DocMe Validation Study PRFX-2020-01

• Research type

  Research Study

• Full title

  A Validation Study Comparing the Heart Rate, Blood Pressure, Oxygen Levels and Temperature Obtained by Video Selfie Using the DocMe™ technology with Those Obtained by Direct Measurement in Healthy People

• IRAS ID

  293532

• Contact name

  Richard Phillips

• Contact email

  richard.phillips@perfexia.health

• Sponsor organisation

  Perfexia Health Technologies

• Clinicaltrials.gov Identifier

  NCT04688112

• Duration of Study in the UK

  0 years, 0 months, 31 days

• Research summary

  The ability to obtain vital signs remotely using a smartphone could lead to a significant advance in telemedicine and be used in a variety of settings:
  - better and more effective triage in general practice/emergency medicine. This could have been particularly the case during the Covid-19 pandemic
  - more effective appointments in hospital and general practice where attendance could be only when required, for example, in the management of hypertension or asthma
  - earlier post-surgical discharge to care-at-home schemes

  When light travels through biological tissues, it is absorbed by bones, skin pigments and both venous and arterial blood. However, as light is more strongly absorbed by blood than the surrounding tissues, the changes in blood flow can be detected in smartphones by analysing changes in the intensity of light.

  The signals from the video images are proportional to the quantity of blood flowing through the blood vessels and even small changes in blood volume can be detected using this method. Analysis of the waveform provides information on a range of physiological measurements affecting the cardiovascular and respiratory systems.

  perfexia has developed DocMe, a method of obtaining and analysing these data, using a 15 second video selfie taken on a smartphone. Images are analysed using an AI which has been trained using machine learning to provide immediate measurements of heart rate, blood pressure, peripheral oxygen saturation and temperature.

  The aim of this study is to compare accuracy of DocMe™ to previously validated medical devices used in clinical practice in 100 healthy subjects. Each subject will be involved for about one hour on one occasion.

  The results from the study will be used to apply for Class IIa designation which will allow perfexia to promote DocMe as a clinically valid medical device.

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  21/NW/0031

• Date of REC Opinion

  27 Apr 2021

• REC opinion

  Further Information Favourable Opinion