Virtual Path Planning for Image-guided Needle Interventions

Evaluation of Adding Virtual Path Planning to the Philips FD20 XperGuide to Reduce Radiation Dose During Image-guided Needle Interventional Procedures.

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.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Diseases; Vascular Diseases; Muscular Diseases; Spinal Diseases; Bone Diseases
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients of all ages. Patient weight is limited to the specification of the patient table.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Patients will be followed starting from the procedure until hospital discharge or until 2 weeks after date of procedure at the latest

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Patients will be followed starting from the procedure until hospital discharge or until 2 weeks after date of procedure at the latest

Collaborators and Investigators

• Sponsor: Philips Clinical & Medical Affairs Global
• Investigators: Principal Investigator: John Racadio, MD, Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: November 27, 2013
• First Submitted That Met QC Criteria: December 19, 2013
• First Posted (Estimate): December 27, 2013

Study Record Updates

• Last Update Posted (Actual): March 16, 2022
• Last Update Submitted That Met QC Criteria: March 7, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Nervous System Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Vascular Diseases; Gastrointestinal Diseases; Digestive System Diseases; Bone Diseases; Spinal Diseases; Muscular Diseases
• Other Study ID Numbers: XCY612-130031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No