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Evaluation of the Chronic Lymphoproliferative Diseases Limited Panel on the BD FACSLyric™ Flow Cytometer

NCT05032313 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 371

Last updated 2024-02-28

No results posted yet for this study

Summary

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

Conditions

  • Chronic Lymphoproliferative Diseases (CLPD)

Interventions

DIAGNOSTIC_TEST

IUO CLPD Limited Panel

This Investigational Panel , comprised of 2 reagents , is intended for in vitro diagnostic use for qualitative flow-cytometric immunophenotyping of mature lymphocyte populations. These reagents are used as an aid in the differential diagnosis of hematologically abnormal patients having Chronic Lymphoproliferative Disease .

Sponsors & Collaborators

  • Becton, Dickinson and Company

    lead INDUSTRY

Principal Investigators

  • Imelda Omana-Zapata, MD, PHD · Becton, Dickinson and Company

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-26
Primary Completion
2023-12-29
Completion
2023-12-29
FDA Device
Yes

Countries

  • United States
  • Portugal
  • Spain
  • Switzerland
  • United Kingdom

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 NCT05032313 on ClinicalTrials.gov