Clinical Applications of Round Window Imaging Anatomy in Cochlear Implant Surgery

Sensorineural Hearing Loss (Disorder) Clinical Trial

Official title:

Clinical Applications of Round Window High Resolution Computerised Tomography Anatomy in Cochlear Implant Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02093806
• Other study ID #: 0140-13-BNZ
• Secondary ID: 0140-13-BNZ
• Status: Active, not recruiting
• Phase: N/A
• First received: March 20, 2014
• Last updated: December 15, 2014
• Start date: January 2014

Study information

• Verified date: December 2014
• Source: Bnai Zion Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical 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 membrane and whether there is a surgical possibility of round window approach in the insertion of electrode array into the cochlea

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:

1. Measured scans: one taken in an orbito-meatal plane

2. Chosen slices: where both the round window niche and the external ear canal are seen on the same slice

3. Distances measured:

1. 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

2. 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.

3. Distance 3: the size of the round window niche (from its anterior to posterior edges)

4. 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.

5. 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

6. Distance 6: size of round window membrane (anterior/medial to posterior/lateral)

7. 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).

4. Angles measured:

1. Between distance 1 and 7 - marking the angle of the "working channel" relatively to the cortex

2. 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Sensorineural
• Sensorineural Hearing Loss (Disorder)

Intervention

Other:
• measurment

Locations

Country	Name	City	State
Israel	Bnai Zion medical center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Bnai Zion Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the size of round window niche and its relation to the cochlea		january-june 2014 (six months)	No
Secondary	sizes of working channel from the mastoid cortex into the round window membrane and its relation to the mastoid sagment of the facial nerve		january-june 2014 (six months)	No