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NCT05467449 Clinical Trial

DxFLEX 10C Clinical Study

Hematological Malignancy Clinical Trial

Official title:
DxFLEX ClearLLab 10C US-IVD Clinical Study Protocol - Clinical Laboratory

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05467449
Other study ID # C76895
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 12, 2022
Est. completion date August 31, 2023

Study information
Verified date February 2024
Source Beckman Coulter, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 527
Est. completion date August 31, 2023
Est. primary completion date May 31, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: Patient specimens targeted for this study will be residual samples with sufficient volume from whole blood, bone marrow, and lymph node meeting the following criteria: 1. Specimens from new cases or follow up patients for myeloid/lymphoid FCI testing. 2. Hematologically abnormal specimens 3. Subjects of any range, ethnicities, and racial backgrounds 4. Specimens from patients with the following medical indications presenting for testing by flow cytometry based on the Bethesda Consensus Guidelines. Exclusion Criteria: There are two (2) groups of exclusion criteria to detail the specimens that should not be counted for the study: 1. Pre-analytical/Pre-screen exclusion criteria 2. Post-acquisition exclusion criteria.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• DxFLEX 10C
A device combining flow cytometry and reagents for immunophenotyping analysis

Locations
Country Name City State
Canada London Health Sciences Centre London Ontario
Germany Munich Leukemia Laboratory (MLL) Munich
United States NeoGenomics Laboratories Aliso Viejo California
United States Quest Diagnostics Lewisville Texas
United States University of Miami Miller School of Medicine Miami Florida
United States PhenoPath Laboratories, PLLC Seattle Washington

Sponsors (1)
Lead Sponsor Collaborator
Beckman Coulter, Inc.

Countries where clinical trial is conducted

United States,  Canada,  Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Flow immunophenotyped normal and abnormal Based on WHO guidelines for Leukemia & Lymphoma immediately after the analysis
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