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PC001- A Study to Evaluate the Usability of PointCheck | Clinical Trials | Clareo Health

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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

NCT04448301•Leuko Labs, Inc.

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 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.
•2. Male or Female aged 18 years or above.
•3. Diagnosed with a hematological (e.g., lymphoma, myeloma) or breast cancer.
•4. Scheduled active treatment with cytotoxic chemotherapy with an associated high/intermediate risk of neutropenia.
•5. Able (in the Investigators opinion) and willing to comply with all study requirements

Exclusion Criteria

•1. Participants with amputations, congenital malformations, or any severe abnormalities of the hands as determined by the investigator.
•2. 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.
•3. Participants with circulating tumour cells in previous or current lab determinations.
•4. Participants with leukemia.
•5. Participants with any condition producing significant tremor (e.g., essential tremor, Parkinson´s disease, dystonic tremor).
•6. Inadequately medically controlled hypotension (systolic blood pressure \<90 and diastolic blood pressure \< 60mmHg).
•7. Participants whose gold standard blood differential was obtained more than 120 minutes after the last evaluation with the medical device.
•8. 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.
•9. Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the subject unsuitable for enrolment.

Locations (1)

Boston Medical Center

Boston, Massachusetts, United States

Key Dates

Start Date

February 9, 2021

Primary Completion Date

June 30, 2025

Completion Date

June 30, 2025

Last Updated

November 6, 2025

Enrollment

ACTUAL participants

Conditions

NeoplasmsNeutropenia

Interventions

PointCheck

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 6, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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PC001- A Study to Evaluate the Usability of PointCheck

Inclusion Criteria

Exclusion Criteria

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