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Evaluation of Methodological and Technical DEvelopmeNts to Improve the Quality and Comfort of Magnetic Resonance Imaging Exam on Voluntary Subjects (EDEN)

C

Central Hospital, Nancy, France

Status

Enrolling

Conditions

Healthy
Pathology

Treatments

Device: MRI examination

Study type

Interventional

Funder types

Other

Identifiers

NCT05218460
2021-A00243-38

Details and patient eligibility

About

The EDEN study will make it possible to evaluate one or more development phases (from design to validation through optimization) of a method or a technique on voluntary subjects, in normal or pathological condition.

Enrollment

720 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for all subjects :

  • to be over 18 year-old,
  • to be enrolled in a social security plan,
  • to have underwent a pre-inclusion medical examination,
  • to give a written consent.

Inclusion Criteria for volunteers with pathology :

  • person with a pathology characterized by a functional and / or morphological alteration that may have an impact on the data collected (images, physiological signals, ...).

Exclusion Criteria for all subjects :

  • any contraindication to MR examination (active medical device, ferromagnetic foreign body, pregnancy, morbid obesity, claustrophobia, ... ),
  • subject under a measure of legal protection,
  • Person who refuses to be informed by a doctor in th event of a fortuitus discovery of an abnormality on the MRI examination requiring additionnal examinations or specific treatment.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

720 participants in 1 patient group

All subjects will have an MRI examination
Experimental group
Treatment:
Device: MRI examination

Trial contacts and locations

1

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Central trial contact

Gabriela HOSSU, PhD; Damien MANDRY, MD, PhD

Data sourced from clinicaltrials.gov

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