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.
Study Type
OBSERVATIONAL
Enrollment
46
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
MD Anderson Cancer Center
Houston, Texas, United States
Usability of PointCheck
The study will confirm if participants can acquire good quality videos in a home like setting. The System Usability Scale (0-100 higher scored indicate a better usability) will be completed by the participants after completing the follow up visit.
Time frame: Up to three-weeks
Accuracy of PointCheck
The preliminary diagnostic accuracy to detect grade IV neutropenia according to CTCAE V5 (\<500 ANC/mm3) measured by the sensitivity and the specificity will be the evaluated with reference to the corresponding laboratory measures acquired at the nadir (follow up) visit.
Time frame: Up to three-weeks
Repeatability of PointCheck
The % agreement of the device to classify neutropenia compared to the laboratory reference will be established
Time frame: Up to three-weeks
Number of participants with device-related adverse events as assessed by CTCAE v5.0
The number (and %) of AEs, SAEs and their relationship with the device use will be the safety endpoint
Time frame: Up to three-weeks
Adherence to PointCheck
The number of days that the participant used the device will be used to evaluate adherence.
Time frame: Up to three-weeks
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