[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560205":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":21,"studyPopulation":22,"armGroups":17,"interventions":23,"overallOfficials":28,"centralContacts":32,"locations":40,"responsibleParty":58,"collaborators":17,"id":60,"slug":17,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":63,"acronym":17,"eligibilityCriteria":64,"healthyVolunteers":65,"sex":66,"minAge":67,"maxAge":17,"enrollmentInfo":68,"targetDuration":17,"studyType":71,"phases":17,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":42,"whyStopped":17,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Perin Health Devices","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Cuffless blood pressure measurement performance","Calculate the mean error and standard deviation of blood pressure (BP) measurements from the PHP relative to the ambulatory blood pressure cuff and determine compliance of the PHP's performance with AAMI standards and ISO 81060-2.","3 months",[14],{"measure":15,"description":16,"timeFrame":12},"Demographic performance variance","Determine any variations in performance on certain demographic groups, including subjects who are overweight, subjects with dark skin pigmentation, or subjects with comorbidities.",null,{"allocation":17,"interventionModel":17,"interventionModelDescription":17,"primaryPurpose":17,"observationalModel":19,"timePerspective":20,"maskingInfo":17},"COHORT","PROSPECTIVE","The study will compare the performance of the PHP to an ambulatory blood pressure cuff across 85 subjects for a 10-minute monitoring period, followed by an optional cold pressor test and an additional 10-minute monitoring period. The study aims to confirm that the calibrated measurement from the wearable device meets AAMI performance standards.","The study population will consist of male and female adult participants aged 18 years or older who are willing and able to provide informed consent and comply with the study procedures. Participants may be healthy or have comorbidities, so long as participants are members of any 'Special Population' as defined by the AAMI standards, including but not limited to pregnant individuals, children, and those with an arm circumference greater than 42 cm. Due to the nature of the investigational device, individuals with pacemakers or a history of reactions to medical adhesives may not participate.",[24],{"type":25,"name":26,"description":27,"armGroupLabels":17,"otherNames":17},"DEVICE","Perin Health Patch","The Perin Health Patch (PHP)is a multimodal wearable health patch, which combines auscultation, electrocardiography (ECG), pulse oximetry via photoplethysmography (PPG), bioimpedance (BioZ), skin temperature, and motion and tilt sensors. The PHP integrates multiwavelength PPG (MWPPG) with blue, green, red, and IR LEDs, allowing for precise calculation of PTT, PWV, and related unique parameters, that are used for the calculation of cuffless blood pressure.",[29],{"name":30,"affiliation":5,"role":31},"Ian M McLane, Ph.D.","PRINCIPAL_INVESTIGATOR",[33,37],{"name":30,"role":34,"phone":35,"phoneExt":17,"email":36},"CONTACT","8186069389","imclane@phasemargin.com",{"name":38,"role":34,"phone":17,"phoneExt":17,"email":39},"Valerie Rennoll, Ph.D.","vrennoll@phasemargin.com",[41],{"facility":5,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","Woodland Hills","California","91364","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-118.60592,34.16834,{"lat":52,"lon":51},[55],{"name":56,"role":34,"phone":57,"phoneExt":17,"email":36},"Ian McLane, Ph.D.","818-606-9389",{"type":59,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR","100560205",false,"NCT06574113","Validation of Cuffless Blood Pressure Measurements Using the Perin Health Patch","Inclusion Criteria:\n\n* Adults aged 18 years or older,\n* Willing and able to provide informed consent,\n* Able to comply with study procedure.\n\nExclusion Criteria:\n\n* Any member defined under 'Special Population' in the AAMI standards (Pregnant, children, arm circumference \\> 42 cm),\n* Patient with a pacemaker,\n* History of reactions to medical adhesives,\n* Inability to comply with the study procedure,\n* Non-English Speaker.",true,"ALL","18 Years",{"count":69,"type":70},85,"ESTIMATED","OBSERVATIONAL","This study aims to validate a proprietary cuffless blood pressure algorithm using measurements from a multi-modal chest-worn medical device, the Perin Health Patch (PHP).",[74],"Blood Pressure",[76,77],"Cuffless blood pressure","Wearable device","2024-08-26",{"date":80,"type":81},"2024-08-28","ACTUAL",{"date":83,"type":81},"2024-08-15",{"date":85,"type":70},"2024-12-31",{"name":5,"class":6},1]