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Blood Collection Device
Tasso+ Self-Collection for Blood Sample Collection
N/A
Recruiting
Led By Sri Bharat Madireddy, Ph.D.
Research Sponsored by American Research Labs
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial will compare a new self-collection device with traditional blood draws to measure biomarkers in the blood. Results will be compared to see how reliable the new device is.
Who is the study for?
This trial is for individuals aged 13 or older who can provide informed consent themselves, or through a parent or guardian if under 18. Participants must be able to understand the study materials and willing to provide blood, urine, or saliva samples.Check my eligibility
What is being tested?
The study is testing the Tasso+ device for self-collecting blood against traditional venipuncture. It aims to see if this new method gives reliable results when checking various health markers in the blood.See study design
What are the potential side effects?
While not explicitly mentioned, potential side effects may include discomfort at the collection site, bruising from needle insertion with traditional venipuncture, and mild bleeding or bruising with Tasso+.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Venous and Tasso+ blood sample correlation for biomarkers being tested.
Secondary outcome measures
Collect patient experience with the Tasso+ blood collection device kit.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Human Blood Specimen CollectionExperimental Treatment2 Interventions
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.
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Who is running the clinical trial?
American Research LabsLead Sponsor
Sri Bharat Madireddy, Ph.D.Principal InvestigatorAmerican Research Labs
Vanaja Reddy Bodeddula, Ph.D.Study DirectorAmerican Research Labs
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am unable to make medical decisions due to a cognitive or mental health condition.I am legally blind or have significant vision loss.I am 13 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Human Blood Specimen Collection
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there openings available for prospective participants in this experiment?
"Affirmative. The clinicaltrials.gov website states that this trial is currently recruiting participants, with the initial posting date of June 1st 2023 and a recent update on the same day. 2500 patients need to be recruited from one site."
Answered by AI
What is the sample size of people participating in this clinical experiment?
"Indeed, clinicaltrials.gov shows that this medical trial began recruiting participants on June 1st 2023 and is still actively enrolling patients today. 2500 individuals are needed from a single site to complete the study."
Answered by AI
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