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Human Factors Validation of OtuVU

Overview

Información sobre este estudio

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.

 

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Rochester, Minn.

Investigador principal de Mayo Clinic

Colin Lea Driscoll, M.D.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available

Otros temas en investigación

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CLS-20543335

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