Laser Ablation of Abnormal Neurological Tissue Using Robotic NeuroBlate System (LAANTERN) Prospective Registry
Conditions: Metastatic Brain Tumor, Primary Brain Tumor, Epileptic/Seizure Foci, Movement Disorders
Sponsor: Monteris Medical

CL10027 
                  LAANTERN Prospective Registry Protocol 
Rev D.2 
Monteris Medical 
Strictly Confidential 
Page 1 of 17 
 
 
 
 
 
 
 
 
 
 
Laser Ablation of Abnormal Neurological Tissue  
using Robotic NeuroBlate® System (LAANTERN)  
Prospective Registry Protocol 
(NCT02392078 23Mar2022) 
 
 
 
 

CL10027 
                  LAANTERN Prospective Registry Protocol 
Rev D.2 
Monteris Medical 
Strictly Confidential 
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PROTOCOL SIGNATURE PAGE 
 
 
Laser Ablation of Abnormal Neurological Tissue  
using Robotic NeuroBlate® System (LAANTERN) 
Prospective Registry Protocol 
 
 
I have read this protocol and agree to adhere to the requirements. I will provide copies of this protocol 
and all pertinent information to the study personnel under my supervision and my hospital institutional 
review board (IRB). I will discuss this material with them and ensure the conduct of the study according to 
this protocol, including applicable laws, regulatory requirements, general standards of good clinical 
practice and any other instructions provided by the Sponsor and the IRB. 
 
 
 
 
 
Site Name 
Site Investigator (Printed Name) 
Site Investigator (Signature) 
Date 

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TABLE OF CONTENTS 
 
1 
Definitions ........................................................................................................................................ 4 
2 
Abbreviations ................................................................................................................................... 6 
3 
Background & Purpose .................................................................................................................... 7 
4 
Study Device .................................................................................................................................... 7 
5 
Study Design Overview .................................................................................................................... 7 
5.1 
Study Objectives ........................................................................................................................ 7 
5.2 
Study Population ....................................................................................................................... 8 
6 
Informed Consent (ICF) ................................................................................................................... 8 
7 
Study Visits ...................................................................................................................................... 8 
7.1 
Description of Standard of Care Assessments ........................................................................ 11 
7.2 
Registry required Questionnaires ............................................................................................ 11 
7.3 
Additional NeuroBlate Procedures .......................................................................................... 12 
7.4 
visit Schedule and Data Collection .......................................................................................... 12 
7.5 
Study Completion or Withdrawal ............................................................................................. 13 
8 
Adverse Event Reporting ............................................................................................................... 13 
8.1 
Reporting of Adverse Events by Clinical Sites ........................................................................ 13 
8.2 
Adverse Event Relatedness .................................................................................................... 14 
8.3 
Safety Committee .................................................................................................................... 14 
9 
Protocol Deviations ........................................................................................................................ 14 
10 
Data Analysis ................................................................................................................................. 14 
11 
Core Lab ........................................................................................................................................ 14 
12 
Study Management ........................................................................................................................ 15 
12.1 
Data Collection and Management ........................................................................................... 15 
13 
Administrative Responsibilities ...................................................................................................... 15 
13.1 
Sponsor Responsibilities ......................................................................................................... 15 
13.2 
Investigator Responsibilities .................................................................................................... 15 
13.3 
Institutional Review Board (IRB) Approval .............................................................................. 16 
13.4 
Confidentiality .......................................................................................................................... 16 
13.5 
Device Accountability .............................................................................................................. 16 
14 
Monitoring ...................................................................................................................................... 16 
15 
Investigator Reports and Records Requirements .......................................................................... 16 
16 
Use of Information and Publication ................................................................................................ 17 
 
 

CL10027 
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1 
DEFINITIONS 
 
Term 
Definition 
Adverse Event (AE) 
Any untoward medical occurrence, unintended disease or injury, untoward 
clinical signs (including abnormal laboratory findings) in subjects, users or other 
person, whether or not related to the medical device. 
 
Engel Classification 
Class I: Free of disabling seizures 
• 
IA: Completely seizure-free since surgery 
• 
IB: Non disabling simple partial seizures only since surgery 
• 
IC: Some disabling seizures after surgery, but free of disabling 
seizures for at least 2 years 
• 
ID: Generalized convulsions with antiepileptic drug withdrawal only 
Class II: Rare disabling seizures (“almost seizure-free”) 
• 
IIA: Initially free of disabling seizures but has rare seizures now 
• 
IIB: Rare disabling seizures since surgery 
• 
IIC: More than rare disabling seizures after surgery, but rare seizures 
for at least 2 years 
• 
IID: Nocturnal seizures only 
Class III: Worthwhile improvement 
• 
IIIA: Worthwhile seizure reduction 
• 
IIIB: Prolonged seizure-free intervals amounting to greater than half the 
follow-up period, but not less than 2 years 
Class IV: No worthwhile improvement 
• 
IVA: Significant seizure reduction 
• 
IVB: No appreciable change 
• 
IVC: Seizures worse 
 
ILAE (International 
League Against 
Epilepsy) 
Classification  
• 
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 
 
Index Procedure 
First NeuroBlate® System procedure after signing the LAANTERN Informed 
Consent Form. 
 
 

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Term 
Definition 
Karnofsky 
Performance Scale 
(KPS) 
The KPS will be collected for brain malignancy subjects only, and for subjects 
16 years and older. The scale runs from 100 to 0, where 100 is “perfect” health 
and 0 is death: 
100 - Normal; no complaints; no evidence of disease. 
90 - Able to carry on normal activity; minor signs or symptoms of 
disease. 
80 - Normal activity with effort; some signs or symptoms of disease. 
70 - Cares for self; unable to carry on normal activity or to do active 
work. 
60 - Requires occasional assistance but is able to care for most of his 
personal needs. 
50 - Requires considerable assistance and frequent medical care. 
40 - Disabled; requires special care and assistance. 
30 - Severely disabled; hospital admission is indicated although death 
not imminent. 
20 - Very sick; hospital admission necessary; active supportive 
treatment necessary. 
10 - Moribund; fatal processes progressing rapidly. 
0 - Dead 
Lansky Performance 
Scale (LPS) 
The LPS will be collected for brain malignancy subjects only, and for subjects 
between 1 year and 16 years of age. The scale runs from 100 to 0, where 100 
is “perfect” health and 0 is death: 
100 – Fully active, normal 
90 – Minor restrictions in strenuous physical activity 
80 – Active, but gets tired more quickly 
70 – Greater restriction of play and less time spent in play activity 
60 – up and around, but active play minimal; keeps busy by being 
involved in quieter activities 
50 – Lying around much of the day, but gets dressed; no active playing 
participates in all quiet play and activities 
40 – Mainly in bed; participates in quiet activities 
30 – Bedbound; needing assistance even for quiet play 
20 – Sleeping often; play entirely limited to very passive activities 
10 – Doesn’t play; does not get out of bed 
0 – Unresponsive 
 
Serious Adverse 
Event (SAE) 
Adverse Event that: 
(a) Led to death 
(b) Led to serious deterioration in the health of the subject, that either resulted 
     in life-threatening illness or injury 
• 
A permanent impairment of a body structure or a body function 
• 
In-patient or prolongation of existing hospitalization  
• 
Medical or surgical intervention to prevent permanent impairment to a body 
structure or a body function 
(c) Led to fetal distress, fetal death or a congenital abnormality or birth defect 
 
 
 
 

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2 
ABBREVIATIONS 
 
Abbreviation 
Term 
AE 
Adverse Event 
CNS 
Central Nervous System 
eCRF 
electronic Case Report Form 
EDC 
Electronic Data Capture 
EQ-5D or EQ-5D -Y 
EuroQol-5 Dimensions adult or youth version 
FACT-Br or FACT-Peds-Br 
Functional Assessment of Cancer Therapy-Brain adult or pediatric 
version 
FDA 
Food and Drug Administration 
ICF 
Informed Consent Form 
ID 
Identification Number 
IFU 
Instructions For Use 
ILAE 
International League Against Epilepsy 
IRB 
Institutional Review Board 
KPS 
Karnofsky Performance Scale 
LITT 
Laser Interstitial Thermal Therapy 
LPS 
Lansky Performance Scale 
MRI 
Magnetic Resonance Imaging 
NBS 
The NeuroBlate® System 
OS 
Overall Survival  
PFS 
Progression Free Survival 
PI 
Primary Investigator 
QOL 
Quality of Life 
QOLIE-31 or QOLIE-48 
Quality of Life in Epilepsy Inventory adult or pediatric version 
SAE 
Serious Adverse Event 
VAS 
Visual Analog Scale 
 
 

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Strictly Confidential 
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3 
BACKGROUND & PURPOSE  
Laser interstitial thermal therapy (LITT) is a minimally invasive technique to necrotize intracranial 
abnormal tissues, originally introduced in 1983. Its use in neurosurgical procedures was historically 
limited by early technical difficulties related to the monitoring and control of the extent of thermal 
distribution. The development of magnetic resonance thermography and its application to LITT has 
allowed for real-time thermal imaging and feedback control during laser energy delivery, allowing for 
precise and accurate delivery of tissue hyperthermia. Improvements in laser probe design, surgical 
stereotactic targeting hardware, and computer monitoring software has accelerated acceptance and 
clinical utilization of LITT as a neurosurgical treatment alternative. There is limited outcome data available 
from utilization of current commercially available LITT systems.  
The NeuroBlate® System (NBS) is a minimally invasive robotic laser thermotherapy tool that is 
manufactured by Monteris Medical. It employs a pulsed surgical laser to deliver targeted energy to 
abnormal brain tissue. With the NBS, a surgeon makes a small hole in the skull, approximately as wide as 
a pencil. A small probe is then used to deliver laser light energy to heat and destroy the target tissue. The 
NBS combines magnetic resonance imaging (MRI) and software-based visualization to necrotize targeted 
tissues in locations in the brain, either superficial or deep. During the procedure, a surgeon operates the 
ablation remotely through a computer module. An MRI-compatible robotic probe driver helps the surgeon 
precisely guide the laser probe to the planned ablation area and apply heat in controlled amounts, until 
the targeted tissue is destroyed. 
To further understand performance and utilization of the NBS in current standard of care, a post-market 
multi-center registry, LAANTERN (Laser Ablation of Abnormal Neurological Tissue using Robotic 
NeuroBlate® system), is designed to collect baseline, procedural and follow-up data on subjects that are 
to undergo thermal therapy using the NBS. The LAANTERN registry is conducted in an observational 
manner with objectives designed for publication purposes. 
 
4 
STUDY DEVICE 
Any commercially available component of NeuroBlate® System may be used for the registry which 
includes, probe, robotic probe driver, and software. For more details regarding system description and 
principle of operation, please refer to the most current Instructions for Use (IFU) found at 
https://www.monteris.com/ifu/  
 
5 
STUDY DESIGN OVERVIEW 
This is a prospective multi-center registry that will include data collection at baseline (prior to NBS 
procedure, which is also referred as the index procedure), index procedure, discharge and up to 5 years 
of follow-up including data from additional NBS procedures. Up to 3,000 subjects may be enrolled at up to 
50 study sites. Some subjects may be enrolled in sub-studies associated with LAANTERN as per site 
participation and sub-study specific consent. 
 
5.1 STUDY OBJECTIVES 
 
Objective 1:  
 
Safety  
Observe safety profile described by NBS or surgical-related SAEs 
Objective 2: Reason for NeuroBlate® 
Objective 3:  Procedural Outcomes 
• 
Local Control 
• 
Progression Free Survival  
• 
Overall Survival  
• 
Seizure Freedom 
o 
Engel and ILAE Classification 
 

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Objective 4: Cognitive & Quality of Life Outcomes 
Collected for subjects based on their disease etiology and age.  
5.2 STUDY POPULATION 
Subjects who meet inclusion criteria and no exclusion criteria and sign the Informed Consent Form (ICF) 
(CL10030) will be considered enrolled in this study. At the time of enrollment, a unique identification 
number (ID) will be assigned to the subject and used to collect all study information via electronic Case 
Report Forms (eCRFs).  
Inclusion Criteria: 
1. Subject or legally authorized representative provides written authorization and/or consent  
2. Subject who is to undergo thermal therapy by the NeuroBlate® System for treatment of their 
neurological disorder 
Exclusion Criteria: 
1. Subject who is, or is expected to be inaccessible for follow-up 
2. Other concurrent medical or other condition (chronic or acute in nature) that, in the opinion of the 
investigator, may prevent participation or otherwise render patient ineligible for the study 
 
6 
INFORMED CONSENT (ICF) 
The Sponsor will provide a template ICF to each site for IRB submission prior to the site initiation. This 
template may be modified to suit the requirements of the individual study site. The Sponsor must pre-
approve all changes to the ICF prior to initial submission to the IRB. A copy of the IRB-approved ICF must 
be sent to the Sponsor and the original copy must be retained at the study site. If the ICF is amended by 
the reviewing IRB, the Sponsor must pre-approve all changes to the ICF prior to submission. In addition, 
a copy of the approved documents must be provided by the Investigator to the Sponsor prior to 
enrollment of subjects in the study.  
The Investigator or assigned designee must administer this approved ICF to each prospective study 
subject and obtain the subject’s signature or a legally authorized representative signature along with the 
date of consent prior to enrollment in the study. The ICF must be obtained in accordance with 21 CFR 
Part 50. Subjects must be informed about their right to withdraw from the study at any time and for any 
reason without sanction, penalty, or loss of benefits to which the subject is otherwise entitled and 
informed that withdrawal from the study will not jeopardize their future medical care. A copy of ICF must 
be given to each subject enrolled in the study. The institutional standard subject consent form does not 
replace the study ICF. 
 
7 
STUDY VISITS 
A subject follow-up schedule is intended to align with typical standard of care practices. Data may be 
collected during in-office subject visits or remotely (e.g. telephone, email, or mail), when feasible and 
appropriate. These modes of data collection aim to help facilitate robust and reliable long-term 
surveillance and survival data collection. For this standard of care registry, the visit windows are 
continuous, however target visit dates are provided below.  Visits should be completed near the target 
visit date or be the most complete visit within the visit window. A visit window tool is available in the EDC 
system. Figure 1 indicates the sequence of subject visits.  
Target Visit Dates: 
• 
Baseline – within 60 days prior to the Index Procedure 
• 
Index Procedure – Day 0 
• 
Discharge – N/A 
• 
1 Month Follow-up Visit – Day 30 
• 
3 Month Follow-up Visit – Day 90  
• 
6 Month Follow-up Visit – Day 180  
• 
1 Year Follow-up Visit – Day 365 
• 
2 Year Follow-up Visit – Day 730 
• 
3 Year Follow-up Visit – Day 1095 

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• 
4 Year Follow-up Visit – Day 1460 
• 
5 Year Follow-up Visit – Day 1825 

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Strictly Confidential 
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Figure 1: Study Flow 

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7.1 DESCRIPTION OF STANDARD OF CARE ASSESSMENTS 
Assessments are collected as conducted based on standard of care: 
• 
Demographics and Health History 
• 
Neurological Exam  
• 
Gait  
• 
Pain Score 
• 
Karnofsky Performance Scale (KPS) or Lansky Performance Scale (LPS) 
• 
Engel/ILAE Classification  
• 
Pain Score; documenting head pain  
• 
MRI scans 
• 
Medications: Data collection will include change in dosage, frequency, and the type of 
medication for the following: 
o 
Steroids 
o 
Anticonvulsants (including antiseizure drugs)  
o 
Chemotherapy medication  
o 
Anticoagulation 
o 
Immunotherapy (e.g. bevacizumab, pembrolizumab) 
 
7.2 REGISTRY REQUIRED QUESTIONNAIRES 
Completion of questionnaires is required for this study. Questionnaires may be completed remotely via 
phone, mail or email if an office visit will not be completed. If a given questionnaire is not completed for a 
subject at Baseline, analysis of questionnaire data for this subject is not possible. Therefore, if the Baseline 
Questionnaire is not completed, this questionnaire is not required during follow-up and will not be 
compensated.   
 
EuroQol-5D (EQ-5D) (All Subjects 16 years old and older); EuroQol-5D-Y (EQ-5D-Y) (All subjects 8-15 
years old)  
The EQ-5D provides simple, generic measure of health for clinical and economic appraisal. This 
questionnaire consists of 2 pages: 1) the EQ-5D-3L descriptive system and 2) the EQ Visual 
Analogue scale (EQ VAS). The descriptive system assesses subject’s mobility, self-care, usual 
activities, pain/discomfort, and anxiety/depression. The EQ VAS records the respondent’s self-rated 
health on an approximately 20 cm vertical, visual analogue scale with endpoints labelled ‘the best 
health you can imagine’ and ‘the worst health you can imagine’. The VAS will be utilized to assess 
subject pain at the lesion site or on head. 
 
FACT–Br (CNS malignancy subjects only 18 years old and older) FACT-Peds-Br-Adolescent (12-17 
years old) and FACT-Peds-Br-Child (7-12 years old)  
Functional Assessment of Cancer Therapy-Brain (FACT-Br) is a commonly used instrument 
measuring general quality of life that reflects symptoms or problems associated with brain 
malignancies across 5 scales. FACT-Br is a brain tumor specific 50-item questionnaire for subjects 
who are not neurologically incapacitated. It will provide an overall QOL score as well as sub-scores 
for physical well-being, social/family well-being, emotional well-being, functional well-being and 
concerns relevant to subjects with brain tumors.  
 
QOLIE-31 (Epilepsy subjects only >18 years old): QOLIE-AD-48 (11-18 years old) QOLCE-55 (Care Giver 
provider). 
The Quality of Life in Epilepsy Inventory (QOLIE-31) contains seven multi-item scales that tap the 
following health concepts: emotional well-being, social functioning, energy/fatigue, cognitive 
functioning, seizure worry, medication effects, and overall quality of life. A QOLIE-31 overall score is 
obtained using a weighted average of the multi-item scale scores. The QOLIE-31 also includes a 
single item that assesses overall health. 
The QOLIE-AD-48 is a survey of health-related quality of life for adolescents (11-18 years of age) 
with epilepsy. 
The QOLCE-55 is a survey of health-related quality of life for pediatrics answered by their care giver. 
 

CL10027 
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Strictly Confidential 
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7.3 ADDITIONAL NEUROBLATE PROCEDURES 
In the case additional NeuroBlate® procedures are performed following the index procedure, this information 
will be collected on the Additional Procedure form. Any adverse events associated with these procedures will 
be collected on an Adverse Event form. Patient follow up schedule is based on the index procedure date. 
Procedure data and reportable adverse events will be collected on all additional NeuroBlate® System 
procedures completed after the Index Procedure. 
 
7.4 VISIT SCHEDULE AND DATA COLLECTION 
Table 1 summarizes the study visit schedule and data collection.  
 
Table 1. Study Visit and Data Collection Schedule 
 
Baseline 
Index 
Procedure 
Discharge 
1M 
3M 
6M 
12M 
Annual visits 
through 5 yrs. 
Demographic and Medical 
History / Epilepsy Etiology  
X 
 
 
 
 
 
 
 
Neurological Exam 
X 
 
X 
X 
X 
X 
X 
X 
Gait 
X 
 
X 
X 
X 
X 
X 
X 
Pain Score 
X 
 
X 
X 
X 
X 
X 
X 
Medication 
X 
X 
X 
X 
X 
X 
X 
X 
KPS or LPS (Brain 
Malignancy only)  
X 
 
X 
X 
X 
X 
X 
X 
FACT-Br or Peds-FACT-Br 
or QOLIE-31 or QOLIE-48 
X 
 
 
X 
X 
X 
X 
X 
EQ-5D or EQ-5D- Y 
X 
 
 
X 
X 
X 
X 
X 
MRI 
 
X 
(Pre and  
post-op) 
 
 
 
 
 
 
Index Procedure Data 
 
X 
 
 
 
 
 
 
Reportable Adverse 
Events  
 
X 
X 
X 
X 
X 
X 
X 
Engel/ILAE Classification 
(Epilepsy subjects Only) 
 
 
 
X 
X 
X 
X 
X 
Additional Procedure Data  
 
X 
X 
X 
X 
X 
X 
X 
End of Study 
End of Study form will be completed upon subject study completion or subject 
withdrawal (See Section 7.5) 

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7.5 STUDY COMPLETION OR WITHDRAWAL 
Subjects will complete the study once their 5-year follow-up visit is completed or if the subject was 
prematurely withdrawn prior to their 5-year visit.  
The subject may be prematurely withdrawn from the study for the following reasons: 
• 
Subject did not have NeuroBlate® Procedure. 
• 
Subject Lost to Follow-up: All efforts shall be made to document at least 3 attempts to 
contact subject, which would include a certified letter to the subject. If attempts to contact 
the subject fail, the subject may be withdrawn from the study and considered lost to 
follow up.  
• 
Subject Withdrawal: A subject may voluntarily withdraw from the study at any time.  
• 
Investigator Withdrawal of Subject: An Investigator may withdraw a subject for reasons 
which may include noncompliance, failure to keep appointments, etc.  
• 
Subject Death: If subject passed away, the expiration date will be considered the end of 
study date. All feasible attempts should be made to confirm date of death, as this is key 
for overall survival analysis. 
 
8 
ADVERSE EVENT REPORTING 
It is the site’s responsibility to report Adverse Events in compliance with their Institutional Review Board. 
 
8.1 REPORTING OF ADVERSE EVENTS BY CLINICAL SITES 
The following adverse events (AE) are considered reportable for this study, as determined by PI 
discretion: 
NeuroBlate® System related AEs 
• 
Adverse events related to the NeuroBlate® System Device (i.e. probe, robotic probe 
driver, software) 
NeuroBlate® Procedure related AEs 
• 
Adverse events that occur due to a NeuroBlate® (LITT) procedure and cannot be directly 
attributed to the NBS Device or surgical procedure 
Surgical Procedure related AEs  
• 
Adverse events that occur due to the surgical procedure and cannot be directly attributed 
to NeuroBlate® System or procedure (i.e. biopsy related event) 
The following adverse events are considered not reportable for this registry: 
• 
Planned hospitalization for a pre-existing condition without serious deterioration in health. 
• 
Any expected postoperative complaints or symptoms such as pain at biopsy site, 
headaches, weakness, cerebral edema, and transient events (less than 30 days from 
procedure) that do not require intervention. If the event involves a clinically significant 
change in severity or duration of symptoms or requires clinical intervention that is 
different from ordinary postoperative care, the event is considered a reportable AE.  
Reportable AEs must be described by duration (start and resolution dates), relationship to the 
NeuroBlate® System or surgical procedure, action taken to resolve the event, and outcome of the event. 
Additional information, such as procedural notes, treatment notes, or clinical summary may be requested 
as supporting documentation.  
  

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8.2 ADVERSE EVENT RELATEDNESS 
The relationship of the AE to the NeuroBlate® System Device (NBS) or the NeuroBlate® (LITT) procedure 
or surgical procedure will be determined by the Primary Investigator (PI) based upon the following 
definitions. 
Definite: The AE follows a reasonable temporal and causative sequence from receipt (or 
attempted receipt) of the device treatment or procedure.  
Possible: The AE follows a reasonable temporal sequence from receipt of the device treatment 
or procedure and the possibility of device treatment or procedure involvement cannot be 
excluded. However, other factors such as underlying disease, concomitant medications, or 
concurrent treatment are presumable. 
Not Related: The AE has no temporal sequence from receipt of the device treatment or 
procedure, or it can be explained by other factors, including underlying disease, concomitant 
medication, or concurrent treatment. Note: If the event is determined to be “Not Related” to either 
the NBS or the Surgical Procedure, it is not considered a reportable AE. 
 
8.3 SAFETY COMMITTEE 
 
A Safety Committee will be used to review reported events to provide unbiased third-party adjudication for 
publications.  
9 
PROTOCOL DEVIATIONS 
A deviation is defined as an event that did not occur according to the registry protocol. For the purpose of 
this registry, and in consideration of standard of care practices across study sites, anticipated protocol 
deviations include: improper consenting of subject (i.e. consent not obtained and improper consenting) 
and not completing study required questionnaires (if not completed at baseline only one deviation needs 
to be completed for that subject or if completed at baseline but a subsequent visit or questionnaire is not 
completed then a deviation for the missed timepoint needs to be completed) A deviation is not required if 
a questionnaire is not completed because the subject does not meet the age requirement for the 
validated QOL.  
All deviations will be reported to Monteris Medical. It is the site’s responsibility to report deviations in 
compliance with their Institutional Review Board. 
 
10 DATA ANALYSIS 
Data collected in this study is observational and there is no pre-defined study hypothesis. Descriptive 
statistics will be used to analyze data. Continuous variables will be summarized with means, standard 
deviations, minimums, and maximums. Categorical variables will be summarized in frequency 
distributions.  
 
11 CORE LAB 
MRIs will be collected according to the Study Visit Schedule. Standard of Care MRI imaging will be sent 
to the Imaging Core Lab for analysis as per the sponsor. The immediate pre-operative and immediate 
post operative images (to include T1 pre-contrast, T1 post-contrast, T2 FLAIR, and any other sequences 
obtained during these timepoints as per standard of care at that institution) are required for upload to 
Monteris. Per core lab or cohort specific needs, additional standard of care imaging at various timepoints 
may be requested by the sponsor in accordance with the site clinical trial agreement (CTA). The sponsor 
will not request MRI sequences or imaging at timepoints that are not considered standard of care per the 
institution.  Please refer to the Image Acquisition Protocol for additional information. 
 
 

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12 STUDY MANAGEMENT 
The study will be performed in accordance with all requirements set forth in the U.S. regulations, 21 Code 
of Federal Regulations (CFR) Parts 50 (Protection of Human Patients), 56 (Institutional Review Board), 
and applicable requirements from the reviewing IRB for the study at each site.  
 
12.1 DATA COLLECTION AND MANAGEMENT  
The study data will be hosted in an electric data capture (EDC) system. The EDC system will be 
compliant with the U.S. regulations, 21 CFR part 11, Electronic Records; Electronic Signatures.  
All required data for this study will be collected on standardized Case Report Forms (CRFs). 
Qualified study staff at each investigational site will perform primary data collection drawn from source 
document (e.g. hospital chart) review. All CRFs will be subject to review for omitted data, gross data 
inconsistencies, illegible data, and deviations. Any deficiencies or deviations will be reviewed, and any 
necessary action determined (e.g. data query, communication to the study center).  
Data review (including crosschecks) will be performed and any discovered errors will be reported to the 
study site using the data correction and query process (as necessary). The study site will review the 
query, respond, and make any necessary corrections or comments. The data cleaning cycle will be 
repeated until all data are considered clean.  
 
13 ADMINISTRATIVE RESPONSIBILITIES  
 
13.1 SPONSOR RESPONSIBILITIES 
The Sponsor’s responsibilities for this study are to: 
• 
Select qualified clinical investigators and study sites 
• 
Provide study protocol training to participating study sites including the Investigator and staff 
conducting the study 
• 
Provide financial support to each study site which is fair, reasonable, and equitable to fair market 
value 
• 
Follow/promote all applicable regulatory standards per CFRs at each study site  
• 
Own and control the use of the data, including review and approval of study-related 
publications/presentations, etc.  
 
13.2 INVESTIGATOR RESPONSIBILITIES 
The Primary Investigator for each site is responsible for ensuring the study is conducted according to: 
• 
All signed agreements (including financial disclosures) 
• 
The Study Protocol 
• 
IRB guidelines 
• 
Applicable FDA regulations 
The Investigator for each site may not begin enrollment until Sponsor receives and approves (when 
necessary) required documents, including a completed and signed Investigator Agreement/Clinical Trial 
Agreement (or equivalent), Protocol Signature Page, IRB and ICF approvals.  
It is acceptable for the Investigator to delegate one or more of the above functions to an associate or Sub-
Investigator or trained Study Coordinator; however, the Investigator remains responsible for the proper 
conduct of the clinical investigation, including obtaining and documenting proper study informed consent, 
collecting all required data, submitting accurate and complete CRFs, etc. 
At each site, appropriate procedures must be followed to maintain subject confidentiality according to 
appropriate local regulations (e.g. Health Insurance Portability and Accountability Act in the U.S.). Each 
site may have its own internal procedures or requirements for use and release of subject medical 

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                  LAANTERN Prospective Registry Protocol 
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information in research studies. Each Investigator is responsible for obtaining appropriate approvals, 
consents, or releases of medical information as dictated by their relevant patient privacy laws. 
The study is not transferable to other sites attended by the Investigator unless prior approval is obtained 
from the appropriate IRB and the Sponsor.  
 
13.3 INSTITUTIONAL REVIEW BOARD (IRB) APPROVAL 
Investigators must submit the study protocol and ICF to their reviewing IRB and obtain IRB written 
approval before being allowed to conduct and participate in the study. Each Investigator must submit to 
the Sponsor a copy of the IRB approval letter, specific to this protocol and addressed to Investigator, 
certifying study approval prior to enrolling subjects into the study. This approval letter should identify the 
study name, study protocol number (including revision number), the date of the approval as well as the 
expiration date of such an approval. The Investigator is also responsible for fulfilling any conditions of 
approval imposed by the IRB, and for maintaining continuation of the approval during the entire study 
period. The Investigator must provide the Sponsor with copies of such approvals.  
 
13.4 CONFIDENTIALITY 
All information and data sent to the Sponsor concerning subjects or their participation in this study will be 
considered confidential. All data used in the analysis and reporting of this evaluation will be used in a 
manner without identifiable reference to the subject.  
 
13.5 DEVICE ACCOUNTABILITY 
Device accountability will NOT be required as there are no investigational devices used in this study.  
 
14 MONITORING  
The Sponsor or a Sponsor representative will monitor the progress of the study as described in the Study 
Monitoring Plan. The Investigator consents to visits by the staff of the Sponsor or its representatives to 
review the study subject medical records, including any test or laboratory data that might have been 
recorded on diagnostic test media (e.g. MRI). 
Subject Records 
The Sponsor will request that any source documents to be submitted to the sponsor, sponsor 
representative be de-identified (subject’s name and other personal identifiers must be removed and 
replaced with the study subject ID).  
These source documents may include but not be limited to: 
• 
Admission, procedural, and discharge reports/notes 
• 
Completed questionnaires  
• 
Documented pain/KPS scores 
• 
Any documentation relevant to a protocol reportable AE/SAE  
• 
Imaging 
 
15  INVESTIGATOR REPORTS AND RECORDS REQUIREMENTS  
The Investigator is responsible for the completion and submission to the Sponsor of all CRFs, AEs or 
other reportable study events (e.g. procedure related complications), and deviations from the protocol. If 
any action is taken by an IRB with respect to the study, the information must be forwarded to the Sponsor 
in a timely manner. 
The Investigator shall prepare and submit complete, accurate, and in a timely manner, the reports listed 
in Table 2 below. In addition to this list, individual IRBs may add additional requirements and/or require a 
different notification time frame. 
 
 
 

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Table 2. Report Types 
Type of Report 
Notification prepared 
by Investigator for 
Notification Time Frame 
Reportable Serious Adverse Events 
as Described in Section 8 
Sponsor 
As soon as possible, preferably 
within 48 hours after discovery 
of event. 
Death or Serious Adverse Event 
IRB per policy 
Withdrawal of IRB Approval 
Sponsor 
Within five (5) working days. 
Deviations to the Protocol 
Sponsor 
IRB per policy 
As soon as possible after 
occurrence of deviation. 
All data must be stored and retained by the investigative site for a minimum of 2 years following a 
notification from Sponsor that all investigative sites are complete, terminated, or discontinued. Should the 
investigator withdraw from the responsibility of retaining study records, then custody of the records 
transfers to a person assuming responsibility. Sponsor will be notified in writing of new custodian by the 
investigative site. 
 
16 USE OF INFORMATION AND PUBLICATION 
The LAANTERN Registry will follow the Publication Plan (CL10084) which outlines the guidelines and 
expectations for LAANTERN publications. For primary manuscript(s) generated from this study, the 
National Principal Investigator of the study may be granted first and/or senior authorship. The order of 
subsequent authors will be determined by their contribution. The number of maximum names on the 
publication will depend on the maximum number of authors allowed by the publisher.  
Manuscript ideas may be generated by any Investigator in the study. Investigators should submit 
publication ideas to the Sponsor for review. An Investigator may also want to publish the study 
experience from his/her own site. The Sponsor reserves the right to review and approve all publications 
and presentations utilizing the study data. The Investigator may proceed with the publication when 
notified by the Sponsor. 
For publication purposes, this study will be submitted for inclusion in the clinical trial study at:  
https://clinicaltrials.gov/ct2/show/NCT02392078