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Accuracy Testing of Hemex Malaria Device (GazelleTM)

"Pilot and Validation studies of a new malaria and sickle cell diagnostic device."

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2019/11/021932
Enrollment
200
Registered
2019-11-08
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B509- Plasmodium falciparum malaria, unspecified Health Condition 2: B529- Plasmodium malariae malaria without complication Health Condition 3: B530- Plasmodium ovale malaria Health Condition 4: B519- Plasmodium vivax malaria without complication

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Hemex Health Inc
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Present with uncomplicated malaria (fever),Other symptomatic patients (fever, chills etc.) visiting the clinic/lab for various diagnostic purposes, Informed consent for all fresh or frozen samples will be obtained from the patient or obtained from the parent/guardian in case the patient is a minor.

Exclusion criteria

Exclusion criteria: Presence of any serious or chronic illness requiring medical attention Informed consent not provided Malaria diagnosis within the last two months Treatment for malaria in last two months

Design outcomes

Primary

MeasureTime frame
Primary endpoint of the study is the accuracy of the Hemex Malaria deviceTimepoint: 4 weeks

Secondary

MeasureTime frame
N/ATimepoint: N/A

Countries

India

Contacts

Public ContactDr Praveen K Bharti

ICMR-National Institute of Research in Tribal Health

saprapbs@yahoo.co.in9926335201

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026