Trials / Active Not Recruiting
Active Not RecruitingNCT03319485
ExAblate Pallidotomy for Medically-Refractory Dyskinesia Symptoms or Motor Fluctuations of Advanced Parkinson's Disease
A Pivotal Clinical Trial of the Management of the Medically-Refractory Dyskinesia Symptoms or Motor Fluctuations of Advanced Idiopathic Parkinson's Disease With Unilateral Lesioning of the Globus Pallidum Using the ExAblate Neuro System
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 92 (actual)
- Sponsor
- InSightec · Industry
- Sex
- All
- Age
- 30 Years
- Healthy volunteers
- Not accepted
Summary
Evaluate the safety and efficacy of unilateral focused ultrasound pallidotomy using the ExAblate 4000 System in the management of dyskinesia symptoms or motor fluctuations for medication refractory, advanced idiopathic Parkinson's disease.
Detailed description
The goal of this prospective, two-arm, sham-controlled, randomized, multi-center pivotal study is to evaluate the safety and efficacy of unilateral focused ultrasound pallidotomy using the ExAblate 4000 System in the management of dyskinesia symptoms or motor fluctuations for medication refractory, advanced idiopathic Parkinson's disease.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ExAblate Pallidotomy | ExAblate Pallidotomy for Parkinson's Disease |
| DEVICE | Sham ExAblate Pallidotomy | ExAblate MRgFUS Sham Procedure |
Timeline
- Start date
- 2018-02-09
- Primary completion
- 2024-07-25
- Completion
- 2026-08-31
- First posted
- 2017-10-24
- Last updated
- 2026-03-20
Locations
20 sites across 8 countries: United States, Canada, Israel, Italy, South Korea, Spain, Taiwan, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03319485. Inclusion in this directory is not an endorsement.