NCT04448301

PC001- A Study to Evaluate the Usability of PointCheck

PC001 - Study to Evaluate the Usability of PointCheck, a Novel Optical Technology for Screening Non-Invasively Severe Neutropenia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 81 (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 90 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
• 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: 2021-02-09
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2020-06-25
• Last updated: 2025-11-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study