Trial Outcomes & Findings for Virtual Path Planning for Image-guided Needle Interventions (NCT NCT02021071)
NCT ID: NCT02021071
Last Updated: 2022-03-16
Results Overview
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
COMPLETED
24 participants
Patients will be followed starting from the procedure until hospital discharge or until 2 weeks after date of procedure at the latest
2022-03-16
Participant Flow
The enrollment of patients occurred between December 3rd 2013 and June 9th 2014.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Virtual Path Planning for Image-guided Needle Interventions
Baseline characteristics by cohort
| Measure |
XperGuide
n=12 Participants
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.
|
XperGuide With Virtual Path Planning
n=12 Participants
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.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Newborn (birth - 1st month)
|
0 participants
n=39 Participants
|
0 participants
n=41 Participants
|
0 participants
n=35 Participants
|
|
Age, Customized
Infant (1st month - 2 years)
|
0 participants
n=39 Participants
|
0 participants
n=41 Participants
|
0 participants
n=35 Participants
|
|
Age, Customized
Child (2 - 12 years)
|
2 participants
n=39 Participants
|
2 participants
n=41 Participants
|
4 participants
n=35 Participants
|
|
Age, Customized
Adolescent (12-21 years)
|
6 participants
n=39 Participants
|
6 participants
n=41 Participants
|
12 participants
n=35 Participants
|
|
Age, Customized
Adult (> 21 years)
|
4 participants
n=39 Participants
|
4 participants
n=41 Participants
|
8 participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
16 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=39 Participants
|
12 participants
n=41 Participants
|
24 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Patients will be followed starting from the procedure until hospital discharge or until 2 weeks after date of procedure at the latestPopulation: SUS Score is only assessed for new technology (arm/group: XperGuide with virtual path planning)
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
Outcome measures
| Measure |
XperGuide With Virtual Path Planning
n=12 Participants
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.
|
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.
|
|---|---|---|
|
System Usability Scale (SUS) Score as a Measure of Qualitative Clinical Usefulness
|
76 Scores on a scale
Standard Deviation 16
|
—
|
SECONDARY outcome
Timeframe: Patients will be followed starting from the procedure until hospital discharge or until 2 weeks after date of procedure at the latestMeasure fluoroscopy time (minutes) needed during needle interventional procedure and compare the collected results with existing data from needle interventional procedures performed using XperGuide alone.
Outcome measures
| Measure |
XperGuide With Virtual Path Planning
n=12 Participants
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.
|
XperGuide With Virtual Path Planning
n=12 Participants
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.
|
|---|---|---|
|
Fluoroscopy Time
|
1.31 Minutes
Interval 0.51 to 8.48
|
0.45 Minutes
Interval 0.03 to 3.49
|
Adverse Events
XperGuide
XperGuide With Virtual Path Planning
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place