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 (IFE)

December 2, 2019 updated by: University Hospital, Strasbourg, France

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

148

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France, 67091
        • Nouvel Hopital Civil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test group: with IFE
Patients treated with IFE software
Device: Planning@IFE and Standard@IFE Software
Active Comparator: Test group: without IFE
Patients treated with Numaris 4 software
Device: MR Syngo (Numaris/4) software

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total duration of the intervention (planning and implementation)
Time Frame: up to 2 weeks
up to 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

October 1, 2015

First Submitted That Met QC Criteria

October 8, 2015

First Posted (Estimate)

October 9, 2015

Study Record Updates

Last Update Posted (Actual)

December 4, 2019

Last Update Submitted That Met QC Criteria

December 2, 2019

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 5261

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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