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
|Condition or disease||Intervention/treatment|
|Gastrointestinal Diseases Bone Diseases Muscular Diseases Spinal Diseases Vascular Diseases||Radiation: XperGuide Radiation: XperGuide with virtual path planning|
|Study Type :||Observational|
|Actual Enrollment :||24 participants|
|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|
Image-guided needle procedures with XperGuide performed prior to this study within institution (retrospective data).
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.
- 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
- 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.
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
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|Principal Investigator:||John Racadio, MD||Children's Hospital Medical Center, Cincinnati|