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

Launched by TASSO INC. · Apr 8, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to collect blood samples using a device called the Tasso device. Instead of the usual method of drawing blood from a vein, this device takes a small sample from the skin. The goal of the study is to see if this method can effectively measure important blood information called a Complete Blood Count (CBC) in patients who have conditions like leukemia, lymphoma, or other blood disorders. Researchers will gather samples from at least 40 patients to compare the results from the Tasso device to the traditional blood draw.

To be eligible for the study, participants need to be at least 18 years old and must be able to give consent to join the study. They should also require a CBC test as part of their regular medical care and have abnormal blood results related to white blood cells (either too few, too many, or an imbalance). Participants will need to have healthy skin at the collection site, which will be on their upper arm or shoulder. It’s important to note that certain individuals, like those with severe health issues or unable to make their own decisions, cannot participate in the study. If you join, you will help researchers understand if this new blood collection method can be a helpful alternative for patients like you.

Gender

ALL

Eligibility criteria

• 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.