NCT07044128 Validate the Efficacy and the Safety of the Keikku Electronic Stethoscope for Its Indication and Intended Purpose, Under the Intended Conditions of Use.
| NCT ID | NCT07044128 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Lapsi Health Holding B.V. |
| Condition | Heart Murmurs |
| Study Type | OBSERVATIONAL |
| Enrollment | 149 participants |
| Start Date | 2025-07-15 |
| Primary Completion | 2025-09-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 149 participants in total. It began in 2025-07-15 with a primary completion date of 2025-09-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07044128 clinical trial?
This trial is open to participants of all sexes, up to 99 Years, studying Heart Murmurs. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07044128 currently recruiting?
Yes, NCT07044128 is actively recruiting participants. Contact the research team at alfgb@yahoo.es for enrollment information.
Where is the NCT07044128 trial being conducted?
This trial is being conducted at Lima, Peru.
Who is sponsoring the NCT07044128 clinical trial?
NCT07044128 is sponsored by Lapsi Health Holding B.V.. The trial plans to enroll 149 participants.