Evaluation of a Support Software in the Planning and Real-time Monitoring of the Insertion of Needles in Interventional Magnetic Resonance Imaging (MRI): Liver Biopsy Case

Not Applicable

Terminated

• Conditions: Liver Biopsy
• Interventions: Device: Planning@IFE and Standard@IFE Software; Device: MR Syngo (Numaris/4) software

• Registration Number: NCT02573545
• Lead Sponsor: University Hospital, Strasbourg, France

Brief Summary

To demonstrate that the use of Standard @IFE and Planning@IFE features of the IFE software, compared to the current method, when planning and inserting the needle under MRI monitoring in the context of liver biopsies enable:

* a facilitation of the planning stages of the procedure (route path, marking of the entry point and alignment of the MRI cutaways on the planned path), resulting in a reduction in the duration of the planning stages,

* a facilitation of the real-time modification of MRI cutaways during the procedure, resulting in a reduction of the duration of the procedure

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Status Verified: 2015-10
• Study First Submitted: 2015-10-01
• Study First Submitted QC: 2015-10-08
• Study First Posted: 2015-10-09
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Last Update Submitted: 2019-12-02
• Last Update Posted: 2019-12-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 148

Inclusion Criteria

• Patient is at least 18 years old
• Affiliated to a social security scheme
• Informed consent
• Patient with an indication of liver biopsy eligible for a biopsy under interventional MRI

Exclusion Criteria

• Patient with a contraindication for MRI exam
• Patient with a contraindication for performing a biopsy
• Pregnancy
• Exclusion period
• Patient unable to receive and understand information about the study
• Patients under guardianship
• Patients under judicial protection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test group: with IFE	Planning@IFE and Standard@IFE Software	Patients treated with IFE software
Test group: without IFE	MR Syngo (Numaris/4) software	Patients treated with Numaris 4 software

Primary Outcome Measures

Name	Time	Method
Total duration of the intervention (planning and implementation)	up to 2 weeks

Trial Locations

Locations (1)

Nouvel Hôpital civil; 🇫🇷 Strasbourg, France