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

NCT ID: NCT02573545

Last Updated: 2019-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2017-10-31

Brief Summary

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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

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Conditions

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Liver Biopsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Test group: with IFE

Patients treated with IFE software

Group Type EXPERIMENTAL

Planning@IFE and Standard@IFE Software

Intervention Type DEVICE

Test group: without IFE

Patients treated with Numaris 4 software

Group Type ACTIVE_COMPARATOR

MR Syngo (Numaris/4) software

Intervention Type DEVICE

Interventions

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Planning@IFE and Standard@IFE Software

Intervention Type DEVICE

MR Syngo (Numaris/4) software

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nouvel Hôpital civil

Strasbourg, , France

Site Status

Countries

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France

Other Identifiers

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5261

Identifier Type: -

Identifier Source: org_study_id

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