Last Updated: 18/12/2019
Feasibility of the Vapor Nanobubble Technology for Malaria Diagnostics (MalariSense Part 1)
Objectives
The objectives of this study will be to determine the sensitivity and specificity of a vapor nanobubble technology (MalariSense) in diagnosing malaria in malaria suspected cases attending a health facility in The Gambia and to identify factors influencing the diagnostic accuracy of MalariSense.
This objective will be achieved through:
- To determine the sensitivity of MalariSense against PCR in diagnosing malaria in malaria suspected cases attending a health facility in The Gambia
- To determine the specificity of MalariSense in diagnosing malaria in malaria suspected cases attending a health facility in The Gambia.
- To identify factors influencing the diagnostic accuracy of MalariSense
- To validate the protocol for a blood vessel identification for the test and assess the safety of the prototype. The study site will be Basse in the Eastern region of The Gambia.
Precision Acoustics, United Kingdom
Standa, Lithuania
X Instruments, United States
This is a proof of concept study that will evaluate the feasibility of a vapor nanobubble technology (MalariSense) for malaria diagnostics. The MalariSense technology will use a highly innovative approach based on the transdermal non-invasive detection of vapor nanobubbles produced by the excitation of malaria-specific hemozoin by safe, low-energy laser pulse.
ClinicalTrials.gov Identifier: NCT02672228
Study Type: Interventional
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Sep 2015 — Jun 2016
$95,139
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