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Virtual Path Planning for Image-guided Needle Interventions

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ClinicalTrials.gov Identifier: NCT02021071
Recruitment Status : Completed
First Posted : December 27, 2013
Results First Posted : August 12, 2016
Last Update Posted : November 22, 2016
Sponsor:
Information provided by (Responsible Party):
Philips Healthcare

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
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.

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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 : December 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients of all ages. Patient weight is limited to the specification of the patient table.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02021071


Locations
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United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Philips Healthcare
Investigators
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Principal Investigator: John Racadio, MD Children's Hospital Medical Center, Cincinnati
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Responsible Party: Philips Healthcare
ClinicalTrials.gov Identifier: NCT02021071    
Other Study ID Numbers: XCY612-130031
First Posted: December 27, 2013    Key Record Dates
Results First Posted: August 12, 2016
Last Update Posted: November 22, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Bone Diseases
Spinal Diseases
Muscular Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases