CompletedEarly Phase 1

Analysis and Reducing Modalities for Artefacts Generated by Bone Conduction Implants and Cochlear Implants Subjected to an MRI Magnetic Field

France21 participantsStarted 2017-11-15

Plain-language summary

Investigator team hypothesize that artifacts generated by the presence of an acoustic implant subjected to the magnetic field of the MRI are variable depending on the type of sequence and can be reduced by structural modifications of the implant and by variations in its appearance positioning with respect to the magnetic field MRI.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 18 years old or more * free of otological, neurological or psychiatric pathology * absence of contraindication to MRI \* * free and informed consent signed Exclusion Criteria: * minor subject, major guardianship or trusteeship and major protected under the law (pregnant women, nursing, parturiante, persons deprived of their liberty) * suject carrier of an implantable device or para magnetic * contraindication to MRI \* * revious otological pathology, tinnitus, deafness * revious cerebral pathology * unable to understand the objectives, issues and risks of the study and to give free and informed consent. * Contraindications to MRI are: Claustrophobia Anxiety attack Morphotype does not allow access to MRI Wearing a metal implant, for example: * a pacemaker * ferromagnetic surgical clips * foreign bodies

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Artefact surface ratio

Timeframe: 1 day

Trial details

NCT IDNCT04116788

SponsorGCS Ramsay Santé pour l'Enseignement et la Recherche

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-09-29

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