Objective Measurement of Ossicular Chain Mobility Using a Palpating Instrument Intraoperatively

Sensoptic SA32 enrolled

Overview

Feasibility of the objective measurement of the ossicular chain mobility, by using a force-measuring device based on a fiber optics sensors (PalpEar).

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Disorder of Middle Ear Otosclerosis of Middle Ear Cholesteatoma, Middle Ear

Interventions

PalpEarDEVICE

Palpation of the middle-ear ossicles using the PalpEar device, to measure mobility of the ossicle chain

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Measurement of the ossicle mobility through the palpation force

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.

Time frame: 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

Difference between normal and impaired ossicular chains

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.

Time frame: 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.

Data from ClinicalTrials.gov

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