Bone Anchored DevicesBAHA-IRMNCT04448600
Bone Conduction Implant and MRI
An observational study of Bone Anchored Devices and Osseo-Integrated Implants, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
Bone conduction implants (BCI) are widely used in cases of conductive/ mixed hearing loss or single side deafness when surgical treatment or air hearing aids are not feasible. There are two types of BCI, abutments (which pass through the skin) and magnets (where a subcutaneous magnet is coupled to an external magnet). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Anchored Devices, Osseo-Integrated Implants, MRI Scans
- What is being tested?
- MRI
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 28 Sep 2020to 26 Sep 2023
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a Baha magnet or abutment hearing implant and having to perform a brain MRI.
Inclusion Criteria Patient over 18 years old Patient with a Baha bone conduction hearing implant, who must perform an MRI examination of the brain, internal auditory canal or middle ear, with or without injection Affiliate or beneficiary of a social security scheme Express consent to participate in the study Exclusion Criteria Patient benefiting from a legal protection measure Pregnant or lactating woman MRI examination not feasible Contraindications to the practice of an MRI: ocular metallic foreign body,certain implanted materials, pacemakers, claustrophobia Contraindications to gadolinium injection, if an MRI is prescribed with gadolinium contrast agent injection allergy, known renal failure: glomerular filtration rate inferior to 30mL by min
Trial locations and contacts
1 site in 1 country.
France1 site
Fondation Ophtalmologique Adolphe de Rothschild (FOR)
Paris, 75019
About this study
Official title: Baha Bone Conduction Implants and Magnetic Resonance Imaging
Bone conduction implants (BCI) are widely used in cases of conductive/ mixed hearing loss or single side deafness when surgical treatment or air hearing aids are not feasible. There are two types of BCI, abutments (which pass through the skin) and magnets (where a subcutaneous magnet is coupled to an external magnet). Pathologies (such as cholesteatoma) leading to the insertion of this hearing implant often require prolonged MRI follow-up. However, both the abutment and the magnet are responsible for imaging artifacts that limit its interpretation. Frequency and extent of these artifacts remain unclear in the literature. In our experience, the magnet, due to its size and composition, produces larger artifacts than the abutment. The main objective of our study is to compare MRI artifacts for each of these device types (abutment and magnet).
Read the detailed description
The patients included in the study will all have a cerebral MRI as part of the cholesteatoma follow-up or for the assessment of cerebral or inner ear pathology.
- ENT evaluation: The position of the implant will be evaluated. The distance from the external ear canal (center of the abutment or center of the magnet) will be measured on the patient using a ribbon meter. The angle between the implant and the orbital plane (in degrees) will be evaluated on a profile photograph.
- Imaging evaluation: MRI examinations will be anonymized and sent to a single core laboratory for reading. One reader, a board-certified neuroradiologist with 5 years of experience in inner ear imaging, blinded to all data, will review all MRI examinations on a dedicated workstation with the Carestream Vue PACS software (Carestream Health, Rochester, NY). The main outcome measures will be the size of artifacts and the interpretability of sequences. The following MRI sequences will be performed on a 1.5T scanner (1.5T Philips®, Ingenia), covering the temporal bones :
ROUTINE SEQUENCES
- 2D Diffusion weighted-imaging (WI)
- High-resolution 3D T2-WI TSE (DRIVE)
- Post-contrast 2D T1-WI TSE (axial and coronal planes)
ADDITIONAL SEQUENCES (approximately 20 minutes of additional acquisition time) :
- 2D DWI (axial and coronal) phase inverted
- 2D T2-WI TSE (axial and coronal planes)
- High-resolution 3D T2-WI gradient echo (bFFE)
- post contrast 3D T1-WI TSE and gradient echo (THRIVE)
- Conditions
- Bone Anchored Devices, Osseo-Integrated Implants, MRI Scans, Artifacts
- Being tested
- MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
The patients included in the study will all have a cerebral MRI as part of the cholesteatoma follow-up or for the assessment of cerebral or inner ear pathology.
- ENT evaluation
What is being measured
The primary outcome is the main question the study is designed to answer.
Artifact size, measured in millimeters, on MRI sequences.
mm
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2020
- Study start28 Sep 2020
- Primary completion26 Sep 2023
- Study completion26 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Anchored DevicesStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04448600
- Sponsor's protocol ID
- 2019-A03233-54
- Acronym
- BAHA-IRM
- Status last verified
- Oct 2023
- First submitted
- 22 Jun 2020
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baha Bone Conduction Implants and Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT04448600
- Acronym / sponsor ID
- BAHA-IRM / 2019-A03233-54
- Conditions
- Bone Anchored Devices, Osseo-Integrated Implants, MRI Scans, Artifacts
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 26 Sep 2023 (actual)
- Study completion
- 26 Sep 2023 (actual)
- First posted
- 26 Jun 2020 (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.
Bone conduction implants (BCI) are widely used in cases of conductive/ mixed hearing loss or single side deafness when surgical treatment or air hearing aids are not feasible. There are two types of BCI, abutments (which pass through the skin) and magnets (where a subcutaneous magnet is coupled to an external magnet). Pathologies (such as cholesteatoma) leading to the insertion of this hearing implant often require prolonged MRI follow-up. However, both the abutment and the magnet are responsible for imaging artifacts that limit its interpretation. Frequency and extent of these artifacts remain unclear in the literature. In our experience, the magnet, due to its size and composition, produces larger artifacts than the abutment. The main objective of our study is to compare MRI artifacts for each of these device types (abutment and magnet).
Detailed description
The patients included in the study will all have a cerebral MRI as part of the cholesteatoma follow-up or for the assessment of cerebral or inner ear pathology.
- ENT evaluation: The position of the implant will be evaluated. The distance from the external ear canal (center of the abutment or center of the magnet) will be measured on the patient using a ribbon meter. The angle between the implant and the orbital plane (in degrees) will be evaluated on a profile photograph.
- Imaging evaluation: MRI examinations will be anonymized and sent to a single core laboratory for reading. One reader, a board-certified neuroradiologist with 5 years of experience in inner ear imaging, blinded to all data, will review all MRI examinations on a dedicated workstation with the Carestream Vue PACS software (Carestream Health, Rochester, NY). The main outcome measures will be the size of artifacts and the interpretability of sequences. The following MRI sequences will be performed on a 1.5T scanner (1.5T Philips®, Ingenia), covering the temporal bones :
ROUTINE SEQUENCES
- 2D Diffusion weighted-imaging (WI)
- High-resolution 3D T2-WI TSE (DRIVE)
- Post-contrast 2D T1-WI TSE (axial and coronal planes)
ADDITIONAL SEQUENCES (approximately 20 minutes of additional acquisition time) :
- 2D DWI (axial and coronal) phase inverted
- 2D T2-WI TSE (axial and coronal planes)
- High-resolution 3D T2-WI gradient echo (bFFE)
- post contrast 3D T1-WI TSE and gradient echo (THRIVE)
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a Baha magnet or abutment hearing implant and having to perform a brain MRI.
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 |
|---|---|---|
| MRIThe patients included in the study will all have a cerebral MRI as part of the cholesteatoma follow-up or for the assessment of cerebral or inner ear pathology. - ENT evaluation | Other | – |
Primary outcome
Artifact size, measured in millimeters, on MRI sequences.
Time frame: baseline
mm
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 26 Oct 2023.
- Individual participant dataSharing planned: No
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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?
An observational study of Bone Anchored Devices and Osseo-Integrated Implants, run by Fondation Ophtalmologique Adolphe de Rothschild 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?
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 26 Oct 2023. 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.
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?
Artifact size, measured in millimeters, on MRI sequences. (time frame: baseline). 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 26 Oct 2023.