Virtual Path Planning for Image-guided Needle Interventions

NCT02021071 | Completed Results

• 1 other identifier: XCY612-130031
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Diseases; Bone Diseases; Muscular Diseases; Spinal Diseases; Vascular Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (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

Study Arms (2)

XperGuide

Image-guided needle procedures with XperGuide performed prior to this study within institution (retrospective data).

Radiation: XperGuide

XperGuide with virtual path planning

Image-guided needle procedures with XperGuide with virtual path planning

Radiation: XperGuide with virtual path planning

Interventions

XperGuide RADIATION

Live 3D image needle guidance which overlays live fluoroscopy and 3D soft tissue imaging data from previous acquired CT, MR or XperCT.

XperGuide

XperGuide with virtual path planning RADIATION

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Pregnant patients.

Sponsors & Collaborators

• Philips Clinical & Medical Affairs Global: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Gastrointestinal Diseases; Bone Diseases; Muscular Diseases; Spinal Diseases; Vascular Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Rami Nachabe, PhD
• Organization: Philips

Rami.Nachabe@philips.com

+1-513-926-1486

Study Officials

• John Racadio, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2013
• First Posted: December 27, 2013
• Study Start: December 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: March 16, 2022
• Results First Posted: August 12, 2016

Record last verified: 2022-03

Locations

US (1)