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

NCT ID: NCT04146246

Last Updated: 2020-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

119 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-11

Study Completion Date

2020-03-13

Brief Summary

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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.

Detailed Description

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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.

Conditions

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G6PD G6PD Deficiency

Keywords

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G6PD Neonate

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Adult

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

G6PD assay

Intervention Type DIAGNOSTIC_TEST

A test for G6PD deficiency.

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.

G6PD assay

Intervention Type DIAGNOSTIC_TEST

A test for G6PD deficiency.

Interventions

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G6PD assay

A test for G6PD deficiency.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

35 Weeks

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Baebies, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rama Sista, PhD

Role: STUDY_DIRECTOR

Director Product Development

Locations

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Duke Health

Durham, North Carolina, United States

Site Status

Wake Med

Raleigh, North Carolina, United States

Site Status

University Hospitals Cleveland Medical Center Rainbow Children's Hospital

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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CSPROJ00004001

Identifier Type: -

Identifier Source: org_study_id