Objective Measurement of Ossicular Chain Mobility Using a Palpating Instrument Intraoperatively
NCT ID: NCT02554422
Last Updated: 2015-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
32 participants
INTERVENTIONAL
2013-12-31
2015-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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PalpEar
Intraoperative palpation of the ossicles using the PalpEar device, to measure mobility of the ossicle chain.
PalpEar
Palpation of the middle-ear ossicles using the PalpEar device, to measure mobility of the ossicle chain
Interventions
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PalpEar
Palpation of the middle-ear ossicles using the PalpEar device, to measure mobility of the ossicle chain
Eligibility Criteria
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Inclusion Criteria
* 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
* Subjects in whom the ossicle chain is missing or incomplete
* Missing informed consent form
* Incapacitated subjects or subjects with impaired judgment capability.
18 Years
ALL
Yes
Sponsors
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Sensoptic SA
INDUSTRY
Responsible Party
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Principal Investigators
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Thomas E. Linder, Prof. MD
Role: PRINCIPAL_INVESTIGATOR
Luzerner Kantonsspital
References
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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. doi: 10.1177/000348940111000106.
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. doi: 10.1288/00005537-197712000-00012.
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. doi: 10.1177/000348940010900506.
Zahnert T, Huttenbrink KB, Bornitz M, Hofmann G. [Intraoperative measurement of stapes mobility using a hand-guided electromagnetic probe]. Laryngorhinootologie. 2001 Feb;80(2):71-7. doi: 10.1055/s-2001-11896. 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. doi: 10.1080/14992020500377899.
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. doi: 10.1097/01.mao.0000226298.36327.3d.
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. doi: 10.1159/000069475.
Other Identifiers
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2013-MD-0014
Identifier Type: -
Identifier Source: org_study_id
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