Feasibility of the Vapor Nanobubble Technology for Malaria Diagnostics (MalariaSense)
NCT02672228 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 208
Last updated 2018-03-22
Summary
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. The objectives of this study will be to determine the sensitivity and specificity of 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
Conditions
Interventions
- DEVICE
-
MalariaSense device
All participants enrolled in the study will be assessed for malaria using the intervention device called MalariaSense technology
Sponsors & Collaborators
-
Precision Acoustics ltd UK
collaborator UNKNOWN -
Standa, UAB Lithuania
collaborator UNKNOWN -
X Instruments LLC, CA, USA
collaborator UNKNOWN -
London School of Hygiene and Tropical Medicine
lead OTHER
Principal Investigators
-
Umberto D'alessandro, PhD, MD · Medical Research Council Unit, The Gambia
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 1 Year
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-10-31
- Primary Completion
- 2015-12-31
- Completion
- 2015-12-31
Countries
- The Gambia
Study Locations
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