Prospective Clinical Study of the Levita Magnetics Surgical System Used for Prostatectomy Surgery
Phase: NA
Conditions: Prostatectomy
Sponsor: Levita Magnetics

 
 
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Prospective Clinical Study of the Levita 
Magnetics Surgical System Used for 
Prostatectomy Surgery 
 
 
 
Protocol Number: CP005 
Revision: B 
October 12, 2018 
 
 
 
 
 
Sponsor: Levita Magnetics International Corporation 
 
Alberto Rodriguez-Navarro, MD  
 
Title: CEO and Founder 
 
Email: CP005@levita.com  
 
Telephone: +1 (650) 204-0529 
 
  
 
+569 8 4799140 
 
 
Sponsor Signature:    
 
 
Sponsor Name: Alberto Rodriguez-Navarro, MD 
 
 
 
 
 
CONFIDENTIALITY STATEMENT 
This study is confidential in nature. All information related to this study is considered 
proprietary and should not be made available to those not directly involved in this study. 
Authorized recipients of this information include Investigators and co-Investigators, 
other health care personnel necessary to conduct the study, and Clinical Investigation 
Ethics Committees and Institutional Review Boards. The personnel provided with data 
from this study are hereby informed of its confidential and proprietary nature. Release of 
these data to individuals other than those listed above requires the prior written 
permission of Levita Magnetics. 

 
 
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PROTOCOL REVIEW PAGE 
 
 
STUDY TITLE: 
Prospective Clinical Study of the Levita Magnetics Surgical 
System Used for Prostatectomy Surgery 
 
PROTOCOL: 
CP005 
 
REVISION: 
B 
 
Investigator’s Statement: I agree to conduct this clinical study in accordance with the 
design and specific provisions of this protocol; modifications to the study or protocol are 
acceptable only with a protocol amendment approved by the study sponsor, and the 
Ethics Committee (EC) if required. I agree to await EC approval for the protocol and 
informed consent before initiating the study, to obtain informed consent from subjects 
prior to their enrollment in the study, to collect and record data as required by this 
protocol and case report forms, submit all reports as required by this protocol, provide 
the requested financial information, and to maintain study documentation for the period 
of time detailed in this protocol. 
 
Investigator Signature 
Date of Signature 
 
 
Investigator Name: 
 
 
 
 
 

 
 
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Protocol Synopsis 
 
Title: 
Prospective Clinical Study of the Levita Magnetics Surgical 
System Used for Prostatectomy Surgery 
Study Objective: 
The purpose of this study is to evaluate the safety and 
effectiveness of the Levita Magnetic Surgical System in 
patients undergoing prostatectomy surgery. 
Study Design: 
Prospective, multicenter, single-arm, open label study 
designed to assess the safety and effectiveness of the Levita 
Magnetic Surgical System in prostatectomy surgery. 
Enrollment Size 
and Number of 
Sites: 
Up to 50 subjects at up to three (3) clinical sites in Chile 
Subject Population: All patients at least 18 years of age presenting for elective 
prostatectomy surgery are potential candidates. 
Primary Safety 
Endpoint: 
All adverse events will be captured and reported.  Adverse 
events will be further summarized by relatedness to the 
device and/or procedure, seriousness and level of severity. 
Primary 
Effectiveness 
Endpoint: 
Ability to adequately retract the prostate to achieve an 
effective exposure of the target tissue.  Adequate retraction is 
achieved if it is not necessary to replace the Levita Magnetic 
Surgical System with another instrument to retract the 
prostate during the procedure. 
Inclusion Criteria: 
Subjects must meet ALL of the following inclusion criteria to 
be eligible for participation in the study: 
• Subject is at least 18 years of age 
• Subject is scheduled to undergo elective prostatectomy 
surgery  
• Subject signs a written Informed Consent  Form (ICF) to 
participate in the study, prior to any study required 
procedures 
Exclusion Criteria: 
Subjects must be EXCLUDED from participation in this study 
if ANY of the following exclusion criteria are met: 
• Significant comorbidities: cardiovascular, neuromuscular, 
chronic obstructive pulmonary disease, and urological 
disease (renal failure) 
• Subjects with pacemakers, defibrillators, or other 
electromedical implants 
• Subjects with ferromagnetic implants 
• Clinical history of impaired coagulation confirmed by 
abnormal blood tests 
• Subject has an anatomical abnormality noted after 

 
 
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initiation of index procedure that would prevent device 
use  
• Subject is not likely to comply with the follow-up 
evaluation schedule 
• Subject is participating in a clinical trial of another 
investigational drug or device 
Study Duration / 
Follow-up Period 
Subjects will be followed for 30 days post-procedure, with 
follow-up visits at hospital discharge and at 7 and 30 days 
post-procedure. 
Clinical Sites and 
Site  
Principal 
Investigators*: 
Jorge Díaz, MD 
Fundacion Arturo Lopez Perez (FALP) 
Santiago, Chile 
 
Sponsor: 
Levita Magnetics International Corporation 
Alberto Rodriguez-Navarro, MD  
Title: CEO and Founder 
Email: CP005@levita.com 
Telephone: +1 (650) 204-0529 
* The second and third sites are pending.  An administrative update to the protocol will 
be made when the sites are finalized. 
 

 
 
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Investigator Agreement and Certification    
 
 
 
Site #_______ 
 
Prospective Clinical Study of the Levita Magnetics Surgical  
System Used for Prostatectomy Surgery 
 
I agree to participate in the clinical investigation of the Magnetic Surgical System sponsored 
by Levita Magnetics (hereinafter “Study Sponsor”). I agree to conduct this investigation 
according to the requirements of the investigational plan provided by the Study Sponsor 
and in accordance with Good Clinical Practice requirements as outlined in ISO 14155 and 
conditions imposed by the reviewing Ethics Committee (EC). I agree to ensure informed 
consent is appropriately obtained from all subjects prior to inclusion in this study. 
 
I understand that this investigation will be monitored by the Study Sponsor and/or a 
designee employed by Study Sponsor. This monitoring will involve periodic inspection of 
my investigational site and ongoing review of the data that is submitted by me to Study 
Sponsor. I am also aware that I may be inspected by a representative of the U.S. Food and 
Drug Administration (FDA) or other regulatory authorities. 
 
I am aware that Study Sponsor reserves the right to discontinue this investigation at any 
time. 
 
My current curriculum vitae is attached along with the curriculum vitae of those physicians 
at this institution who will be using this investigational device or participating in this study as 
co-Investigators under my supervision. These include the extent and type of our relevant 
experience with pertinent dates and locations. 
 
I certify that I have not been involved in an investigation that was terminated for 
noncompliance at the insistence of Study Sponsor, this institution’s Ethics Committee (EC) 
or any regulatory authority. 
 
I understand that this investigation, protocol, and trial results are confidential and I agree 
not to disclose any such information to any person other than a representative of Study 
Sponsor or regulatory authority without the prior written consent of Study Sponsor. 
 
I will provide financial information by completing a Levita Financial Disclosure Form and 
update it as necessary. 
 
Accepted by 
Principal Investigator Signature 
date 
Co-Investigator Signature 
date 
Co-Investigator Signature 
date 
Co-Investigator Signature 
Date 
Co-Investigator Signature 
date 

 
 
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Table of Contents 
1 INTRODUCTION ........................................................................................................ 8 
1.1 
BACKGROUND AND RATIONALE ............................................................................ 8 
2 SURGICAL SYSTEM DEVICE DESCRIPTION ......................................................... 9 
3 INDICATION FOR USE ............................................................................................ 10 
4 STUDY PURPOSE AND OBJECTIVE ..................................................................... 10 
5 STUDY ENDPOINTS ................................................................................................ 10 
5.1 
PRIMARY SAFETY ENDPOINT ............................................................................. 11 
5.2 
PRIMARY EFFECTIVENESS ENDPOINT ................................................................. 11 
ABILITY TO ADEQUATELY RETRACT THE PROSTATE TO ACHIEVE AN EFFECTIVE 
EXPOSURE OF THE TARGET TISSUE.  ADEQUATE RETRACTION IS ACHIEVED IF IT IS NOT 
NECESSARY TO REPLACE THE LEVITA MAGNETIC SURGICAL SYSTEM WITH ANOTHER 
INSTRUMENT TO RETRACT THE PROSTATE DURING THE PROCEDURE. .......................... 11 
5.3 
OTHER OUTCOME ASSESSMENTS ...................................................................... 11 
6 STUDY DESIGN ....................................................................................................... 11 
6.1 
OVERVIEW ....................................................................................................... 11 
6.2 
SAMPLE SIZE AND NUMBER OF CENTERS ............................................................ 11 
6.3 
STUDY DURATION ............................................................................................. 11 
7 STUDY PROCEDURES ........................................................................................... 12 
7.1 
SUBJECT ELIGIBILITY, PRE-SCREENING, AND EXCLUSIONS .................................. 12 
7.2 
ENROLLMENT AND WRITTEN INFORMED CONSENT ............................................... 12 
7.3 
SCREENING/BASELINE EVALUATION ................................................................... 13 
7.4 
PROCEDURE ..................................................................................................... 13 
7.5 
POST-PROCEDURE / HOSPITAL DISCHARGE ........................................................ 13 
7.6 
FOLLOW-UP ...................................................................................................... 13 
7.7 
UNPLANNED FOLLOW-UP VISITS ........................................................................ 14 
7.8 
EARLY DISCONTINUATION / WITHDRAWAL ........................................................... 14 
7.9 
LOST TO FOLLOW-UP SUBJECTS ........................................................................ 14 
8 RISK / BENEFIT ANALYSIS .................................................................................... 14 
8.1 
BENEFITS ......................................................................................................... 14 
8.2 
RISKS .............................................................................................................. 15 
8.3 
MINIMIZATION OF RISK AND MONITORING PROCEDURES ...................................... 15 
9 STATISTICAL SECTION .......................................................................................... 16 
9.1 
STATISTICAL METHODS ..................................................................................... 16 
9.2 
SAMPLE SIZE JUSTIFICATION ............................................................................. 16 
10 DATA MANAGEMENT ........................................................................................... 17 
10.1 
DATA COLLECTION ............................................................................................ 17 
10.2 
DATA PROCESSING ........................................................................................... 17 

 
 
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11 MONITORING AND QUALITY CONTROL PROCEDURES .................................. 17 
11.1 
CONTROL OF SYSTEMIC ERROR/ BIAS ................................................................ 17 
11.2 
MONITORING AND AUDITING .............................................................................. 18 
11.3 
DEVICE ACCOUNTABILITY .................................................................................. 19 
12 ADVERSE EVENTS ............................................................................................... 20 
12.1 
DEFINITIONS ..................................................................................................... 20 
12.2 
ADVERSE EVENT REPORTING ............................................................................ 21 
12.3 
ADVERSE EVENT SEVERITY ............................................................................... 22 
12.4 
EVENT RELATIONSHIP ....................................................................................... 22 
12.5 
SUBJECT DEATH ............................................................................................... 24 
12.6 
DEVICE DEFICIENCY .......................................................................................... 24 
13 STUDY OVERSIGHT ............................................................................................. 24 
13.1 
PHYSICIAN ADJUDICATOR .................................................................................. 24 
14 STUDY ADMINISTRATION .................................................................................... 24 
14.1 
STATEMENT OF COMPLIANCE ............................................................................. 24 
14.2 
ETHICS COMMITTEE (EC) APPROVAL ................................................................. 25 
14.3 
INFORMED CONSENT ......................................................................................... 25 
14.4 
AMENDING THE PROTOCOL ................................................................................ 26 
14.5 
PROTOCOL DEVIATIONS/VIOLATIONS AND MEDICAL EMERGENCIES ...................... 26 
14.6 
PRE-STUDY DOCUMENTATION REQUIREMENTS ................................................... 26 
14.7 
RECORD RETENTION ......................................................................................... 27 
14.8 
CRITERIA FOR TERMINATING STUDY ................................................................... 27 
14.9 
CRITERIA FOR SUSPENDING/TERMINATING AN INVESTIGATIONAL SITE ................... 27 
14.10 PUBLICATION POLICY ........................................................................................ 28 
14.11 SPONSOR RESPONSIBILITIES ............................................................................. 28 
14.12 INVESTIGATOR RESPONSIBILITIES ....................................................................... 28 
15 REFERENCES ....................................................................................................... 29 
16 REVISION HISTORY .............................................................................................. 29 
 
APPENDIX 1: INFORMED CONSENT FORM 
 
 

 
 
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1 
INTRODUCTION 
1.1 
Background and Rationale 
Since the introduction of minimally invasive surgery (MIS) in the 1980’s, 
laparoscopy has become the preferred approach for most intra-abdominal 
procedures. One of the key components of laparoscopic surgery, of any 
surgery for that matter, is the ability to achieve and maintain adequate 
visualization of the surgical target throughout the procedure. A number of 
surgical instruments (retractors) have been developed to help mobilize organs 
to obtain an adequate surgical view during MIS procedures. Most of these 
instruments require an additional abdominal wall puncture/incision to use 
them, leading to potentially increased risk of postoperative pain and additional 
scars, as well as incision-related complications such as injury to major blood 
vessels and bowel, infection, incision-related hernias, scarring and chronic 
incisional pain.  The interest in less invasiveness in surgery is aimed at 
reducing the number of abdominal incisions, providing less postoperative 
pain, reducing the risk of incision-related complications, improving the 
cosmetic results, and increasing overall patient satisfaction after surgery 
(Nguyen et al).  
 
Levita Magnetics International Corp. has developed the Levita® Magnetic 
Surgical System (MSS) that can be used for tissue/organ mobilization and 
does not require an additional abdominal wall puncture/incision.  The MSS is 
comprised of a Magnetic Grasper and an external Magnetic Controller. The 
Magnetic Grasper Device is compatible with a 10 mm laparoscopic port. The 
Magnetic Grasper Device is placed internally during laparoscopic surgery and 
is mobilized by the external magnetic field of the Magnetic Controller through 
the abdominal wall.  
 
The safety and effectiveness of the Levita Magnetic Surgical System has 
been 
demonstrated 
for 
the 
retraction 
of 
the 
gallbladder 
during 
cholecystectomy (Rivas et al.). This pivotal study, published in the Annals of 
Surgery and conducted in Chile, supported the marketing clearance of the 
MSS in the United States in 2016.  Initial US experience (Haskins et al.), 
performed at the Cleveland Clinic, confirmed the results described in the 
Rivas publication.   Use of the MSS for gallbladder retraction is similar to the 
proposed use in this study, as both involve the retraction of an organ that will 
be extracted. 
 
This current study is intended to evaluate the safety and effectiveness of the 
Magnetic Surgical System for prostate retraction and expand the 
understanding of the Magnetic Surgical System as a tool for less invasive 
surgery. 

 
 
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2 
SURGICAL SYSTEM DEVICE DESCRIPTION 
The Levita Magnetic Surgical System (MSS) is composed of two handheld 
instruments: a Magnetic Grasper Device and an external Magnetic Controller.  
The Magnetic Grasper Device (Figure 1) is comprised of two main components: 
a Detachable Grasper and a Delivery/Retrieval Shaft.  Once the Magnetic 
Grasper Device is inserted through an access port and the Grasper is attached to 
the desired tissue, the Detachable Grasper can be detached from the 
Delivery/Retrieval Shaft and controlled externally using the Magnetic Controller.  
Traction of the tissue is maintained through the magnetic field attraction between 
the Detachable Grasper and the Magnetic Controller.   The Magnetic Grasper 
Device is compatible with a ≥ 10 mm laparoscopic port. The Magnetic Grasper 
Device is single-use, disposable, and provided sterile to the user.  
 
 
Figure 1. Magnetic Grasper Device 
 
The Magnetic Controller (Figure 2) is a single unit with handles that is held 
external to the body and emits a magnetic field that attracts the Detachable 
Grasper. Once the Detachable Grasper is attached to the desired tissue and 
detached from the Delivery/Retrieval Shaft, the Magnetic Controller is placed 
external to the body to magnetically attract the Detachable Grasper to manipulate 
the target tissue. Adjusting the distance between the Magnetic Controller and the 
Detachable Grasper will modulate the magnetic attraction used for tissue 
retraction/manipulation. If desired, the user can connect the Magnetic Controller 
to a commercially available surgical support arm that is compatible with a 
hexagon-shaped mounting stem. The external Magnetic Controller is re-usable, 
provided non-sterile to the user, and must be placed in an off-the-shelf sterile bag 
prior to use.   

 
 
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       Figure 2. Magnetic Controller 
 
The Magnetic Grasper Device is actuated via its handle with two distinct scissor-
type motions to open and close the Detachable Grasper jaws and to release the 
Detachable Grasper from the Delivery/Retrieval Shaft.  The Magnetic Grasper 
Device can be used for mobilization in the same manner as a conventional tissue 
grasper, or its Detachable Grasper can be released and used with the external 
Magnetic Controller.  When the Detachable Grasper is released from the 
Delivery/Retrieval Shaft, the Delivery/Retrieval Shaft can be removed and 
mobilization of the tissue can be achieved through the magnetic attraction 
between the Detachable Grasper and the external Magnetic Controller. This 
access port is therefore available for use with other surgical tools.  When the 
procedure is completed, the Delivery/Retrieval Shaft may be reinserted to 
retrieve the Detachable Grasper. 
3 
INDICATION FOR USE 
Following is the Indications for Use as it pertains to use of the device in this 
study:  The Magnetic Surgical System is designed to grasp and retract the 
prostate in prostatectomy procedures to facilitate access to and visualization of 
the surgical site.  
4 
STUDY PURPOSE AND OBJECTIVE 
The purpose of this study is to evaluate the safety and effectiveness of the Levita 
Magnetic Surgical System in patients undergoing prostatectomy surgery. 
5 
STUDY ENDPOINTS 
The following endpoints will be evaluated in all subjects who undergo 
prostatectomy surgery using the Magnetic Surgical System.  

 
 
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5.1 
Primary Safety Endpoint 
All adverse events will be captured and reported.  Adverse events will be 
further summarized by relatedness to the device and/or procedure, 
seriousness and level of severity. 
5.2 
Primary Effectiveness Endpoint 
Ability to adequately retract the prostate to achieve an effective exposure 
of the target tissue.  Adequate retraction is achieved if it is not necessary 
to replace the Levita Magnetic Surgical System with another instrument to 
retract the prostate during the procedure. 
5.3 
Other Outcome Assessments 
• Operative time  
• Time spent in the Post Anesthesia Care Unit (PACU) 
• Length of stay (LOS) (time from admittance to post-anesthesia care unit 
until hospital discharge) 
• Conversion rate (conversion to an open procedure due to inadequate 
MSS performance) 
• Estimated blood loss 
• Device malfunctions 
 
6 
STUDY DESIGN 
6.1 
Overview 
This is a prospective, multicenter, single-arm, open label study designed to 
assess the safety and effectiveness of the Levita Magnetic Surgical System in 
prostatectomy surgery. 
6.2 
Sample Size and Number of Centers 
The study will be conducted at up to three (3) study sites with a target 
maximum of 50 subjects in which the Levita Magnetic Surgical System is 
used for prostatectomy procedures. 
6.3 
Study Duration 
Enrollment of subjects in this study is anticipated to take up to 12 months. 
Clinical follow-up evaluations will be conducted at discharge, and 7 and 30 
days following surgery. The total study duration is expected to be 
approximately 13 months. 

 
 
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7 
STUDY PROCEDURES 
7.1 
Subject Eligibility, Pre-Screening, and Exclusions 
All subjects presenting for elective prostatectomy surgery are potential 
candidates, and will be screened for eligibility. A Screening/Enrollment Log 
will be provided to the study sites to maintain a cumulative tracking of all 
screened subjects. 
 
Subjects must meet all study entrance criteria for enrollment in the clinical 
study. Reasons for screening failure(s) will be documented. 
7.1.1 
Inclusion Criteria 
Subjects must meet ALL of the following inclusion criteria to be eligible 
for participation in the study: 
• Subject is at least 18 years of age 
• Subject is scheduled to undergo elective prostatectomy surgery 
• Subject, or authorized representative, signs a written Informed 
Consent  Form (ICF) to participate in the study, prior to any study 
required procedures 
7.1.2 
Exclusion Criteria 
Subjects must be EXCLUDED from participation in this study if ANY of 
the following exclusion criteria are met: 
• Significant comorbidities: cardiovascular, neuromuscular, chronic 
obstructive pulmonary disease, and urological disease (renal 
failure) 
• Subjects with pacemakers, defibrillators, or other electromedical 
implants 
• Subjects with ferromagnetic implants 
• Clinical history of impaired coagulation confirmed by abnormal 
blood tests 
• Subject has an anatomical abnormality noted after initiation of 
index procedure that would prevent device use  
• Subject is not likely to comply with the follow-up evaluation 
schedule 
• Subject is participating in a clinical trial of another investigational 
drug or device 
7.2 
Enrollment and Written Informed Consent 
Patients who pass initial pre-screening will be asked to sign the Informed 
Consent Form (ICF) (See Appendix 1) before any study-specific tests or 
procedures are performed. The Investigator will inform the potential subject of 
the elements of the clinical study, including risks, potential benefits and 
required follow-up procedures, prior to obtaining the potential subject’s 
informed consent. 

 
 
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7.3 
Screening/Baseline Evaluation 
The Screening visit will occur within 30 days prior to the prostatectomy 
procedure. 
 
The following evaluations are required at the time of subject screening 
/baseline: 
• Demographic Information: gender, race, age, weight, and height, and 
smoking status 
• Medical / Surgical History 
• Pre-operative blood draw for determination of coagulation disorders  
7.4 
Procedure 
The Investigator will perform the surgical procedure in accordance with the 
methods detailed in the Instructions for Use. 
 
The following intra-operative data will be collected: 
• General anesthesia time 
• Operative time (from the first incision to the last suture’s placement) 
• Device and procedure observations  
• Conversion to open surgical procedure 
• The need for an additional surgical tool to retract the prostate  
• Estimated blood loss 
• Video recording of the overall procedure 
• Adverse events 
7.5 
Post-Procedure / Hospital Discharge 
Before hospital discharge the following data will be collected: 
• Length of hospital stay (time from admittance to post-anesthesia care unit 
until hospital discharge) 
• Length of time spent in Post Anesthesia Care Unit (PACU) 
• Adverse events, if any 
7.6 
Follow-up 
All subjects will be asked to return to the investigational site at 7 days and 
again at 30 days post-procedure according to the study schedule described in 
Table 1.   Subjects will be queried about adverse events at these study visits.  
Study visits should be scheduled as closely as possible to the earlier part of 
the time period to allow for rescheduling if needed due to last minute 
schedule changes. Visits not completed within the specified time period will 
be regarded as deviations.  
 
 
 

 
 
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Table 1: Schedule of Assessments 
Assessment 
Time Frame 
Pre-op 
Index 
Procedure  
7 day follow-up 
30 day follow-up 
Visit Window 
- 30 days 
NA 
(± 3 days) 
(± 7 days) 
Informed Consent 
√ 
 
 
 
Medical History 
√ 
 
 
 
Demographics 
√ 
 
 
 
Blood Tests 
√ 
 
 
 
Intra-operative 
assessments 
 
√ 
 
 
Adverse events 
 
√ 
√ 
√ 
 
7.7 
Unplanned Follow-up Visits 
Subjects returning for unscheduled visits will be reported on the Unscheduled 
Visit case report form.  
7.8 
Early Discontinuation / Withdrawal  
All subjects will be informed of their right to withdraw from the clinical study at 
any time without penalty or loss of benefits to which the subject is otherwise 
entitled. Additionally, the Investigator may prematurely discontinue any 
subject’s participation in the study if the Investigator feels that the subject can 
no longer fully comply with the requirements of the study or if any of the study 
procedures are deemed potentially harmful to the subject. The reason for 
early discontinuation will be documented in the source documents and the 
Study Termination case report form. 
7.9 
Lost to Follow-up Subjects 
Every attempt will be made to have all subjects complete the follow-up visit 
schedule. A subject will not be considered lost to follow-up unless efforts to 
obtain compliance are unsuccessful. At a minimum, the effort to obtain follow-
up information will include three attempts to make contact via telephone or 
email and if unsuccessful, then a certified letter from the Investigator will be 
sent to the subject’s last known address. In general, the study Site 
Coordinator should attempt to contact the subject as soon as possible after 
any missed visit to reschedule the visit. 
8 
RISK / BENEFIT ANALYSIS 
8.1 
Benefits 
Possible benefits of the Levita Magnetic Surgical System are a reduction in 
the number of surgical incisions needed to perform the surgery, with 
associated reduction in post-operative pain and scaring, a shorter length of 
stay in the hospital, and a faster recovery.  

 
 
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8.2 
Risks 
There are risks associated with use of the Levita Magnetic Surgical System 
including: 
• Electromagnetic field incompatibility or interference  
• Malfunctioning of the device 
• Breakage of the device 
• Allergic reaction related to the device 
• Abdominal wall/cavity/tissue and/or organ injury or damage (e.g. 
inflammation, redness) 
• Infection 
• Tissue damage, including hematoma, bleeding or petechaie 
• Vascular injury 
• Gastro-intestinal injury 
• Organ perforation 
• Need for extended surgery 
• Additional surgical intervention due to any of the above factors (includes 
reoperation) 
 
These adverse events do not include all adverse events, which occur with 
surgery in general, but are important considerations particular to laparoscopic 
instrumentation. 
 
8.3 
Minimization of Risk and Monitoring Procedures 
Levita Magnetics has attempted to mitigate risks as much as possible through 
product design and development which included in vivo performance testing, 
human factors testing, non-clinical performance testing, clinical testing of the 
device in other surgical procedures, biocompatibility testing, sterilization 
validation, reprocessing validation and shelf life validation.  Additionally, 
careful labeling, instructions for use (IFU) and training are provided as 
detailed below. 
 
Risks will be further mitigated through selection of qualified physicians with 
competence in minimally invasive surgery, appropriate training, and study 
monitoring. 
• Investigators who participate in the study will be experienced and skilled in 
laparoscopic 
surgical 
techniques. 
Additionally, 
Investigators, 
in 
conjunction with the investigational site, will have adequate resources for 
participation in a clinical study. 
• The study has been designed to ensure treatment and follow-up of 
subjects are consistent with current medical practice. 
• Each Investigator will ensure oversight and approval of the study by the 
Ethics Committee (EC) prior to initiation of the clinical study at his/her 
investigational site. 

 
 
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• The Investigator and study personnel will be trained on the clinical 
protocol. 
• All Investigators who have not previously used the Levita MSS will 
undergo training with simulation models using the MSS prior to first use 
during the clinical study. 
• All Investigators and operating room support personnel will be provided 
with a detailed IFU during training and as a reference for review as 
needed. 
§ The IFU details appropriate safety zones for use of the Magnetic Controller 
in an OR setting and considerations for users of a product with a strong 
magnet. 
• 
Study personnel are also trained with and receive a “Magnetic Surgery 
Screening Checklist” and Operating Room (OR) signage to ensure safe 
use of the system for subjects and users. 
• Subjects will be carefully evaluated against the inclusion/exclusion criteria 
prior to entering the clinical study to ensure that their diagnosis and 
medical status are appropriate for participation in the clinical study. 
• Subjects will be monitored up to the 30-day follow-up visit as defined in 
the study protocol. The follow-up visit will be with an Investigator to 
monitor the subjects’ status.  
• A study Investigator will evaluate the subject for any adverse events 
potentially related to the device. 
• Data from the investigative sites will be monitored throughout the study. 
Levita Magnetics or its designee will conduct monitoring visits at the 
investigative sites at the initiation of the study and periodically throughout 
the study to evaluate protocol compliance and to determine if there are 
any issues that may affect the safety or welfare of the subjects. 
9 
STATISTICAL SECTION 
9.1 
Statistical Methods 
Data collected in the study will be presented using various descriptive 
statistics. Descriptive summaries will be the basis of study reports to generate 
an overall summary of the safety and effectiveness for the device.  
 
Descriptive tables will be produced for baseline characteristics including 
demographics and medical history. 
 
Missing data on study endpoints will be described.  
9.2 
Sample Size Justification 
This is a single-arm, multicenter, investigational study. Consistent with the 
pivotal trial that supported the first marketing authorization in the United 
States for use of the device in laparoscopic cholecystectomy, no formal 
sample size estimation has been performed.  It is expected that enrollment of 

 
 
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50 subjects will provide appropriate evidence of safe and effective use of the 
MSS in this additional subject population. 
10 
DATA MANAGEMENT 
10.1 Data Collection 
Data will be collected on paper case report forms (CRF) supplied by the 
Sponsor. The Site Principal Investigator is responsible for the accuracy and 
completeness of all study documentation. 
 
Corrections to the CRF must be corrected by drawing a single line through 
the incorrect data, entering the correct data beside the incorrect entry, then 
initialing and dating the correction. Incorrect data must not be obscured. The 
use of pencil, erasable ink, or correction fluid on CRFs is prohibited. All fields 
must be completed, e.g. if the item was not done, mark “N/D”. If the item is 
not applicable to an individual case, mark the field “N/A”. 
 
CRFs will be printed on 3-part NCR paper (or equivalent) so that both the site 
and monitor/Sponsor will have copies of the CRFs.  The second copy may be 
sent to the Sponsor for remote monitoring.  Any other subject information sent 
to the Sponsor must be redacted of personal identification information. 
 
A unique study number will be assigned to each subject. All information 
recorded on the CRF about the subject will be recorded with the study 
number on it. The main database will contain only the study number to 
identify the subject. The code with subject name and study number will be 
maintained in a secured designated location at the site and will be inspected 
by study monitors and auditors. Any computerized data will be password 
protected. 
 
Levita Magnetics or its designee will be responsible for database design and 
management for this study. 
10.2 Data Processing 
Prior to data entry, monitoring, as detailed below, will be completed.  In 
association with data entry, the data will be reviewed for further 
inconsistencies or incongruities.  If warranted, a data clarification form or 
communication will be used to query the Investigator. Data entry will be either 
100% audited or double data entry will be used to ensure accurate and 
complete study information. 
11 
MONITORING AND QUALITY CONTROL PROCEDURES 
11.1 Control of Systemic Error/ Bias 
Clinical monitors will verify subject data and ensure compliance with Good 
Clinical Practices (GCPs), clinical protocol and other study requirements.  As 

 
 
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detailed in Section 13, an Independent Physician will adjudicate all adverse 
events for relatedness, severity and seriousness. The adjudication results will 
be used for purposes of data analysis.  The Site Investigator’s analysis will 
also be presented in the final clinical study report. 
11.2 Monitoring and Auditing 
Monitoring visits to the clinical sites will be made periodically during the study, 
to ensure that all aspects of the current, approved protocol/amendment(s) are 
followed. 
 
Prior to the enrollment of any subject in this study, site study personnel will be 
trained to Good Clinical Practice, the protocol and the device including 
Instructions For Use and management of a magnetic device.  Additionally, the 
procedure for obtaining informed consent and the procedure for reporting 
adverse events will be reviewed.  
 
Site monitoring visits will be performed by the Monitor on a regular basis 
during which case report forms will be 100% verified against source 
documentation. Data will be reviewed for safety information, legibility, 
completeness, accuracy, and logical consistency. Additional computer 
programs (e.g. edit checks) that identify selected protocol violations, out-of-
range data, and other data errors may be used to help monitor the trial. 
Investigators will be required to make corrections to any data errors. 
 
The Monitor is responsible for ensuring, through personal contact with the 
Investigator and site personnel, that the members of the clinical staff clearly 
understand and accept the obligations incurred in this investigation, and that 
these obligations are being fulfilled throughout the study. Specifically, the 
Monitor will interact with the site via telephone contact and periodic on-site 
visits to ensure that: 
• Study facilities continue to be acceptable for the conduct of the study 
• Regulatory and study documents are complete and current 
• The protocol is being followed 
• Protocol amendments have been approved by the EC and the hospital 
director (as applicable), and the Sponsor has received the approval in 
writing prior to implementation of the protocol revision 
• Qualified subjects are enrolled in a timely manner 
• Accurate, complete, and current records are maintained for all subjects 
• The information recorded and submitted to the Sponsor is representative 
of the subject record and other supporting documentation 
• Inconsistent and incomplete data are addressed and resolved 
• Accurate, complete, and timely adverse event reports are being made to 
the Sponsor 
• The Site Principal Investigator continues to assume primary responsibility 
for the study 
• Investigational devices are properly stored, dispensed, and accounted for 

 
 
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The Investigator or designee must, upon request, provide to the Monitor or 
regulatory authority the necessary study records for a thorough review of the 
study’s progress. These records include, but are not limited to, case 
report forms and original documents and records such as hospital and 
clinic charts, consent forms, laboratory records, and pharmacy dispensing 
records. 
 
The Monitor will provide a written report to the Sponsor after each on-site 
visit. The report will identify the personnel participating in the visit, the 
activities performed, any protocol deviations, and any action items/corrective 
actions identified. 
 
If compliance problems or protocol deviations are noted, the Sponsor will 
recommend corrective action. If the response from the Investigator is not 
adequate, the Sponsor will terminate the site’s participation in the study and 
notify the regulatory authorities (if applicable). 
 
The study may also be subject to a quality assurance audit by Levita 
Magnetics or its designees, as well as inspection by regulatory authorities. 
 
It is important that the Investigator and relevant study personnel are available 
during the monitoring visits and possible audits and that sufficient time is 
devoted to the process. 
11.3 Device Accountability 
Access to investigational devices shall be controlled and used only in the 
clinical investigation and according to the protocol. 
 
The Sponsor shall keep records to document the physical location of all 
investigational devices from shipment (or hand-carry) to the sites until return 
or disposal. 
 
The Site Principal Investigator or an authorized designee shall keep records 
documenting the receipt, use, return, and disposal of the investigational 
device, which shall include: 
• The date of receipt 
• Identification of each investigational device (lot number) 
• The date of use 
• Subject study identification number 
• Date of return of unused, expired, or malfunctioning investigational device, 
if applicable 
• Date of disposal, if applicable 
 
The Investigator must explain in writing the reasons for any discrepancy 
noted in device accountability. 

 
 
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12 
ADVERSE EVENTS 
12.1 Definitions 
12.1.1 Adverse Event (AE) 
AEs are any untoward medical occurrence, unintended disease or injury, 
or untoward clinical signs (including abnormal laboratory findings) in 
which subjects, users or other persons, whether or not related to the 
investigational medical device.  This definition includes events related to 
the procedures involved.  For users or other persons, this definition is 
restricted to events related to investigational medical devices. 
 
All adverse events, regardless of relationship to the device, must be 
recorded on the case report forms provided. Adverse events that occur 
during this study should be treated by established standards of care. 
 
Adverse events shall be assessed and documented at the time of the 
procedure and at all study follow-up visits. Each Investigator shall 
provide source documentation as requested by the Sponsor to facilitate 
reporting and adjudication of these events. 
12.1.2 Serious Adverse Event (SAE) 
An adverse event is considered a SAE if it: 
• Led to death 
• Led to a serious deterioration in the health of the subject, that either 
resulted in: 
a) A life-threatening illness or injury, or 
b) A permanent impairment of a body structure or a body function, or 
c) In-patient 
hospitalization, 
or 
prolongation 
of 
existing 
hospitalization, or  
d) medical or surgical intervention to prevent permanent life-
threatening illness or injury or permanent impairment to body 
structure or a body function. 
• Led to fetal distress, fetal death or a congenital abnormality 
 
Planned hospitalization for a pre-existing condition, without serious 
deterioration in health, is not considered a serious adverse event. 
12.1.3 Serious Adverse Device Effect (SADE) 
A serious adverse device effect is defined as an adverse event related to 
the use of an investigational medical device that has resulted in any of 
the consequences characteristic of a serious adverse event.   
 

 
 
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12.1.4 Unanticipated Serious Adverse Device Effect (USADE) 
An USADE is a serious adverse device effect which by its nature, 
incidence, severity or outcome has not been identified in the current 
version of the investigational plan. 
 
12.2 Adverse Event Reporting 
Any adverse event that occurs during the course of the study must be 
reported using the Adverse Event (AE) Form in the CRFs and the Investigator 
must sign each report. The Investigator must determine whether the adverse 
event is serious or unanticipated, its severity, and the relationship of each 
adverse event to the investigational device or procedure.   As noted in 
Section 13, an Independent Physician Adjudicator will also adjudicate all AE 
data. 
 
Pre-existing medical conditions or symptoms occurring prior to the 
laparoscopic procedure involving the Levita Magnetic Surgical System should 
not be reported as adverse events, unless there is a worsening of the pre-
existing medical condition. 
 
All serious adverse events, including unanticipated serious adverse device 
effects, must be reported to the Sponsor within 24 hours of the site first 
becoming aware of the event via email (CP005@levita.com).  At a minimum, 
the AE CRF should be provisionally completed, scanned and sent via email. 
The Sponsor will contact the site for additional information, if required. 
 
For any adverse event that is ongoing at the time of the initial report, periodic 
follow-up information is required until the adverse event is resolved or is not 
expected to change. The site should submit relevant follow-up information 
related to the adverse event as soon as it is available. 
 
Depending upon the nature and seriousness of the adverse event, the 
Sponsor may request the Investigator to provide copies of the subject’s 
medical records (such as the subject’s laboratory tests and hospital records, 
Investigator summaries, etc.) to document the adverse event. The Sponsor is 
available to respond to any medical issues that arise during the conduct of 
this study. 
 
The Investigator will report all serious adverse events, including unanticipated 
serious adverse device effects, to the EC according to the EC requirements. 
A copy of this EC communication should be sent to the Sponsor. 
 
Within 10 working days of notification, the Sponsor will report all unanticipated 
adverse device effects to the appropriate authority, all participating 
Investigators, and all reviewing ECs. The Sponsor will ensure that safety 

 
 
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reporting for the study is conducted in compliance with all pertinent 
requirements and regulations. 
12.3 Adverse Event Severity 
The Investigator must determine the severity of the adverse event according 
to the following definitions: 
 
Mild The adverse event is noticeable to the subject, but 
does not interfere with routine activity; the symptoms 
are easily tolerated and transient in nature. 
 
Moderate The adverse event interferes with routine activity but 
responds to symptomatic therapy or rest; the 
symptoms are poorly tolerated and sustained. 
 
Severe The adverse event significantly limits the subject’s 
ability 
to 
perform 
routine 
activities 
despite 
symptomatic therapy. The adverse event requires 
medical 
or 
surgical 
treatment 
or 
results 
in 
hospitalization. 
 
Life-Threatening The subject is at immediate risk of death. 
12.4 Event Relationship 
The following lists the potential event attribution categories. 
12.4.1 Device Related 
An adverse event is considered device-related when the clinical event 
has a reasonable time sequence associated with use of the 
investigational device and is unlikely to be attributed to concurrent 
disease or other procedures or medications. It is reasonable to believe 
that the device directly caused or contributed to the adverse event. 
 
The Investigator will evaluate the relationship of the adverse event to the 
Levita Magnetic Surgical System according to the following definitions: 
 
Definite The adverse event is clearly related to the 
investigational device: the event has a temporal 
relationship to the investigational device, follows a 
known pattern of response, or is otherwise logically 
related to the investigational device, and no 
alternative cause is present. 
 
Probable The 
adverse 
event 
is 
likely 
related 
to 
the 
investigational device: the event has a temporal 
relationship to the investigational device, follows a 
known or suspected pattern of response, or is 
otherwise logically related to the investigational 
device, but an alternative cause may be present. 

 
 
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 Not likely The adverse event is unlikely related to the 
investigational device: the event does not follow a 
clear temporal relationship to the investigational 
device or does not follow a known pattern of 
response, or is otherwise likely to be due to the 
subject’s clinical state or other modes of therapy. 
 
Not related The adverse event is clearly not related to the 
investigational device: the event has no temporal or 
other relationship to the administration of the 
investigational device, follows no known or suspected 
pattern of response, and an alternative cause is 
present. 
 
Unknown Unable to determine the relationship based on all 
available information. 
12.4.2 Procedure-Related 
An adverse event is considered to be procedure-related when it is 
reasonable to believe that the event is associated with the index 
procedure and is not specific to the investigational device. Other 
devices, surgical techniques, or medications required specifically for the 
procedure may have contributed to the occurrence of the event. 
 
The Investigator will evaluate the relationship of the adverse event to the 
procedure according to the following definitions: 
 
Definite The adverse event is clearly related to the procedure: 
the event has a temporal relationship to the 
procedure, follows a known pattern of response, or is 
otherwise logically related to the procedure, and no 
alternative cause is present. 
 
Probable The adverse event is likely related to the procedure: 
the event has a temporal relationship to the 
procedure, follows a known or suspected pattern of 
response, or is otherwise logically related to the 
procedure, but an alternative cause may be present. 
 
Not likely The adverse event is unlikely related to the 
procedure: the event does not follow a clear temporal 
relationship to the procedure or does not follow a 
known pattern of response, or is otherwise likely to be 
due to the subject’s clinical state or other modes of 
therapy. 
 
Not related The adverse event is clearly not related to the 
procedure: the event has no temporal or other 
relationship to the procedure, follows no known or 

 
 
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suspected pattern of response, and an alternative 
cause is present. 
 
Unknown Unable to determine the relationship based on all 
available information. 
 
12.5 Subject Death 
Any subject death during the investigation must be reported to Levita 
Magnetics within 24 hours of Investigator’s knowledge of the death. The 
Adverse Event CRF must be completed and include a complete description of 
the relevant details of the death. A copy of the death records, death 
certificates and an autopsy report (if performed) are required to be sent to the 
Sponsor. In addition, subject death must be reported to the EC in accordance 
with EC requirements. 
12.6 Device Deficiency 
All device deficiencies related to the identity, quality, durability, reliability, 
safety or performance (includes malfunctions, use errors, and inadequate 
labeling) of the device shall be documented. Sponsor will assess all device 
deficiencies that could have led to a serious adverse device effect. 
 
In the event of a suspected malfunction or device deficiency, the 
investigational device should be returned to the Sponsor for analysis. 
Instructions for returning the investigational device will be provided by the 
Sponsor. 
13 
STUDY OVERSIGHT 
13.1 Physician Adjudicator 
An Independent Physician Adjudicator (IPA) will be responsible for the 
adjudication of all reported adverse events. The IPA will be a General 
Surgeon familiar with laparoscopic surgery who is not an Investigator in the 
trial and does not have a financial conflict of interest in relation to the Study 
Sponsor. The adjudication process will include determination of device and 
procedure relatedness, whether the AE was anticipated or unanticipated, and 
the AE’s seriousness and severity. If there is insufficient evidence to make 
these determinations, the IPA may choose to request additional information.  
All available data will be presented for review to the IPA. 
14 
STUDY ADMINISTRATION 
14.1 Statement of Compliance 
The clinical investigations will be in accordance with the ethical principles of 
the Declaration of Helsinki (59th WMA General Assembly, Seoul, October 
2008), ISO 14155:2011 and ICH-GCP Guidelines.  The clinical investigation 
shall not commence until approval by the EC.  Any additional requirements 

 
 
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imposed by the EC or regulatory authority shall be followed. The Sponsor 
shall maintain a Clinical Trial Liability Policy with an insurance company. 
14.2 Ethics Committee (EC) Approval 
The study protocol shall be reviewed and approved by the site’s EC prior to 
subject enrollment. All proposed changes to the investigational plan must be 
reviewed and approved by the Sponsor in writing prior to implementation. 
Significant changes to the investigational plan must be approved in writing by 
the Sponsor and the EC prior to implementation. A significant change is one 
which may increase the risk or present a new risk to a subject, or which may 
adversely affect the scientific validity of the study and/or study data. 
 
Prior to shipment of investigational devices, a signed copy of the EC approval 
letter identifying the clinical study and investigational site is required to be 
submitted to the Sponsor. Investigators are responsible for obtaining and 
maintaining annual renewal of the study by their EC (or according to renewal 
schedule imposed by the EC). Evidence of renewal and continued EC 
approval must be provided to the Sponsor accordingly. 
14.3 Informed Consent 
Written informed consent is mandatory and must be obtained from all 
subjects as per local regulations, prior to their participation in the study. A 
sample of the Informed Consent is provided in Appendix 1. 
 
It is the responsibility of the Investigator to ensure written informed consent 
from each subject, or the legally authorized representative of the subject, is 
obtained prior to the initiation of any study-related procedures. 
 
Study participation is voluntary, and refusal to participate will involve no 
penalty or loss of benefits to which the subject is otherwise entitled. 
 
Study personnel fully knowledgeable in the purposes and procedures of the 
study will approach all prospective study participants. The facilities and 
settings in which prospective participants will be presented with the 
opportunity to learn about and consent to participation in the study will provide 
them sufficient quiet and unhurried time to be informed of the study and to 
ask questions prior to the initiation of study procedures. Study personnel will, 
after presenting the study to prospective participants, assess the subject’s 
understanding and autonomy by asking the subject to explain the study in 
his/her own words. 
 
Once that step is completed, consent will be able to be given by the subject 
signing the consent form. A copy of the consent form will be given to all 
consented participants. 
 

 
 
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Signed subject consent forms must be retained in the study files by the 
Investigator, and be available for review by the Sponsor and/or regulatory 
agencies, as applicable. 
 
The informed consent form and any other written information provided to 
subjects will be revised whenever important new information becomes 
available, or if there is an amendment to the protocol which necessitates a 
change to the content of subject information and/or to the consent form. The 
Investigator will inform the subject of changes in a timely manner, and will ask 
the subject to confirm his/her continuation in the study by signing a revised 
consent form. 
 
Any revised informed consent form and other written information provided to 
subjects must receive approval from the EC and Sponsor prior to use. 
14.4 Amending the Protocol 
This protocol is to be followed exactly, and will only be altered by written 
amendments. Amendments must be approved by all parties responsible for 
approving the protocol prior to implementation. The Informed Consent and 
CRFs will be reviewed to ensure these are amended if necessary. 
 
Administrative changes that do not affect the benefit/risk ratio or scientific 
validity of the study (e.g., editorial changes for clarity) may be made with just 
approval from the Sponsor and will be documented as a protocol revision. 
14.5 Protocol Deviations/Violations and Medical Emergencies 
A protocol deviation or violation is a failure to comply with the requirements of 
the clinical study as specified in the protocol. Examples of protocol deviations 
include late visits, missed visits, and required follow-up testing not completed. 
An example of a protocol violation includes enrollment of a study subject who 
fails to meet inclusion/exclusion criteria as specified in the protocol or failure 
to obtain informed consent. Each Investigator shall conduct this clinical study 
in accordance with the study protocol and any conditions required by the 
reviewing EC. 
 
Deviations/violations from clinical protocol requirements will be reviewed and 
evaluated on an ongoing basis and, as necessary, appropriate corrective 
actions put into place. Levita Magnetics accepts the right of the Investigator to 
deviate from the protocol in an emergency when necessary to safeguard the 
life or the physical well-being of a study subject, but such deviation must be 
reported within 24 hours of implementation to the EC and Sponsor.  
14.6 Pre-Study Documentation Requirements 
Prior to shipment of investigational product, the following documents must be 
provided to Levita Magnetics: 
• Signed protocol/protocol amendments 

 
 
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• Signed and dated Investigator Agreement(s) 
• A copy of the written EC approval of the protocol 
• A copy of the written EC approval of the Informed Consent Form 
• Signed and dated Curriculum Vitae of the Investigator(s) 
• Copy of the Investigator(s)’ current medical license(s), or equivalent 
• Signed and dated Financial Disclosure Form(s) 
14.7 Record Retention 
The Investigator will maintain all essential trial documents and source 
documentation that support the data collected on the study subjects in 
compliance with ICH/GCP guidelines. Documents must be retained until at 
least 2 years have elapsed since the date the investigation is completed or 
terminated or the records are no longer required to support a regulatory 
submission, whichever date is later. These documents will be retained for a 
longer period of time by agreement with Levita Magnetics or in compliance 
with other regulatory requirements. The Investigator will take measures to 
ensure that these essential documents are not accidentally damaged or 
destroyed. If for any reason the Investigator withdraws responsibility for 
maintaining these essential documents, custody must be transferred to an 
individual who will assume responsibility. Levita Magnetics must receive 
written notification of this custodial change. 
14.8 Criteria for Terminating Study 
Levita Magnetics reserves the right to terminate the study but intends only to 
exercise this right for valid scientific or business reasons or reasons related to 
protection of subjects. Investigators and associated ECs will be notified in 
writing in the event of termination. 
 
Possible reasons for study termination include: 
• The discovery of an unexpected, significant, or unacceptable risk to 
subjects enrolled in the study. 
• A decision on the part of Levita Magnetics to suspend or discontinue 
further regulatory submissions for the device. 
14.9 Criteria for Suspending/Terminating an Investigational Site 
Levita Magnetics reserves the right to stop the enrollment of subjects at an 
investigational site at any time after the study initiation visit if no subjects have 
been enrolled or if the center has multiple or severe protocol violations 
without justification or fails to follow remedial actions. 
 
Possible reasons for suspending/terminating a study center include: 
• Failure to obtain written Informed Consent. 
• Failure to report SAE or USADE to Levita Magnetics within 24 hours of 
knowledge. 
• Failure to complete data forms prior to the scheduled monitoring visits. 

 
 
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• Loss of (or unaccounted for) investigational product inventory. 
14.10 Publication Policy 
It is anticipated that the Investigators involved will publish the results of this 
study.   Listing of authors shall follow accepted standards of authorship, such 
as those established by International Committee of Medical Journal Editors 
(ICMJE).  Any manuscripts pertaining to this study shall be reviewed for 
technical and scientific accuracy by Levita Magnetics prior to submission for 
publication.  Levita Magnetics shall be responsible for approving the peer-
reviewed journals for submission of the manuscript and for requesting edits 
prior to submission.  
14.11 Sponsor Responsibilities 
The Sponsor, Levita Magnetics, is responsible for selecting qualified 
Investigators and providing them with the information and materials 
necessary to conduct this trial appropriately, ensuring proper monitoring of 
the investigation, that EC review and approval are obtained, and ensuring that 
the Investigators and the reviewing EC are promptly notified of significant new 
information about this investigation. 
 
Specifically, the Sponsor will be responsible for: 
• Securing compliance with the clinical protocol, Investigators’ agreement, 
and local regulations; 
• Conducting evaluations of all adverse events; 
• Controlling the distribution of the device(s) under investigation; 
• Maintaining records and reports; 
• Analyzing and reporting data; 
• Designating appropriately qualified medical personnel to be available to 
advise on study related medical questions or problems 
 
This study may be used to support regulatory submissions to the United 
States Food and Drug Administration or to regulatory agencies in other 
countries.  If so used, it is the responsibility of the Sponsor to complete such 
applications. 
14.12 Investigator Responsibilities 
Investigators are responsible for items as detailed below:   
• Agree to sign and adhere to the Investigator Agreement. 
• Obtain approval from the EC including subsequent protocol amendments 
and changes to the Informed Consent form and obtaining annual EC 
approval and renewal throughout the duration of the study. 
• Await EC approval, as well as, any additional hospital requirements prior 
to requesting written informed consent from any potential study subject or 
prior to allowing any subject to participate in the study. 
• Complete and provide signed Financial Disclosure information prior to the 
study and maintain this information for the duration of the study. 

 
 
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• Agree to participate in Investigator meetings, if scheduled, by Levita 
Magnetics. 
• Be willing to perform and be capable of performing the surgical 
procedures as outlined in this protocol. 
• Comply with all required elements of this protocol (e.g., perform testing 
and follow-up as specified). 
• Agree to obtain written Informed Consent before any study specific 
procedures are performed. 
• Control any investigational device(s) stored at their site. 
• Be aware of, and comply with, GCP and applicable regulatory 
requirements. 
• Permit monitoring and auditing by the Sponsor, and inspection by the 
regulatory authorities. 
• Have available an adequate number of qualified staff and adequate 
facilities to properly conduct the study. 
• Ensure study personnel are adequately informed about the protocol, the 
investigational device and study-related duties and functions. 
15 
REFERENCES 
Haskins IN, Strong AT, Allemang MT, Bencsath KP, Rodriquez JH, Kroh MD. 
Magnetic surgery: first U.S. experience with a novel device.  Surg Endosc.  
2018;32(2):895-899. DOI 10.1007/s00464-017-5762-z 
 
Nguyen NT, Smith BR, Reavis KM, Nguyen X-MT, Nguyen B, Stamos MJ. 
Strategic laparoscopic surgery for improved cosmesis in general and bariatric 
surgery: analysis of initial 127 cases. J Laparoendosc Adv Surg Tech A. 
2012;22(4):355-361. doi:10.1089/lap.2011.0370. 
 
Rivas H, Robles I, Riquelme F, et al. Magnetic Surgery. Ann Surg. 
2018;267(1):88-93. doi:10.1097/SLA.0000000000002045. 
16 
REVISION HISTORY 
Revision 
Date 
Description of Change 
A 
 June 20, 2018 
   Initial release 
B 
 October 12, 2018 
Expansion of number of subjects 
from 30 to 50