PC001- A Study to Evaluate the Usability of PointCheck

NCT04448301 | Completed FDA Device

• 1 other identifier: H-39964
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Medical Device; Technology; Non-invasive

Outcome Measures

Primary Outcomes (2)

• PointCheck's Usability

  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.

  Up to two-weeks

• System Usability Scale (0-100 higher scores indicates better usability)

  To confirm the usability of the system using the System Usability Scale

  Up to three-weeks

Secondary Outcomes (4)

• PointCheck's Precision

  Up to two-weeks

• PointCheck's Accuracy

  Up to three-weeks

• PointCheck's Utility

  Up to three-weeks

• Number of participants with device-related adverse events as assessed by CTCAE v5.0

  Up to three-weeks

Other Outcomes (1)

• Diagnostic performance for a second cutoff

  Up to three-weeks

Study Arms (1)

PointCheck Cohort

EXPERIMENTAL

Diagnostic Test: PointCheck

Interventions

PointCheck DIAGNOSTIC_TEST

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

PointCheck Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand the purpose and risks of the study and to provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations.
• Male or Female aged 18 years or above.
• Diagnosed with a hematological (e.g., lymphoma, myeloma) or breast cancer.
• Scheduled active treatment with cytotoxic chemotherapy with an associated high/intermediate risk of neutropenia.
• Able (in the Investigators opinion) and willing to comply with all study requirements

You may not qualify if:

• Participants with amputations, congenital malformations, or any severe abnormalities of the hands as determined by the investigator.
• Participants with a history of vasculitis, Raynaud syndrome, scleroderma, mixed connective tissue disease or any other rheumatologic systemic condition that could produce microcirculatory changes in the nailfold.
• Participants with circulating tumour cells in previous or current lab determinations.
• Participants with leukemia.
• Participants with any condition producing significant tremor (e.g., essential tremor, Parkinson´s disease, dystonic tremor).
• Inadequately medically controlled hypotension (systolic blood pressure \<90 and diastolic blood pressure \< 60mmHg).
• Participants whose gold standard blood differential was obtained more than 120 minutes after the last evaluation with the medical device.
• Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
• Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the subject unsuitable for enrolment.

Sponsors & Collaborators

• Leuko Labs, Inc.: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (1)

• Lamaj G, Pablo-Trinidad A, Butterworth I, Bell N, Benasutti R, Bourquard A, Sanchez-Ferro A, Castro-Gonzalez C, Jimenez-Ubieto A, Baumann T, Rodriguez-Izquierdo A, Pottier E, Shelton A, Martinez-Lopez J, Sloan JM. Usability Evaluation of a Noninvasive Neutropenia Screening Device (PointCheck) for Patients Undergoing Cancer Chemotherapy: Mixed Methods Observational Study. J Med Internet Res. 2022 Aug 9;24(8):e37368. doi: 10.2196/37368.

  PMID: 35943786 DERIVED

MeSH Terms

Conditions

Neoplasms; Neutropenia

Condition Hierarchy (Ancestors)

Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Study Officials

• Mark Sloan, MD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: June 25, 2020
• Study Start: February 9, 2021
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: November 6, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)