Disorder of Middle EarPalpEarNCT02554422
Objective Measurement of Ossicular Chain Mobility Using a Palpating Instrument Intraoperatively
A study testing PalpEar in people with Disorder of Middle Ear and Otosclerosis of Middle Ear, run by Sensoptic SA.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Disorder of Middle Ear, Otosclerosis of Middle Ear, Cholesteatoma, Middle Ear
- What is being tested?
- PalpEar
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Dec 2013to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Children
- Subjects in whom the ossicle chain is missing or incomplete
- Missing informed consent form
- Incapacitated subjects or subjects with impaired judgment capability.
About this study
Official title: Messung Der Beweglichkeit Der Gehörknöchelchenkette während Einer Ohroperation. ("Objective Measurements of Ossicular Chain Mobility Using a Palpating Instrument Intraoperatively")
Feasibility of the objective measurement of the ossicular chain mobility, by using a force-measuring device based on a fiber optics sensors (PalpEar).
Read the 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.
- Being tested
- PalpEar
- Medical subject headings
- Cholesteatoma, Middle Ear
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PalpEarDevice
Palpation of the middle-ear ossicles using the PalpEar device, to measure mobility of the ossicle chain
| Study group | Role | What they receive |
|---|---|---|
| PalpEar | Experimental | Intraoperative palpation of the ossicles using the PalpEar device, to measure mobility of the ossicle chain. Receives: Device: PalpEar |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Secondary outcomes (1)
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2015 (estimated)
- Study startDec 2013
- Primary completionFeb 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Disorder of Middle EarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sensoptic SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas E. Linder, Prof. MD, Principal investigator, Luzerner Kantonsspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02554422
- Sponsor's protocol ID
- 2013-MD-0014
- Acronym
- PalpEar
- Status last verified
- Sep 2015
- First submitted
- 15 Sep 2015
- Last updated
- 18 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Huber A, Linder T, Ferrazzini M, Schmid S, Dillier N, Stoeckli S, Fisch U. Intraoperative assessment of stapes movement. Ann Otol Rhinol Laryngol. 2001 Jan;110(1):31-5. doi: 10.1177/000348940111000106.
PubMed 11201805Zöllner F. Die bisherigen Ergebnisse der Schallsondenunersuchungen. Arch Ohren-, Nasen- und Kehlkopfheilkunde 1951;159:358-364
Shea MC Jr. Postinflammatory osteogenic fixation of the stapes. Laryngoscope. 1977 Dec;87(12):2056-65. doi: 10.1288/00005537-197712000-00012.
PubMed 926970Lau HH, Michler H, Zollner F. Versuch einer technischen Verbesserung der Schallsonde. Acta Otolaryngol 1963;56:421-7
Gyo K, Sato H, Yumoto E, Yanagihara N. Assessment of stapes mobility by use of a newly developed piezoelectric ceramic device. A preliminary experiment in dogs. Ann Otol Rhinol Laryngol. 2000 May;109(5):473-7. doi: 10.1177/000348940010900506.
PubMed 10823476Zahnert T, Huttenbrink KB, Bornitz M, Hofmann G. [Intraoperative measurement of stapes mobility using a hand-guided electromagnetic probe]. Laryngorhinootologie. 2001 Feb;80(2):71-7. doi: 10.1055/s-2001-11896. German.
PubMed 11253568Koike T, Murakoshi M, Hamanishi S, Yuasa Y, Yuasa R, Kobayashi T, Wada H. An apparatus for diagnosis of ossicular chain mobility in humans. Int J Audiol. 2006 Feb;45(2):121-8. doi: 10.1080/14992020500377899.
PubMed 16566250Hato N, Kohno H, Okada M, Hakuba N, Gyo K, Iwakura T, Tateno M. A new tool for testing ossicular mobility during middle ear surgery: preliminary report of four cases. Otol Neurotol. 2006 Aug;27(5):592-5. doi: 10.1097/01.mao.0000226298.36327.3d.
PubMed 16868506Seidman MD, Standring RT, Ahsan S, Marzo S, Shohet J, Lumley C, Verzal K. Normative data of incus and stapes displacement during middle ear surgery using laser Doppler vibrometry. Otol Neurotol. 2013 Dec;34(9):1719-24. doi: 10.1097/MAO.0b013e3182976528.
PubMed 23928515Hato N, Stenfelt S, Goode RL. Three-dimensional stapes footplate motion in human temporal bones. Audiol Neurootol. 2003 May-Jun;8(3):140-52. doi: 10.1159/000069475.
PubMed 12679625
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Messung Der Beweglichkeit Der Gehörknöchelchenkette während Einer Ohroperation. ("Objective Measurements of Ossicular Chain Mobility Using a Palpating Instrument Intraoperatively")
- ClinicalTrials.gov ID
- NCT02554422
- Acronym / sponsor ID
- PalpEar / 2013-MD-0014
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Sensoptic SAIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 18 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PalpEar | Experimental | Device: PalpEarIntraoperative palpation of the ossicles using the PalpEar device, to measure mobility of the ossicle chain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- Children
- Subjects in whom the ossicle chain is missing or incomplete
- Missing informed consent form
- Incapacitated subjects or subjects with impaired judgment capability.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PalpEarPalpation of the middle-ear ossicles using the PalpEar device, to measure mobility of the ossicle chain | Device | PalpEar |
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.
1 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2015.
- Background: PubMed 11201805Huber A, Linder T, Ferrazzini M, Schmid S, Dillier N, Stoeckli S, Fisch U. Intraoperative assessment of stapes movement. Ann Otol Rhinol Laryngol. 2001 Jan;110(1):31-5. doi: 10.1177/000348940111000106.
- BackgroundZöllner F. Die bisherigen Ergebnisse der Schallsondenunersuchungen. Arch Ohren-, Nasen- und Kehlkopfheilkunde 1951;159:358-364
- Background: PubMed 926970Shea MC Jr. Postinflammatory osteogenic fixation of the stapes. Laryngoscope. 1977 Dec;87(12):2056-65. doi: 10.1288/00005537-197712000-00012.
- BackgroundLau HH, Michler H, Zollner F. Versuch einer technischen Verbesserung der Schallsonde. Acta Otolaryngol 1963;56:421-7
- Background: PubMed 10823476Gyo K, Sato H, Yumoto E, Yanagihara N. Assessment of stapes mobility by use of a newly developed piezoelectric ceramic device. A preliminary experiment in dogs. Ann Otol Rhinol Laryngol. 2000 May;109(5):473-7. doi: 10.1177/000348940010900506.
- Background: PubMed 11253568Zahnert T, Huttenbrink KB, Bornitz M, Hofmann G. [Intraoperative measurement of stapes mobility using a hand-guided electromagnetic probe]. Laryngorhinootologie. 2001 Feb;80(2):71-7. doi: 10.1055/s-2001-11896. German.
- Background: PubMed 16566250Koike T, Murakoshi M, Hamanishi S, Yuasa Y, Yuasa R, Kobayashi T, Wada H. An apparatus for diagnosis of ossicular chain mobility in humans. Int J Audiol. 2006 Feb;45(2):121-8. doi: 10.1080/14992020500377899.
- Background: PubMed 16868506Hato N, Kohno H, Okada M, Hakuba N, Gyo K, Iwakura T, Tateno M. A new tool for testing ossicular mobility during middle ear surgery: preliminary report of four cases. Otol Neurotol. 2006 Aug;27(5):592-5. doi: 10.1097/01.mao.0000226298.36327.3d.
- Background: PubMed 23928515Seidman MD, Standring RT, Ahsan S, Marzo S, Shohet J, Lumley C, Verzal K. Normative data of incus and stapes displacement during middle ear surgery using laser Doppler vibrometry. Otol Neurotol. 2013 Dec;34(9):1719-24. doi: 10.1097/MAO.0b013e3182976528.
- Background: PubMed 12679625Hato N, Stenfelt S, Goode RL. Three-dimensional stapes footplate motion in human temporal bones. Audiol Neurootol. 2003 May-Jun;8(3):140-52. doi: 10.1159/000069475.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas E. Linder, Prof. MD principal investigator
Luzerner Kantonsspital
Questions about this trial
What is this clinical trial studying?
A study testing PalpEar in people with Disorder of Middle Ear and Otosclerosis of Middle Ear, run by Sensoptic SA.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02554422, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2015.