Abstract
Objective
To describe the development of the Stereotactic Laser Ablation for Temporal Lobe Epilepsy study protocol in the context of current practice. An ideal treatment for drug‐resistant epilepsy remains an ongoing area of research. Although there are several options available, each has challenges that not only make deciding on the appropriate treatment not clear‐cut but also create difficulties in designing clinical studies to provide evidence in support of the treatment.
Methods
A prospective, single‐arm, multicenter study designed to evaluate safety and efficacy of the VisualaseTM MRI‐Guided Laser Ablation System for the treatment of temporal lobe epilepsy will include up to 150 patients with a primary efficacy endpoint of seizure freedom (defined as Engel Class I) for the first 12 months following the procedure and a primary safety endpoint of incidence of qualifying device‐, procedure‐, or anesthesia‐related adverse events through 12 months following the procedure.
Results
Primary endpoints will be assessed against historical values of safety and efficacy of anterior temporal lobectomy.
Significance
The scientific and payor communities typically demand randomized controlled trials (RCTs) as definitive evidence for safety and efficacy claims. However, in circumstances where the medical device has already been cleared by regulatory authorities and is readily available in the market, an RCT may not be feasible to execute. It is therefore crucial to gain acceptance by both the scientific community and regulators to design a study that will satisfy all concerned.
MAY