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DxFLEX 10C Clinical Study

NCT05467449 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 527

Last updated 2024-02-13

No results posted yet for this study

Summary

A multi-center method comparison study is designed per CLSI-EP09 A3. This study compares the qualitative immunophenotype agreement between DxFLEX and Navios EX to demonstrate the accuracy of the DxFLEX-10C system. A series of precision studies will be conducted with each focusing on different aspects of the DxFLEX-10C system.

Conditions

  • Hematological Malignancy

Interventions

DEVICE

DxFLEX 10C

A device combining flow cytometry and reagents for immunophenotyping analysis

Sponsors & Collaborators

  • Beckman Coulter, Inc.

    lead INDUSTRY

Principal Investigators

  • Guoyan Cheng, PhD · Beckman Coulter, Inc.

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-12
Primary Completion
2023-05-31
Completion
2023-08-31
FDA Device
Yes

Countries

  • United States
  • Canada
  • Germany

Study Locations

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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 NCT05467449 on ClinicalTrials.gov