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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02573545
Recruitment Status : Terminated (Difficulty recruiting patients)
First Posted : October 9, 2015
Last Update Posted : December 4, 2019
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Liver Biopsy Device: Planning@IFE and Standard@IFE Software Device: MR Syngo (Numaris/4) software Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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
Study Start Date : January 2013
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy MRI Scans

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



Primary Outcome Measures :
  1. Total duration of the intervention (planning and implementation) [ Time Frame: up to 2 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02573545


Locations
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France
Nouvel Hôpital civil
Strasbourg, France, 67091
Sponsors and Collaborators
University Hospital, Strasbourg, France
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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT02573545    
Other Study ID Numbers: 5261
First Posted: October 9, 2015    Key Record Dates
Last Update Posted: December 4, 2019
Last Verified: October 2015
Keywords provided by University Hospital, Strasbourg, France:
liver