Hearing ImplantsEarly Phase 1ArtefactNCT04116788
Analysis and Reducing Modalities for Artefacts Generated by Bone Conduction Implants and Cochlear Implants Subjected to an MRI Magnetic Field
A Early Phase 1 study testing Artefact IRM assessment in people with Hearing Implants and Implant Hearing Artefact, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing Implants, Implant Hearing Artefact
- What is being tested?
- Artefact IRM assessment
- Type of treatment
- Medical device
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- 15 Nov 2017to 30 Sep 2018
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years old or more
- free of otological, neurological or psychiatric pathology
- absence of contraindication to MRI *
- free and informed consent signed
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis and Reducing Modalities for Artefacts Generated by Bone Conduction Implants and Cochlear Implants Subjected to an MRI Magnetic Field - Artefact
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.
Read the detailed description
Little scientific data is available on the artifacts generated by hearing implants. Indeed, hearing rehabilitation for deaf people was given priority over the potential constraints of imaging. Investigator team find less than 10 articles with a search of following keywords on the pubmed database: Artifacts AND MRI AND cochlear implants. Only one of these articles deals with demagnetization. There is only one article dealing with artifacts with the Bonebridge implant. There are no studies with the Attract implant and a recent one with the new Synchrony mobile magnet implant, but by removing the magnet which implies a minimum response time and therefore not compatible with emergency care.
In total, the literature is quite poor mainly considering the priority of auditory rehabilitation on the realization of subsequent imaging.
However, the current "democratization" of hearing implants and their increasing use in children and adults requires reflection on not only the safety of examinations of healthy volunteers, but also of the implant itself. also on the relevance of the interpretation of imaging especially cerebral.
The pilot study done, suggested that the placement of the implant (in this case the Bonebridge) has an influence on the size of the artifact and the possibilities of interpretation.
It seems appropriate to continue this protocol of analysis, both on the implants in bone conduction, and also on the cochlear implants to demonstrate the impact of the implant on the MRI images and also the impact of the magnetic field on the implant itself, and possibly publish recommendations for clinical practice.
- Conditions
- Hearing Implants, Implant Hearing Artefact
- Being tested
- Artefact IRM assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artefact IRM assessmentDevice
IRM
What is being measured
The primary outcome is the main question the study is designed to answer.
Artefact surface ratio
The primary endpoint will be the percentage of artefact area (SA) induced by the magnetic implant relative to the overall sectional area of the artifactless skull section (SC).
The measured artefact surface will therefore be related to the reference surface and the artefact percentage will be calculated by the following formula:
Ratio (R) = Area artifact (SA) / Area cut (SC) * 100
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start15 Nov 2017
- Primary completion29 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing ImplantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la Recherche
- Sponsor type
- University, hospital or other
- Collaborators
- Dr Arnaud Devèze
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04116788
- Sponsor's protocol ID
- 2016-A01036-45
- Acronym
- Artefact
- Status last verified
- Jul 2026
- First submitted
- 3 Oct 2019
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis and Reducing Modalities for Artefacts Generated by Bone Conduction Implants and Cochlear Implants Subjected to an MRI Magnetic Field - Artefact
- ClinicalTrials.gov ID
- NCT04116788
- Acronym / sponsor ID
- Artefact / 2016-A01036-45
- Conditions
- Hearing Implants, Implant Hearing Artefact
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- Dr Arnaud Devèze
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 29 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 7 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Little scientific data is available on the artifacts generated by hearing implants. Indeed, hearing rehabilitation for deaf people was given priority over the potential constraints of imaging. Investigator team find less than 10 articles with a search of following keywords on the pubmed database: Artifacts AND MRI AND cochlear implants. Only one of these articles deals with demagnetization. There is only one article dealing with artifacts with the Bonebridge implant. There are no studies with the Attract implant and a recent one with the new Synchrony mobile magnet implant, but by removing the magnet which implies a minimum response time and therefore not compatible with emergency care.
In total, the literature is quite poor mainly considering the priority of auditory rehabilitation on the realization of subsequent imaging.
However, the current "democratization" of hearing implants and their increasing use in children and adults requires reflection on not only the safety of examinations of healthy volunteers, but also of the implant itself. also on the relevance of the interpretation of imaging especially cerebral.
The pilot study done, suggested that the placement of the implant (in this case the Bonebridge) has an influence on the size of the artifact and the possibilities of interpretation.
It seems appropriate to continue this protocol of analysis, both on the implants in bone conduction, and also on the cochlear implants to demonstrate the impact of the implant on the MRI images and also the impact of the magnetic field on the implant itself, and possibly publish recommendations for clinical practice.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years old or more
- free of otological, neurological or psychiatric pathology
- absence of contraindication to MRI *
- free and informed consent signed
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artefact IRM assessmentIRM | Device | – |
Primary outcome
Artefact surface ratio
Time frame: 1 day
The primary endpoint will be the percentage of artefact area (SA) induced by the magnetic implant relative to the overall sectional area of the artifactless skull section (SC). The measured artefact surface will therefore be related to the reference surface and the artefact percentage will be calculated by the following formula: Ratio (R) = Area artifact (SA) / Area cut (SC) * 100
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Artefact IRM assessment in people with Hearing Implants and Implant Hearing Artefact, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Artefact surface ratio (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.