Trials / Completed
CompletedNCT03465761
Staged Bilateral Exablate Treatment of Medication Refractory Essential Tremor
A Clinical Trial to Evaluate the Safety and Efficacy of Staged Bilateral Exablate Treatment of Medication Refractory Essential Tremor
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 7 (actual)
- Sponsor
- InSightec · Industry
- Sex
- All
- Age
- 22 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this prospective, multi-site, single-arm, open-label study is to capture the safety and efficacy (outcome) of bilateral staged Exablate treatment in subjects with bilateral medication-refractory essential tremor (ET). The staged second procedure will be performed at least 9 months after the first side. The benefit of real-time feedback will allow the physician to maximize benefit without jeopardizing safety. This study is designed as a prospective, open-label, single arm, multi-site study design.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ExAblate | Bilateral side treatment of Essential Tremor |
Timeline
- Start date
- 2019-01-03
- Primary completion
- 2021-12-07
- Completion
- 2025-11-17
- First posted
- 2018-03-14
- Last updated
- 2026-03-20
Locations
2 sites across 2 countries: Spain, United Kingdom
Source: ClinicalTrials.gov record NCT03465761. Inclusion in this directory is not an endorsement.