to 99 years old, who are having routine, non-urgent heart check-ups. If you take part, two different doctors will listen to your heart sounds—one with the Keikku device and one with a regular stethoscope—without sharing their findings with each other. They will note whether they hear any heart murmurs and how clear the sounds are. This study will only take about one day for each participant and is happening at a single location in Peru. Importantly, pregnant women cannot join this study. Researchers will compare the results from both devices and watch for any problems or side effects to make sure the new stethoscope is both accurate and safe for everyday medical use.

Gender

ALL

Eligibility criteria

• 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