Virtual Path Planning for Image-guided Needle Interventions

Completed

• Conditions: Gastrointestinal Diseases; Bone Diseases; Spinal Diseases; Vascular Diseases; Muscular Diseases
• Interventions: Radiation: XperGuide; Radiation: XperGuide with virtual path planning

• Registration Number: NCT02021071
• Lead Sponsor: Philips Clinical & Medical Affairs Global

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.

Study Timeline

• Study First Submitted: 2013-11-27
• Study Start: 2013-12
• Study First Submitted QC: 2013-12-19
• Study First Posted: 2013-12-27
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Results First Submitted: 2015-12-22
• Results First Submitted QC: 2016-07-05
• Results First Posted: 2016-08-12
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-07
• Last Update Posted: 2022-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
XperGuide	XperGuide	Image-guided needle procedures with XperGuide performed prior to this study within institution (retrospective data).
XperGuide with virtual path planning	XperGuide with virtual path planning	Image-guided needle procedures with XperGuide with virtual path planning

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States