Prospective Use of Philips iSuite for Interventional Procedures
NCT ID: NCT03432936
Last Updated: 2025-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
12 participants
INTERVENTIONAL
2021-06-01
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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MRI guided procedure software evaluation
Evaluate the workflow and effectiveness of the Philips Interventional iSuite software during biopsies and/or ablations versus standard MR imaging in aiding needle placement.
MRI guided procedure software evaluation
MRI guided ablation/biopsy using standard MR imaging along with Philips Interventional iSuite software tools.
Interventions
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MRI guided procedure software evaluation
MRI guided ablation/biopsy using standard MR imaging along with Philips Interventional iSuite software tools.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
90 Years
ALL
No
Sponsors
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Philips Healthcare
INDUSTRY
Mayo Clinic
OTHER
Responsible Party
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David A. Woodrum
Principal Investigator
Principal Investigators
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David A Woodrum, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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17-007674
Identifier Type: -
Identifier Source: org_study_id
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