Intraoperative EABR for Decision Making

NCT ID: NCT03745560

Last Updated: 2024-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-23

Study Completion Date

2026-05-23

Brief Summary

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In this study patients undergoing simultaneous translabyrinthine vestibular schwannoma resection and cochlear implantation are included. The goal of the study is to correlate the eABR results with postoperative hearing results.

Detailed Description

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Patients undergoing translabyrinthine vestibular schwannoma resection are included in the study. Preoperatively an eABR is carried out, as well as before and after tumor resection.

Postoperatively patients are fitted with a cochlear implant as routinely carried out. The postoperative hearing results with cochlear implant are correlated to the eABR results. The study is an observational study since eABR measurements are not part of the study. A correlation between eABR results categorized in three groups (good response, weak response, no response) with monosyllable understanding with cochlear implant (measured with Freiburger monosyllables test).

Conditions

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Vestibular Schwannoma Hearing Loss

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients between 18 and 99 years undergoing translabyrinthine vestibular schwannoma resection
* Patients wanted hearing rehabilitation with a cochlear implant

Exclusion Criteria

* patients who do not want to be part of the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Christoph Arnoldner

OTHER

Sponsor Role lead

Responsible Party

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Christoph Arnoldner

Assoc. Prof PD. Dr.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Christoph Arnoldner, MD

Role: PRINCIPAL_INVESTIGATOR

MUW, Allgemeines Krankenhaus

Locations

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AKH, MUW

Vienna, Austria, Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Valerie Dahm

Role: CONTACT

01/40400/33300

Facility Contacts

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Valerie Dahm, MD

Role: primary

004314040033300

References

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Gadenstaetter AJ, Auinger AB, Gerlitz M, Riss D, Yildiz E, Roessler K, Matula C, Dahm V, Arnoldner C. Long-Term Follow-Up After Translabyrinthine IAC Tumor Removal With Simultaneous Cochlear Implantation. Otol Neurotol. 2024 Sep 6. doi: 10.1097/MAO.0000000000004313. Online ahead of print.

Reference Type DERIVED
PMID: 39284021 (View on PubMed)

Other Identifiers

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1111/2017

Identifier Type: -

Identifier Source: org_study_id

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