Vestibular SchwannomaNCT03745560
Intraoperative EABR for Decision Making
An observational study of Vestibular Schwannoma and Hearing Loss, run by Christoph Arnoldner at 1 site in Austria.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Vestibular Schwannoma, Hearing Loss
- How many people
- 15 participants
- Where
- 1 siteAustria
- Study dates
- 23 May 2017to 23 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing translabyrinthine vestibular schwannoma resection and cochlear implantation
Who may be able to join
- Patients between 18 and 99 years undergoing translabyrinthine vestibular schwannoma resection
- Patients wanted hearing rehabilitation with a cochlear implant
Who cannot join
- patients who do not want to be part of the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
AKH, MUW
Vienna, Austria, 1090
Valerie Dahm, MD, 004314040033300, valerie.dahm@meduniwien.ac.at
About this study
Official title: Simultaneous Translabyrinthine Surgery of Vestibular Schwannoma and Cochlear Implantation with Intraoperative EBERA and Correlation to Hearing Results - a Pilot Study
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.
Read the detailed description
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
- Vestibular Schwannoma, Hearing Loss
- Keywords
- Cochlear implant
- Medical subject headings
- Neuroma, Acoustic, Hearing Loss
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of eABR results to postoperative hearing results
eABR is correlated with postoperative hearing results eABR will be divided in three categories - good response, weak response, no response.
Hearing results will be measured with speech understanding in Freiburg monosyllables word test which is measured in % of monosyllables understanding at 65 and 80dB
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start23 May 2017
- Primary completion23 May 2026 (estimated)
- Study completion23 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vestibular SchwannomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christoph Arnoldner
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christoph Arnoldner, Medical University of Vienna
- Investigators
- Christoph Arnoldner, MD, Principal investigator, MUW, Allgemeines Krankenhaus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03745560
- Sponsor's protocol ID
- 1111/2017
- Status last verified
- Nov 2024
- First submitted
- 3 Nov 2018
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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. 2025 Dec 1;46(10):1310-1315. doi: 10.1097/MAO.0000000000004313. Epub 2025 Nov 12.
PubMed 39284021
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simultaneous Translabyrinthine Surgery of Vestibular Schwannoma and Cochlear Implantation with Intraoperative EBERA and Correlation to Hearing Results - a Pilot Study
- ClinicalTrials.gov ID
- NCT03745560
- Acronym / sponsor ID
- 1111/2017
- Conditions
- Vestibular Schwannoma, Hearing Loss
- Keywords
- Cochlear implant
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Christoph ArnoldnerUniversity, hospital or other
- Study start
- 23 May 2017 (actual)
- Primary completion
- 23 May 2026 (estimated)
- Study completion
- 23 May 2026 (estimated)
- First posted
- 19 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing translabyrinthine vestibular schwannoma resection and cochlear implantation
Key inclusion criteria (2 listed)
- Patients between 18 and 99 years undergoing translabyrinthine vestibular schwannoma resection
- Patients wanted hearing rehabilitation with a cochlear implant
Key exclusion criteria (1 listed)
- patients who do not want to be part of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation of eABR results to postoperative hearing results
Time frame: 2 years
eABR is correlated with postoperative hearing results eABR will be divided in three categories - good response, weak response, no response. Hearing results will be measured with speech understanding in Freiburg monosyllables word test which is measured in % of monosyllables understanding at 65 and 80dB
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Derived from this study: PubMed 39284021Gadenstaetter 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. 2025 Dec 1;46(10):1310-1315. doi: 10.1097/MAO.0000000000004313. Epub 2025 Nov 12.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christoph Arnoldner, MD principal investigator
MUW, Allgemeines Krankenhaus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vestibular Schwannoma and Hearing Loss, run by Christoph Arnoldner at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valerie Dahm (01/40400/33300, valerie.dahm@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of eABR results to postoperative hearing results (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03745560, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.