Virtual Path Planning for Image-guided Needle Interventions

• Sponsor: Philips Clinical & Medical Affairs Global (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02021071
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Duration (Months): 6
• Patients Per Site Per Month: 4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Diseases; Bone Diseases; Muscular Diseases; Spinal Diseases; Vascular Diseases	Radiation: XperGuide; Radiation: XperGuide with virtual path planning

Detailed Description

The investigational device is used for image guidance by virtually planned path and X-ray data.

Study Design

• Study Type: Observational
• Actual Enrollment: 24 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Evaluation of Adding Virtual Path Planning to the Philips FD20 XperGuide to Reduce Radiation Dose During Image-guided Needle Interventional Procedures.
• Study Start Date: Dec 1, 2013
• Actual Primary Completion Date: Jun 1, 2014
• Actual Study Completion Date: Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
XperGuide Image-guided needle procedures with XperGuide performed prior to this study within institution (retrospective data).	Radiation: 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	Radiation: 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.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45229

Sponsors and Collaborators

• Philips Clinical & Medical Affairs Global

Investigators

• Principal Investigator: John Racadio, MD, Children's Hospital Medical Center, Cincinnati

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Philips Clinical & Medical Affairs Global
• ClinicalTrials.gov Identifier: NCT02021071
• Other Study ID Numbers: XCY612-130031
• First Posted: Dec 27, 2013
• Last Update Posted: Mar 16, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Bone Diseases; Spinal Diseases; Muscular Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases

Study Results

Participant Flow

Recruitment Details	The enrollment of patients occurred between December 3rd 2013 and June 9th 2014.

Arm/Group Title	XperGuide	XperGuide With Virtual Path Planning
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	12	12
COMPLETED	12	12
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	XperGuide	XperGuide With Virtual Path Planning	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	12	12	24
Age, Customized (participants) [Number]
Newborn (birth - 1st month)	0 0%	0 0%	0 0%
Infant (1st month - 2 years)	0 0%	0 0%	0 0%
Child (2 - 12 years)	2 16.7%	2 16.7%	4 16.7%
Adolescent (12-21 years)	6 50%	6 50%	12 50%
Adult (> 21 years)	4 33.3%	4 33.3%	8 33.3%
Sex: Female, Male (Count of Participants)
Female	8 66.7%	8 66.7%	16 66.7%
Male	4 33.3%	4 33.3%	8 33.3%
Region of Enrollment (participants) [Number]
United States	12 100%	12 100%	24 100%

Outcome Measures

1. Primary Outcome

Title	System Usability Scale (SUS) Score as a Measure of Qualitative Clinical Usefulness
Description	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

Outcome Measure Data

Analysis Population Description

SUS Score is only assessed for new technology (arm/group: XperGuide with virtual path planning)

Arm/Group Title	XperGuide With Virtual Path Planning
Arm/Group Description	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.
Measure Participants	12
Mean (Standard Deviation) [Scores on a scale]	76 (16)

2. Secondary Outcome

Title	Fluoroscopy Time
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XperGuide	XperGuide With Virtual Path Planning
Arm/Group Description	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.	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.
Measure Participants	12	12
Median (Full Range) [Minutes]	1.31	0.45

Adverse Events

Time Frame	During procedure
Arm/Group Title	XperGuide		XperGuide With Virtual Path Planning
Arm/Group Description	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.		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.
All Cause Mortality
	XperGuide		XperGuide With Virtual Path Planning
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	XperGuide		XperGuide With Virtual Path Planning
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)
Other (Not Including Serious) Adverse Events
	XperGuide		XperGuide With Virtual Path Planning
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.