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Simultaneous Cochlear Implantation During Translabyrinthine Resection of Vestibular Schwannoma

Primary Purpose

Vestibular Schwannoma, Cochlear Implantation

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Cochlear implant

About this trial

This is an interventional treatment trial for Vestibular Schwannoma

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with a vestibular schwannoma undergoing a translabyrinthine resection with intact hearing in the contralateral ear

Exclusion Criteria:

Sites / Locations

Seilesh Babu

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cochlear implantation

Arm Description

Simultaneous cochlear implantation with tumor resection

Outcomes

Primary Outcome Measures

Measurement of Hearing Parameters

Audiologist assesses changes in understanding of the AzBio test (words in quiet and words in background noise) post cochlear implantation.

Measurement of Hearing Parameters

Audiologist assesses changes in understanding of 50 random consonant-nucleus-consonant sounds.

Measurement of Hearing Parameters

Audiologist assesses changes in understanding changes in understanding of Speech, Spatial and Qualities of Hearing.

Secondary Outcome Measures

Measurement of Change of Physical Symptoms Associated with Hearing Loss

Patients will complete the Dizziness Handicap Inventory

Assessment of Change of Physical Symptoms Associated with Hearing Loss

Patients will complete the Tinnitus Handicap Inventory

Assessment of incision site healing

Surgeon evaluates wound hearing over 3 months

Full Information

NCT ID

NCT03958006

First Posted

March 18, 2019

Last Updated

April 18, 2023

Sponsor

Ascension South East Michigan

1. Study Identification

Unique Protocol Identification Number

NCT03958006

Brief Title

Simultaneous Cochlear Implantation During Translabyrinthine Resection of Vestibular Schwannoma

Official Title

Simultaneous Cochlear Implantation During Translabyrinthine Resection of Vestibular Schwannoma

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

December 5, 2018 (Actual)

Primary Completion Date

January 30, 2023 (Actual)

Study Completion Date

January 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ascension South East Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

This study will address the feasibility of simultaneous cochlear implantation during resection of a vestibular schwannoma.

Detailed Description

This is prospective study patients undergoing a translabyrinthine resection for a vestibular schwannoma with intact hearing in the contralateral ear. During surgery, simultaneous cochlear implantation will be performed if the cochlear nerve can be identified and preserved during the resection. Relevant data to be collected will include patient demographics, details related to the vestibular schwannoma including side, size, symptoms (specifically pre-operative hearing loss, degree of tinnitus), and status of hearing in the contralateral ear. Surgical details to be recorded will include date of surgery, surgical time, and whether the cochlear nerve was identified and preserved. Details related to the post-operative course to be recorded include length of stay in the hospital, post-operative complications such as wound infection or cerebral spinal fluid (CSF) leak, and need for revision or additional procedures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vestibular Schwannoma, Cochlear Implantation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cochlear implantation

Arm Type

Experimental

Arm Description

Simultaneous cochlear implantation with tumor resection

Intervention Type

Device

Intervention Name(s)

Cochlear implant

Intervention Description

Tumor resection with cochlear implant

Primary Outcome Measure Information:

Title

Measurement of Hearing Parameters

Description

Audiologist assesses changes in understanding of the AzBio test (words in quiet and words in background noise) post cochlear implantation.

Time Frame

1 month, 3 months and 6 months postoperatively.

Title

Measurement of Hearing Parameters

Description

Audiologist assesses changes in understanding of 50 random consonant-nucleus-consonant sounds.

Time Frame

1 month, 3 months and 6 months postoperatively.

Title

Measurement of Hearing Parameters

Description

Audiologist assesses changes in understanding changes in understanding of Speech, Spatial and Qualities of Hearing.

Time Frame

1 month, 3 months and 6 months postoperatively.

Secondary Outcome Measure Information:

Title

Measurement of Change of Physical Symptoms Associated with Hearing Loss

Description

Patients will complete the Dizziness Handicap Inventory

Time Frame

1, 3 and 6 months postoperatively

Title

Assessment of Change of Physical Symptoms Associated with Hearing Loss

Description

Patients will complete the Tinnitus Handicap Inventory

Time Frame

1, 3 and 6 months postoperatively

Title

Assessment of incision site healing

Description

Surgeon evaluates wound hearing over 3 months

Time Frame

1 week, and 1 and 3 months postoperatively

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with a vestibular schwannoma undergoing a translabyrinthine resection with intact hearing in the contralateral ear Exclusion Criteria: -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Seilish Babu, MD

Organizational Affiliation

Michigan Ear Institute, Farmington Hills, MI

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seilesh Babu

City

Farmington Hills

State/Province

Michigan

ZIP/Postal Code

48334

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

29490548

Citation

Dos Santos Neto PH, Zamponi JO, Hamerschmidt R, Wiemes GRM, Rassi MS, Borba LAB. Simultaneous cochlear implantation as a therapeutic option in vestibular schwannoma surgery: case report. Neurosurg Focus. 2018 Mar;44(3):E9. doi: 10.3171/2017.12.FOCUS17670.

Results Reference

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PubMed Identifier

24335931

Citation

Lloyd SK, Glynn FJ, Rutherford SA, King AT, Mawman DJ, O'Driscoll MP, Evans DG, Ramsden RT, Freeman SR. Ipsilateral cochlear implantation after cochlear nerve preserving vestibular schwannoma surgery in patients with neurofibromatosis type 2. Otol Neurotol. 2014 Jan;35(1):43-51. doi: 10.1097/MAO.0000000000000185.

Results Reference

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PubMed Identifier

28819872

Citation

Bohr C, Muller S, Hornung J, Hoppe U, Iro H. [Hearing restoration with cochlear implants after translabyrinthine vestibular schwannoma resection]. HNO. 2017 Sep;65(9):758-765. doi: 10.1007/s00106-017-0404-2. German.

Results Reference

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PubMed Identifier

26498948

Citation

Hassepass F, Arndt S, Aschendorff A, Laszig R, Wesarg T. Cochlear implantation for hearing rehabilitation in single-sided deafness after translabyrinthine vestibular schwannoma surgery. Eur Arch Otorhinolaryngol. 2016 Sep;273(9):2373-83. doi: 10.1007/s00405-015-3801-8. Epub 2015 Oct 23.

Results Reference

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PubMed Identifier

28602150

Citation

DeHart AN, Broaddus WC, Coelho DH. Translabyrinthine vestibular schwannoma resection with simultaneous cochlear implantation. Cochlear Implants Int. 2017 Sep;18(5):278-284. doi: 10.1080/14670100.2017.1337665. Epub 2017 Jun 12.

Results Reference

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PubMed Identifier

27816972

Citation

Sanna M, Medina MD, Macak A, Rossi G, Sozzi V, Prasad SC. Vestibular Schwannoma Resection with Ipsilateral Simultaneous Cochlear Implantation in Patients with Normal Contralateral Hearing. Audiol Neurootol. 2016;21(5):286-295. doi: 10.1159/000448583. Epub 2016 Nov 5.

Results Reference

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PubMed Identifier

29099442

Citation

Rooth MA, Dillon MT, Brown KD. Prospective Evaluation of Patients Undergoing Translabyrinthine Excision of Vestibular Schwannoma with Concurrent Cochlear Implantation. Otol Neurotol. 2017 Dec;38(10):1512-1516. doi: 10.1097/MAO.0000000000001570.

Results Reference

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Simultaneous Cochlear Implantation During Translabyrinthine Resection of Vestibular Schwannoma

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