Feasibility of Middle Ear OCT Imaging

Erasmus University

Status: Not yet enrolling

Conditions: Image, Body

Treatments: Device: Aurisvue

Study type: Interventional

Funder types: Other

Identifiers

NCT05445388

NL81519.078.22

Details and patient eligibility

About

Feasibility of structural and functional imaging of the middle ear and its constituents by optical coherence tomography.

Full description

Rationale: Various middle ear diseases can affect anatomical structures of the middle ear in different ways. Unfortunately, current methods for assessing the structure and function of the constituents of the middle ear are limited and often fail to provide all clinically relevant data. Optical coherence tomography (OCT) is a technology that can provide valuable, additional information with a newly developed prototype OCT-device for structural and functional imaging of the middle ear.

Objective: To assess the feasibility and the clinical potential of structural and functional OCT imaging with a newly developed OCT-device in patients with various middle ear problems.

Study design: Observational study Study population: Adult patients presenting with various middle ear complaints at the Ear Nose Throat department of the Department of Otorhinolaryngology and Head and Neck Surgery, Erasmus Medical Center, Rotterdam, the Netherlands.

Main study parameters/endpoints: Percentage of patients in which structural OCT imaging was feasible (i.e., the OCT images showed a discernible tympanic membrane (TM) and at least one of the ossicles).

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The burden is minimal: patient examination with Aurisvue is similar to the conventional examination with a standard otoscope and will take approximately 5 to 10 minutes. The risks are negligible: imaging is done with light levels well below the maximum permissible exposure level and sound levels to induce movement of the TM and the ossicular chain are well below the hazardous threshold.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age 18 or older
• competent, willing and able to cooperate

Exclusion criteria

• any acute or chronic condition that would limit the ability of the patient to participate in the study, per attending physician's indication
• refusal to give informed consent
• pregnancy or breastfeeding

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

OCT imaging

Experimental group

Description:

OCT imaging

Treatment:

Device: Aurisvue