Feasibility Study on Laser Interstitial Thermal Therapy Ablation for the Treatment of Medical Refractory Epilepsy (FLARE)

Status: Terminated
Location: See all (5) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Multicenter, open-label, prospective designed study to characterize the performance of brain laser interstitial thermal therapy (LITT) ablation using the Monteris NeuroBlate System for the treatment of drug-refractory medial temporal lobe epilepsy in subjects who are candidates for LITT surgery.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Diagnosis of unilateral medial temporal lobe epilepsy (MTLE) confirmed clinically and with either (1) ictal scalp recording and MRI evidence of mesial temporal sclerosis or (2) intracranial ictal onset consistent with hippocampal origin

• Averages 1 or more complex partial seizures or secondary generalized seizures compatible with MTLE per month

• On stable antiepileptic medications

• Meets the criteria for a medial temporal lobe resection and is a candidate for LITT

• 18 years or older at the time of consent

Locations
United States
Arizona
St. Joseph's Hospital and Medical Center
Phoenix
Connecticut
Yale University School of Medicine
New Haven
Kansas
University of Kansas Medical Center
Kansas City
New York
Mount Sinai West
New York
South Carolina
Medical University of South Carolina
Charleston
Time Frame
Start Date: April 21, 2017
Completion Date: June 24, 2019
Participants
Target number of participants: 4
Treatments
Other: NeuroBlate LITT Treatment
This is a single arm study. All eligible study subjects will undergo LITT with the NeuroBlate System.
Authors
Related Therapeutic Areas
Sponsors
Leads: Monteris Medical

This content was sourced from clinicaltrials.gov

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