Objective Measurement of Ossicular Chain Mobility Using a Palpating Instrument Intraoperatively (PalpEar)

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ClinicalTrials.gov Identifier: NCT02554422

Recruitment Status : Completed

First Posted : September 18, 2015

Last Update Posted : September 18, 2015

Sponsor:

Information provided by (Responsible Party):

Sensoptic SA

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Disorder of Middle Ear Otosclerosis of Middle Ear Cholesteatoma, Middle Ear	Device: PalpEar	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	32 participants
Allocation:	N/A
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Basic Science
Official Title:	Messung Der Beweglichkeit Der Gehörknöchelchenkette während Einer Ohroperation. ("Objective Measurements of Ossicular Chain Mobility Using a Palpating Instrument Intraoperatively")
Study Start Date :	December 2013
Actual Primary Completion Date :	February 2015
Actual Study Completion Date :	August 2015

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Cholesteatoma

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: PalpEar Intraoperative palpation of the ossicles using the PalpEar device, to measure mobility of the ossicle chain.	Device: PalpEar Palpation of the middle-ear ossicles using the PalpEar device, to measure mobility of the ossicle chain

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02554422

Sponsors and Collaborators

Sensoptic SA

Investigators

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Principal Investigator:	Thomas E. Linder, Prof. MD	Luzerner Kantonsspital

More Information

Publications:

Huber A, Linder T, Ferrazzini M, Schmid S, Dillier N, Stoeckli S, Fisch U. Intraoperative assessment of stapes movement. Ann Otol Rhinol Laryngol. 2001 Jan;110(1):31-5.

Zöllner F. Die bisherigen Ergebnisse der Schallsondenunersuchungen. Arch Ohren-, Nasen- und Kehlkopfheilkunde 1951;159:358-364

Shea MC Jr. Postinflammatory osteogenic fixation of the stapes. Laryngoscope. 1977 Dec;87(12):2056-65.

Lau HH, Michler H, Zollner F. Versuch einer technischen Verbesserung der Schallsonde. Acta Otolaryngol 1963;56:421-7

Gyo K, Sato H, Yumoto E, Yanagihara N. Assessment of stapes mobility by use of a newly developed piezoelectric ceramic device. A preliminary experiment in dogs. Ann Otol Rhinol Laryngol. 2000 May;109(5):473-7.

Zahnert T, Hüttenbrink KB, Bornitz M, Hofmann G. [Intraoperative measurement of stapes mobility using a hand-guided electromagnetic probe]. Laryngorhinootologie. 2001 Feb;80(2):71-7. German.

Koike T, Murakoshi M, Hamanishi S, Yuasa Y, Yuasa R, Kobayashi T, Wada H. An apparatus for diagnosis of ossicular chain mobility in humans. Int J Audiol. 2006 Feb;45(2):121-8.

Hato N, Kohno H, Okada M, Hakuba N, Gyo K, Iwakura T, Tateno M. A new tool for testing ossicular mobility during middle ear surgery: preliminary report of four cases. Otol Neurotol. 2006 Aug;27(5):592-5.

Seidman MD, Standring RT, Ahsan S, Marzo S, Shohet J, Lumley C, Verzal K. Normative data of incus and stapes displacement during middle ear surgery using laser Doppler vibrometry. Otol Neurotol. 2013 Dec;34(9):1719-24. doi: 10.1097/MAO.0b013e3182976528.

Hato N, Stenfelt S, Goode RL. Three-dimensional stapes footplate motion in human temporal bones. Audiol Neurootol. 2003 May-Jun;8(3):140-52.

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Responsible Party:	Sensoptic SA
ClinicalTrials.gov Identifier:	NCT02554422
Other Study ID Numbers:	2013-MD-0014
First Posted:	September 18, 2015 Key Record Dates
Last Update Posted:	September 18, 2015
Last Verified:	September 2015

Additional relevant MeSH terms:

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Otosclerosis Cholesteatoma, Middle Ear Cholesteatoma Keratosis	Skin Diseases Ear Diseases Otorhinolaryngologic Diseases

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