Image, Body Clinical Trial
Official title:
Feasibility of Structural and Functional Imaging of the Middle Ear and Its Constituents by Optical Coherence Tomography
Verified date | June 2022 |
Source | Erasmus Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Feasibility of structural and functional imaging of the middle ear and its constituents by optical coherence tomography.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Erasmus Medical Center |
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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