PatiEnt Neuropsychological outcomeS After laseR Ablation (PENSAR)

Monteris Medical

Status: Completed

Conditions: Cognitive Change

Treatments: Device: Neuroblate System

Study type: Observational

Funder types: Industry

Identifiers

NCT05075850

PENSAR LAANTERN Registry

Details and patient eligibility

About

PatiEnt Neuropsychological outcomeS After laseR ablation

Full 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.

Enrollment: 81 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient or legally authorized representative provides written authorization and/or consent.
2. Patient is enrolled in the LAANTERN trial and had an epilepsy diagnosis without the presence of a malignant brain tumor.
3. Patient is 16 years of age or older.
4. Patient has completed a baseline comprehensive neuropsychological assessment with a neuropsychologist.

Exclusion criteria

1. Patient does not complete the index LITT procedure as specified in the LAANTERN registry.

Trial design