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

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-31

Study Completion Date

2024-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of Tasso+ Blood Self-Collection for Clinical Diagnostic Assessment of Various Biomarkers

NCT05852925

Blood Self-Collection for Clinical Diagnostic Assessments

RECRUITING NA

A Multi-site Clinical Evaluation of Capillary Blood Samples Collected Using the Tasso+SST Device for Downstream Analyte Testing

NCT06392269

Serum Analytes

RECRUITING

Tasso-SST OnDemand Comparator Pilot Study

NCT04713748

C3PI Study Testing Group

COMPLETED NA

Clinical Performance of Capillary Blood Samples Collected Using the Tasso+ Serum Gel Capillary Blood Collection System for Clinical Chemistry Testing of 14 Analytes on an Abbott Alinity Analyzer

NCT07260799

Serum Analytes

RECRUITING

Evaluating Technologies for Point-of-Care Blood Collections by Patients

NCT06507566

Healthy

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Leukopenia Leukocytosis Neutropenia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No