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

NCT04146246 | Completed FDA Device

• 1 other identifier: CSPROJ00004001
• Study Type: observational
• Target: 119
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

G6PD; G6PD Deficiency

Keywords

G6PD; Neonate

Outcome Measures

Primary Outcomes (1)

• G6PD enzymatic activity in adults and neonates

  G6PD enzymatic activity in the FINDER System for adults and neonates compared to the G6PD activity tested using a known FDA cleared assay/instrument combination

  Immediately following a blood draw.

Secondary Outcomes (2)

• Point of care/near patient results and clinical laboratory results

  Immediately following a blood draw.

• Arterial/venous whole blood results and tissue capillary test results

  Immediately following a blood draw.

Study Arms (2)

Adult

Adults aged 18 years or older. Collect whole blood sample via venous/arterial puncture and, where possible, finger stick.

Diagnostic Test: G6PD assay

Neonate

Neonates gestational age \>35 weeks or older. Collect whole blood sample via heel prick or, where an in dwelling line already exists, via arterial/umbilical draw.

Diagnostic Test: G6PD assay

Interventions

G6PD assay DIAGNOSTIC_TEST

A test for G6PD deficiency.

Adult; Neonate

Eligibility Criteria

• Age: 35 Weeks - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults who are at least 18 years of age or older. Neonates who are at least 35 gestational weeks old, recruited from the well baby nursery or the NICU.

You may qualify if:

• Neonates aged \>35 gestational weeks or older.
• Adult subjects who are age 18 and older.
• Adult subjects who weigh at least 110 pounds.
• All ethnicities.
• Male and female subjects.

You may not qualify if:

• Adult subjects who weigh less than 110 pounds.
• Subjects with anemia for which an attending physician will not authorize a blood draw.
• Subjects who have received a blood transfusion.
• Subjects who are pregnant.

Sponsors & Collaborators

• Baebies, Inc.: lead

Study Sites (3)

Duke Health

Durham, North Carolina, 27705, United States

Location

Wake Med

Raleigh, North Carolina, 27610, United States

Location

University Hospitals Cleveland Medical Center Rainbow Children's Hospital

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Glucosephosphate Dehydrogenase Deficiency

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Rama Sista, PhD

  Director Product Development

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: October 31, 2019
• Study Start: November 11, 2019
• Primary Completion: March 13, 2020
• Study Completion: March 13, 2020
• Last Updated: November 23, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)