RecruitingNCT04991831
A Post-Approval Registry for Exablate 4000 Type 1.0 and Type 1.1 for Unilateral Thalamotomy for the Treatment of Medication-Refractory Tremor Dominant Idiopathic Parkinson's Disease
Sponsor
InSightec
Enrollment
50 participants
Start Date
Apr 28, 2022
Study Type
OBSERVATIONAL
Conditions
Summary
The objectives of this study are to collect the long-term safety and effectiveness data of performing thalamotomy for tremor dominant Parkinson's Disease (TDPD) using the Exablate Neuro system.
Eligibility
Min Age: 30 YearsMax Age: 99 Years
Inclusion Criteria4
- Men and women, age 30 years and older
- Subject undergoing an Exablate procedure for their planned TDPD treatment; per local institution standard of care.
- Subject is willing to cooperate with the Registry requirements including compliance with the regimen and completion of all study visits
- Subject has signed and received a copy of the approved informed consent form
Exclusion Criteria1
- Subject does not agree to participate or is unlikely to participate for the entirety of the study.
Interventions
DEVICEUnilateral thalamotomy
Unilateral thalamotomy using focused ultrasound for the treatment of medication-refractory tremor dominant idiopathic Parkinson's Disease.
Locations(8)
View Full Details on ClinicalTrials.gov
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NCT04991831