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| Name | Class |
|---|---|
| Philips Healthcare | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRI guided procedure software evaluation | Experimental | Evaluate the workflow and effectiveness of the Philips Interventional iSuite software during biopsies and/or ablations versus standard MR imaging in aiding needle placement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI guided procedure software evaluation | Device | MRI guided ablation/biopsy using standard MR imaging along with Philips Interventional iSuite software tools. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Needle placement efficiency into target lesion | Needle placement efficiency record time to final needle position, and compare overall similarity of use with current CT guided intervention during the interventional procedure in order to determine how the iSuite may facilitate intervention with the MRI environment. Each operator will fill out a short questionnaire after each intervention. | Baseline (completion of MRI-guided biopsy and /or ablation procedure) |
| Measure | Description | Time Frame |
|---|---|---|
| Software ease of use in targeting lesion for treatment | Evaluate the ease of use of the software for needle placement | Baseline (completion of MRI-guided biopsy and /or ablation procedure) |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David A Woodrum, M.D., Ph.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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