CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 167 enrolled
Drug / intervention
Visualase MRI-Guided Laser Ablationdevice
Likely dose
MRI-guided laser ablation of the amygdala and hippocampus using the Visualase SystemAI-extracted
Key inclusion· 6
  • ✓History of drug-resistant mesial temporal lobe epilepsy (MTLE)
  • ✓If VNS implanted, must have failed to achieve sustained seizure freedom for at least 6 months
  • ✓Average of at least 1 complex partial or secondarily generalized seizure compatible with MTLE per month
  • ✓Video EEG shows evidence of seizures from one temporal lobe consistent with MTLE
Key exclusion· 10
  • ✕History of previous intracranial surgery for treatment of epileptic seizures
  • ✕Persistent extra-temporal or predominant contralateral focal interictal spikes or slowing, or generalized interictal spikes on EEG
  • ✕Seizures with contralateral or extra-temporal ictal onset on EEG
  • ✕Aura and/or ictal behavior suggest an extra-temporal focus

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02844465
NCT02844465N/ACompleted
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Stereotactic Laser Ablation for Temporal Lobe Epilepsy

MedtronicNeuro·interventional·Posted Jul 26, 2016·Updated Jan 17, 2025

In Brief

A clinical study evaluating Visualase MRI-Guided Laser Ablation for Temporal Lobe Epilepsy. Completed, enrolled 167 participants across 23 sites.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTemporal Lobe Epilepsy
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJul 26, 2016
Enrollment StartDec 1, 2016
Primary CompletionDec 11, 2023
TodayJul 2, 2026
Enrollment to primary: 7.0 yearsPosted 9.9 years ago

Interventions

Visualase MRI-Guided Laser Ablationdevice

All subjects will undergo MRI-guided laser ablation of the amygdala and hippocampus with the Visualase System.