Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06535152
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
Lifelight Non-Invasive Blood Pressure and Heart Rate Validation Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
CLINIMARK Clinical Investigation Plan Lifelight Non-Invasive Blood Pressure Validation Study PR 2021-443
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Lifelight is a novel calibration-free software-only medical device that contactlessly measures pulse rate and blood pressure by measuring remote photoplethysmography rPPG signals of a patients face using a standard smartphone or tablet camera
By conducting this validation study we aimed to demonstrate the accuracy of Lifelight for classifying the full range of clinically relevant blood pressures as hypertensive or non-hypertensive and demonstrate its accuracy for measuring pulse rate and the blood pressure of people with blood pressures relevant to Stage 1 hypertension
By conducting this validation study we aimed to demonstrate the accuracy of Lifelight for classifying the full range of clinically relevant blood pressures as hypertensive or non-hypertensive and demonstrate its accuracy for measuring pulse rate and the blood pressure of people with blood pressures relevant to Stage 1 hypertension
Detailed Description:
Lifelight was investigated in a study that followed the data collection and data analysis methodology outlined in ISO 81060-22018AMD 12020 Non-invasive Sphygmomanometers - Part 2 Clinical investigation of automated measurement type This validation study was conducted by independent laboratory Element Materials Technology Boulder formerly Clinimark a global leader for clinical testing of vital sign data for medical devices and consumer wearable products The study generated data from 85 people aged 18-85 with the wide-ranging distribution of blood pressures specified in ISO 81060-22018AMD 12020The accuracy of Lifelights blood pressure measurements was assessed by comparing Lifelights measurements with measurements made by dual-observer manual auscultation using the same-arm sequential method specified in ISO 81060-22018AMD 12020 The accuracy of Lifelights pulse rate measurements was assessed by comparing Lifelights measurements with concurrent ECG-derived heart rate values Data was collected in an Independent Review Board-approved study conducted by independent laboratory Clinimark now Element in the USA and repurposed for the testing of the new improved model in the latest version of the Lifelight EA device The data collected consists of 85 participants with three readings each The participants were resting before their measurements were taken to ensure stable blood pressure For each Lifelight measurement two sets of blood pressure measurements were taken using dual-observer manual auscultation The first measurement was taken before the Lifelight measurement and the second just after If there was too much variation between the before and after measurement or between the two independent observers the measurement was discarded and repeated For this validation procedure the measurements taken during the original study were re-processed in the new updated algorithm
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None