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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05445388
Other study ID # NL81519.078.22
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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