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

Recruitingn/aAges any - 99 YearsAllLapsi Health Holding B.V.
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Digital stethoscope using MEMS sensor and mobile application for cardiac auscultation
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Where

1 site
Clinica Internacional San Borja
Lima, Peru
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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