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Feasibility Study on LITT for Medical Refractory Epilepsy

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ClinicalTrials.gov Identifier: NCT02820740
Recruitment Status : Terminated (Terminated (failure to enroll))
First Posted : July 1, 2016
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Monteris Medical

Tracking Information
First Submitted Date  ICMJE June 8, 2016
First Posted Date  ICMJE July 1, 2016
Last Update Posted Date August 14, 2019
Actual Study Start Date  ICMJE April 21, 2017
Actual Primary Completion Date June 24, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2016)
  • Adverse events [ Time Frame: 2 Years ]
    Characterize adverse events experienced in medial temporal lobe epilepsy subjects undergoing LITT using the NeuroBlate System. Adverse events will be collected based on subject reports and subject examination/testing.
  • Changes in neuropsychological functioning [ Time Frame: 1 Year ]
    Characterize changes to neuropsychological functioning experienced in medial temporal lobe epilepsy subjects undergoing LITT using the NeuroBlate System. Descriptive statistics (via neuropsychological assessment tools) will be reported for the measured score at baseline and each follow-up visit.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02820740 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2016)
  • Changes in seizure frequency [ Time Frame: 2 Years ]
    Characterize changes in seizure frequency experienced in medial temporal lobe epilepsy subjects undergoing LITT using the NeuroBlate System by utilizing patient diary to evaluate seizure occurrences.
  • Surgical outcome classification [ Time Frame: 2 Years ]
    Characterize the Engel and ILAE surgical outcome classification in medial temporal lobe epilepsy subjects undergoing LITT using the NeuroBlate System. Classifications will be determined by the Investigator.
  • Changes in quality of life [ Time Frame: 2 Years ]
    Characterize the changes in quality of life in subjects with medical temporal lobe epilepsy undergoing LITT using the NeuroBlate System. Quality of life will be measured using the QOLIE-31 questionnaire.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility Study on LITT for Medical Refractory Epilepsy
Official Title  ICMJE Feasibility Study on Laser Interstitial Thermal Therapy Ablation for the Treatment of Medical Refractory Epilepsy (FLARE)
Brief 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.
Detailed Description

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

The NeuroBlate System uses precise, high-intensity laser light to initiate necrosis of abnormal brain tissue through thermal ablation while limiting injury to healthy tissue. Unlike traditional brain surgery, LITT does not require a large opening in the skull.

Subjects who meet the study eligibility criteria and sign the informed consent form will undergo the LITT procedure. Subjects, or their caregivers, are required to keep a seizure diary throughout the study, beginning after surgery. The study will monitor and record subjects' seizure frequency, antiepileptic medications, and physical and emotional health.

Subjects treated with NeuroBlate will have 2 years of follow-up. Throughout study participation, the study investigator will continuously monitor and document both effectiveness and safety data at study appointments.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Epilepsy
Intervention  ICMJE Device: NeuroBlate System
Laser Interstitial Thermal Therapy
Study Arms  ICMJE NeuroBlate LITT Treatment
This is a single arm study. All eligible study subjects will undergo LITT with the NeuroBlate System.
Intervention: Device: NeuroBlate System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 12, 2019)
4
Original Estimated Enrollment  ICMJE
 (submitted: June 28, 2016)
45
Actual Study Completion Date  ICMJE June 24, 2019
Actual Primary Completion Date June 24, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Relevant Inclusion Criteria are listed below

  • 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

Relevant Exclusion Criteria are listed below

  • Previous diagnosis of psychogenic/non-epileptic seizures
  • Previous diagnosis of primary generalized seizures
  • IQ less than 70
  • Subject has a MRI-incompatible implanted electronic device or any metallic prosthesis or implant for which brain MRI is contraindicated
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02820740
Other Study ID Numbers  ICMJE FLARE
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Monteris Medical
Study Sponsor  ICMJE Monteris Medical
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dennis Spencer, MD Yale University
PRS Account Monteris Medical
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP