Feasibility of the Vapor Nanobubble Technology for Malaria Diagnostics (MalariaSense)
MalariaSense
1 other identifier
interventional
208
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedFirst Posted
Study publicly available on registry
February 3, 2016
CompletedMarch 22, 2018
March 1, 2018
2 months
September 14, 2015
March 20, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
"Hemozoin-generated vapour nanobubble (H-VNB) amplitude thresholds among malaria infected and uninfected individuals"
Day 1
Secondary Outcomes (2)
Safety profile of Malarisense technology for malaria diagnosis
Day 1 - Day 3
Correlation of incidence rate ratio of hemozoin-positive traces with level of parasite density as determined by microscopy
Day1 - Day 3
Study Arms (1)
MalariaSense device
EXPERIMENTALThis study will involve the evaluation of a medical diagnostic device. All participants enrolled in the study will be assessed for malaria using MalariSense Technology and will aslo get rapid diagnostic tests (RDTs), microscopy, PCR
Interventions
All participants enrolled in the study will be assessed for malaria using the intervention device called MalariaSense technology
Eligibility Criteria
You may qualify if:
- Patients presenting to the health facility with suspected uncomplicated malaria
- Provision of informed consent
You may not qualify if:
- Neonates and under 12 months old
- Pregnant women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- London School of Hygiene and Tropical Medicinelead
- Precision Acoustics ltd UKcollaborator
- Standa, UAB Lithuaniacollaborator
- X Instruments LLC, CA, USAcollaborator
Study Sites (1)
Basse Health Centre
Basse, Upper River Region, The Gambia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Umberto D'alessandro, PhD, MD
Medical Research Council Unit, The Gambia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2015
First Posted
February 3, 2016
Study Start
October 1, 2015
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
March 22, 2018
Record last verified: 2018-03