CompletedNot Applicable

Objective Measurement of Ossicular Chain Mobility Using a Palpating Instrument Intraoperatively

32 participantsStarted 2013-12

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Measurement of the ossicle mobility through the palpation force

Timeframe: 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.

Trial details

NCT IDNCT02554422

SponsorSensoptic SA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-02

View on ClinicalTrials.gov More Disorder of Middle Ear trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.