Stereotactic Laser Ablation for Mesial Temporal Lobe Epilepsy: A prospective, multicenter, single-arm study.

Publication/Presentation Date

6-1-2020

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 Visualase

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.

Volume

61

Issue

6

First Page

1183

Last Page

1189

ISSN

1528-1167

Disciplines

Medicine and Health Sciences

PubMedID

32412094

Department(s)

Department of Medicine

Document Type

Article

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