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

Recruiting now

Conditions studied: Heart Murmurs, Wheezing

In brief

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.

Key facts

Study ID

NCT07044128

Run by

Lapsi Health Holding B.V.

People needed

149

Starts

2025-07-15

Expected to finish

2025-10-15

Last updated by the study team

2025-06-29

Who can join

Age: any, up to 99. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• Clinica Internacional San Borja — Lima, Peru (enrolling)

Full record on ClinicalTrials.gov

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