A Comparator Study of a Tasso Device to Traditional Venous Blood Sampling Methods for Complete Blood Count (CBC) With 5-part Differential in Patients With Leukemia, Lymphoma, and/or Other Blood Cell Disorders
Tasso Inc.
Summary
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.
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DeviceTasso+ CBC
Novel blood collection device
Location
- Lineberger Comprehensive Cancer CenterChapel Hill, North Carolina