[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596336":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":10,"centralContacts":24,"locations":30,"responsibleParty":44,"collaborators":46,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":58,"sex":59,"minAge":10,"maxAge":60,"enrollmentInfo":61,"targetDuration":10,"studyType":64,"phases":10,"briefSummary":65,"conditions":66,"keywords":69,"overallStatus":33,"whyStopped":10,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Lapsi Health Holding B.V.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Keikku Stethoscope Evaluation Group - Pediatric",null,"This group includes pediatric participants undergoing non-urgent cardiac evaluation. Each participant receives heart sound assessments using both the investigational Keikku electronic stethoscope and a conventional analog stethoscope. The primary aim is to compare the accuracy of murmur detection between the two devices. Evaluations are performed by two separate physicians to ensure independent assessment.",[13],"Device: Digital stethoscope using MEMS sensor and mobile application for cardiac auscultation",{"label":15,"type":10,"description":16,"interventionNames":17},"Keikku Stethoscope Evaluation Group - Adults","This group includes adult participants undergoing non-urgent cardiac evaluation. Each participant receives heart sound assessments using both the investigational Keikku electronic stethoscope and a conventional analog stethoscope. The primary aim is to compare the accuracy of murmur detection between the two devices. Evaluations are performed by two separate physicians to ensure independent assessment.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"DEVICE","Digital stethoscope using MEMS sensor and mobile application for cardiac auscultation","The intervention is a digital stethoscope system comprising a handheld device with a micro-electromechanical system (MEMS) sensor and a Bluetooth Low Energy (BLE) connection to a mobile application (Keikku Mobile App) installed on an iOS or Android smartphone. The device captures auscultation sounds from standard precordial locations (mitral, tricuspid, aortic, and pulmonary), transmits them in real time to the mobile application, and stores the recordings on a secure, GDPR-compliant cloud server. The device does not interpret sounds. Each auscultation lasts 15 seconds per site. Physicians use Bluetooth headphones to listen during recording. The application allows for annotation and review of sound data. The intervention is administered once per participant during a single study visit, immediately followed by a comparator auscultation using a conventional analog stethoscope by a second blinded physician.",[15,9],[25],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"Alfredo Gilberto Guerreros Benavides","CONTACT","+51 1 6196161","alfgb@yahoo.es",[31],{"facility":32,"status":33,"city":34,"state":10,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":10},"Clinica Internacional San Borja","RECRUITING","Lima","15036","Peru","PE",{"type":39,"coordinates":40},"Point",[41,42],-77.02824,-12.04318,{"lat":42,"lon":41},{"type":45,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[47],{"name":48,"class":49},"Clínica Internacional","OTHER","100596336","validate-the-efficacy-and-the-safety-of-the-keikku-electronic-stethoscope-for-its-indication-and-intended-purpose-under-the-intended-conditions-of-use-100596336",false,"NCT07044128","Validate the Efficacy and the Safety of the Keikku Electronic Stethoscope for Its Indication and Intended Purpose, Under the Intended Conditions of Use.","Prospective, Controlled, Open-label Study Evaluating the Keikku Electronic Stethoscope","KCI-1","Inclusion Criteria:\n\n* Pediatric, including newborn (from birth to 1 month of age), or adult (aged 99 or below) individuals.\n* Individuals who are either:\n\n  * presenting for initial, non-urgent outpatient evaluation of a cardiac murmur or for non-urgent cardiac clearance; or\n  * presenting for return, non-urgent outpatient evaluation of a cardiac murmur; or\n  * undergoing initial or recurrent, non-urgent evaluation of a cardiac murmur in inpatient setting; or\n  * undergoing non-urgent cardiac clearance in inpatient setting.\n\nExclusion Criteria:\n\npregnant female individuals",true,"ALL","99 Years",{"count":62,"type":63},149,"ESTIMATED","OBSERVATIONAL","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.\n\nThe 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.\n\nThe 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.\n\nThe goal is to find out if the Keikku electronic stethoscope is accurate and safe for doctors to use in real medical settings.",[67,68],"Heart Murmurs","Wheezing",[70,67,71,72,73,74,75,76,77,78,79,80,81,82],"Stethoscopes","Cardiac Auscultation","Diagnostic Techniques and Procedures","Medical Device Evaluation","Sound Recording and Reproduction","Pediatric Cardiology","Adult Cardiology","Telemedicine","Signal Processing, Computer-Assisted","Electronic Health Records","Clinical Accuracy","Safety Assessment","Prospective Studies","2025-06-23",{"date":85,"type":86},"2025-06-29","ACTUAL",{"date":88,"type":63},"2025-07-15",{"date":90,"type":63},"2025-10-15",{"name":5,"class":6},1]