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出境医 / 临床实验 / Simultaneous Cochlear Implantation During Translabyrinthine Resection of Vestibular Schwannoma

Simultaneous Cochlear Implantation During Translabyrinthine Resection of Vestibular Schwannoma

Study Description
Brief Summary:
This study will address the feasibility of simultaneous cochlear implantation during resection of a vestibular schwannoma.

Condition or disease Intervention/treatment Phase
Vestibular Schwannoma Cochlear Implantation Device: Cochlear implant Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Simultaneous Cochlear Implantation During Translabyrinthine Resection of Vestibular Schwannoma
Actual Study Start Date : December 5, 2018
Estimated Primary Completion Date : November 6, 2021
Estimated Study Completion Date : November 6, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Cochlear implantation
Simultaneous cochlear implantation with tumor resection
 Device: Cochlear implant
Tumor resection with cochlear implant
Outcome Measures
Primary Outcome Measures :
  1. Measurement of Hearing Parameters [ Time Frame: 1 month, 3 months and 6 months postoperatively. ]
    Audiologist assesses changes in understanding of the AzBio test (words in quiet and words in background noise) post cochlear implantation.

  2. Measurement of Hearing Parameters [ Time Frame: 1 month, 3 months and 6 months postoperatively. ]
    Audiologist assesses changes in understanding of 50 random consonant-nucleus-consonant sounds.

  3. Measurement of Hearing Parameters [ Time Frame: 1 month, 3 months and 6 months postoperatively. ]
    Audiologist assesses changes in understanding changes in understanding of Speech, Spatial and Qualities of Hearing.


Secondary Outcome Measures :
  1. Measurement of Change of Physical Symptoms Associated with Hearing Loss [ Time Frame: 1, 3 and 6 months postoperatively ]
    Patients will complete the Dizziness Handicap Inventory

  2. Assessment of Change of Physical Symptoms Associated with Hearing Loss [ Time Frame: 1, 3 and 6 months postoperatively ]
    Patients will complete the Tinnitus Handicap Inventory

  3. Assessment of incision site healing [ Time Frame: 1 week, and 1 and 3 months postoperatively ]
    Surgeon evaluates wound hearing over 3 months


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

Contacts and Locations

Contacts
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Contact: Seilesh Babu, MD (248) 865-4444 sbabu@gmail.com
Contact: Marianne Lahey, BSN (248) 465-4828 Marianne.Lahey@ascension.org

Locations
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United States, Michigan
Seilesh Babu Recruiting
Farmington Hills, Michigan, United States, 48334
Contact: Seilesh Babu, M.D.    248-865-4444      
Sponsors and Collaborators
Ascension South East Michigan
Investigators
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Principal Investigator: Seilish Babu, MD Michigan Ear Institute, Farmington Hills, MI
Tracking Information
First Submitted Date  ICMJE March 18, 2019
First Posted Date  ICMJE May 21, 2019
Last Update Posted Date February 18, 2021
Actual Study Start Date  ICMJE December 5, 2018
Estimated Primary Completion Date November 6, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
  • Measurement of Hearing Parameters [ Time Frame: 1 month, 3 months and 6 months postoperatively. ]
    Audiologist assesses changes in understanding of the AzBio test (words in quiet and words in background noise) post cochlear implantation.
  • Measurement of Hearing Parameters [ Time Frame: 1 month, 3 months and 6 months postoperatively. ]
    Audiologist assesses changes in understanding of 50 random consonant-nucleus-consonant sounds.
  • Measurement of Hearing Parameters [ Time Frame: 1 month, 3 months and 6 months postoperatively. ]
    Audiologist assesses changes in understanding changes in understanding of Speech, Spatial and Qualities of Hearing.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
  • Measurement of Change of Physical Symptoms Associated with Hearing Loss [ Time Frame: 1, 3 and 6 months postoperatively ]
    Patients will complete the Dizziness Handicap Inventory
  • Assessment of Change of Physical Symptoms Associated with Hearing Loss [ Time Frame: 1, 3 and 6 months postoperatively ]
    Patients will complete the Tinnitus Handicap Inventory
  • Assessment of incision site healing [ Time Frame: 1 week, and 1 and 3 months postoperatively ]
    Surgeon evaluates wound hearing over 3 months
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Simultaneous Cochlear Implantation During Translabyrinthine Resection of Vestibular Schwannoma
Official Title  ICMJE Simultaneous Cochlear Implantation During Translabyrinthine Resection of Vestibular Schwannoma
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Vestibular Schwannoma
  • Cochlear Implantation
Intervention  ICMJE Device: Cochlear implant
Tumor resection with cochlear implant
Study Arms  ICMJE Experimental: Cochlear implantation
Simultaneous cochlear implantation with tumor resection
Intervention: Device: Cochlear implant
Publications *
  • 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.
  • 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.
  • Bohr C, Müller 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.
  • 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.
  • 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. Review.
  • 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 20, 2019) 		6
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 6, 2021
Estimated Primary Completion Date November 6, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

-
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Seilesh Babu, MD (248) 865-4444 sbabu@gmail.com
Contact: Marianne Lahey, BSN (248) 465-4828 Marianne.Lahey@ascension.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03958006
Other Study ID Numbers  ICMJE 1349609
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ascension South East Michigan
Study Sponsor  ICMJE Ascension South East Michigan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Seilish Babu, MD Michigan Ear Institute, Farmington Hills, MI
PRS Account Ascension South East Michigan
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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