Gastrointestinal DiseasesNCT02021071
Virtual Path Planning for Image-guided Needle Interventions
An observational study of Gastrointestinal Diseases and Bone Diseases, run by Philips Clinical & Medical Affairs Global at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastrointestinal Diseases, Bone Diseases, Muscular Diseases
- What is being tested?
- XperGuide and XperGuide with virtual path planning
- Type of treatment
- Surgery or procedure
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Jun 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients of all ages. Patient weight is limited to the specification of the patient table.
Who may be able to join
- 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.
Who cannot join
- -Pregnant patients.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Evaluation of Adding Virtual Path Planning to the Philips FD20 XperGuide to Reduce Radiation Dose During Image-guided Needle Interventional Procedures.
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.
Read the detailed description
The investigational device is used for image guidance by virtually planned path and X-ray data.
- Conditions
- Gastrointestinal Diseases, Bone Diseases, Muscular Diseases, Spinal Diseases, Vascular Diseases
- Being tested
- XperGuide, XperGuide with virtual path planning
- Medical subject headings
- Gastrointestinal Diseases, Bone Diseases, Muscular Diseases, Spinal Diseases, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XperGuideRadiation
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 planningRadiation
Instrument guidance allowing certain tasks that would normally occur using continuous X-ray guidance to be performed with reduced dose for patient and staff.
| Study group | Role | What they receive |
|---|---|---|
| XperGuide | Image-guided needle procedures with XperGuide performed prior to this study within institution (retrospective data). Receives: Radiation: XperGuide | |
| XperGuide with virtual path planning | Image-guided needle procedures with XperGuide with virtual path planning Receives: Radiation: XperGuide with virtual path planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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.
Measured: Patients will be followed starting from the procedure until hospital discharge or until 2 weeks after date of procedure at the latest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gastrointestinal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Racadio, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02021071
- Sponsor's protocol ID
- XCY612-130031
- Status last verified
- Mar 2022
- First submitted
- 27 Nov 2013
- Last updated
- 16 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Adding Virtual Path Planning to the Philips FD20 XperGuide to Reduce Radiation Dose During Image-guided Needle Interventional Procedures.
- ClinicalTrials.gov ID
- NCT02021071
- Acronym / sponsor ID
- XCY612-130031
- Conditions
- Gastrointestinal Diseases, Bone Diseases, Muscular Diseases, Spinal Diseases, Vascular Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 27 Dec 2013 (estimated)
- Results
- Posted 12 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigational device is used for image guidance by virtually planned path and X-ray data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XperGuide | – | Radiation: XperGuideImage-guided needle procedures with XperGuide performed prior to this study within institution (retrospective data). |
| XperGuide with virtual path planning | – | Radiation: XperGuide with virtual path planningImage-guided needle procedures with XperGuide with virtual path planning |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients of all ages. Patient weight is limited to the specification of the patient table.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- -Pregnant patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XperGuideLive 3D image needle guidance which overlays live fluoroscopy and 3D soft tissue imaging data from previous acquired CT, MR or XperCT. | Radiation | XperGuide |
| XperGuide with virtual path planningInstrument guidance allowing certain tasks that would normally occur using continuous X-ray guidance to be performed with reduced dose for patient and staff. | Radiation | XperGuide with virtual path planning |
Primary outcome
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
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Racadio, MD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Diseases and Bone Diseases, run by Philips Clinical & Medical Affairs Global at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2022; AzTrials last refreshed its copy on 28 Oct 2026.