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OpenTrials
Completed

NCT Number: NCT02021071

Virtual Path Planning for Image-guided Needle Interventions

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.

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Key information

Conditions

Gastrointestinal Diseases Bone Diseases Cardiovascular Diseases Digestive System Diseases Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Spinal Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 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.

Primary outcomes

  1. System Usability Scale (SUS) Score as a Measure of Qualitative Clinical Usefulness

    Time frame: 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 outcomes

  1. Fluoroscopy Time

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Philips Clinical & Medical Affairs Global

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 27, 2013
Registry last updated
Mar 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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