PC001- A Study to Evaluate the Usability of PointCheck
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|ClinicalTrials.gov Identifier: NCT04448301|
Recruitment Status : Not yet recruiting
First Posted : June 25, 2020
Last Update Posted : June 25, 2020
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
|Condition or disease||Intervention/treatment||Phase|
|Neoplasms Neutropenia||Diagnostic Test: PointCheck||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||PC001 - Study to Evaluate the Usability of PointCheck, a Novel Optical Technology for Screening Non-Invasively Severe Neutropenia|
|Estimated Study Start Date :||July 1, 2020|
|Estimated Primary Completion Date :||June 1, 2021|
|Estimated Study Completion Date :||June 5, 2021|
|Experimental: PointCheck Cohort||
Diagnostic Test: PointCheck
This is a usability study on PointCheck, a new technology to detect chemotherapy-induced neutropenia
- PointCheck's Usability [ Time Frame: Single-point evaluation (baseline) ]To gather data with the ultimate goal of determining the usability of the proposed non-invasive method measured by the number of errors of correct videos acquired for analyses.
- Number of participants with device-related adverse events as assessed by CTCAE v5.0 [ Time Frame: Single-point evaluation (baseline) ]To confirm PointCheck's safety determining the % of AEs and SAEs related to the device use.
- PointCheck's Precision [ Time Frame: Single-point evaluation (baseline) ]To perform an exploratory analysis of the precision of PointCheck's estimation of neutropenia status from two independent one-minute videos.
- PointCheck's Accuracy [ Time Frame: Single-point evaluation (baseline) ]To perform a exploratory analysis of PointCheck's accuracy (e.g., sensitivity, specificity, predictive values) to detect severe neutropenia compared with the gold standard blood analysis method employed by Boston Medical Center core laboratory in the range between ≤500 and >500 absolute neutrophil count/µL.
- PointCheck's Utility [ Time Frame: Single-point evaluation (baseline) ]To evaluate the number of patients that had to be rescheduled because the sole presence of neutropenia and how many of them were correctly detected with PointCheck.
- System Usability Scale (0-100) [ Time Frame: Single-point evaluation (baseline) ]To confirm the usability of the system using the System Usability Scale
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): NCT04448301
|Contact: Álvaro Sánchez-Ferro, MDfirstname.lastname@example.org|
|Principal Investigator:||Mark Sloan, MD||Boston Medical Center|