Objective Measurement of Ossicular Chain Mobility Using a Palpating Instrument Intraoperatively

NCT02554422 | Completed

• 1 other identifier: 2013-MD-0014
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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 (1)

• Difference between normal and impaired ossicular chains

  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.

Study Arms (1)

PalpEar

EXPERIMENTAL

Intraoperative palpation of the ossicles using the PalpEar device, to measure mobility of the ossicle chain.

Device: PalpEar

Interventions

PalpEar DEVICE

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

PalpEar

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Children
• Subjects in whom the ossicle chain is missing or incomplete
• Missing informed consent form
• Incapacitated subjects or subjects with impaired judgment capability.

Sponsors & Collaborators

• Sensoptic SA: lead

Related Publications (10)

• 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.

  PMID: 11201805 BACKGROUND

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

  BACKGROUND

• Shea MC Jr. Postinflammatory osteogenic fixation of the stapes. Laryngoscope. 1977 Dec;87(12):2056-65. doi: 10.1288/00005537-197712000-00012.

  PMID: 926970 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 10823476 BACKGROUND

• 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.

  PMID: 11253568 BACKGROUND

• 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.

  PMID: 16566250 BACKGROUND

• 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.

  PMID: 16868506 BACKGROUND

• 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.

  PMID: 23928515 BACKGROUND

• 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.

  PMID: 12679625 BACKGROUND

MeSH Terms

Conditions

Cholesteatoma, Middle Ear

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Cholesteatoma; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Thomas E. Linder, Prof. MD

  Luzerner Kantonsspital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2015
• First Posted: September 18, 2015
• Study Start: December 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 18, 2015

Record last verified: 2015-09