Recruiting

Tasso+ Blood

Sponsor:

American Research Labs

Code:

NCT05852925

Conditions

Blood Self-Collection for Clinical Diagnostic Assessments

Eligibility Criteria

Sex: All

Age: 13+

Healthy Volunteers: Accepted

Interventions

Traditional Venipuncture

Tasso+

Study Details

Brief summary:

This study aims to assess the effectiveness and reliability of the Tasso+ capillary blood self-collection device in the clinical diagnostic assessment of various biomarkers. The study will collect blood specimens using both the Tasso+ self-collection device and traditional venipuncture. The biomarker analysis results from both specimen types will be compared for correlation.

Conditions

Blood Self-Collection for Clinical Diagnostic Assessments

Study ID

NCT05852925

Start date

Jul 25, 2023

Status verified date

Aug, 2025

Completion date

Jul, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13+

Healthy Volunteers: Accepted

Inclusion Criteria:

To participate in this study, an individual must meet all the following criteria:

1. Age: Participants must be 13 years of age or older.
2. Medical history: There may be no specific medical history requirements for inclusion, although participants may need to meet certain general health criteria.
3. Sample type: Participants must be willing and able to provide the human specimens needed for the study, such as blood, urine, or saliva.
4. Ability to provide consent: Participants must have the ability to provide informed consent to participate in the study, either on their own behalf if they are legally able to do so, or with the consent of a parent or guardian if they are under 18 years of age.
5. Language proficiency: Participants must be able to read and understand the language used in the study materials, such as informed consent forms and instructions for specimen collection.

Exclusion Criteria:

Participation in this study will be excluded for individuals who meet the following criterion:

1. Blind or visually impaired: Participants who are unable to see or have significant visual impairment that would make it difficult for them to participate in the study.
2. Decisionally impaired: Participants who are unable to provide informed consent due to cognitive impairment, developmental disability, or other mental health conditions that affect decision-making capacity.
3. Educationally disadvantaged: Participants who lack the education or literacy skills required to understand the study procedures or provide informed consent.
4. Hospitalized: Participants who are currently hospitalized, as they may not be able to participate in the study due to their medical condition or limited mobility.
5. Prisoners: Participants who are incarcerated in correctional facilities, as their participation may raise ethical concerns or require additional regulatory approvals.
6. Terminally ill: Participants who have a terminal illness or life-limiting condition that may affect the study results or pose additional risks to their health.

Excluding individuals with these characteristics from the study is intended to ensure their safety and well-being and to maintain the integrity of the study results.

Study Design

Enrollment

2500 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Human Blood Specimen Collection

Blood will be collected from each participant using two different methods: the Tasso+ device and the traditional venipuncture approach. Both collection procedures are carried out sequentially at the study site. A phlebotomist performs the traditional venipuncture and the participant collects blood using two Tasso+ devices, following provided instructions. The lab results will be analyzed to assess the correlation of biomarkers between blood samples obtained by the participant using the Tasso+ device and those collected via venipuncture.

Interventions

Traditional Venipuncture

Traditional blood collection is performed and the necessary amount of blood is collected into the collection tubes (either SST or Lithium Heparin tubes based on the biomarker being tested).

Tasso+

The Tasso+ is the blood self-collection device used in the study and this device enables the collection of microliter capillary whole blood samples into compatible reservoirs. In this study, the reservoirs utilized include either SST or Lithium Heparin microtainers based on the biomarker being tested.

Primary outcome measure

  • Venous and Tasso+ blood sample correlation for biomarkers being tested. [ Time Frame: 1 Year ]

Central Contacts and Locations

Central contacts

Sri Bharat Madireddy, Ph.D.

5616504699sri@celestamedical.com

Vanaja Reddy Bodeddula, Ph.D.

5619030806vanaja@celestamedical.com

Locations

American Research Labs

Recruiting

Atlantis, Florida, United States, 33462

Contacts

Sri Bharat Madireddy, Ph.D.

5616504699sri@celestamedical.com

Vanaja Reddy Bodeddula, Ph.D.

5619030806vanaja@celestamedical.com

Principal Investigator:

Sri Bharat Madireddy, Ph.D.

More Information

Sponsor

American Research Labs

Last update posted

Aug 29, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by American Research Labs on 2025-08-29.