A non-interventional clinical validation study of the Exponential Deep Examination (EDE) scanner in the detection of human immunodeficiency virus (HIV), tuberculosis (TB) and malaria

EDE Research Institute0 sites2,320 target enrollmentFebruary 27, 2024

Overview

No summary available.

Registry

who.int

Start Date

February 27, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

EDE Research Institute

•Inclusion criteria
•For Group 1 (symptomatic patients suspected of HIV/TB/malaria/HCV):
•Male or female, aged \=18 years
•Asymptomatic/symptomatic patients suspected of HIV, or symptomatic patients suspected of TB,
•malaria, or HCV based on physician’s clinical evaluation, which may include laboratory (eg, liver
•function tests, CBC) or radiological (eg, chest X\-ray) tests per routine clinical practice
•Patient agrees to undergo the non\-invasive EDE scanner test and standard diagnostic testing for the
•respective infectious disease (HIV/TB/malaria/HCV) \- per routine standard of care, in parallel
•Provision of signed informed consent
•For Group 2 (healthy participants):

•Exclusion criteria
•For Group 1 (symptomatic patients suspected of HIV/TB/malaria/HCV):
•Current or previous history of treatment for HIV, TB, malaria, or HCV
•Patients suspected to be co\-infected with more than one of the infectious diseases of interest
•(HIV/TB/malaria/HCV)
•Current or previous participation in any investigational drug or medical device study in the past 3
•Patients on any concomitant antibiotic or antiviral treatment
•For Group 2 (healthy participants):
•Current or previous participation in any investigational drug or medical device study in the past 3
•Participants on any concomitant antibiotic or antiviral treatment