No registrations found.
ID
Source
Brief title
Health condition
no disorders
Sponsors and support
Intervention
Outcome measures
Primary outcome
Meaningfulness: The operator will rate the meaningfulness on a 11 point Scale.
Secondary outcome
- Usability: The operator will rate the usability of the Azurion AR. It will be assessed by using the System Usability Score (SUS).
- Image quality: The operator will rate the image quality of the virtually presented medical images on a 5 point Likert Scale.
- Ergonomics: The operator will indicate to what extend he/she is affected by 17 prompted symptoms using the visual fatigue questionnaire.
- Workload: The operator will fill out a task load questionnaire, the raw version of the NASA Task Load Index (TLX) to assess the workload on six subscales with 21 gradations.
Background summary
Augmented Reality (AR) has the potential to improve the clinical workflow in the future by providing greater flexibility in the way users interact with the Philips Azurion system. AR allows flexible augmented display of 2D and 3D data overlaid or mixed with the real world. It offers more natural interaction, for instance by voice control or gesture interaction. The goal of this study is to investigate the user benefits and requirements for combining AR with Philips Azurion system and to study the possibilities how an AR head-mounted display (HMD) could be used together with the Philips Azurion system in Image Guided Therapies. The study is about an application research and not about patient research.
Study objective
No formal statistical hypothesis is planned.
Study design
No follow-up is required per protocol. Patient will be followed according to regular clinical standard of care.
Intervention
N/A The study is not about patient research but application research.
Peggy Goossen-Nachtigall
+31 6 110 343 34
peggy.nachtigall@philips.com
Peggy Goossen-Nachtigall
+31 6 110 343 34
peggy.nachtigall@philips.com
Inclusion criteria
- Operators who are certified IR/IOs, performing interventional vascular and oncology procedure
- Operators that are 18 years of age or older, or of legal age to give informed consent per state or national law.
- Procedures taken place in the angiography suite, with the same criteria as for the normal procedures that are not limited to standard angiographic I/O procedures and Image-Guided drainages using ultrasound or fluoroscopy.
- Patients elected for the procedures described, that are able to give informed consent per state or national law.
Exclusion criteria
- Operator or subject is Philips employee or their family members residing with this Philips employee.
- Operators that wear normal eye wear that do not fit underneath the AR HMD.
- Operators that are color blind and or have strabismus as eye deficiencies.
- All vulnerable subjects such as subjects lacking the capacity to provide consent, patients in emergency situations, pregnant or breast feeding women, or any other subject who meets an exclusion criteria, according to applicable national laws, if any.
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9127 |
| Other | MEC-U : W20.089 |