Actively Recruiting
Validate the Efficacy and the Safety of the Keikku Electronic Stethoscope for Its Indication and Intended Purpose, Under the Intended Conditions of Use.
Led by Lapsi Health Holding B.V. · Updated on 2025-06-29
149
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
L
Lapsi Health Holding B.V.
Lead Sponsor
C
Clínica Internacional
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Validate the Efficacy and the Safety of the Keikku Electronic Stethoscope for Its Indication and Intended Purpose, Under the Intended Conditions of Use.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pediatric or adult individuals from birth to 99 years old
- Presenting for initial, non-urgent outpatient evaluation of a cardiac murmur or cardiac clearance
- Presenting for return, non-urgent outpatient evaluation of a cardiac murmur
- Undergoing initial or recurrent, non-urgent inpatient evaluation of a cardiac murmur
- Undergoing non-urgent cardiac clearance in inpatient setting
You will not qualify if you...
- Pregnant female individuals
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Clinica Internacional San Borja
Lima, Peru, 15036
Actively Recruiting
Research Team
A
Alfredo Gilberto Guerreros Benavides
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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