NCT02554422

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")

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Sensoptic SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

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

Timeline

• Start date: 2013-12-01
• Primary completion: 2015-02-01
• Completion: 2015-08-01
• First posted: 2015-09-18
• Last updated: 2015-09-18