Study to Evaluate the Usability of PointCheck
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|ClinicalTrials.gov Identifier: NCT04448314|
Recruitment Status : Active, not recruiting
First Posted : June 25, 2020
Last Update Posted : October 21, 2021
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.
|Condition or disease||Intervention/treatment|
|Neoplasms Chemotherapy-induced Neutropenia||Diagnostic Test: PointCheck|
|Study Type :||Observational|
|Actual Enrollment :||90 participants|
|Official Title:||Study to Evaluate the Usability of PointCheck, a Novel Optical Technology for Screening Non-Invasively Severe Neutropenia|
|Actual Study Start Date :||February 11, 2020|
|Estimated Primary Completion Date :||March 2022|
|Estimated Study Completion Date :||March 2022|
- Diagnostic Test: PointCheck
This is a usability study on PointCheck, a new technology to detect chemotherapy-induced neutropenia
- PointCheck's Usability [ Time Frame: Up to two-weeks ]To gather data with the ultimate goal of determining the usability of the proposed non-invasive method measured by the the number and % of user errors (globally and per error type) observed in the clinic visits. In addition, the number and % of users successfully completing the test without errors will be measured.
- System Usability Scale (0-100 higher scores indicate better usability) [ Time Frame: Up to two-weeks ]To confirm the usability of the system using the System Usability Scale
- PointCheck's Precision [ Time Frame: Up to two-weeks ]To perform an exploratory analysis of the percentage agreement of PointCheck's estimation of WBC from two independent one-minute videos.
- PointCheck's Accuracy [ Time Frame: Up to two-weeks ]To perform a exploratory analysis of PointCheck's accuracy (e.g., sensitivity, specificity, AUROC) to detect severe neutropenia compared with the gold standard blood analysis method employed by the 12 de Octubre Hospital core laboratory in the range between ≤500 and >500 ANC/µL.
- PointCheck's Utility [ Time Frame: Up to two-weeks ]To evaluate the % of patients that had to be rescheduled because the sole presence of neutropenia and how many of them were correctly detected with PointCheck.
- PointCheck's Safety: total number (%) of AEs and SAEs [ Time Frame: Up to two-weeks ]The number (and %) of AEs, SAEs and their relationship with the device use will be the safety endpoint
- Exploratory diagnostic performance for a second cutoff [ Time Frame: Up to two-weeks ]The preliminary diagnostic accuracy to detect grade III neutropenia according to CTCAE V5 (<1000 ANC/mm3) 13 measured by the sensitivity and the specificity will be the evaluated with reference to the corresponding laboratory measures acquired.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04448314
|Hospital Universitari Dexeus. Grupo Quirónsalud|
|Barcelona, Spain, 08028|
|Hospital Universitario 12 de Octubre|
|Madrid, Spain, 28049|
|Principal Investigator:||Joaquin Martinez López, MD||Fundación de Investigación del Hospital 12 de Octubre|