ExAblate Neuro Registry
Research type
Research Study
Full title
Global Registry: ExAblate 4000 transcranial MR guided focused ultrasound (TcMRgFUS) of Neurological Disorders: Essential Tremors, Tremor Dominant Idiopathic Parkinson’s Disease, and Neuropathic pain
IRAS ID
222045
Contact name
Wladyslaw Gedroyc
Contact email
Sponsor organisation
Insightec Ltd.
Duration of Study in the UK
5 years, 10 months, 1 days
Research summary
Research Summary:
This project will be observational in nature, collecting both retrospective and prospective data, regarding patient treatment and safety information with the ExAblate Neuro system for exploratory purposes. Patients will be asked to participate in standardized clinical outcomes measures as well as complete various health related quality of life questionnaires at baseline and follow-up visits.Lay summary of study results: This is a multi-center study. In total, 14 sites participated in the study. All sites are now closed for enrollment and follow up.
In total 217 subjects were enrolled in this study.
Adverse Events
Procedures related to these areas of the brain have known, expected side effects that are transient in nature. These were not captured as per protocol.
Serious Adverse Events
There were two adverse events reported. Subject 112014 reported dramatic improvement for his tremor in left upper extremity after the ExAblate treatment. DSMB reviewed this event and was deemed to be Unrelated to the ExAblate device as the area chosen for targeting was correctly lesioned, but that the target was incorrectly chosen. Subject 320305 was enrolled in ET002J study and moved to ND001 study for follow-up.
Protocol Deviations
To date, there have been no protocol deviations reported for this study.REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
18/YH/0029
Date of REC Opinion
31 Jan 2018
REC opinion
Further Information Favourable Opinion