Status:
COMPLETED
Lifelight Non-Invasive Blood Pressure and Heart Rate Validation Study
Lead Sponsor:
Xim Limited
Collaborating Sponsors:
Element Materials Technology
Mind Over Matter Medtech Ltd
Conditions:
Hypertension
Eligibility:
All Genders
18-85 years
Phase:
NA
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 patient's fa...
Detailed Description
Lifelight was investigated in a study that followed the data collection and data analysis methodology outlined in ISO 81060-2:2018/AMD 1:2020 "Non-invasive Sphygmomanometers - Part 2: Clinical investi...
Eligibility Criteria
Inclusion
- Healthy volunteers aged 18 to 85 years old
Exclusion
- Participants were excluded from the study if they were medically unsuitable for participation at time of visit, any heart dysrhythmias (except respiratory sinus arrhythmia) as confirmed with a 3 lead ECG, compromised circulation or peripheral vascular disease, clotting disorders, female participants who were pregnant or trying to get pregnant, excessive facial hair, and conditions that affect the skin, such as anaemia, jaundice, rosacea, psoriasis, acute acne, and erythropoietic protoporphyria.
- Participants could choose to withdraw themselves from the study without prejudice or they could be withdrawn by study investigators for predetermined reasons. Data excluded from the analysis was documented with justifications.
Key Trial Info
Start Date :
May 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 3 2023
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT06535152
Start Date
May 18 2023
End Date
August 3 2023
Last Update
August 2 2024
Active Locations (1)
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1
Element Materials Technology
Louisville, Colorado, United States, 80027