EpilepsyNCT02820740

Feasibility Study on LITT for Medical Refractory Epilepsy

A study testing NeuroBlate System in people with Epilepsy, run by Monteris Medical at 5 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Epilepsy
What is being tested?: NeuroBlate System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4 participants
Where: 5 sitesUnited States
Study dates: 21 Apr 2017to 24 Jun 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Medical University of South Carolina
Charleston, South Carolina, 29425
University of Kansas Medical Center
Kansas City, Kansas, 66160
Yale University School of Medicine
New Haven, Connecticut, 06520
Mount Sinai West
New York, New York, 10019
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013

Other trials in United States

About this study

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

Read the 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.

Conditions: Epilepsy
Being tested: NeuroBlate System
Keywords: Epilepsy, Medial Temporal Lobe Epilepsy, Seizure, NeuroBlate, LITT, Quality of Life
Medical subject headings: Epilepsy, Seizures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NeuroBlate SystemDevice
Laser Interstitial Thermal Therapy

Study groups in NCT02820740
Study group	Role	What they receive
NeuroBlate LITT Treatment	Other	This is a single arm study. All eligible study subjects will undergo LITT with the NeuroBlate System. Receives: Device: NeuroBlate System

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 1 Year

Secondary outcomes (3)

Changes in Seizure Frequency
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.
Measured: 2 Years
Surgical Outcome Classification
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.
Engel Scale Class I: Free of disabling seizures Class II: Rare disabling seizures Class III: Worthwhile improvement Class IV: No worthwhile improvement
ILAE Outcome Scale Class 1: Completely seizure free; no auras Class 2: Only auras; no other seizures Class 3: 1 to 3 seizure days per year; ± auras Class 4: 4 seizure days per year to 50% reduction of baseline seizure days; ± auras Class 5: Less than 50% reduction of baseline seizure days; ± auras Class 6: More than 100% increase of baseline seizure days; ± auras
Measured: 2 Years
Changes in Quality of Life
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 (Quality of Life in Epilepsy) questionnaire. Score scale 0-100 with 100 indicating a higher reported quality of life across seven different categories (seizure worry, overall quality of life, social functioning, emotional wellbeing, medication effects, energy/fatigue, and cognitive functioning).
Measured: 2 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Apr 201724 Jun 2019

First posted1 Jul 2016 (estimated)
Study start21 Apr 2017
Primary completion24 Jun 2019
Study completion24 Jun 2019

Why it stopped: Terminated (failure to enroll)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for EpilepsyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02820740
Sponsor's protocol ID: FLARE
Status last verified: May 2024
First submitted: 8 Jun 2016
Last updated: 12 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
Study of NRTX-1001 Neural Cell Therapy in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (EPIC (EPIlepsy Cell Therapy))
Mesial Temporal Lobe Epilepsy
RecruitingObservational study
Electrocardiographic Changes Associated With Epilepsy
ECG Changes
Recruiting
Combined CM and STN Stimulation for Motor Epilepsy
Motor Epilepsy
Not yet recruiting
Lily's Grace Temporal Interference
Epilepsy
Not yet recruiting
Characterisation of Laryngeal Evoked Potentials Induced by Vagus Nerve Stimulation in Refractory Epilepsy Patients
Refractory Epilepsy, Epilepsy

All Epilepsy trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Feasibility Study on Laser Interstitial Thermal Therapy Ablation for the Treatment of Medical Refractory Epilepsy (FLARE)
ClinicalTrials.gov ID: NCT02820740
Acronym / sponsor ID: FLARE
Conditions: Epilepsy
Keywords: Epilepsy, Medial Temporal Lobe Epilepsy, Seizure, NeuroBlate, LITT, Quality of Life
Study type: Interventional
Recruitment status: TerminatedReason stopped: Terminated (failure to enroll)
Enrolment: 4 participants (actual)
Lead sponsor: Monteris MedicalIndustry (pharma, biotech, devices)
Study start: 21 Apr 2017 (actual)
Primary completion: 24 Jun 2019 (actual)
Study completion: 24 Jun 2019 (actual)
First posted: 1 Jul 2016 (estimated)
Results: Posted 12 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
NeuroBlate LITT Treatment	Other	Device: NeuroBlate SystemThis is a single arm study. All eligible study subjects will undergo LITT with the NeuroBlate System.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NeuroBlate SystemLaser Interstitial Thermal Therapy	Device	NeuroBlate LITT Treatment

Primary outcome

Number of Participants With 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.

3 secondary outcomes

Changes in Seizure Frequency
Time frame: 2 Years
Surgical Outcome Classification
Time frame: 2 Years
Changes in Quality of Life
Time frame: 2 Years

Results and safety

Results posted to the registry on 12 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
NeuroBlate LITT Treatment	4	2

Primary outcome: Number of Participants With Adverse Events

Time frame: 2 Years. Count of participants. Unit: Participants

Measure	NeuroBlate LITT Treatment n = 2
Value	2

Population analysed: The per-protocol analysis was not completed because the study was terminated early and the data collected was insufficient for the analysis despite two subjects completing the study at 24 months.

Primary outcome: Changes in Neuropsychological Functioning

Time frame: 1 Year. Mean (Full Range). Unit: Time in seconds

Measure	NeuroBlate LITT Treatment n = 2
Baseline Trails Making Trial A	29.5 (24 to 35)
Baseline Trails Making Trial B	66 (47 to 85)
1 Year Trails Making A	32.5 (26 to 39)
1 Year Trails Making B	59.5 (43 to 76)

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

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from the time of patient consent (prior to the surgical procedure) to study withdraw/completion, up to 24 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NeuroBlate LITT Treatment	2 of 2 (100%)	0 of 2 (0%)	0 of 2

Limitations and caveats (from the sponsor): The per-protocol analysis was not completed because the study was terminated early and data was insufficient for analysis.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Epilepsy

RecruitingPhase 3
Study of NRTX-1001 Neural Cell Therapy in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (EPIC (EPIlepsy Cell Therapy))
Mesial Temporal Lobe Epilepsy
RecruitingObservational study
Electrocardiographic Changes Associated With Epilepsy
ECG Changes
Recruiting
Combined CM and STN Stimulation for Motor Epilepsy
Motor Epilepsy
Not yet recruiting
Lily's Grace Temporal Interference
Epilepsy
Not yet recruiting
Characterisation of Laryngeal Evoked Potentials Induced by Vagus Nerve Stimulation in Refractory Epilepsy Patients
Refractory Epilepsy, Epilepsy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dennis Spencer, MD principal investigator

Yale University

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing NeuroBlate System in people with Epilepsy, run by Monteris Medical at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events (time frame: 2 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02820740.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024.