NCT05075850

PatiEnt Neuropsychological outcomeS After laseR Ablation

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 81 (actual)
• Sponsor: Monteris Medical · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: —

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.

Conditions

• Cognitive Change

Interventions

Type	Name	Description
DEVICE	Neuroblate System	All subjects will undergo comprehensive neuropsychological assessment post-LITT per standard of care practice. Visual field testing will be conducted in a subset of enrolled patients.

Timeline

• Start date: 2021-09-29
• Primary completion: 2023-09-30
• Completion: 2023-09-30
• First posted: 2021-10-13
• Last updated: 2025-04-06
• Results posted: 2025-04-06

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study