Completed study

Official Study Title
Pulse PhotoplethysmogAaphy as an early tool for the diagnosis of sepsis thrOUgh a two-stage Development approach

Brief Description
PROUD-1 is an interventional trial aiming to validate the diagnostic accuracy of a new optical biosensor for the diagnosis of sepsis and for COVID-19.

Details
Status: Completed
Study Type: Interventional
Study phase: II
Study sites: 4 sites in Greece
Actual enrolment: 196 participants

ClinicalTrials.gov Identifier: NCT04149132
EUDAMED: CIV-19-06-028824
National Organization for Medicines Approval: MD 3/19
National Ethics Committee Approval: MD 3/19

Study Start: November 2019
Study Completion: June 2020

Condition/Disease studied: Sepsis
Keywords: early diagnosis; infection; pulse photoplethysmography

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