Feasibility of the Vapor Nanobubble Technology for Malaria Diagnostics (MalariaSense)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02672228
• Date of registration: 14/09/2015
• Prospective Registration: Yes
• Primary sponsor: London School of Hygiene and Tropical Medicine
• Public title: Feasibility of the Vapor Nanobubble Technology for Malaria Diagnostics (MalariaSense) MalariaSense
• Scientific title: Feasibility of the Vapor Nanobubble Technology (MalariSense) for Malaria Diagnostics
• Date of first enrolment: October 2015
• Target sample size: 208
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02672228
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Gambia

Contacts

• Name: Umberto D'alessandro, PhD, MD
• Affiliation: Medical Research Council Unit, The Gambia

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients presenting to the health facility with suspected uncomplicated malaria

- Provision of informed consent

Exclusion Criteria:

- Neonates and under 12 months old

- Pregnant women



Age minimum: 1 Year
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Malaria

Intervention(s)

Device: MalariaSense device

Primary Outcome(s)

"Hemozoin-generated vapour nanobubble (H-VNB) amplitude thresholds among malaria infected and uninfected individuals" [Time Frame: Day 1]

Secondary Outcome(s)

Safety profile of Malarisense technology for malaria diagnosis [Time Frame: Day 1 - Day 3]

Correlation of incidence rate ratio of hemozoin-positive traces with level of parasite density as determined by microscopy [Time Frame: Day1 - Day 3]

Secondary ID(s)

SCC 1430

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Standa, UAB Lithuania

Precision Acoustics ltd UK

X Instruments LLC, CA, USA