Tasso+™ for Blood Collection in Healthy Subjects

Overseen By Peter Addo, PharmD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Resilience Government Services, Inc.

Must not be taking: Immunomodulators, Corticosteroids

Disqualifiers: HIV, Hepatitis B, Hepatitis C, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new blood collection device called Tasso+™ to evaluate its effectiveness in clinical settings. Researchers aim to identify the best method for handling blood samples by comparing different processing techniques. The trial seeks healthy adults without major health issues. Participants should not have untreated medical conditions, chronic illnesses, or recent infections. As an unphased trial, this study allows participants to contribute to innovative research that could enhance blood collection methods.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you must stop taking your current medications. However, you cannot use systemic immunomodulatory therapy, including oral corticosteroids, within the past 6 months, or medications or supplements that could affect organ function within 30 days prior to screening until the end of the study.

What prior data suggests that the Tasso+ device is safe for blood collection?

Research has shown that the Tasso+ device is safe for collecting blood. The FDA has approved this lancet, confirming it meets U.S. government safety standards. Studies have found that Tasso+ is safe for blood sampling and usually not painful. Designed for one-time use, the device helps prevent infections. Incorrect use can increase infection risk, but following instructions reduces this risk. Overall, users have received Tasso+ positively. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Tasso+™ blood collection method because it offers a new, potentially more efficient way to collect and process blood samples. Unlike traditional methods that require complex handling and processing at the collection site, Tasso+™ allows samples to be centrifuged and aliquoted either at the lab or at the collection site before shipping, providing flexibility and possibly reducing error. This could lead to faster, more reliable results and make blood sample management easier, especially in remote or resource-limited settings.

What evidence suggests that the Tasso+ device is effective for blood collection?

Research has shown that the Tasso+ device effectively collects blood. In one study, it successfully collected blood samples from 93% of patients. This device simplifies and enhances the comfort of drawing blood. Another study found that 87% of participants viewed the device positively, and 77% expressed willingness to use it again. In this trial, participants will be divided into two cohorts to evaluate the Tasso+ device's effectiveness in different settings. The Tasso+ device works with regular blood collection tubes, making it suitable for various needs. ^{2 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults aged 18 or older who are healthy or in stable health, as determined by medical history and physical exams. They must understand the study and agree to its procedures. Pregnant individuals can participate if confirmed by a urine test.

Inclusion Criteria

I am generally healthy or have stable health conditions.

Able to understand and willing to provide informed consent and able to comply with the study procedures and restrictions.

Exclusion Criteria

I do not have HIV, hepatitis B, or hepatitis C.

Acute illness within 14 days prior to device use unless it is determined by the Investigator that the illness is mild in severity and unlikely to progress.

Medical history, or physical examination (including vital signs) findings, that suggest to the Investigator that the participant has undiagnosed or untreated medical condition(s) that could confound the AE evaluation and thereby undermine the study objectives.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training and Initial Assessment

Participants receive training on the Tasso+ blood collection device and initial assessments are conducted

1 day

1 visit (in-person)

Blood Collection and Evaluation

Participants use the Tasso+ device for blood collection, and samples are evaluated for integrity, reliability, and usability

57 days

Multiple visits (in-person and virtual)

Follow-up

Participants are monitored for safety and effectiveness after the final blood collection

28 days

What Are the Treatments Tested in This Trial?

Interventions

• Tasso+™

Trial Overview The study is testing Tasso+™, a technology designed for patients to collect their own blood samples at the point of care during clinical trials. It aims to evaluate its ease of use and effectiveness.

How Is the Trial Designed?

Group I: Cohort A Active Control 1 Intervention

Samples centrifuged/aliquoted after arrival at central lab.

Group II: Cohort B Active Control 1 Intervention

Samples centrifuged/aliquoted at collection Site before shipment to central lab.

Who Is Running the Clinical Trial?

Resilience Government Services, Inc.

Lead Sponsor

Trials

38

Recruited

32,700+

Alachua Government Services, Inc.

Lead Sponsor

ICON Government and Public Health Solutions, Inc

Collaborator

Trials

2

Recruited

200+

Joint Program Executive Office Chemical, Biological, Radiological, and Nuclear Defense Enabling Biotechnologies

Collaborator

Trials

3

Recruited

1,000+

Published Research Related to This Trial

In a 2-year study across 23 hospitals, the PIVO blood collection system significantly reduced preanalytical errors by 56% compared to traditional blood collection methods like venipuncture, improving specimen quality.

Using the PIVO system also led to a 19% lower rate of IV catheter replacements, indicating that it not only enhances blood collection but also contributes to better catheter longevity and patient comfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicenter Study of Needle-Free Blood Collection System for Reducing Specimen Error and Intravenous Catheter Replacement. Pendleton, B., LaFaye, R.[2023]

The Neoheel Safety Lancet is specifically designed to minimize pain and trauma during blood sampling in neonates, which is crucial for testing serious congenital conditions.

The article discusses the risks associated with traditional blood sampling methods, such as pain, bleeding, and infection, highlighting the importance of using safer alternatives like the Neoheel Safety Lancet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A safety lancet for neonatal blood spot tests: a design that facilitates pain-free, atraumatic samples. Goodwin, S., Supachana, N.[2019]

The PIVO™ device was used for approximately 7600 blood draws and demonstrated a significantly lower hemolysis rate of 1.8% compared to 3.3% for traditional venipuncture and central line methods, indicating better sample quality.

Using PIVO™ not only reduces the risk of hemolysis by 39% but also minimizes the need for invasive needle punctures, enhancing patient comfort while maintaining high-quality laboratory specimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a new venous catheter blood draw device and its impact on specimen hemolysis rates. Natali, R., Wand, C., Doyle, K., et al.[2022]

In a study involving 100 preterm infants, using an automatic incision device for heel blood sampling resulted in significantly less bruising and inflammation compared to a conventional manual lancet, indicating a safer option for these vulnerable patients.

The automatic device required fewer punctures to obtain the necessary blood volume (2.6 times fewer), making the procedure less traumatic while still allowing for effective blood collection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An automatic incision device for obtaining blood samples from the heels of preterm infants causes less damage than a conventional manual lancet. Vertanen, H., Fellman, V., Brommels, M., et al.[2019]

A new device allows for the collection of up to 100 μL of blood from a single fingerstick, which can then be dispensed in variable increments, reducing the need for multiple fingersticks during testing.

In tests with naive users, the device demonstrated accuracy and precision comparable to traditional pipettors, and users found it easy to use, suggesting it could improve patient comfort and testing efficiency in point-of-care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel device for collecting and dispensing fingerstick blood for point of care testing. Sauer-Budge, AF., Brookfield, SJ., Janzen, R., et al.[2018]

The PIVO needleless blood collection device was found to be as effective as traditional venipuncture in collecting high-quality blood samples without hemolysis or clotting, based on a study involving adult healthy volunteers.

Patients reported a better experience with the PIVO device, experiencing less pain compared to conventional blood collection methods, suggesting it may improve patient comfort during blood draws.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Needle-Free Blood Draw Device for Sample Collection From Short Peripheral Catheters. Cadacio, C., Nachamkin, I.[2022]

Current recommendations for skin puncture depth in newborns (2.4 mm) may be too deep, as preliminary data shows that the distance from skin to bone is often less than this, suggesting a need for revised guidelines.

An experimental lancet with a shorter tip length (1.8 mm) successfully collected blood from newborns in most tested pediatric centers, indicating that device design can improve blood collection outcomes, but success also depends on the skill of the phlebotomist.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Skin-puncture and blood-collecting technique for infants: update and problems. Meites, S.[2019]

In a study involving 100 healthy adults, different types of safety lancets were tested for their effectiveness in collecting capillary blood, revealing that lancets with blades collected significantly more blood (up to 118.3 μL) compared to those with needles (as low as 42.4 μL).

All safety lancets were generally well-tolerated with low pain levels, but those with blades caused more discomfort than needle-equipped lancets, with Medlance Plus being the least painful option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood volume and pain perception during finger prick capillary blood sampling: are all safety lancets equal? Serafin, A., Malinowski, M., Prażmowska-Wilanowska, A.[2022]

The implementation of safety-engineered devices (SEDs) for lancets in a tertiary hospital led to a complete elimination of lancet-related needlestick injuries (NSIs) within two years, demonstrating their efficacy in enhancing safety for healthcare workers.

Although the use of SED lancets resulted in a slight increase in costs, the investment was justified by the zero incidence of NSIs, with an incremental cost-effectiveness ratio of $210 per injury avoided, indicating a worthwhile financial commitment to improve safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Elimination of Lancet-Related Needlestick Injuries Using a Safety-Engineered Lancet: Experience in a Hospital. An, HS., Ko, S., Bang, JH., et al.[2020]

The study tested experimental lancets of different widths (1.0, 1.25, and 1.5 mm) for blood collection in infants, aiming to reduce the risk of bone injury during skin punctures.

Results indicated that the success of blood collection was more dependent on the skill and experience of the phlebotomist rather than the size of the lancet or the age of the child.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A study of experimental lancets for blood collection to avoid bone infection of infants. Meites, S., Hamlin, CR., Hayes, JR.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11218524/

Evaluation of the Tasso+ blood self-collection device for ... A Tasso + CB sample was successfully collected in 28/30 (93%) patients, and 44 paired samples were analyzed. Concordance for detection of CMV DNAemia above the ...

2. tassoinc.com tassoinc.com/tasso-plus

Tasso+ The Tasso+ device is a blood lancet that collects whole liquid blood samples. Multiple standard collection tubes are compatible.

3. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-7-2024-e3676

Tasso+™ for Blood Collection in Healthy Subjects In a 2-year study across 23 hospitals, the PIVO blood collection system significantly reduced preanalytical errors by 56% compared to traditional blood ...

4. journals.lww.com journals.lww.com/stdjournal/fulltext/2024/08000/using_an_innovative_method_for_self_collection_of.3.aspx

Using an Innovative Method for Self-Collection of Capillary ... Of the participants, 87% had a positive attitude toward use of the device, and 77% would use it again for self-sampling at home. Participants rated the use of ...

5. tassoinc.com tassoinc.com/

Tasso, Inc. The Tasso+ device is a blood lancet that collects whole liquid blood samples. Multiple standard collection tubes are compatible. See the Tasso+ ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/K221131.pdf

August 12, 2022 Tasso, Inc. Director of Regulatory Affairs The safety lancet is intended for capillary blood sampling. The Tasso+ is a single-use blood lancing device intended for obtaining microliter.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11135758/

Novel Device for Self-Collecting Blood Samples in Trials In summary, capillary blood collection using the Tasso-SST device appears to be an acceptable, safe, and relatively painless method with high ...

8. fife-flute-b5c9.squarespace.com fife-flute-b5c9.squarespace.com/s/Tasso_DeviceInstructions.pdf

PN0389-01, 07 IFU, Tasso+ Device Only Tasso+ is a sterile, disposable blood lancing device. ... Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne.