Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2025-12-26 @ 6:52 AM
Study NCT ID:
NCT05075850
Status:
COMPLETED
Last Update Posted:
2025-04-06
First Post:
2021-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
PatiEnt Neuropsychological outcomeS After laseR Ablation
Sponsor:
Monteris Medical
Organization:
Study Overview
Official Title:
PatiEnt Neuropsychological outcomeS After laseR Ablation
Status:
COMPLETED
Status Verified Date:
2025-04
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:
PENSAR
Brief Summary:
PatiEnt Neuropsychological outcomeS After laseR ablation
Detailed Description:
This is a multicenter sub-study that will include comprehensive neuropsychological assessment data collection done at baseline (within 1 year prior to the index LITT procedure) and at follow-up (at least 6 months from the index LITT procedure). Visual field testing will be conducted in a subset of enrolled patients. Up to 250 subjects may be enrolled at up to 15 study sites.
Study Oversight
Has Oversight DMC:
False
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?: