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NCT03432936 Clinical Trial

Prospective Use of Philips iSuite for Interventional Procedures

Cancer Clinical Trial

Official title:
Prospective Use of Philips iSuite for Interventional Procedures

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03432936
Other study ID # 17-007674
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date June 1, 2021
Est. completion date May 2025

Study information
Verified date January 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 7
Est. completion date May 2025
Est. primary completion date May 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion criteria: - Patients already scheduled for a percutaneous MR guided procedure Exclusion criteria: - Pregnant Women

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• MRI guided procedure software evaluation
MRI guided ablation/biopsy using standard MR imaging along with Philips Interventional iSuite software tools.

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (2)
Lead Sponsor Collaborator
Mayo Clinic Philips Healthcare

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. Will assess for 3 years with interval assessment each year
Secondary Software ease of use in targeting lesion for treatment Evaluate the ease of use of the software for needle placement Will assess for 3 years with interval assessment each year
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