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BD OneFlow CLPD Panel (BD OneFlow LST, and B-CLPD T1 to T4 Assays) on the BD FACSLyric System.

NCT05557422 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 322

Last updated 2024-09-26

No results posted yet for this study

Summary

Multi-site, prospective performance study to determine equivalency between the investigational CLPD Full Panel on the FACSLyric system versus the final clinical diagnosis.

Conditions

  • Chronic Lymphoproliferative Diseases (CLPD)

Interventions

DIAGNOSTIC_TEST

BD OneFlow LST, and B-CLPD T1 to T4 Assays

a panel of fluorochrome-conjugated antibodies for qualitative flow-cytometric immunophenotyping of mature lymphocyte populations on the BD FACSLyric™ flow cytometer with BD FACSuite™ Clinical application.

Sponsors & Collaborators

  • Becton, Dickinson and Company

    lead INDUSTRY

Principal Investigators

  • Imelda Omana-Zapata, MD, Ph.D · Becton, Dickinson and Company

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-12
Primary Completion
2024-05-08
Completion
2024-05-08
FDA Device
Yes

Countries

  • United States
  • Netherlands
  • Portugal
  • Spain
  • Switzerland

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 NCT05557422 on ClinicalTrials.gov