Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02672228
Recruitment Status : Completed
First Posted : February 3, 2016
Last Update Posted : March 22, 2018
Sponsor:
Collaborators:
Precision Acoustics ltd UK
Standa, UAB Lithuania
X Instruments LLC, CA, USA
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine

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

Condition or disease Intervention/treatment Phase
Malaria Device: MalariaSense device Not Applicable

Detailed Description:

This is a proof of concept study that will evaluate the feasibility of a vapor nanobubble technology (MalariSense) for malaria diagnostics. The primary objective is to determine the sensitivity of MalariSense against microscopy in diagnosing malaria in malaria suspected cases attending a health facility in The Gambia. The secondary objectives include the following;

  1. To determine the sensitivity of MalariSense against PCR in diagnosing malaria in malaria suspected cases attending a health facility in The Gambia
  2. To determine the specificity of MalariSense in diagnosing malaria in malaria suspected cases attending a health facility in The Gambia.
  3. To identify factors influencing the diagnostic accuracy of MalariSense
  4. 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. The study will be conducted during the malaria transmission season (August to December 2015). Participants will be patients with suspected uncomplicated malaria presenting to the outpatient department of Basse Health centre. At baseline, suspected malaria cases (clinical assessment) will be asked to provide informed consent and then transferred to the MRC Basse field station where a finger prick blood sample will be collected for a malaria rapid diagnostic test (RDT), microscopy and on filter paper for subsequent molecular studies. In addition, they will be tested using the Malarisense Technology. Measurements will be taken from the wrist, ear lobe and finger tips. The laboratory prototype of the device will include three major components: pulsed laser with the fiber output, integrated handheld probe with the fiber launch in the center and an ultrasound sensor with pre-amplifier, and the signal acquisition hardware with software.

The study will enrol a total sample size of 50 patients with confirmed malaria. It is estimated that about 125 to 167 suspected cases will need to be screened/tested to get this sample size. The Sample size will be increased by 10% to allow for any missing values - therefore up to 185 suspected cases screened. In addition, a convenience sample of 30 malaria negative participants will be enrolled for comparisons between malaria positive and malaria negative populations. RDT positive patients will be provided with antimalarial treatment while the others will receive treatment according to their condition. Microscopy and species-specific PCR will be performed later. Microscopy results will be taken as the gold standard.

There will not be any active follow up. Study participants will be asked to come back 2 days after the test, or earlier if they notice a problem.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 208 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Feasibility of the Vapor Nanobubble Technology (MalariSense) for Malaria Diagnostics
Study Start Date : October 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Experimental: MalariaSense device
This 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
Device: MalariaSense device
All participants enrolled in the study will be assessed for malaria using the intervention device called MalariaSense technology




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

Secondary Outcome Measures :
  1. Safety profile of Malarisense technology for malaria diagnosis [ Time Frame: Day 1 - Day 3 ]
    Safety of the MalariSense Technology for malaria diagnosis over 3 days of observation

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02672228


Locations
Layout table for location information
Gambia
Basse Health Centre
Basse, Upper River Region, Gambia
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Precision Acoustics ltd UK
Standa, UAB Lithuania
X Instruments LLC, CA, USA
Investigators
Layout table for investigator information
Principal Investigator: Umberto D'alessandro, PhD, MD Medical Research Council Unit, The Gambia
Layout table for additonal information
Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT02672228    
Other Study ID Numbers: SCC 1430
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Malaria
Protozoan Infections
Parasitic Diseases