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NCT07044128: KCI-1
Validate the Efficacy and the Safety of the Keikku Electronic Stethoscope for Its Indication and Intended Purpose, Under the Intended Conditions of Use.
trial testing Digital stethoscope using MEMS sensor and mobile application for cardiac auscultation in Heart Murmurs in 149 participants. Currently enrolling.
15 September 2025
Quick facts
| Lead sponsor | Lapsi Health Holding B.V. |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 149 |
| Start date | 15 July 2025 |
| Primary completion | 15 September 2025 |
| Estimated completion | 15 October 2025 |
| Sites | 1 location across Peru |
Drugs / interventions tested
- Digital stethoscope using MEMS sensor and mobile application for cardiac auscultation
Conditions studied
- Heart Murmurs — all drugs for Heart Murmurs →
- Wheezing — all drugs for Wheezing →
Sponsor
Lapsi Health Holding B.V.
Who can join
Under 99, any sex, with Heart Murmurs or Wheezing. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07044128
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Heart Murmurs
Currently open trials in the same condition.
- NCT06155643 — EKO SENSORA: Detecting Clinically Significant Murmurs · NA · recruiting
- NCT05987670 — Triple Cardiovascular Disease Detection With an Artificial Intelligence-enabled Stethoscope · NA · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07044128 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Lapsi Health Holding B.V.
- Last refreshed: 29 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07044128.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing