Clinical Trials Directory

Trials / Completed

CompletedNCT01938677

Gamma Knife Radiosurgery vs Initial Conservative Treatment for Vestibular Schwannoma Patients With Preserved Hearing, a Prospective Randomized Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
67 (actual)
Sponsor
Karolinska Institutet · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

Summary

The effect of Gamma knife radiosurgery (GKRS) on hearing loss, in patients with vestibular schwannoma (VS) and preserved hearing is still unclear. Retrospective data indicate that the hearing is preserved in most patient years after the gamma knife treatment. Recent prospective data suggests that radiosurgery could be a hearing preserving treatment for these patients. The main objective of this study is to evaluate if GKRS can inhibit progression of hearing loss in patients with VS. Patients with preserved hearing will be offered to participate in the study and randomized ether to GKRS or initial conservative treatment for their vestibular schwannoma. They will then be followed with scheduled magnetic resonance image(MRI) and audiometry and evaluated after one, three and five years after treatment.

Conditions

Interventions

TypeNameDescription
RADIATIONInitial Gamma knife radiosurgery

Timeline

Start date
2013-04-01
Primary completion
2022-12-01
Completion
2022-12-01
First posted
2013-09-10
Last updated
2024-04-18

Locations

1 site across 1 country: Sweden

Source: ClinicalTrials.gov record NCT01938677. Inclusion in this directory is not an endorsement.