Clinical Trials Logo

Clinical Trial Summary

Tumors arising from the VIIIth Nerve (vestibulo-cochlear nerve) typically present with progressive unilateral hearing loss and tinnitus. VIIIth Nerve tumors with documented growth on serial MRI scans typically lead to deafness in the affected ear over time. Radiation (Gamma Knife® or stereotactic radiosurgery) may preserve hearing in ~80% while surgery (middle cranial fossa or retrosigmoid approach) may preserve hearing in 16 - 40% of small tumors, although initial hearing preservation by both modalities may fail over time. Surgical resection via the translabyrinthine approach is the safest way to remove many of these tumors, but involves loss of all hearing. In all treatment modalities, the vascular supply (the labyrinthine artery, a terminal branch of AICA with no collaterals) to the cochlea is at risk. After devascularization, the cochlea frequently fills with fibrous tissue or ossifies (labyrinthitis ossificans), making it impossible to place a cochlear implant should it be required later. The incidence of this is 46% in our patients. This study seeks to determine the feasibility of preserving the cochlear duct with an obdurator so that patients undergoing translabyrinthine removal of VIIIth nerve tumors may retain the option of a cochlear implant at a later time.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03261726
Study type Interventional
Source Ascension South East Michigan
Contact
Status Withdrawn
Phase N/A
Start date August 4, 2017
Completion date March 4, 2021

See also
  Status Clinical Trial Phase
Active, not recruiting NCT01199978 - Hearing Outcomes Using Fractionated Proton Radiation Therapy for Vestibular Schwannoma Phase 2
Recruiting NCT06322342 - Phase 2 Ascending Dose Safety and Efficacy Study of RVP-001, a Manganese-based MRI Contrast Agent Phase 2
Completed NCT00863122 - Concentration and Activity of Lapatinib in Vestibular Schwannomas Early Phase 1
Recruiting NCT03079999 - Study of Aspirin in Patients With Vestibular Schwannoma Phase 2
Completed NCT03210285 - WES of NF2-associated in Comparison to Sporadic Vestibular Schwannomas - Correlation With Clinical Data
Completed NCT04241679 - Auditory Nerve Test System During Vestibular Schwannoma Resection N/A
Recruiting NCT03393689 - RGD PET/MRI in Sporadic Vestibular Schwannoma Phase 2
Not yet recruiting NCT06112509 - Evolution of Vestibular Function After Treatment of a Vestibular Schwannoma by Gamma-knife Radio-surgery N/A
Recruiting NCT04004377 - Acoustic Neuroma: Assessing the Quality of Life by the Scale PANQOL of Patients Operated or Supervised
Withdrawn NCT03057678 - Evaluating the Pre-Positioning Frame for Robotic Acoustic Neuroma Removal Surgery N/A
Terminated NCT02282917 - Exploratory Evaluation of AR-42 Histone Deacetylase Inhibitor in the Treatment of Vestibular Schwannoma and Meningioma Early Phase 1