Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02554422
Other study ID # 2013-MD-0014
Secondary ID
Status Completed
Phase N/A
First received September 15, 2015
Last updated September 16, 2015
Start date December 2013
Est. completion date August 2015

Study information

Verified date September 2015
Source Sensoptic SA
Contact n/a
Is FDA regulated No
Health authority Switzerland: Swissmedic
Study type Interventional

Clinical Trial Summary

Feasibility of the objective measurement of the ossicular chain mobility, by using a force-measuring device based on a fiber optics sensors (PalpEar).


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.


Read more »

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sensoptic SA

References & Publications (10)

See more »

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 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. No
Secondary 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. 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. No
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04551612 - Level of Middle Cranial Fossa Dura in Patients With Cholesteatoma
Recruiting NCT06246682 - Impact of Mastoid Condition on Results of Endoscopic Management of Cholesteatoma N/A