Ignite Creation Date:
2024-05-06 @ 6:46 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05774041
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2023-03-07
Brief Title:
Visualization of the STN and GPi for DBS
Sponsor:
Surgical Information Sciences Inc
Organization:
Surgical Information Sciences Inc
Study Overview
Official Title:
Visualization of the STN and GPi for DBS Surgery in Patients with Parkinsons Disease
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VISION
Brief Summary:
The purpose of the study is to determine if using SIS System for DBS planning results in less distance between the planned target location and the actual implanted lead location than DBS planning without SIS System
Detailed Description:
This is a prospective controlled open-label multicenter post-market trial to compare standard of care DBS surgery to standard of care plus visualization with the SIS System The purpose of the study is to determine if using SIS System for DBS planning results in less distance between the planned target location and the actual implanted lead location than DBS planning without SIS System
Parkinsons Disease subjects indicated for DBS will undergo standard DBS surgery with preoperative planning for targeting of STN or GPi as indicated Subjects will be followed through six months after initial DBS programming to collect clinical outcomes
Parkinsons Disease subjects indicated for DBS will undergo standard DBS surgery with preoperative planning for targeting of STN or GPi as indicated Subjects will be followed through six months after initial DBS programming to collect clinical outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None