Clinical Applications of Round Window Imaging Anatomy in Cochlear Implant Surgery

NCT02093806 | Unknown DMC

• 1 other identifier: 0140-13-BNZ
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Sensorineural Hearing Loss (Disorder)

Outcome Measures

Primary Outcomes (1)

• the size of round window niche and its relation to the cochlea

  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

  january-june 2014 (six months)

Study Arms (1)

CT of the temporal bone

Other: measurment

Interventions

measurment OTHER

CT of the temporal bone

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bnai Zion Medical Center: lead

Study Sites (1)

Bnai Zion medical center

Haifa, Israel

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michal Luntz, Prof.

  chair of otorhinolaryngology department at the Bnai Zion medical center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Michal Luntz

Study Record Dates

• First Submitted: March 20, 2014
• First Posted: March 21, 2014
• Study Start: January 1, 2014
• Primary Completion: June 1, 2015
• Last Updated: December 16, 2014

Record last verified: 2014-12

Locations

IL (1)