Virtual Path Planning for Image-guided Needle Interventions

Vascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02021071
• Other study ID #: XCY612-130031
• Status: Completed
• Start date: December 2013
• Est. completion date: June 2014

Study information

• Verified date: March 2022
• Source: Philips Clinical & Medical Affairs Global
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Bone Diseases
• Digestive System Diseases
• Gastrointestinal Diseases
• Muscular Diseases
• Spinal Diseases
• Vascular Diseases

Intervention

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
Instrument guidance allowing certain tasks that would normally occur using continuous X-ray guidance to be performed with reduced dose for patient and staff.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Philips Clinical & Medical Affairs Global

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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