Study to Evaluate the Usability of PointCheck

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

94 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-11

Study Completion Date

2023-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Neoplasms Chemotherapy-induced Neutropenia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

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PointCheck

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Study subjects must be 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 hematological malignancy (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 tumor cells in previous or current lab determinations.
4. Unstable participants or participants with hypotension (systolic blood pressure \<90 and diastolic blood pressure \< 60mmHg).
5. 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.
6. Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the subject unsuitable for enrolment.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No