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

NCT02573545 | Terminated

• 1 other identifier: 5261
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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

Conditions

Liver Biopsy

Keywords

liver

Outcome Measures

Primary Outcomes (1)

• Total duration of the intervention (planning and implementation)

  up to 2 weeks

Study Arms (2)

Test group: with IFE

EXPERIMENTAL

Patients treated with IFE software

Device: Planning@IFE and Standard@IFE Software

Test group: without IFE

ACTIVE COMPARATOR

Patients treated with Numaris 4 software

Device: MR Syngo (Numaris/4) software

Interventions

Planning@IFE and Standard@IFE Software DEVICE

Test group: with IFE

MR Syngo (Numaris/4) software DEVICE

Test group: without IFE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Nouvel Hôpital civil

Strasbourg, 67091, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2015
• First Posted: October 9, 2015
• Study Start: January 1, 2013
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: December 4, 2019

Record last verified: 2015-10

Locations

FR (1)