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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PalpEar
Sponsored by
Sensoptic SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Disorder of Middle Ear

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    PalpEar

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Difference between normal and impaired ossicular chains
    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.

    Full Information

    First Posted
    September 15, 2015
    Last Updated
    September 16, 2015
    Sponsor
    Sensoptic SA
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02554422
    Brief Title
    Objective Measurement of Ossicular Chain Mobility Using a Palpating Instrument Intraoperatively
    Acronym
    PalpEar
    Official Title
    Messung Der Beweglichkeit Der Gehörknöchelchenkette während Einer Ohroperation. ("Objective Measurements of Ossicular Chain Mobility Using a Palpating Instrument Intraoperatively")
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2013 (undefined)
    Primary Completion Date
    February 2015 (Actual)
    Study Completion Date
    August 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Sensoptic SA

    4. Oversight

    Data Monitoring Committee
    No

    5. 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).
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Disorder of Middle Ear, Otosclerosis of Middle Ear, Cholesteatoma, Middle Ear

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    32 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PalpEar
    Arm Type
    Experimental
    Arm Description
    Intraoperative palpation of the ossicles using the PalpEar device, to measure mobility of the ossicle chain.
    Intervention Type
    Device
    Intervention Name(s)
    PalpEar
    Intervention Description
    Palpation of the middle-ear ossicles using the PalpEar device, to measure mobility of the ossicle chain
    Primary Outcome Measure Information:
    Title
    Measurement of the ossicle mobility through the palpation force
    Description
    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.
    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.
    Secondary Outcome Measure Information:
    Title
    Difference between normal and impaired ossicular chains
    Description
    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.
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Thomas E. Linder, Prof. MD
    Organizational Affiliation
    Luzerner Kantonsspital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    11201805
    Citation
    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.
    Results Reference
    background
    Citation
    Zöllner F. Die bisherigen Ergebnisse der Schallsondenunersuchungen. Arch Ohren-, Nasen- und Kehlkopfheilkunde 1951;159:358-364
    Results Reference
    background
    PubMed Identifier
    926970
    Citation
    Shea MC Jr. Postinflammatory osteogenic fixation of the stapes. Laryngoscope. 1977 Dec;87(12):2056-65. doi: 10.1288/00005537-197712000-00012.
    Results Reference
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    Citation
    Lau HH, Michler H, Zollner F. Versuch einer technischen Verbesserung der Schallsonde. Acta Otolaryngol 1963;56:421-7
    Results Reference
    background
    PubMed Identifier
    10823476
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    11253568
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    16566250
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    16868506
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23928515
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    12679625
    Citation
    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.
    Results Reference
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    Objective Measurement of Ossicular Chain Mobility Using a Palpating Instrument Intraoperatively

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