Clinical Trial: Objective Measurement of Ossicular Chain Mobility Using a Palpating Instrument Intraoperatively
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Messung Der Beweglichkeit Der Gehörknöchelchenkette während Einer Ohroperation. ("Objective Measurements of Ossicular Chain Mobility Using a Palpating Instrument Intraoperatively&q
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 Summary: 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.
Sponsor: Sensoptic SA
Current Primary Outcome: 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. ]
Original Primary Outcome: Same as current
Current Secondary Outcome: 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. ]
Original Secondary Outcome: Same as current
Information By: Sensoptic SA
Dates:
Date Received: September 15, 2015
Date Started: December 2013
Date Completion:
Last Updated: September 16, 2015
Last Verified: September 2015