Vitestro Human Factors Testing
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 25-001275
About this study
The purpose of this study is validation testing is the testing conducted at the end of the device development process to assess user interactions with a device user interface to identify use errors that would or could result in serious harm to the patient or user. Human factors validation testing is also used to assess the effectiveness of risk management measures.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Citeria:
Supervisor (n=15): phlebotomist
- ≥ 18 years
- Trained in supervisor training
- Phlebotomy training certificate (equals ~1 year of experience)
Exclusion Citeria:
- Prior experience operating the VD
- Vitestro employee
Inclusion Criteria:
Supervisor (n=15): no phlebotomy experience
- ≥ 18 years
- Trained in supervisor training
- High school diploma
Exclusion Criteria:
- Prior phlebotomy working experience.
- Prior experience operating the VD
- Vitestro employee
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 2/04/2025. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Brooke Katzman, Ph.D. |
Contact us for the latest status |
|
More information
Publications
Publications are currently not available