Clinical Applications of Round Window Imaging Anatomy in... | NCT02093806

Studies
Clinical Applications of Round Window Imaging Anatomy in Cochlear Implant Surgery

NCT02093806

Sponsor

Bnai Zion Medical Center

Status

Unknown status

Last Update Posted

Dec 16, 2014Estimated

Enrollment

100Actual

Phase

Not provided

Conditions

Sensorineural Hearing Loss (Disorder)

Interventions

measurment

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
0140-13-BNZ	Other Grant/Funding Number	TRADIS GAT LTD. ISRAEL

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Jun 2015Estimated

Completion Date

Not provided

First Submitted Date

Mar 20, 2014

First Submission Date that Met QC Criteria

Mar 20, 2014

First Posted Date

Mar 21, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 15, 2014

Last Update Posted Date

Dec 16, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

MICHAL.LUNTZ, Prof. Michal Luntz, Bnai Zion Medical CenterPrincipal Investigator

Lead Sponsor

Bnai Zion Medical CenterOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

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:
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).
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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Label	Type	Description	Intervention Names
CT of the temporal bone			Other: measurment

Name	Type	Description	Arm Group Labels	Other Names
measurment	Other		CT of the temporal bone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the size of round window niche and its relation to the cochlea		january-june 2014 (six months)

Secondary Outcomes

Measure	Description	Time Frame
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)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michal Luntz, Prof.	chair of otorhinolaryngology department at the Bnai Zion medical center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bnai Zion medical center		Haifa			Israel

Condition Browse Module

MeSH Terms

ID	Term
D006319	Hearing Loss, Sensorineural

Ancestor Terms

ID	Term
D034381	Hearing Loss
D006311	Hearing Disorders
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided