Usability, Adherence and Diagnostic Performance of PointCheck in Pediatric Population

Completed

• Conditions: Hematologic Malignancy

• Registration Number: NCT04889937
• Lead Sponsor: Leuko Labs, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-11
• Study First Submitted QC: 2021-05-13
• Study First Posted: 2021-05-17
• Study Start: 2021-09-07
• Primary Completion: 2023-07-31
• Study Completion: 2023-07-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-08
• Last Update Posted: 2025-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Usability of PointCheck	Up to three-weeks	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.

Secondary Outcome Measures

Name	Time	Method
Accuracy of PointCheck	Up to three-weeks	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.
Adherence to PointCheck	Up to three-weeks	The number of days that the participant used the device will be used to evaluate adherence.
Repeatability of PointCheck	Up to three-weeks	The % agreement of the device to classify neutropenia compared to the laboratory reference will be established
Number of participants with device-related adverse events as assessed by CTCAE v5.0	Up to three-weeks	The number (and %) of AEs, SAEs and their relationship with the device use will be the safety endpoint

Trial Locations

Locations (1)

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States