Overview

Gentamicin Treatment Prior to Schwannoma Surgery - Residual Function

Status:
Withdrawn
Trial end date:
2020-09-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of the study is to determine whether vestibular and postural compensation following schwannoma surgery is improved by ablating remaining vestibular function prior to surgery, through gentamicin injections in the middle ear.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Lund University
Treatments:
Gentamicins
Criteria
Inclusion Criteria:

- diagnosed with vestibular schwannoma and surgical treatment is advised

- remaining vestibular function

Exclusion Criteria:

- impaired decision making

- no remaining vestibular function

- signs of central nervous dysfunction

- neurofibromatosis

- Patients are advised not to participate in the gentamicin arm but encouraged to
participate in the 'non-gentamicin' arm:

- when hearing is better than 30decibel (dB) i pure tone average (500, 1000, 2000,
3000/4000 Hz) and speech discrimination better than 70% -when the neurosurgeon aim at
hearing preservation surgery and do not want to risk gentamicin- associated hearing
loss