Bone Diseases, Gastrointestinal Diseases, Muscular Diseases, Spinal Diseases, Vascular Diseases
Conditions
Brief summary
Philips Healthcare has added a virtual path planner to the current commercially available XperGuide software platform and that has the potential to significantly reduce dose during image-guided needle interventions.
Detailed description
The investigational device is used for image guidance by virtually planned path and X-ray data.
Interventions
RADIATIONXperGuide
Live 3D image needle guidance which overlays live fluoroscopy and 3D soft tissue imaging data from previous acquired CT, MR or XperCT.
RADIATIONXperGuide with virtual path planning
Instrument guidance allowing certain tasks that would normally occur using continuous X-ray guidance to be performed with reduced dose for patient and staff.
Sponsors
Philips Clinical & Medical Affairs Global
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients at any age who are referred for a clinically indicated XperGuide interventional procedure. * The informed consent has been signed by the participant, parent or legal guardian as appropriate.
Exclusion criteria
-Pregnant patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| System Usability Scale (SUS) Score as a Measure of Qualitative Clinical Usefulness | Patients will be followed starting from the procedure until hospital discharge or until 2 weeks after date of procedure at the latest | Evaluate the workflow, usability, and clinical impact of device by assessing clinical outcome and success of the procedures. The SUS is a simple, ten-item attitude Likert scale giving a global view of subjective assessments of usability developed by Brooke, J. The user needs to provide agreement or disagreement for the 10 statements. After the appearing of the SUS in literature and once part of the ISO standard ISO 9241 Part 11 it has become an industry standard and has been used for over 25 years to measure usability. The minimum score is 0 and the maximum core is 100. Analysis of 500 studies with SUS showed that the average SUS score is a 68. A SUS score above a 68 would be considered above average and anything below 68 is below average |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fluoroscopy Time | Patients will be followed starting from the procedure until hospital discharge or until 2 weeks after date of procedure at the latest | Measure fluoroscopy time (minutes) needed during needle interventional procedure and compare the collected results with existing data from needle interventional procedures performed using XperGuide alone. |
Countries
United States
Participant flow
Recruitment details
The enrollment of patients occurred between December 3rd 2013 and June 9th 2014.
Participants by arm
| Arm | Count |
|---|---|
| XperGuide Image-guided needle procedures with XperGuide performed prior to this study within institution (retrospective data)
XperGuide: Live 3D image needle guidance which overlays live fluoroscopy and 3D soft tissue imaging data from previous acquired CT, MR or XperCT. | 12 |
| XperGuide With Virtual Path Planning Image-guided needle procedures with XperGuide with virtual path planning
XperGuide with virtual path planning: Instrument guidance allowing certain tasks that would normally occur using continuous X-ray guidance to be performed with reduced dose for patient and staff. | 12 |
| Total | 24 |
Baseline characteristics
| Characteristic | Total | XperGuide With Virtual Path Planning | XperGuide |
|---|---|---|---|
| Age, Customized Adolescent (12-21 years) | 12 participants | 6 participants | 6 participants |
| Age, Customized Adult (> 21 years) | 8 participants | 4 participants | 4 participants |
| Age, Customized Child (2 - 12 years) | 4 participants | 2 participants | 2 participants |
| Age, Customized Infant (1st month - 2 years) | 0 participants | 0 participants | 0 participants |
| Age, Customized Newborn (birth - 1st month) | 0 participants | 0 participants | 0 participants |
| Region of Enrollment United States | 24 participants | 12 participants | 12 participants |
| Sex: Female, Male Female | 16 Participants | 8 Participants | 8 Participants |
| Sex: Female, Male Male | 8 Participants | 4 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
System Usability Scale (SUS) Score as a Measure of Qualitative Clinical Usefulness
Evaluate the workflow, usability, and clinical impact of device by assessing clinical outcome and success of the procedures. The SUS is a simple, ten-item attitude Likert scale giving a global view of subjective assessments of usability developed by Brooke, J. The user needs to provide agreement or disagreement for the 10 statements. After the appearing of the SUS in literature and once part of the ISO standard ISO 9241 Part 11 it has become an industry standard and has been used for over 25 years to measure usability. The minimum score is 0 and the maximum core is 100. Analysis of 500 studies with SUS showed that the average SUS score is a 68. A SUS score above a 68 would be considered above average and anything below 68 is below average
Time frame: Patients will be followed starting from the procedure until hospital discharge or until 2 weeks after date of procedure at the latest
Population: SUS Score is only assessed for new technology (arm/group: XperGuide with virtual path planning)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| XperGuide With Virtual Path Planning | System Usability Scale (SUS) Score as a Measure of Qualitative Clinical Usefulness | 76 Scores on a scale | Standard Deviation 16 |
Secondary
Fluoroscopy Time
Measure fluoroscopy time (minutes) needed during needle interventional procedure and compare the collected results with existing data from needle interventional procedures performed using XperGuide alone.
Time frame: Patients will be followed starting from the procedure until hospital discharge or until 2 weeks after date of procedure at the latest
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| XperGuide With Virtual Path Planning | Fluoroscopy Time | 1.31 Minutes |
| XperGuide With Virtual Path Planning | Fluoroscopy Time | 0.45 Minutes |