NCT03432936

Prospective Use of Philips iSuite for Interventional Procedures

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Cancer
• Tumor

Interventions

Type	Name	Description
DEVICE	MRI guided procedure software evaluation	MRI guided ablation/biopsy using standard MR imaging along with Philips Interventional iSuite software tools.

Timeline

• Start date: 2021-06-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2018-02-14
• Last updated: 2026-04-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study