NCT05218460

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
720

participants targeted

Target at P75+ for not_applicable healthy

Timeline
13mo left

Started May 2022

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
May 2022May 2027

First Submitted

Initial submission to the registry

January 4, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 1, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

May 23, 2022

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2027

Last Updated

September 7, 2022

Status Verified

September 1, 2022

Enrollment Period

5 years

First QC Date

January 4, 2022

Last Update Submit

September 2, 2022

Conditions

HealthyPathology

Outcome Measures

Primary Outcomes (2)

  • Image quality based on standard imaging quality criteria

    The image quality will be appreciated visually at least by a radiologist or a researcher.

    6 months after the last inclusion

  • Signal quality based on standard signal quality criteria

    The signal quality will be appreciated visually at least by a radiologist or a researcher.

    6 months after the last inclusion

Secondary Outcomes (3)

  • Comparison of the Signal to Noise Ratio obtained by the component of the MRI system under development and the reference situation.

    6 months after the last inclusion

  • Comparison of the Contrast to Noise Ratio obtained by the component of the MRI system under development and the reference situation.

    6 months after the last inclusion

  • Comparison of blurring and artefacts obtained by the component of the MRI system under development and the reference situation.

    6 months after the last inclusion

Study Arms (1)

All subjects will have an MRI examination

EXPERIMENTAL
Device: MRI examination

Interventions

MRI examinationDEVICE

All subjects (healthy and pathological subjects) will have an MRI examination with a component of the MRI system under development.

All subjects will have an MRI examination

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to be over 18 year-old,
  • to be enrolled in a social security plan,
  • to give a written consent.
  • \- person with a pathology characterized by a functional and / or morphological alteration that may have an impact on the data collected (images, physiological signals, ...).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Nancy

Nancy, 54000, France

RECRUITING

Related Publications (1)

  • Leclere J, Isaieva K, Drouot G, Gillet R, Felblinger J, Vuissoz PA, Dubernard X. Quantifying symmetry in mandibular condyle motion: a real-time MRI approach. J Oral Facial Pain Headache. 2025 Dec;39(4):227-234. doi: 10.22514/jofph.2025.079. Epub 2025 Dec 12.

    PMID: 41436119DERIVED

Central Study Contacts

Damien MANDRY, MD, PhD

CONTACT

+33383154202d.mandry@chru-nancy.fr

Gabriela HOSSU, PhD

CONTACT

+33383155096g.hossu@chru-nancy.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 4, 2022

First Posted

February 1, 2022

Study Start

May 23, 2022

Primary Completion (Estimated)

May 23, 2027

Study Completion (Estimated)

May 23, 2027

Last Updated

September 7, 2022

Record last verified: 2022-09

Locations

FR(1)