Feasibility of Middle Ear OCT Imaging

Image, Body Clinical Trial

Official title:

Feasibility of Structural and Functional Imaging of the Middle Ear and Its Constituents by Optical Coherence Tomography

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05445388
• Other study ID #: NL81519.078.22
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: June 2022
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Image, Body

Intervention

Device:
• Aurisvue
OCT imaging of the middle ear

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Middle ear structures identified with the Aurisvue OCT device	Identification of each of the following anatomical middle ear structures with Aurisvue: tympanic membrane, malleus, incus, stapes and promontory (visible or not visible)	1 Year
Secondary	OCT-vibrometry measurements with the Aurisvue OCT device	Number of middle ear structures (tympanic membrane, malleus, incus and stapes) on which OCT-vibrometry measurements by Aurisvue succeeded.	1 Year