Cholesteatoma, Middle Ear, Disorder of Middle Ear, Otosclerosis of Middle Ear
Conditions
Brief summary
Feasibility of the objective measurement of the ossicular chain mobility, by using a force-measuring device based on a fiber optics sensors (PalpEar).
Detailed description
The aim of this study was to develop and test a palpating instrument, which enables the experienced and occasional otologic surgeon to record force in three dimensions during his standard palpation of each ossicle at surgery and al-lows correlation of his subjective impression with objective measurement results. The first task was to incorporate force sensing capability into a standard 45° angulated 2.5 mm hook, which is commonly used to palpate, disconnect and luxate ossicles during middle ear surgery.
Interventions
DEVICEPalpEar
Palpation of the middle-ear ossicles using the PalpEar device, to measure mobility of the ossicle chain
Sponsors
Sensoptic SA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adult subjects * Normally scheduled for middle-ear or internal-ear surgery as a result of an ear disease and for whom a routine assessment of the mobility of the ossicle chain is in order. The targeted subject population consists of patients undergoing stapedotomy for otosclerosis and subjects with a normal ossicular chain who are subject to the placement of a cochlear implant to treat hearing loss.
Exclusion criteria
* Children * Subjects in whom the ossicle chain is missing or incomplete * Missing informed consent form * Incapacitated subjects or subjects with impaired judgment capability.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of the ossicle mobility through the palpation force | 1 day. The measurements are performed during day 1, in parallel with the underlying surgery, and therefore assessed within the time frame of 1 day. | The palpation forces needed to move the middle-ear ossicles out from their resting position will be measured through a force sensing device. The measured palpation forces are measured in equivalent gram-force \[gF\]. The primary outcome of the study is to demonstrate if a relation can be established between the subjective feeling of the surgeon and an objective measurement of the palpation force. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference between normal and impaired ossicular chains | 1 day. The measurements are performed during day 1, in parallel with the underlying surgery, and therefore assessed within the time frame of 1 day. | A comparison between ossicular chains judged as normal by the surgeon and impaired ossicular chains will be performed, to assess if a significant difference can be extracted from the measurement of the palpation force. This would help in a future diagnosis assisted by a force sensing device. |
Outcome results
None listed