NCT02844465

Stereotactic Laser Ablation for Temporal Lobe Epilepsy (Slate)

Stereotactic Laser Ablation for Temporal Lobe Epilepsy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 167 (actual)
• Sponsor: MedtronicNeuro · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The study is designed to evaluate the safety and efficacy of the Visualase MRI-guided laser ablation system for mesial temporal epilepsy (MTLE).

Detailed description

The purpose of the study is to evaluate the safety and efficacy of the Visualase MRI-guided laser ablation system for necrotization or coagulation of epileptogenic foci in patients with intractable mesial temporal lobe epilepsy. The study will include approximately 150 adult patients with drug-resistant MTLE treated at selected epilepsy centers across the United States. After the Visualase procedure, patients will be followed for 12 months and evaluated for freedom from seizures, quality of life, adverse events, and neuropsychological outcomes.

Conditions

• Temporal Lobe Epilepsy

Interventions

Type	Name	Description
DEVICE	Visualase MRI-Guided Laser Ablation	All subjects will undergo MRI-guided laser ablation of the amygdala and hippocampus with the Visualase System.

Timeline

• Start date: 2016-12-01
• Primary completion: 2023-12-11
• Completion: 2023-12-11
• First posted: 2016-07-26
• Last updated: 2025-01-17
• Results posted: 2025-01-17

Locations

23 sites across 1 country: United States

Regulatory

• FDA-regulated device study