Clinical trial NCT02554422: Objective Measurement of Ossicular Chain Mobility Using a Palpating Instrument Intraoperatively
Official title: Messung Der Beweglichkeit Der Gehörknöchelchenkette während Einer Ohroperation. ("Objective Measurements of Ossicular Chain Mobility Using a Palpating Instrument Intraoperatively")
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disorder of Middle Ear
Otosclerosis of Middle Ear
Cholesteatoma, Middle Ear
Lead sponsor: Sensoptic SA
Sponsor class: INDUSTRY
First posted: 2015-09-18
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Measurement of the ossicle mobility through the palpation force
timeFrame: 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.
Secondary outcomes:
measure: Difference between normal and impaired ossicular chains
timeFrame: 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.
Other outcomes:
Locations:
Study officials:
affiliation: Luzerner Kantonsspital
name: Thomas E. Linder, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References:
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