NCT02820740

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2016

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 1, 2016

Completed
10 months until next milestone

Study Start

First participant enrolled

April 21, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2019

Completed
5.1 years until next milestone

Results Posted

Study results publicly available

July 12, 2024

Completed
Last Updated

July 12, 2024

Status Verified

May 1, 2024

Enrollment Period

2.2 years

First QC Date

June 8, 2016

Results QC Date

May 4, 2023

Last Update Submit

July 11, 2024

Conditions

Epilepsy

Keywords

EpilepsyMedial Temporal Lobe EpilepsySeizureNeuroBlateLITTQuality of Life

Outcome Measures

Primary Outcomes (2)

  • Number of Participants With Adverse Events

    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.

    2 Years

  • Changes in Neuropsychological Functioning

    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.

    1 Year

Secondary Outcomes (3)

  • Changes in Seizure Frequency

    2 Years

  • Surgical Outcome Classification

    2 Years

  • Changes in Quality of Life

    2 Years

Study Arms (1)

NeuroBlate LITT Treatment

OTHER

This is a single arm study. All eligible study subjects will undergo LITT with the NeuroBlate System.

Device: NeuroBlate System

Interventions

NeuroBlate SystemDEVICE

Laser Interstitial Thermal Therapy

NeuroBlate LITT Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • years or older at the time of consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Mount Sinai West

New York, New York, 10019, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

EpilepsySeizures

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

The per-protocol analysis was not completed because the study was terminated early and data was insufficient for analysis.

Results Point of Contact

Title
Clinical Program Manager
Organization
Monteris Medical
medicalaffairs@monteris.com
763-401-1727

Study Officials

  • Dennis Spencer, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2016

First Posted

July 1, 2016

Study Start

April 21, 2017

Primary Completion

June 24, 2019

Study Completion

June 24, 2019

Last Updated

July 12, 2024

Results First Posted

July 12, 2024

Record last verified: 2024-05

Locations

US(5)