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Objective Measurement of Ossicular Chain Mobility Using a Palpating Instrument Intraoperatively | Clinical Trials | Clareo Health

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Objective Measurement of Ossicular Chain Mobility Using a Palpating Instrument Intraoperatively

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

NCT02554422•Sensoptic SA

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

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.

Key Dates

Start Date

December 1, 2013

Primary Completion Date

February 1, 2015

Completion Date

August 1, 2015

Last Updated

September 18, 2015

Enrollment

ACTUAL participants

Conditions

Disorder of Middle EarOtosclerosis of Middle EarCholesteatoma, Middle Ear

Interventions

PalpEar

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 18, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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