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NCT04713748 · ClinicalTrials.gov registry record · NA
Tasso-SST OnDemand Comparator Pilot Study
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 135
- Enrollment target
NCT04713748: Completed NA study, sponsored by Duke University.
NCT04713748 is a NA study that has completed, run by Duke University. The registered enrollment target is 135 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04713748, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 135 participants
- Enrollment target
Study 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. 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.
Primary Outcome
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).
Interventions
- DEVICE Tasso-SST on Demand
- OTHER Regular Phlebotomy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 135 participants |
| Start Date | 2021-01-15 |
| Est. Completion | 2021-03-11 |
| Phase | NA |
What the finished NCT04713748 record still lists
NCT04713748 is an interventional study that assigns participants to a tested intervention. The registered 135 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Tasso-SST on Demand is the first listed.
NCT04713748 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04713748 about?
NCT04713748 is a clinical study titled "Tasso-SST OnDemand Comparator Pilot Study". 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 collec...
What is the current status of trial NCT04713748?
This trial is currently completed. It is a NA study. The enrollment target is 135 participants. The study started on 2021-01-15. Estimated completion is 2021-03-11.
What interventions are being tested in trial NCT04713748?
The interventions under investigation include: Tasso-SST on Demand (DEVICE), Regular Phlebotomy (OTHER).
Who is sponsoring clinical trial NCT04713748?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04713748's enrollment target sits among peer trials
135 726th of 2000 higher than 1,273 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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