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Usability, Adherence and Diagnostic Performance of PointCheck in Pediatric Population

NCT04889937 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 46

Last updated 2025-03-11

No results posted yet for this study

Summary

Single-site non-significant risk, open-label clinical investigation designed to validate the usability, adherence, and preliminary diagnostic performance of a novel technology to detect neutropenia. Study participants will be managed as per the standard of care practice with a baseline and nadir visit including laboratory determinations. Participants will also be evaluated with the device at both time points and with daily measurements during the two-week period in between.

Conditions

  • Hematologic Malignancy

Interventions

DEVICE

PointCheck

PointCheckTM is intended for use to aid in the assessment of severe neutropenia in the home or clinic setting in subjects receiving myelosuppressive chemotherapy with intermediate to high febrile neutropenia risk. The device non-invasively captures real-time videos of blood flow in the nailfold microcirculation and utilizes visible light, a microscope and a computer vision software to provide a qualitative result. The device is limited to use as a preliminary assessment tool in conjunction with standard of care, including temperature monitoring and clinical assessment. It is not to be used as a stand-alone determinant of severe neutropenia or for any other diagnostic purpose

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    collaborator OTHER

  • Center for Advancing Point of Care Technologies

    collaborator OTHER

  • Leuko Labs, Inc.

    lead INDUSTRY

Principal Investigators

  • Branko Cuglievan, MD · M.D. Anderson Cancer Center

Eligibility

Min Age
7 Years
Max Age
39 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-07
Primary Completion
2023-07-31
Completion
2023-07-31
FDA Device
Yes

Countries

  • United States

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 NCT04889937 on ClinicalTrials.gov