NCT04889937

Usability, Adherence and Diagnostic Performance of PointCheck in Pediatric Population

A Study to Evaluate the Usability, Adherence and Diagnostic Performance of a Novel System to Non-Invasively Detect Severe Neutropenia

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 46 (actual)
• Sponsor: Leuko Labs, Inc. · Industry
• Sex: All
• Age: 7 Years – 39 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2021-09-07
• Primary completion: 2023-07-31
• Completion: 2023-07-31
• First posted: 2021-05-17
• Last updated: 2025-03-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study