C3PI Study Testing GroupNCT04713748
Tasso-SST OnDemand Comparator Pilot Study
A study testing Tasso-SST on Demand and Regular Phlebotomy in people with C3PI Study Testing Group, run by Duke University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- C3PI Study Testing Group
- What is being tested?
- Tasso-SST on Demand and Regular Phlebotomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2021to 11 Mar 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke CTSI Translational Population Health Office
Kannapolis, North Carolina, 28081
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- C3PI Study Testing Group
- Being tested
- Tasso-SST on Demand, Regular Phlebotomy
- Keywords
- Tasso-SST
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tasso-SST on DemandDevice
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.
Regular PhlebotomyOther
Participants will have a small blood sample collected via regular venipuncture.
| Study group | Role | What they receive |
|---|---|---|
| Tasso- SST blood collection | Other | About 100 participants will have blood collected by two methods-regular phlebotomy and Tasso-SST, in this pilot study. Receives: Device: Tasso-SST on Demand |
| Regular Venipuncture | Other | About 100 participants will have blood collected by two methods-regular phlebotomy and Tasso-SST, in this pilot study. Receives: Other: Regular Phlebotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (+)
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).
Measured: up to 17 days after onset of symptoms
Reliability of the Abbott Alinity Nucleocapsid IgG Antibody Assay Using TASSO-SST Collected Blood Samples
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.
Measured: 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
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.
Measured: up to 17 days after onset of symptoms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start15 Jan 2021
- Primary completion11 Mar 2021
- Study completion11 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for C3PI Study Testing GroupStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- L.Kristin Newby, MD, MHS, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04713748
- Sponsor's protocol ID
- Pro00107313
- Status last verified
- Jul 2022
- First submitted
- 11 Jan 2021
- Last updated
- 28 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Compare Serology Results From Blood Collected Using Tasso-SST OnDemand Device Compared to Venipuncture
- ClinicalTrials.gov ID
- NCT04713748
- Acronym / sponsor ID
- Pro00107313
- Conditions
- C3PI Study Testing Group
- Keywords
- Tasso-SST
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 11 Mar 2021 (actual)
- Study completion
- 11 Mar 2021 (actual)
- First posted
- 19 Jan 2021 (actual)
- Results
- Posted 28 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Tasso- SST blood collection | Other | Device: Tasso-SST on DemandAbout 100 participants will have blood collected by two methods-regular phlebotomy and Tasso-SST, in this pilot study. |
| Regular Venipuncture | Other | Other: Regular PhlebotomyAbout 100 participants will have blood collected by two methods-regular phlebotomy and Tasso-SST, in this pilot study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tasso-SST on DemandParticipants 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. | Device | Tasso- SST blood collection |
| Regular PhlebotomyParticipants will have a small blood sample collected via regular venipuncture. | Other | Regular Venipuncture |
Primary outcome
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).
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
L.Kristin Newby, MD, MHS principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tasso-SST on Demand and Regular Phlebotomy in people with C3PI Study Testing Group, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2022.