To assess the feasibility and the clinical potential of structural and functional OCT imaging with Aurisvue in patients with various middle ear problems.
ID
Source
Brief title
Condition
- Middle ear disorders (excl congenital)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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).
Secondary outcome
- Number of middle ear structures (TM, ossicles) on which OCT-vibrometry
measurements by Aurisvue succeeded.
- For diagnostic correlation with other clinical data sources (only as far as
they are available from the standard of care):
o microscopic otoscopy (description)
o CT-scan
o MRI-scan
o pure-tone audiogram
o tympanogram
o surgical report (if available)
Background summary
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. Aurisvue is a
newly developed prototype OCT-device for structural and functional imaging of
the middle ear.
Study objective
To assess the feasibility and the clinical potential of structural and
functional OCT imaging with Aurisvue in patients with various middle ear
problems.
Study design
Observational study.
Study burden and risks
The examination time is estimated at 10 minutes. The research is expected to be
minimally burdensome because the technology is not invasive.
The risks are estimated as very limited.
Dr. Molewaterplein 40
Rotterdam 3015GD
NL
Dr. Molewaterplein 40
Rotterdam 3015GD
NL
Listed location countries
Age
Inclusion criteria
Suspected middle ear problem
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, including:
o Abnormally narrow or stenotic external meatus (ear canal)
o Movement disorder causing inability to keep head still during imaging
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL81519.078.22 |