NCT04448600

Brief 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). 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

June 22, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 26, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

September 28, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 26, 2023

Completed
Last Updated

October 26, 2023

Status Verified

October 1, 2023

Enrollment Period

3 years

First QC Date

June 22, 2020

Last Update Submit

October 25, 2023

Conditions

Bone Anchored DevicesOsseo-Integrated ImplantsMRI ScansArtifacts

Outcome Measures

Primary Outcomes (1)

  • Artifact size, measured in millimeters, on MRI sequences.

    mm

    baseline

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with a Baha magnet or abutment hearing implant and having to perform a brain MRI.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation Ophtalmologique Adolphe de Rothschild (FOR)

Paris, 75019, France

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2020

First Posted

June 26, 2020

Study Start

September 28, 2020

Primary Completion

September 26, 2023

Study Completion

September 26, 2023

Last Updated

October 26, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)