PC001- A Study to Evaluate the Usability of PointCheck

Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 any type of active lymphoma or myeloma. 4. Scheduled treatment with cytotoxic chemotherapy including e.g., regimens with antimetabolites, platins, taxanes, topoisomerase inhibitors, Vinca alkaloids, anthracyclines. 5. Able (in the Investigators opinion) and willing to comply with all study requirements

Exclusion Criteria

  1. 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. 2. Participants with amputations, congenital malformations, Raynaud phenomena, signs of vasculitis, or any severe abnormalities of the hands as determined by the investigator. 3. Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the subject unsuitable for enrollment.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
PointCheck Cohort
  • Diagnostic Test: PointCheck
    This is a usability study on PointCheck, a new technology to detect chemotherapy-induced neutropenia

Recruiting Locations

Boston Medical Center
Boston, Massachusetts 02118
Contact:
Mark Sloan, MD

More Details

Status
Recruiting
Sponsor
Leuko Labs, Inc.

Study Contact

Álvaro Sánchez-Ferro, MD
+34619223086
alvaro@leuko.io