Prospective Use of Philips iSuite for Interventional Procedures

Mayo Clinic

Status: Invitation-only

Conditions: Tumor; Cancer

Treatments: Device: MRI guided procedure software evaluation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03432936

17-007674

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients already scheduled for a percutaneous MR guided procedure

Exclusion criteria

• Pregnant Women

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

12 participants in 1 patient group

MRI guided procedure software evaluation

Experimental group

Description:

Evaluate the workflow and effectiveness of the Philips Interventional iSuite software during biopsies and/or ablations versus standard MR imaging in aiding needle placement.

Treatment:

Device: MRI guided procedure software evaluation