Objective Measurement of Ossicular Chain Mobility Using a Palpating Instrument Intraoperatively

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

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Key information

Conditions

Disorder of Middle Ear Cholesteatoma Cholesteatoma, Middle Ear Ear Diseases Keratosis Otorhinolaryngologic Diseases Otosclerosis of Middle Ear Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PalpEar

Device

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

Primary outcomes

Measurement of the ossicle mobility through 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.

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 outcomes

Difference between normal and impaired ossicular chains

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.

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.

Sponsors and collaborators

Lead sponsor

Sensoptic SA

Industry

Registry information

Official study title

Messung Der Beweglichkeit Der Gehörknöchelchenkette während Einer Ohroperation. ("Objective Measurements of Ossicular Chain Mobility Using a Palpating Instrument Intraoperatively")

Acronym: PalpEar

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Sep 18, 2015
Registry last updated: Sep 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed