Feasibility of Middle Ear OCT Imaging

Sponsor

Erasmus Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05445388

Collaborator

(none)

100

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Image, Body	Device: Aurisvue	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Device Feasibility

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: OCT imaging OCT imaging	Device: Aurisvue OCT imaging of the middle ear

Arm

Intervention/Treatment

Experimental: OCT imaging

OCT imaging

Device: Aurisvue

OCT imaging of the middle ear

Outcome Measures

Primary Outcome Measures

Middle ear structures identified with the Aurisvue OCT device [1 Year]
Identification of each of the following anatomical middle ear structures with Aurisvue: tympanic membrane, malleus, incus, stapes and promontory (visible or not visible)

Secondary Outcome Measures

OCT-vibrometry measurements with the Aurisvue OCT device [1 Year]
Number of middle ear structures (tympanic membrane, malleus, incus and stapes) on which OCT-vibrometry measurements by Aurisvue succeeded.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Erasmus Medical Center

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.

Responsible Party:

Dr. R.M. Metselaar MD, PhD, Dr. R.M. Metselaar MD PhD, Erasmus Medical Center

ClinicalTrials.gov Identifier:

NCT05445388

Other Study ID Numbers:

NL81519.078.22

First Posted:

Jul 6, 2022

Last Update Posted:

Jul 6, 2022

Last Verified:

Jun 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Dr. R.M. Metselaar MD, PhD, Dr. R.M. Metselaar MD PhD, Erasmus Medical Center

Middle Ear

Study Results

No Results Posted as of Jul 6, 2022