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. ]

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.


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. ]

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.


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