Clinical Trials Logo
  1. Home
  2. G6PD Deficiency
  3. NCT04146246

Comparative Evaluation of the FINDER Instrument and FINDER G6PD Cartridge in Adults and Neonates

G6PD Deficiency Clinical Trial

Official title:
Comparative Evaluation of the FINDERTM Instrument and FINDERTM G6PD Cartridge in Adults and Neonates

Clinical Trial Summary

A prospective clinical study to compare the clinical performance of the FINDER™ Instrument and the G6PD assay to an FDA cleared instrument/reagent combination in adult and neonate populations.

Clinical Trial Description

A prospective clinical study to compare the clinical performance of the FINDER™ Instrument and the G6PD assay to an FDA cleared instrument/reagent combination in adult and neonate populations. Neonate and adult subjects will be recruited from 3 clinical sites. Neonate samples will be collected as heel prick unless an in dwelling line is already in place at which point a venous or arterial/umbilical sample will be collected. Adult samples will be collected as venous/arterial samples and finger stick samples. Samples will be tested at the point of care/near patient and in the clinical laboratory using the FINDER Instrument and G6PD assay on a digital microfluidic platform. Samples will also be sent to a third party CLIA laboratory for test using an FDA 510(k) cleared instrument/reagent combination for G6PD. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04146246
Study type Observational
Source Baebies, Inc.
Contact
Status Completed
Phase
Start date November 11, 2019
Completion date March 13, 2020
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05096702 - Operational Feasibility of Appropriate Radical Cure of Plasmodium Vivax With Tafenoquine or Primaquine After Quantitative G6PD Testing in Brazil
Recruiting NCT04073953 - Primaquine Enantiomers in G6PD Deficient Human Volunteers Phase 1
Completed NCT02434952 - Safety and Tolerability of Low Dose Primaquine Phase 4
Enrolling by invitation NCT03655223 - Early Check: Expanded Screening in Newborns
Completed NCT04081272 - Effect of G6PD Deficiency on Red Blood Cell Storage
Recruiting NCT05026489 - G6PD Deficiency in Infarction Patients in Shaanxi Province
Terminated NCT03337152 - Assessing a Risk Model for G6PD Deficiency Phase 4
Completed NCT05753150 - Operational Feasibility of Appropriate Plasmodium Vivax Radical Cure After G6PD Testing in Thailand
Completed NCT04010695 - Validation of Diagnostics to Identify Glucose-6-phosphate Dehydrogenase Activity in the US N/A
Completed NCT04033640 - Evaluation of a Diagnostic to Identify Glucose-6-phosphate Dehydrogenase (G6PD) Deficiency in Brazil N/A
Completed NCT01931644 - At-Home Research Study for Patients With Autoimmune, Inflammatory, Genetic, Hematological, Infectious, Neurological, CNS, Oncological, Respiratory, Metabolic Conditions
Active, not recruiting NCT03529396 - Safety and Efficacy of Different Regimens of Primaquine on Vivax Malaria Treatment in G6PD Deficient Patients Phase 2
Recruiting NCT05874271 - Short Course Primaquine for the Radical Cure of P. Vivax - Papua New Guinea N/A
Recruiting NCT04088513 - Safety and Efficacy of Aspirin in Stroke Patients With Glucose-6-phosphate Dehydrogenase Deficiency (SAST) Phase 4
Not yet recruiting NCT05571748 - Oxidative Stress, Carbohydrate Metabolism Disorders and G6PD Deficiency N/A
Not yet recruiting NCT02937376 - Effects of N-acetyl Cystein (NAC) Supplementation in G6PD Deficient Individuals After Acute Exercise Early Phase 1
Completed NCT02937363 - Effects of Alpha Lipoic Acid Supplementation in G6PD Deficient Individuals After Acute Exercise N/A
Recruiting NCT05879224 - Short Course Primaquine for the Radical Cure of P. Vivax Malaria - Indonesia N/A
Completed NCT04054661 - Validation of a Diagnostic Test for Glucose-6-phosphate Dehydrogenase (G6PD) Deficiency in Anti-coagulated Blood N/A