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Reference Range for abioSCOPE® Device With the PSP Assay in a Generally Healthy Adult Population

NCT04409561 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2022-03-02

No results posted yet for this study

Summary

This is a single center, prospective, biomarker-result-blinded observational study evaluating immunoassay measurements of pancreatic stone protein (PSP) performed on Abionic's abioSCOPE device with the PSP assay on generally healthy adults representative of the US population.

Conditions

Interventions

DEVICE

Blood collection

9 mL K3-EDTA anticoagulated venous whole blood and 9 mL lithium heparin anticoagulated venous whole blood will be collected, processed in plasma and stored until the shipment to the sponsor for PSP measurement on the abioSCOPE device with IVD CAPSULE PSP kits

Sponsors & Collaborators

  • Boston Biomedical Associates

    collaborator OTHER

  • Ocean State Clinical Coordinating Center

    collaborator UNKNOWN

  • Abionic SA

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-15
Primary Completion
2021-11-15
Completion
2022-01-15
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04409561 on ClinicalTrials.gov