Sensorineural Hearing Loss (Disorder)NCT02093806
Clinical Applications of Round Window Imaging Anatomy in Cochlear Implant Surgery
An observational study of Sensorineural Hearing Loss (Disorder), run by Bnai Zion Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to measure the size of the round window niche and its relation to the mastoid segment of the facial nerve and the mastoid cortex, using high resolution computerized tomography of the temporal bone, in order to assess preoperatively what is the extent of obstruction of the round window… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Sensorineural Hearing Loss (Disorder)
- What is being tested?
- measurment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2014to Jun 2015
- Phase
- Observational
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 100 patient who were suffering from profound sensory neural hearing loss and underwent a high resolution computerized tomography of the temporal bone prior to cochlear implantation surgery
Who may be able to join
- age 20 years old or older
- high resolution computerized tomography of the temporal bone (slices ≤1mm) before the surgery
- on the measured slices both the round window niche and the posterior wall of the external ear canal are seen
Who cannot join
- inner, middle or external ear malformation
- temporal bone malformation
- status post cochlear implant
- status post temporal bone trauma
- slices were the round window niche and the posterior wall of the external ear canal are not seen on the same slice
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Applications of Round Window High Resolution Computerised Tomography Anatomy in Cochlear Implant Surgery
The purpose of this study is to measure the size of the round window niche and its relation to the mastoid segment of the facial nerve and the mastoid cortex, using high resolution computerized tomography of the temporal bone, in order to assess preoperatively what is the extent of obstruction of the round window membrane and whether there is a surgical possibility of round window approach in the insertion of electrode array into the cochlea
Read the detailed description
The assessment of the anatomy of the round window will be executed using the stractured measuring software used for imaging of the Bnai Zion medical center (CARESTREAM PACS Ver. 11.0, CARSTREAM HEALTH INC.) in IAC window (centered at 700 with a total width of 4000) in the available zoom by the software (usually 400-800%).
Measuring the length (mm) and angle will be executed by the software's structured rulers.
Measuring protocol:
- Measured scans: one taken in an orbito-meatal plane
- Chosen slices: where both the round window niche and the external ear canal are seen on the same slice
- Distances measured:
- Distance 1: between the anterior edge of the round window niche and the cortex of the mastoid, with a minimal distance of 0.5mm to the posterior wall of the external ear canal
- Distance 2: between the posterior edge of the round window niche and the cortex of the mastoid, with a minimal distance of 0.3mm to the anterior edge of the mastoid segment of the facial nerve.
- Distance 3: the size of the round window niche (from its anterior to posterior edges)
- Distance 4: between the anterior (most medial) edge of the round window membrane to a point at least 0.3mm anterior to the mastoid segment of the facial nerve.
- Distance 5: between the posterior (most lateral) edge of the round window membrane to a point at least 0.3mm anterior to the mastoid segment of the facial nerve
- Distance 6: size of round window membrane (anterior/medial to posterior/lateral)
- Distance 7: between the lateral edges of distance 1 and 2 marking the cortical size of the "working channel" created between the lines (from the cortex to the round window).
- Angles measured:
- Between distance 1 and 7 - marking the angle of the "working channel" relatively to the cortex
- Between distance 1, passing in the middle of distance 3 to the middle of distance 6 - marking the angle of possible insertion from the working channel into the cochlea
- Conditions
- Sensorineural Hearing Loss (Disorder)
- Being tested
- measurment
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measurmentOther
| Study group | Role | What they receive |
|---|---|---|
| CT of the temporal bone | Not described Receives: Other: measurment |
What is being measured
The primary outcome is the main question the study is designed to answer.
the size of round window niche and its relation to the cochlea
Measured: january-june 2014 (six months)
Secondary outcomes (1)
sizes of working channel from the mastoid cortex into the round window membrane and its relation to the mastoid sagment of the facial nerve
Measured: january-june 2014 (six months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2014 (estimated)
- Study startJan 2014
- Primary completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensorineural Hearing Loss (Disorder)Studies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, MICHAL.LUNTZ, Bnai Zion Medical Center
- Investigators
- Michal Luntz, Prof., Principal investigator, chair of otorhinolaryngology department at the Bnai Zion medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02093806
- Sponsor's protocol ID
- 0140-13-BNZ
- Other IDs
- 0140-13-BNZ
- Status last verified
- Dec 2014
- First submitted
- 20 Mar 2014
- Last updated
- 16 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Applications of Round Window High Resolution Computerised Tomography Anatomy in Cochlear Implant Surgery
- ClinicalTrials.gov ID
- NCT02093806
- Acronym / sponsor ID
- 0140-13-BNZ
- Conditions
- Sensorineural Hearing Loss (Disorder)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- Jan 2014
- Primary completion
- Jun 2015 (estimated)
- First posted
- 21 Mar 2014 (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.
The purpose of this study is to measure the size of the round window niche and its relation to the mastoid segment of the facial nerve and the mastoid cortex, using high resolution computerized tomography of the temporal bone, in order to assess preoperatively what is the extent of obstruction of the round window membrane and whether there is a surgical possibility of round window approach in the insertion of electrode array into the cochlea
Detailed description
The assessment of the anatomy of the round window will be executed using the stractured measuring software used for imaging of the Bnai Zion medical center (CARESTREAM PACS Ver. 11.0, CARSTREAM HEALTH INC.) in IAC window (centered at 700 with a total width of 4000) in the available zoom by the software (usually 400-800%).
Measuring the length (mm) and angle will be executed by the software's structured rulers.
Measuring protocol:
- Measured scans: one taken in an orbito-meatal plane
- Chosen slices: where both the round window niche and the external ear canal are seen on the same slice
- Distances measured:
- Distance 1: between the anterior edge of the round window niche and the cortex of the mastoid, with a minimal distance of 0.5mm to the posterior wall of the external ear canal
- Distance 2: between the posterior edge of the round window niche and the cortex of the mastoid, with a minimal distance of 0.3mm to the anterior edge of the mastoid segment of the facial nerve.
- Distance 3: the size of the round window niche (from its anterior to posterior edges)
- Distance 4: between the anterior (most medial) edge of the round window membrane to a point at least 0.3mm anterior to the mastoid segment of the facial nerve.
- Distance 5: between the posterior (most lateral) edge of the round window membrane to a point at least 0.3mm anterior to the mastoid segment of the facial nerve
- Distance 6: size of round window membrane (anterior/medial to posterior/lateral)
- Distance 7: between the lateral edges of distance 1 and 2 marking the cortical size of the "working channel" created between the lines (from the cortex to the round window).
- Angles measured:
- Between distance 1 and 7 - marking the angle of the "working channel" relatively to the cortex
- Between distance 1, passing in the middle of distance 3 to the middle of distance 6 - marking the angle of possible insertion from the working channel into the cochlea
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT of the temporal bone | – | Other: measurment |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 100 patient who were suffering from profound sensory neural hearing loss and underwent a high resolution computerized tomography of the temporal bone prior to cochlear implantation surgery
Key inclusion criteria (3 listed)
- age 20 years old or older
- high resolution computerized tomography of the temporal bone (slices ≤1mm) before the surgery
- on the measured slices both the round window niche and the posterior wall of the external ear canal are seen
Key exclusion criteria (5 listed)
- inner, middle or external ear malformation
- temporal bone malformation
- status post cochlear implant
- status post temporal bone trauma
- slices were the round window niche and the posterior wall of the external ear canal are not seen on the same slice
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 |
|---|---|---|
| measurment | Other | CT of the temporal bone |
Primary outcome
the size of round window niche and its relation to the cochlea
Time frame: january-june 2014 (six months)
1 secondary outcome
sizes of working channel from the mastoid cortex into the round window membrane and its relation to the mastoid sagment of the facial nerve
Time frame: january-june 2014 (six months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2014.
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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.
Michal Luntz, Prof. principal investigator
chair of otorhinolaryngology department at the Bnai Zion medical center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sensorineural Hearing Loss (Disorder), run by Bnai Zion Medical Center at 1 site in Israel.
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 5 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: status not confirmed, as of the sponsor's last update on 16 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
the size of round window niche and its relation to the cochlea (time frame: january-june 2014 (six months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Dec 2014.