Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06584383
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-30
Brief Title:
A Prospective Randomized Controlled Trial to Test Safety and Effectiveness of Unilateral Exablate MR-guided Focused Ultrasound Subthalamotomy in Patients With Early-Stage Parkinsons Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Early Focus II A Prospective Randomized Controlled Trial to Test Safety and Effectiveness of Unilateral Exablate MR-guided Focused Ultrasound MRgFUS Subthalamotomy in Patients With Early-Stage Parkinsons Disease ESPD
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This prospective randomized multicenter study aims to evaluate in Early-Stage Parkinsons Disease ESPD patients the safety and effectiveness of treatment with Exablate MRgFUS subthalamotomy vs best medical treatment
Detailed Description:
This is a prospective randomized ratio 21 multicenter study to evaluate in Early-Stage Parkinsons Disease ESPD patients the safety and effectiveness of treatment with Exablate MRgFUS subthalamotomy vs best medical treatment Patients assigned to the treatment arm will receive unilateral Exablate MRgFUS subthalamotomy Patients assigned to control group will receive best medical treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None