Staged Bilateral Exablate Treatment of Medication Refractory Essential Tremor
NCT03465761 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7
Last updated 2026-03-20
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
- DEVICE
-
ExAblate
Bilateral side treatment of Essential Tremor
Sponsors & Collaborators
-
InSightec
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 22 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-01-03
- Primary Completion
- 2021-12-07
- Completion
- 2025-11-17
Countries
- Spain
- United Kingdom
Study Locations
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