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")

Sponsors

Lead Sponsor: Sensoptic SA

Source Sensoptic SA
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.

Overall Status Completed
Start Date December 2013
Completion Date August 2015
Primary Completion Date February 2015
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Measurement of the ossicle mobility through 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 Outcome
Measure Time Frame
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.
Enrollment 32
Condition
Intervention

Intervention Type: Device

Intervention Name: PalpEar

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

Arm Group Label: PalpEar

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Thomas E. Linder, Prof. MD Principal Investigator Luzerner Kantonsspital
Verification Date

September 2015

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: PalpEar

Type: Experimental

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

Acronym PalpEar
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Basic Science

Masking: None (Open Label)

Source: ClinicalTrials.gov