Human Factors Validation of OtuVU
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: 22-008174
About this study
The purpose of this study is to assess whether the OtoVU endoscopy system is safe, effective, and works as intended for.
The purpose of the human factors validation study is to evaluate the usability of the OtoVU system.
The purpose of the design validation study is to establish that the OtoVU system meets the intended use and to establish that the OtoVU system meets the user needs.
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 Criteria:
Study participants taking the role as circulating clinical personnel and scrub personnel must have the following:
- A high school diploma, or equivalent, minimum level of education.
- Professional working proficiency, or higher, in English.
- Experience working in the OR and trained in aseptic technique.
- The role of circulating clinical personnel can be undertaken by the following people: doctor, surgeon, surgical trainee, surgical technician, or other adequately trained personnel.
- The role of scrub personnel can be undertaken by the following people: surgical technician, surgeon, surgical trainee, or other adequately trained personnel.
Study participants taking the role of the surgeon must have the following:
- A good working knowledge of ENT anatomy.
- Have worked with cadaveric tissue or live patients in the past.
Exclusion Criteria:
- < 18 years of age.
- The role of surgeon can be undertaken by the following people: surgeon or surgical trainee. Individuals may take on multiple roles throughout the study, but not during the same test session.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 8/4/22. 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 Colin Lea Driscoll, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available