deltatrials
Completed OBSERVATIONAL NCT04448600

Bone Conduction Implant and MRI (BAHA-IRM)

Baha Bone Conduction Implants and Magnetic Resonance Imaging

Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Interventions MRI
Updated 12 times since 2020 Last updated: Oct 25, 2023 Started: Sep 28, 2020 Primary completion: Sep 26, 2023 Completion: Sep 26, 2023
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT04448600, this observational or N/A phase trial focuses on Artifacts and Bone Anchored Devices and remains completed. Sponsored by Fondation Ophtalmologique Adolphe de Rothschild, it has been updated 12 times since 2020, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Study Description(click to expand)

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...

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)

Status Flow

~Jul 2020 – ~Nov 2020 · 4 months · monthly snapshotActive Not Recruiting~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshotRecruiting~Jan 2021 – ~Jun 2021 · 5 months · monthly snapshotRecruiting~Jun 2021 – ~Sep 2021 · 3 months · monthly snapshotRecruiting~Sep 2021 – ~Oct 2021 · 30 days · monthly snapshotRecruiting~Oct 2021 – ~Nov 2022 · 13 months · monthly snapshotRecruiting~Nov 2022 – ~Mar 2023 · 4 months · monthly snapshotRecruiting~Mar 2023 – ~Nov 2023 · 8 months · monthly snapshotRecruiting~Nov 2023 – ~Jul 2024 · 8 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

12 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed

  2. Sep 2024 — Present [monthly]

    Completed

  3. Jul 2024 — Sep 2024 [monthly]

    Completed

  4. Nov 2023 — Jul 2024 [monthly]

    Completed

    Status: RecruitingCompleted

  5. Mar 2023 — Nov 2023 [monthly]

    Recruiting

Show 7 earlier versions
  1. Nov 2022 — Mar 2023 [monthly]

    Recruiting

  2. Oct 2021 — Nov 2022 [monthly]

    Recruiting

  3. Sep 2021 — Oct 2021 [monthly]

    Recruiting

  4. Jun 2021 — Sep 2021 [monthly]

    Recruiting

  5. Jan 2021 — Jun 2021 [monthly]

    Recruiting

  6. Nov 2020 — Jan 2021 [monthly]

    Recruiting

    Status: Active Not RecruitingRecruiting

  7. Jul 2020 — Nov 2020 [monthly]

    Active Not Recruiting

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Fondation Ophtalmologique Adolphe de Rothschild
Data source: Fondation Ophtalmologique Adolphe de Rothschild

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations