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
| Type | Name | Description |
|---|---|---|
| RADIATION | Initial 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.