Ignite Creation Date:
2025-12-24 @ 6:34 PM
Ignite Modification Date:
2025-12-25 @ 4:04 PM
Study NCT ID:
NCT02415257
Status:
WITHDRAWN
Last Update Posted:
2020-09-11
First Post:
2015-01-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Gentamicin Treatment Prior to Schwannoma Surgery - No Residual Function
Sponsor:
Lund University
Organization:
Study Overview
Official Title:
Gentamicin Treatment Prior to Vestibular Schwannoma Surgery in Patients With no Measurable Remaining Vestibular Function
Status:
WITHDRAWN
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to determine whether vestibular and postural compensation following schwannoma surgery is improved by ablating vestibular function prior to surgery, even if vestibular function is absent according to modern assessment techniques
Detailed Description:
Patients subjected to vestibular schwannoma surgery most often suffer from vertigo after surgery, even if no vestibular function can be found in pre-surgical assessment. According to retrospective data about 33% of patients scheduled for surgery do not have any measurable vestibular function. Even the occurrence of spontaneous nystagmus has been recorded in patients with no or very little function prior to surgery (Parietti-Winkler et al. 2008 JNNP). This indicates that despite new methods of measuring vestibular function, remaining vestibular function can be present and patients might benefit from pre-treatment of gentamicin (Tjernström et al. 2009 JNNP)
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: