NCT04448314

Study to Evaluate the Usability of PointCheck

Study to Evaluate the Usability of PointCheck, a Novel Optical Technology for Screening Non-Invasively Severe Neutropenia

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 94 (actual)
• Sponsor: Leuko Labs, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This a study about the usability of PointCheck a novel non-invasive technology for monitoring chemotherapy-induced neutropenia. The study will include patients with cancer visiting the outpatient hematology clinic for their standard of care chemotherapy administration. A final sample size of 60 oncologic outpatients will be enrolled and studied with the technology. The main objective is to evaluate the usability of PointCheck. Secondary outcomes include a preliminary assessment of PointCheck diagnostic accuracy and precision. For this, study subjects will be tested twice with PointCheck during the same session and the usability in an at-home simulated environment by naïve users will be evaluated.

Conditions

• Neoplasms
• Chemotherapy-induced Neutropenia

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	PointCheck	This is a usability study on PointCheck, a new technology to detect chemotherapy-induced neutropenia

Timeline

• Start date: 2020-02-11
• Primary completion: 2023-06-30
• Completion: 2023-06-30
• First posted: 2020-06-25
• Last updated: 2023-08-22

Locations

3 sites across 1 country: Spain