Prospective Use of Philips iSuite for Interventional Procedures
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MRI guided procedure software evaluation.
- Who it may be relevant to
- Registry conditions: Cancer, Tumor. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This research study is being done to look at new MRI imaging guidance software, Philips Interventional iSuite software, to see if using will improve the physician's ability to quickly place and guide needle tip position for biopsies and ablations.
Detailed description
The purpose of this study is to evaluate Philips Interventional iSuite software used for MRI guided procedures in the MRI suite. The real-time MRI Imaging software will be used during an MRI procedure to take continuous pictures.
The Philips Interventional iSuite software package has not received FDA 510(k) clearance. The Investigator will be evaluating and publishing on the use of this software as a clinical aid in performing interventional procedures within the MR suite. The primary evaluation will be weighted toward enhanced facilitation of ablation procedures. However, the software will not replace standard MR imaging for final confirmation of needle tip position and ablation margins.
Interventions
- Device MRI guided procedure software evaluation
MRI guided ablation/biopsy using standard MR imaging along with Philips Interventional iSuite software tools.
Primary outcome measures
- Needle placement efficiency into target lesion [Time frame: Baseline (completion of MRI-guided biopsy and /or ablation procedure)]
Secondary outcome measures (1)
- Software ease of use in targeting lesion for treatment [Time frame: Baseline (completion of MRI-guided biopsy and /or ablation procedure)]
Eligibility criteria
Inclusion criteria
- Patients already scheduled for a percutaneous MR guided procedure
Exclusion criteria
- Pregnant Women
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Device feasibility
Study locations
United States · 1 center
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT03432936 · 17-007674