Tasso-SST OnDemand Comparator Pilot Study

July 5, 2022 updated by: Duke University

Pilot Study to Compare Serology Results From Blood Collected Using Tasso-SST OnDemand Device Compared to Venipuncture

Purpose and objective: The purpose of this pilot study is participant user acceptance testing of the Tasso-SST OnDemand device to collect blood for antibody testing. The study will also compare antibody testing results from blood collected using the Tasso-SST OnDemand device compared to blood collected by phlebotomy.

Study activities and population group: All participants enrolled in the MURDOCK C3PI Study (Pro Pro00105703), and actively participating in the testing cohort (n=300), will be emailed about the study. One or more reminder emails may be sent. The study seeks to enroll up to 100 participants.

Participants will collect blood using the Tasso-SST OnDemand at the same visit where blood will be collected via phlebotomy for the MURDOCK C3PI study. Blood samples will be spun and processed for serum, which will be shipped frozen to analytical lab at Duke. Participants will complete a short survey about their experience using the Tasso-SST OnDemand device.

Data analysis and risk/safety issues: The study team will evaluate correlation between results from blood collected by the two methods and qualitatively exam participant survey results. There are no risk/safety issues. Risk of reaction at the collection site is similar to that of phlebotomy and is described in the electronic consent form.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Purpose: The purpose of this pilot study is participant user acceptance testing of the Tasso-SST OnDemand device to collect blood for antibody testing. The study will also compare antibody testing results from blood collected using the Tasso-SST On-Demand device compared to blood collected by phlebotomy.

Design and Procedure: Participants will collect a small blood sample using the Tasso-SST OnDemand device during a serology blood draw visit already scheduled for the MURDOCK C3PI Study (Pro00105703). Participants will be provided a kit that includes written, step-by-step instructions that include pictures. Participants will also have the option to watch a brief video on using the device, available online, prior to collection. The Tasso-SST OnDemand device collects whole capillary blood, at a minimum volume of 80ul.

A standard blood draw will also be done and both blood samples will be spun and processed for serum. Serum will be frozen and shipped to the lab at Duke for antibody testing. Antibody results will be compared between the two methods.

Participants will be sent a brief survey to learn about their experience using the Tasso-SST OnDemand device.

Selection of Subject:

Subject Recruitment: All participants meeting eligibility criteria will be emailed about the study. One or more reminder emails may be sent about the study. The study seeks to enroll up to 100 participants.

The Tasso-SST OnDemand device sticks to the skin with a light adhesive. When the button is pressed, a vacuum forms and a lancet pricks the surface of the skin. The vacuum draws blood out of the capillaries and into a tube attached to the bottom of the device. The Investigator Brochure is attached to this submission.

Risk and Benefit Assessment: The Tasso-SST OnDemand device uses an adhesive - the device should be removed immediately if there are any signs of an allergic reaction. There is risk of bruising or soreness at the site where blood is drawn. There is also a slight possibility of infection, and a rare risk of fainting.

Participants can minimize risk by closely following the instructions provided with the kits.

Trained staff will be present should the participant have any concerns or issues.

The study does not have a direct benefit to participants. The information learned could lead to future use of the Tasso-SST OnDemand device to collect blood safely at home.

Data Analysis and Data Safety Monitoring: The study team will evaluate correlation between results from blood collected by the two methods in this pilot study and qualitatively exam participant survey results. Summary statistics will be generated for survey responses, and qualitative data will be reviewed.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
135

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Kannapolis, North Carolina, United States, 28081
        • Duke CTSI Translational Population Health Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must be a study participant enrolled in the MURDOCK C3PI Study (Pro00105703), participating in the testing cohort of the study.
  • Participants are therefore 18 years of age or older, and
  • willing to read and complete the consent process.

Exclusion Criteria:

  • No exclusion criteria; however, only up to 100 participants will be enrolled. If more than 100 participants sign consent, some interested participants may not take part in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Tasso- SST blood collection
About 100 participants will have blood collected by two methods-regular phlebotomy and Tasso-SST, in this pilot study.
Device: Tasso-SST on Demand
Participants will collect a small blood sample using the Tasso-SST OnDemand device during a serology blood draw visit already scheduled for the MURDOCK C3PI Study (Pro00105703). Participants will be provided a kit that includes written, step-by-step instructions that include pictures. Participants will also have the option to watch a brief video on using the device, available online, prior to collection. Both blood samples will be spun and processed for serum. Serum will be frozen and shipped to the lab at Duke for antibody testing. Antibody results will be compared between the two methods.
Other: Regular Venipuncture
About 100 participants will have blood collected by two methods-regular phlebotomy and Tasso-SST, in this pilot study.
Other: Regular Phlebotomy
Participants will have a small blood sample collected via regular venipuncture.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sensitivity is Calculated as the Percentage of the Abbott Alinity Nucleocapsid IgG Antibody Assay Positive Cases Testing Positive Using TASSO-SST Collected Blood Samples. Se=N Tasso(+) / N Phlebotomy Antibody (+) Assay (+)
Time Frame: up to 17 days after onset of symptoms
Sensitivity is defined as the number detected as positive on the new screen (Tasso) divided by the number defined as positive under the 'gold standard' multiplied by 100%. This is presented as a comparison to testing of blood samples obtained by routine phlebotomy as the gold standard (Abbott Alinity nucleocapsid IgG antibody assay drawn by a phlebotomist).
up to 17 days after onset of symptoms
Reliability of the Abbott Alinity Nucleocapsid IgG Antibody Assay Using TASSO-SST Collected Blood Samples
Time Frame: up to 17 days after onset of symptoms

Interclass correlation (ICC) uses the 2 measures (Tasso & SST), measured on the same subjects. ICC is defined as the Variance between Persons (Var-P) divided by the Variance within Persons (error) Var-E.

ICC is defined as Var-P/(Var-P + Var-E). confidence intervals are easily defined by incorporating sample size.

Presented as the interclass correlation coefficient between TASSO-SST collected and routine phlebotomy sample results.
up to 17 days after onset of symptoms
Bias Between TASSO-SST Collected Blood Samples and Routine Phlebotomy Samples in the Abbott Alinity Nucleocapsid IgG Antibody Assay
Time Frame: up to 17 days after onset of symptoms
Bias is measured using the Bland-Altman method. Here, the difference the values by the 2 measures (Phlebotomy-Tasso) (difference) is compared to the average of Phlebotomy & Tasso (average). Bias is defined as differences which vary from 0, and is measured by (1) assessing if the average difference is non-zero, and (2) if the difference is systematically more or less close to 0 as the average increases. Presented as the regression slope.
up to 17 days after onset of symptoms

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: L.Kristin Newby, MD, MHS, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 11, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 11, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 11, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 19, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 28, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00107313

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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