A Comparator Study of a Tasso Device Blood Sample to Traditional Venous Blood Sample for CBC

Tasso Inc.

Status: Not yet enrolling

Conditions: Leukocytosis; Neutropenia; Leukopenia

Treatments: Device: Tasso+ CBC

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06360952

T23-03

Details and patient eligibility

About

This study will evaluate the feasibility of using capillary blood samples collected with the Tasso device for analysis of CBC in diseased patients with leukemia, lymphoma, and/or other blood cell disorders.

This investigation will include a minimum of 40 sample sets from unique patients.

Full description

This study will evaluate the feasibility of using capillary blood samples collected with the Tasso device for analysis of CBC in diseased patients with leukemia, lymphoma, and/or other blood cell disorders.

This investigation will include a minimum of 40 sample sets from unique patients.

The primary aim of this study is to demonstrate the agreement between capillary blood collected using the Tasso device and venous blood collected in a K2EDTA (dipotassium ethylenediaminetetraacetic acid) tube according to established sampling procedures for quantification of WBC and ANC as part of a standard CBC panel with 5-part differential.

The secondary aim of the study is to demonstrate the agreement between Tasso device and venous samples for the measurement of additional analytes evaluated as part of a standard CBC panel with 5-part differential, including PLTs, HGB, RBC, Hct, MCV, lymphocytes, monocytes, eosinophils, and basophils.

An exploratory aim of this research is to evaluate patient acceptance of the Tasso device in a diseased population.

Adverse Events (AEs) occurring up to 24 hours after use of the Tasso device will be evaluated.

Patient response to using the Tasso device will be collected via simple survey.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Willing and able to provide written (or electronic) informed consent prior to study entry
2. At least 18 years of age
3. Requiring a CBC blood test as part of the patient's standard of care
4. Have abnormal laboratory results of either leukopenia, leukocytosis or neutropenia.
5. Normal skin integrity and healthy skin appearance around the capillary collection site (upper arm/shoulder area on at least one side)

Exclusion criteria

1. Unable to give full and free consent to participate in a study due to limited capacity or risk of undue influence or coercion (including but not limited to children, prisoners, individuals with diminished decision-making capacity, illiterate or educationally disadvantaged populations) or any other individual who is unable to give full and free consent in the judgement of the investigator
2. At the determination of the treating physician, unsuitable for enrollment due to severe immunocompromised status or other comorbidities.

Trial design

40 participants in 3 patient groups

leukopenia

Description:

Participants that have abnormal laboratory results for leukopenia. Participants will be assigned to all cohorts they have abnormal laboratory results for.

Treatment:

Device: Tasso+ CBC

leukocytosis

Description:

Participants that have abnormal laboratory results for leukocytosis. Participants will be assigned to all cohorts they have abnormal laboratory results for.

Treatment:

Device: Tasso+ CBC

neutropenia

Description:

Participants that have abnormal laboratory results for neutropenia. Participants will be assigned to all cohorts they have abnormal laboratory results for.

Treatment:

Device: Tasso+ CBC