Prospective, Multi-center, Single-arm, Open Label Study Designed to Assess the Safety and Feasibility of Liver Retraction With the Levita Magnetic Surgical System: Extended Magnetic Grasper Device
Phase: NA
Conditions: Bariatric Surgery Candidate, Hiatal Hernia
Sponsor: Levita Magnetics

 
 
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Prospective, multi-center, single-arm, open label 
study designed to assess the safety and 
feasibility of Liver Retraction with the Levita 
Magnetic Surgical System: Extended Magnetic 
Grasper Device 
 
 
Investigational Product: 
MSS: MGD-Ext 
Protocol Name: 
Enhanced Magnetic Liver Retraction 
Protocol Number: 
LVT009 
 
 
Revision: B 
19 Jun 2024  
 
 
 
 
 
 
 
 
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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1. ADMINISTRATIVE INFORMATION 
 
1.1 CONTACTS 
 
 Medical, Clinical, and Operational Support 
 
Sponsor Name: 
Levita Magnetics 
 
 
Sponsor Telephone Number: 
+1 650-204-0529 
 
 
Sponsor Email: 
CP009@levita.com 
 
 
Manufacturer and Sponsor Address: 
Levita Magnetics Corp. 
 
453 Ravendale Dr, Suite G 
Mountain View, CA 94043 USA 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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1.2 Sponsor Protocol Approval 
 
 Representatives of Levita Magnetics 
This study will be conducted with the highest respect for the individual participants in 
accordance with the requirements of this clinical study protocol and in accordance 
with the following: 
The ethical principles that have their origin in the Declaration of Helsinki. 
International Conference for Harmonisation Harmonised Tripartite Guideline for Good 
Clinical Practice E6 (ICH GCP E6). 
 
All applicable laws and regulations, including, without limitation, data privacy laws and 
regulations. 
 
SIGNATURES 
 
 
 
 
 
Dr. Alberto Rodríguez Navarro, CEO Levita 
Magnetics  
 
Date 
 
 
 
 
 
 
Dr. Dana Portenier, Medical-Expert Duke 
University 
Date 
 
 
 
 
 
 
 
 
 
 
 
 
 
9 July 2024
July 9, 2024

 
 
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Investigator Agreement and Certification 
Clinical Evaluation of Magnetic Surgical System: Extended Magnetic Grasper 
Device  
 
 
I will provide copies of the clinical trial protocol and all pertinent information to all 
individuals responsible to me who assist in the conduct of the study.  I will discuss 
this material with them to ensure they are fully informed regarding the investigational 
products and the conduct of the study.  
 
I agree to ensure informed consent is appropriately obtained from all subjects prior 
to inclusion in this study in accordance with requirements as specified in ICH 
Guideline for Good Clinical Practice; Section 4.8 and ISO 14155. I will fulfill all 
responsibilities for submitting pertinent information to the Ethics Committee (EC).  I 
will use only the informed consent form approved by the Sponsor and the EC or its 
representative. 
 
I understand that this study will not be initiated without approval of the appropriate 
EC and that all administrative requirements of the governing body of the institution 
will be complied with fully. 
 
I also agree to report all information or data in accordance with the protocol and I 
agree to report without unjustified delay, all Adverse Events (AEs) and Serious 
Adverse Events (SAEs) that could have led to any Unanticipated Adverse Device 
Events (UADEs).  
 
I understand that this investigation may be monitored by the Study Sponsor and/or a 
designee employed by Study Sponsor and agree that Levita Magnetics and/or 
designee will have access to any original source documents from which paper case 
report form (CRF) information may have been generated. This monitoring would 
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. 
 
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 

 
 
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of Study Sponsor or regulatory authority without the prior written consent of Study 
Sponsor. 
 
I also agree to have control over all clinical supplies (including investigational products) 
provided by Levita Magnetics and/or designee and collect and handle all clinical data in 
accordance with the protocol. I further agree not to originate or use the name of Levita 
Magnetics and/or Magnetic Surgical System: Extended Magnetic Grasper Device or any 
of its employees, in any publicity, news release or other public announcement, written or 
oral, whether to the public, press or otherwise, relating to this protocol, to any amendment 
hereto, or to the performance hereunder, without the prior written consent of Levita. 
 
I will provide financial information by completing a Levita Financial Disclosure Form 
and update it as necessary. 
 
I herewith declare that I agree with the protocol described in detail in this document 
and agree to conduct the study in accordance with the protocol and in compliance 
with Good Clinical Practice and all applicable regulatory requirements. 
 
 
 
 Accepted by 
 Principal Investigator Signature         Printed name 
date 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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Protocol Synopsis 
 
 
Sponsor 
Levita Magnetics 
Protocol Title 
Prospective, multi-center, single-arm, open label study 
designed to assess the safety and feasibility of Liver 
Retraction with the Levita Magnetic Surgical System: 
Extended Magnetic Grasper Device 
 
Protocol Number  
LVT009 
Investigational 
Device 
Magnetic Surgical System: Extended Magnetic Grasper Device  
 
Device Description Compared to the Magnetic Surgical System (MSS) that is cleared 
for market in the U.S. per 510(k) K223673 and commercially 
available in Chile, the investigational device (MSS Version 2) 
comprises the same external Magnetic Controller and a modified 
version of the cleared Magnetic Grasper Device with a longer 
Grasper Tip (12.5 cm compared to 6.5 cm).  
Study Objective 
The purpose of this study is to evaluate the safety and 
effectiveness of the Extended Magnetic Grasper Device in 
patients undergoing bariatric and/or hiatal hernia procedures, 
as a liver retractor grasping the liver and/or the tissue 
surrounding the crus of the diaphragm. 
Study Design 
Prospective, multi-center, single-arm, open label study. 
Enrollment Size 
and Number of 
Sites 
Up to 30 subjects will be competitively enrolled in up to 3 
clinical sites in Chile. 
Subject Population All patients at least 18 years of age presenting for elective 
bariatric and/or hiatal hernia surgery are potential candidates. 
Rationale 
Levita has developed an alternative system to provide liver 
retraction with a Version 2 of the Magnetic Grasper Device that 
can be attached to the liver or the tissue surrounding the crus 
of the diaphragm. 

 
 
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Safety Outcomes 
All adverse events will be captured and reported.  Adverse 
events will be summarized by relatedness to the device 
and/or procedure, seriousness and level of severity.   
Feasibility Outcomes Ability to adequately mobilize the liver to achieve an effective 
exposure of the target tissue.  Adequate mobilization is not 
achieved if it is necessary to use another liver retractor during 
the procedure. 
Inclusion Criteria 
Participants must meet ALL of the following inclusion criteria 
to be eligible for participation in the study: 
• At least 18 years of age. 
• Scheduled to undergo elective bariatric and/or hiatal 
hernia procedures.  
• Willing and able to provide 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: 
• Individuals with pacemakers, defibrillators, or other 
electromedical implants. 
• Individuals with ferromagnetic implants. 
• American Society of Anesthesiologists (ASA) score of III 
or IV. 
• Significant comorbidities: cardiovascular, neuromuscular, 
chronic obstructive pulmonary disease, and urological 
disease (renal failure). 
• Clinical history of impaired coagulation confirmed by 
abnormal blood tests. 
• Individuals has signs of hepatic abnormality (e.g.: 
cirrhosis, liver failure, increase in liver enzymes, etc.). 
• Anatomical abnormality or disease of intended target tissue 
noted after initiation of index procedure that would prevent 
device use.  
• Pregnant or wishes to become pregnant during the length 
of study participation.  
• Individual is not likely to comply with the follow-up 
evaluation schedule.  
• 
Participating in a clinical trial of another investigational 
drug or device. 
• Prisoner or under incarceration. 
 

 
 
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Study Duration / 
Follow-up Period 
Subjects will be followed for 30 days post-procedure, with 
follow-up visits at hospital discharge, 7 days, and 30 days 
post-procedure. 
Clinical Sites* and 
Site  
Principal 
Investigators* 
Julio Jiménez, MD 
Hospital Luis Tisné 
Santiago, Chile 
 
Pablo Marín, MD 
Clínica Colonial  
Santiago, Chile 
 
Ignacio Robles, MD 
Clínica INDISA 
Santiago, Chile 
 
Medical Expert 
Dana Portenier, MD 
Chief of Bariatrics and Metabolic Surgery 
Duke University, Durham, NC, USA 
*Additional Investigators and Clinical Sites will be listed in a study report or separate 
document. 
 
 
 
 
 

 
 
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Table of Contents 
 
1. ADMINISTRATIVE INFORMATION.............................................................................2  
1.1 CONTACTS ............................................................................................................ 2 
2. ABBREVIATIONS / ACRONYMS ........................................................................... 11 
3. INTRODUCTION ..................................................................................................... 12 
3.1 
BACKGROUND AND RATIONALE ......................................................................... 12 
4. SURGICAL SYSTEM DEVICE DESCRIPTION ...................................................... 13 
5. INDICATION FOR USE .......................................................................................... 14 
6. STUDY PURPOSE AND OBJECTIVE ................................................................... 15 
7. STUDY ENDPOINTS .............................................................................................. 15 
7.3 
OTHER ASSESSMENTS ...................................................................................... 15 
8. STUDY DESIGN ..................................................................................................... 16 
8.1 
OVERVIEW ....................................................................................................... 16 
8.2 
SAMPLE SIZE AND NUMBER OF CENTERS ........................................................... 16 
8.3 
STUDY DURATION ............................................................................................ 16 
9. STUDY PROCEDURES .......................................................................................... 16 
9.1 
SUBJECT ELIGIBILITY, PRE-SCREENING, AND EXCLUSIONS .................................. 16 
9.2 
SCREENING/BASELINE EVALUATION ................................................................... 17 
9.3 
PROCEDURE .................................................................................................... 18 
9.4 
POST-PROCEDURE / HOSPITAL DISCHARGE ....................................................... 18 
9.5 
FOLLOW-UP ..................................................................................................... 18 
9.6 
UNPLANNED FOLLOW-UP VISITS ........................................................................ 18 
9.7 
EARLY DISCONTINUATION / WITHDRAWAL .......................................................... 19 
9.8 
LOST TO FOLLOW-UP SUBJECTS ........................................................................ 19 
9.9 
STUDY EXIT ..................................................................................................... 19 
9.10 
STUDY SCHEDULE OF ASSESSMENTS ................................................................ 19 
10. RISK / BENEFIT ANALYSIS ................................................................................ 20 
10.1 
BENEFITS ........................................................................................................ 20 
10.2 
RISKS .............................................................................................................. 20 
10.3 
MINIMIZATION OF RISK AND MONITORING PROCEDURES ...................................... 20 
11. STATISTICAL SECTION ...................................................................................... 22 
11.1 
STATISTICAL METHODS .................................................................................... 22 
11.2 
SAMPLE SIZE JUSTIFICATION ............................................................................. 22 
11.3 
SAFETY VARIABLES .......................................................................................... 22 

 
 
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11.4 
SAFETY ........................................................................................................... 22 
11.5 
DEMOGRAPHICS ............................................................................................... 22 
11.6 
HANDLING MISSING DATA ................................................................................. 23 
11.7 
INTERIM ANALYSIS ............................................................................................ 23 
12. DATA MANAGEMENT ......................................................................................... 23 
12.1 
DATA COLLECTION ........................................................................................... 23 
12.2 
DATA PROCESSING .......................................................................................... 24 
12.3 
FINAL CLINICAL STUDY REPORT ........................................................................ 24 
12.4 
PUBLICATION POLICY ....................................................................................... 24 
13. MONITORING AND QUALITY CONTROL PROCEDURES ................................ 24 
13.1 
CONTROL OF SYSTEMIC ERROR/ BIAS ............................................................... 24 
13.2 
MONITORING AND AUDITING .............................................................................. 25 
13.3 
DEVICE ACCOUNTABILITY .................................................................................. 26 
14. ADVERSE EVENTS ............................................................................................. 26 
14.1 
DEFINITIONS .................................................................................................... 26 
14.2 
ADVERSE EVENT REPORTING ............................................................................ 27 
14.3 
ADVERSE EVENT SEVERITY .............................................................................. 29 
14.4 
EVENT RELATIONSHIP ...................................................................................... 29 
14.5 
SUBJECT DEATH .............................................................................................. 30 
14.6 
DEVICE DEFICIENCY ......................................................................................... 31 
15 STUDY ADMINISTRATION ................................................................................... 31 
15.1 
STATEMENT OF COMPLIANCE ............................................................................ 31 
15.2 
ETHICS COMMITTEE (EC) APPROVAL ................................................................. 31 
15.3 
INFORMED CONSENT ........................................................................................ 32 
15.4 
PROTECTION OF PATIENT CONFIDENTIALITY ....................................................... 33 
15.5 
AMENDING THE PROTOCOL ............................................................................... 33 
15.6 
PROTOCOL DEVIATIONS/VIOLATIONS AND MEDICAL EMERGENCIES ...................... 33 
15.7 
PRE-STUDY DOCUMENTATION REQUIREMENTS .................................................. 34 
15.8 
RECORD RETENTION ........................................................................................ 34 
15.9 
SITE CLOSE-OUT .............................................................................................. 35 
15.10 STUDY SUSPENSION OR EARLY TERMINATION .................................................... 35 
15.11 CRITERIA FOR SUSPENDING/TERMINATING AN INVESTIGATIONAL SITE .................. 35 
15.12 SPONSOR RESPONSIBILITIES ............................................................................. 36 
15.13 INVESTIGATOR RESPONSIBILITIES ...................................................................... 37 
16 REFERENCES ....................................................................................................... 39 
17 REVISION HISTORY ............................................................................................. 39 
 
 
 
 

 
 
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2. ABBREVIATIONS / ACRONYMS  
 
Abbreviations 
Definitions 
AE 
Adverse Event 
CFR 
Code of Federal Regulations 
CRF  
Case Report Form  
EC 
Ext 
Ethics Committee 
Extended  
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
GDP 
Good Documentation Practice  
HIPPA 
Health Insurance Portability and Accountability Act 
ICF 
Informed Consent Form 
ICH 
International Council for Harmonization 
IFU 
Instructions for Use 
IRB 
Institutional Review Board 
ISO 
International Organization for Standardization 
LOS 
Length of Stay 
MC 
MGD 
Magnetic Controller 
Magnetic Grasper Device 
MIS 
Minimally Invasive Surgery 
MSS 
Magnetic Surgical System 
N/A 
Not Applicable 
N/D 
Not Done 
OR 
Operating Room 
PACU 
Post Anesthesia Care Unit 
PD 
Protocol Deviation 
PI 
Principal Investigator 
PP 
Per Protocol 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event  
SD 
Standard Deviation 
SDV 
Source Document Verification  
SOC 
Standard of Care 
SOP 
Standard Operating Procedures 
UADE 
Unanticipated Adverse Device Effect 
 
 
 

 
 
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3. INTRODUCTION 
3.1 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. During certain MIS procedures, the 
patient’s internal organs, such as the liver, can block or obscure the surgical view. 
A number of surgical instruments (retractors) have been developed to help 
mobilize abdominal 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.  
 
When used for liver mobilization, the Magnetic Surgical System delivers and 
attaches its Detachable Grasper tip to the liver border. The handle portion of the 
Magnetic Grasper Device is then removed from the body, leaving the Detachable 
Grasper attached to the liver and the introduction port available for use by another 
instrument. With the Detachable Grasper attached to the liver, the external 
Magnetic Controller is placed external to the abdominal wall, thereby attracting 
the Detachable Grasper for the purposes of liver mobilization. The Magnetic 
Controller can then be moved freely, facilitating unrestricted shaft-less tissue 
mobilization. At the end of the procedure, the Detachable Grasper is decoupled 
from the Magnetic Controller, recoupled with the Magnetic Grasper Device handle 
and removed from the patient.  
 
The safety and effectiveness of the Levita Magnetic Surgical System has been 
demonstrated in multiple studies (Rivas et al, Haskins, et al, Luengas et al, Welsh 
et al, Davis et al) and is FDA cleared for liver retraction in bariatric procedures.  

 
 
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Nevertheless, the current system can present some limitations when a clear 
exposure of the hiatus is needed. In order to overcome that limitation, a Version 
2 of the Grasper Tiphas been developed with a longer total length. Whereas the 
original Grasper Tip of the Magnetic Grasper Device is 6cm long, the Version 2 
Grasper Tip is 12.5cm long. This will enable retraction of the liver in a different 
way in that Version 2 not only grasps the liver, but also may be used to grasp the 
tissue surrounding the crus of the diaphragm for increased retraction of the 
liver for better exposure of the target tissue. 
 
This current study is intended to evaluate the safety and effectiveness of this new 
version of the Magnetic Surgical System for liver mobilization and expand the 
understanding of the Magnetic Surgical System as a tool for less invasive 
surgery. 
 
4. 
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 
 
 

 
 
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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 or connected to a surgeon controlled arm (MARSTM 
system). 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.   
 
 
 
 
       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 MC. 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. 
 
5. 
INDICATION FOR USE 
The Magnetic Surgical System is designed for grasping the liver and the tissue 
surrounding the crus of the diaphragm and retract the liver in bariatric and/or 
hiatal hernia procedures to facilitate access to and visualization of the surgical 
site (Figure 3). 

 
 
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Figure 3. Intended Use 
 
6. 
STUDY PURPOSE AND OBJECTIVE 
The purpose of this study is to evaluate the safety and effectiveness of the Levita 
Magnetic Surgical System Version 2 in patients undergoing bariatric and/or hiatal 
hernia procedures. 
 
7. 
STUDY ENDPOINTS 
The following endpoints will be evaluated in all subjects who undergo bariatric 
and/or hiatal hernia procedures using the Magnetic Surgical System.  
 
7.1 Safety Outcomes  
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. 
7.2 Feasibility Outcomes  
Ability to adequately mobilize the liver to achieve an effective exposure of 
the target tissue.  Adequate mobilization is not achieved if it is necessary to 
use another liver retractor during the procedure. 
7.3 Other 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). 

 
 
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• Conversion rate (conversion to an open procedure due to inadequate MSS 
performance). 
• Estimated blood loss. 
• Device malfunctions. 
 
8. 
STUDY DESIGN 
8.1 Overview 
This is a prospective, multicenter, single-arm, open label study designed to 
assess the safety and effectiveness of the Levita Magnetic Surgical System: 
Extended Magnetic Grasper Device in bariatric and/or hiatal hernia 
procedures. 
8.2 Sample Size and Number of Centers 
The study will be conducted at up to three (3) study sites with a target maximum 
of 30 subjects in which the Levita Magnetic Surgical System is used for liver 
mobilization. 
8.3 Study Duration 
Enrollment of subjects in this study is anticipated to take up to 6 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 7 
months. 
 
9. 
STUDY PROCEDURES 
9.1 Subject Eligibility, Pre-Screening, and Exclusions 
All subjects presenting for elective bariatric and/or hiatal hernia procedures 
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. 
9.1.1 
Inclusion Criteria 
Subjects must meet ALL of the following inclusion criteria to be eligible for 
participation in the study: 
• At least 18 years of age. 
• Scheduled to undergo elective bariatric and/or hiatal hernia 
procedures.  
• Willing and able to provide a written Informed Consent  Form (ICF) 
to participate in the study prior to any study required procedures. 

 
 
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9.1.2 
Exclusion Criteria 
Subjects must be EXCLUDED from participation in this study if ANY of the 
following exclusion criteria are met: 
• Individuals with pacemakers, defibrillators, or other electromedical 
implants.  
• Individuals with ferromagnetic implants. 
• American Society of Anesthesiologists (ASA) score of III or IV. 
• Significant comorbidities: cardiovascular, neuromuscular, chronic 
obstructive pulmonary disease, and urological disease (renal 
failure). 
• Clinical history of impaired coagulation confirmed by abnormal 
blood tests. 
• Individuals has signs of hepatic abnormality (e.g.: cirrhosis, liver 
failure, increase in liver enzymes, etc.). 
• Anatomical abnormality or disease of intended target tissue noted 
after initiation of index procedure that would prevent device use. 
• Pregnant or wishes to become pregnant during the length of study 
participation.  
• Individual is not likely to comply with the follow-up evaluation 
schedule.  
• Participating in a clinical trial of another investigational drug or 
device. 
• Prisoner or under incarceration. 
9.2 
Screening/Baseline Evaluation 
Patients will be prescreened for eligibility and if qualified will be approached 
with the study information and asked if they are willing to participate. The 
Screening visit will occur within 30 days prior to the procedure. 
 
Informed consent will be obtained per Section 13.3. All patients who sign a 
consent form are considered study subjects. A study participant is considered 
enrolled after they have signed an informed consent form and after the 
inclusion/exclusion criteria have been met. 
 
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 if 
warranted. 

 
 
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• Urine pregnancy test for women of childbearing potential.  Note that if 
the screening test is more than 1 week prior to the index procedure, a 
second urine pregnancy test is required within 7 days of the index 
procedure. 
9.3 
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 mobilize the liver.  
• Estimated blood loss. 
• Video recording of the overall procedure. 
• Adverse events. 
• Device malfunctions. 
9.4 
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. 
9.5 
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 ¡Error! N
o se encuentra el origen de la referencia..   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 visit window 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.  
 
 
 
 
 
9.6 
Unplanned Follow-up Visits 
Subjects returning for unscheduled visits will be reported on the Unscheduled 
Visit case report form.  
 

 
 
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9.7 
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. 
9.8 
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 after each missed visit to reschedule the 
visit. 
 
9.9 
Study Exit 
Subjects will be considered to have completed and exited the study after the 
30 day follow up visit has been completed. 
 
9.10 Study Schedule of Assessments 
 
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 
√ 
 
 
 
Pregnancy Test * 
 √ 
√ 
 
 
Intra-operative 
assessments 
 
√ 
 
 

 
 
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Adverse events 
 
√ 
√ 
√ 
 
* Urine pregnancy test for all women of childbearing potential at pre-op visit 
and repeated within 7 days of index procedure unless pre-op visit/prior urine 
pregnancy test was within 7 days of index procedure. 
10. 
RISK / BENEFIT ANALYSIS 
10.1 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.  
10.2 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 petechiae. 
• 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. 
 
10.3 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, biocompatibility 
testing, sterilization validation, reprocessing validation and shelf-life validation.  
Additionally, careful labeling, instructions for use (IFU) and training are 
provided as detailed below. 

 
 
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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 
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. 
 
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. 
 
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. 

 
 
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11. 
STATISTICAL SECTION 
11.1 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.  
11.2 Sample Size Justification 
This is a single-arm, multicenter investigational study and considering the 
pivotal trial that supported the first marketing authorization in the United States 
for use of the device in cholecystectomy procedures, enrollment of 30 subjects 
is expected to provide appropriate evidence of safe and effective use of MSS 
in this additional subject population. 
11.3  Safety Variables 
Safety will be monitored via the reported Adverse Events, in this study. All 
adverse events will be captured and reported. Adverse events will be 
summarized by relatedness to the device and/or procedure, seriousness, and 
level of severity.  
11.4 Safety  
All adverse events for participants in the safety population will be reported. See 
Section 14 for definitions   
● Serious Adverse Events. 
● Non-serious Adverse Events.  
● Device Related Serious Adverse Events. 
Results will include the number of participants experiencing each type of 
event as well as the number of events. 
11.5 Demographics 
Subject demographics will be summarized using descriptive statistics (mean, 
median, Standard Deviation (SD), minimum, maximum), number of subjects 
for continuous variables (e.g., age), and frequency distributions (number and 
percentage of subjects) for categorical variables (e.g., sex at birth, race, and 
ethnicity). 

 
 
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11.6 Handling Missing Data 
Only subjects with non-missing data for safety will be used. 
 
11.7 Interim Analysis 
Interim analysis plays a crucial role in ensuring the ongoing safety and 
efficacy of the trial. The interim analysis will involve an evaluation of 
accumulated data after 15 subjects to assess the predefined endpoints. 
 
12. 
DATA MANAGEMENT 
12.1 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. The subject ID is 
assigned at the time of consent. The subject ID format will be ##-###. The first 
part of the ID (##) represents the Site ID. The second part of the ID (###) 
represents the unique subject number. For example, the third subject as site 
01 would have subject ID 01-003. 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. 

 
 
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12.2 Data Processing 
Prior to data entry into the Levita database, monitoring, as detailed below, will 
be completed.  In association with data entry, the data will be reviewed for 
further inconsistencies or incongruities. All data will be collected on source 
documents and source document verification (SDV) will be conducted to 
ensure data collected are reliable and allow reconstruction and evaluation of 
the study. In the SDV process, information reported by the Investigator is 
compared with the original records to ensure that it is complete, accurate, and 
valid.  
 
The Monitor shall generate queries for data errors and discrepancies 
discovered in their review of source documents. When queries are necessary, 
the Monitor will submit a data clarification form. Upon notification, the 
Investigator or designee will respond with a reason for the discrepancy and 
document that data is correct as documented or will provide a corrected 
resolution to the data field. The Monitor shall review the resolution and close 
the query, if appropriate. If additional information is required, the Monitor will 
continue the process until all data requirements are satisfied. 
12.3 Final Clinical Study Report 
A final report will be completed, even if the study is prematurely terminated. 
12.4 Publication Policy 
Information concerning the study device, patent applications, processes, 
unpublished scientific data, the Protocol and other pertinent information is 
confidential and remains the property of the Sponsor.  
 
The clinical investigation will be registered in a publicly accessible database. 
At the conclusion of the trial, the results may be prepared and used in support 
of a regulatory submission and provided at major meeting(s). The publication 
of results from any center experience within the trial is not allowed unless there 
is written consent from the Sponsor.  
 
A publication strategy plan will be developed as a collaboration between the 
Principal Investigators and the Sponsor, Levita Magnetics. 
 
13. MONITORING AND QUALITY CONTROL PROCEDURES 
13.1 Control of Systemic Error/ Bias 
Clinical monitors may verify subject data and ensure compliance with Good 
Clinical Practices (GCP), clinical protocol and other study requirements.   

 
 
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13.2 Monitoring and Auditing 
Monitoring visits to the clinical sites may be made periodically during the study, 
to ensure that it is conducted in accordance with the protocol and the following 
guidelines and standards: ISO 14155, The Code of Federal Regulations 21 
CFR Part 812 and country specific regulations. Levita Magnetics intends to 
monitor the investigational site at an interval consistent with the screening rate.   
 
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.  
 
The Monitor will ensure 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 potentially periodic on-site visits to ensure 
that:  
• Enrolled subjects are appropriately consented. 
• Regulatory and study documents are complete and current. 
• The protocol is appropriately followed. 
• Protocol and any amendments have been approved by the EC, the 
hospital director (as applicable), and the Sponsor has received the 
approval in writing. 
• Accurate, complete, and current records are maintained for all subjects. 
• Source data verification may be undertaken to ensure 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. 
• Investigational devices are properly stored, dispensed and accounted for. 
• Study facilities continue to be acceptable for the conduct of the study. 
• The site Principal Investigator continues to assume primary responsibility 
for the study. 
  
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, original documents, records such as hospital and clinic charts, consent 
forms, laboratory records, and any other study related documents. 
  
The Monitor will provide a written report to the Director of Clinical Operations 
after each on-site visit. The report will identify the personnel participating in the 

 
 
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visit, the activities performed, any protocol deviations, and any action 
items/corrective actions identified. 
  
If compliance problems or protocol deviations are noted, the Director of Clinical 
Operations 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 EC and the regulatory authorities (if applicable).  
  
The study may also be subject to a quality assurance audit by the Sponsor or 
its designees, as well as inspection by appropriate 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. 
13.3 Device Accountability 
Access to investigational devices shall be controlled and used only in the 
clinical investigation by trained and delegated investigators and according to 
the protocol. 
 
The Sponsor shall keep records to document the physical location of all 
investigational devices from shipment (or hand-carried) 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. 
 
The Investigator must explain in writing the reasons for any discrepancy noted 
in device accountability. 
 
14. 
ADVERSE EVENTS 
14.1 Definitions 
14.1.1 Adverse Event (AE) 
AEs are any untoward medical occurrence, unintended disease or injury, 
or untoward clinical signs (including abnormal laboratory findings) in 

 
 
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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 by the Investigator as to its relationship 
and level of relatedness to the investigational device, assessment, and/or 
procedure, 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. 
14.1.2 Serious Adverse Event (SAE) 
An adverse event is considered "serious" (SAE) if, in the view of either 
the Investigator or Sponsor, it results in any of the following outcomes: 
•  Death 
•  Life-threatening 
•  Hospitalization (initial or prolonged) 
•  Disability or permanent change 
•  Congenital Anomaly/Birth Defect 
•  Required Intervention to Prevent Permanent Impairment or Damage 
• Other Serious (Important Medical Events) 
 Planned hospitalization for a pre-existing condition, without serious 
deterioration in health, is not considered a serious adverse event. 
14.1.3    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.   
14.1.4    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. 
 
14.2 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 

 
 
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serious or unanticipated, its severity, and the relationship of each adverse 
event to the investigational device or procedure. In addition, the Investigator 
will identify the date of onset and duration of the AE. 
 
Pre-existing medical conditions or symptoms occurring prior to the 
laparoscopic procedure involving the MSS 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 (CP009@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. All adverse events will 
be monitored until they are adequately resolved or explained.  If an AE 
continues after the study participation ends, the Sponsor and Investigator 
should discuss the need and/or methods for continued surveillance of the 
event. 
 
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 serious and 
unanticipated serious adverse device effects, to the reviewing EC according to 
the EC local reporting requirements. A copy of this EC communication should 
be sent to the Sponsor. 
 
The Sponsor will ensure that safety reporting for the study is conducted in 
compliance with all pertinent requirements and regulations. 
 
The Sponsor’s evaluation of UADEs must be reported to the FDA, all reviewing 
ECs, and participating Investigators within 10 working days of knowledge of the 
event by the Sponsor.  All UADE will be reported to the FDA according to 
regulatory reporting requirements found in CFR 812.46. 
 

 
 
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14.3 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. 
14.4 Event Relationship 
The following lists the potential event attribution categories. 
14.4.1 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. 
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. 

 
 
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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. 
14.4.2 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 products, 
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 suspected pattern of response, and an alternative cause is 
present. 
 
Unknown: Unable to determine the relationship based on all available 
information. 
14.5 
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. 

 
 
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14.6 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 for potential regulatory 
reporting requirements. 
 
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. 
15 
STUDY ADMINISTRATION 
15.1 Statement of Compliance 
The rights, safety, and wellbeing of clinical investigation subjects shall be 
protected consistent with the ethical principles outlined in the Declaration of 
Helsinki.  This shall be understood, observed and applied at every step in this 
clinical investigation.  
 
It is expected that all parties will share in the responsibility for ethical conduct 
in accordance with their respective roles in the investigation.  The Sponsor and 
the Investigator shall avoid improper influence or inducement of the patient, 
Monitor, Investigator, or other parties participating in or contributing to the 
clinical investigation.   
 
The Investigator will ensure that this study is conducted in full conformity with 
the principles set forth in The Belmont Report: Ethical Principles and 
Guidelines for the Protection of Human Subjects of Research, as drafted by 
the US National Commission for the Protection of Human Subjects of 
Biomedical and Behavioral Research (April 18, 1979) and codified in 45 CFR 
Part 46 and/or the ICH E6; 21 CFR, part 50, the Declaration of Helsinki, 
CIOMS, and the International Ethical Guidelines for Biomedical Research 
Involving Human Subjects (2002). The Sponsor shall maintain a Clinical Trial 
Liability Policy with an insurance company. 
15.2 Ethics Committee (EC) Approval 
The study protocol shall be reviewed and approved by the Investigator’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. 
 

 
 
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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. 
15.3 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. 
 
Informed consent will be obtained as outlined in 21 CFR Part 50 and the ICH 
Guideline Good Clinical Practice E6(R2), 9 November 2016). 
 
It is the responsibility of the Investigator to ensure written informed consent 
from each 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 for their records. 
 
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. 

 
 
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Any revised informed consent form and other written information provided to 
subjects must receive approval from the EC and Sponsor prior to use. 
 
Subjects may withdraw consent at any time throughout the course of the trial. 
The rights and welfare of the subjects will be protected by emphasizing to them 
that the quality of their medical care will not be adversely affected if they decline 
to participate in this study. 
 
15.4 Protection of Patient Confidentiality 
At all times throughout the clinical investigation, confidentiality will be observed 
by all parties involved.  All data shall be secured against unauthorized access.  
Privacy and confidentiality of information about each patient shall be preserved 
in the reports and in any publication.  Each patient participating in this study will 
be assigned a unique identifier.  All CRFs will be tracked, evaluated, and stored 
using only this unique identifier. 
The investigational site will maintain a confidential study patient list (paper or 
electronic) identifying all enrolled participants.  This list will contain the assigned 
study patient’s unique identifier and name.  The Site Principal Investigator (PI) 
bears responsibility for keeping this list confidential.  This list will not be provided 
to the Sponsor and is only to be used at the study center. 
Monitors and auditors will have access to the study patient list and other 
personally identifying information of study subjects to ensure that data reported 
in the CRF corresponds to the person who signed the Informed Consent Form 
(ICF) and the information contained in the original source documents.  Such 
personally identifying information may include, but is not limited to, the patient’s 
name, address, date of birth, gender, race, and medical record number. 
Any source documents copied for monitoring purposes by the Sponsor will have 
patient identifiable information redacted and be identified by using the assigned 
patient’s unique identifier in an effort to protect patient confidentiality. 
 
15.5 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. 
 
15.6 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 

 
 
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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.  
15.7 Pre-Study Documentation Requirements 
Prior to shipment of investigational product, the following documents must be 
provided to Levita Magnetics: 
• Signed protocol/protocol amendments. 
• 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). 
15.8 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 or local requirements; 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. To avoid error, the study site should contact Levita 
prior to the destruction of study records to ensure that they no longer need to 
be retained.  In addition, Sponsor should be contacted if the Investigator plans 
to leave the investigational site so that arrangements can be made for the 
handling or transfer of study records. 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. 
 

 
 
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In the event of an FDA audit, the Investigator must allow FDA access to the 
study records for inspection and copying. The Investigator must inform Levita 
Magnetics of any FDA audit and provide Levita with a copy of Form FDA 483 
(List of Observations) if issued. 
15.9 Site Close-out  
At the time of the site close-out visit, the Monitor will collect all outstanding 
study documents, ensure that the Investigator’s files are accurate and 
complete, review record retention requirements with the Investigator, make a 
final accounting of all study supplies, and ensure that all applicable 
requirements are met for the study.  The observations and actions made at this 
visit will be documented in a final closeout report. 
 
15.10 Study Suspension or Early Termination 
Levita Magnetics reserves the right to terminate the study but intends only to 
exercise this right for valid scientific, administrative 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: 
• Unexpectedly high occurrence of adverse events unknown to date in 
respect to their nature, severity, or duration, or the unexpected incidence 
of known adverse events. 
• Obtaining new scientific knowledge that shows that the study is no 
longer valid or necessary. 
• Insufficient recruitment of patients. 
• Unanticipated 
adverse 
device 
effect 
(UADE) 
presenting 
an 
unreasonable risk to participants (Sponsor may terminate the study 
immediately). 
If the study is discontinued or suspended prematurely, the Sponsor shall 
promptly inform all Investigator(s) / Investigational center(s) of the termination 
or suspension and the reason(s) for this.  The IRB shall also be informed 
promptly and provided with the reason(s) for the termination or suspension by 
the Sponsor or by the Site PI / investigational center(s).  Regulatory authorities 
and the personal physicians of the patients may also need to be informed if 
deemed necessary. 
15.11 Criteria for Suspending/Terminating an Investigational Site 
Levita Magnetics reserves the right to stop the enrollment of subjects or 
terminate an investigational site at any time after the study initiation visit for any 
of the following reasons: 
 
• Failure to obtain written Informed Consent. 

 
 
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• Failure to report SAE or USADE to Levita Magnetics within 24 hours of 
knowledge. 
• Repeated failure to complete Case Report Forms (CRFs) Loss of (or 
unaccounted for) investigational product inventory. 
• Repeated protocol violations. 
• Failure of Investigator to comply with training or IFU. 
• Failure to screen at least 1 patient and within any 2-week period.  
• Persistent non-compliance with the protocol. 
• Persistent non-compliance with EC or regulatory requirements. 
15.12 Sponsor Responsibilities 
The Sponsor, Levita Magnetics, has the overall responsibility of the study and 
will work to ensure compliance with the Investigational Plan, elements of ICH 
Guideline Good Clinical Practice E6(R2), 9 November 2016, signed study 
agreements and 21 CFR 812.2(b).   
 
The Sponsor will be responsible for, but not limited to, conducting the following 
tasks: 
• Select qualified Investigators. 
• Select qualified Monitors and other contract study personnel. 
• Provide the Investigational Plan and any subsequent amendments. 
• Sign the protocol.  
• Provide appropriate information and device training to Investigators and 
study site staff.  
• Promptly inform the Investigators and where applicable Institutional 
Review Boards (IRBs), if the study is prematurely terminated or 
suspended and the reason for the termination or suspension. 
• Provide protocol initiation training to include investigational device 
instructions for use, the Investigational Plan, CRF completion 
guidelines, and guidelines for obtaining informed consent. 
• Coordinate ongoing communication with Monitors and study sites to 
resolve any problems concerning the protocol or data collection.  Every 
effort will be made to ensure compliance with the protocol. 
• Retain ownership of all clinical data generated in this study and control 
the use of the data for purposes of regulatory submissions to the FDA. 
• Protect patient confidentiality.  
• Collect, store, and keep secure, at a minimum, the following documents: 
• A current Curriculum Vitae and if applicable, medical license of each 
Investigator. 
• The name of the institutions where the study will be conducted. 
• The IRB approval, in writing, and relevant correspondence. 
• Correspondence with FDA (as required). 
• Investigator Agreement. 

 
 
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• Protocol Signature Page. 
• Appropriate insurance certificates (as necessary) e.g., CLIA/CAP  
• IRB Approved ICF. 
• Names / contact information for Monitor(s). 
• Copies of signed and dated CRFs. 
• Records of any adverse events and adverse device effects. 
• Statistical analyses and underlying supporting data. 
• Final report. 
• The Sponsor will be responsible for maintaining study records per 21 
CFR 812.140(b) and ICH E6 (R1) and ICH E6(R2). 
• The Sponsor will be responsible for monitoring the investigation per 21 
CFR 812.46 and ICH E6 (R1) and ICH E6(R2). 
• The Sponsor will be responsible for reporting per 21 CFR 812.50(b). 
 
15.13 Investigator Responsibilities 
Selected 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. 
• 
Agree to participate in Investigator meetings, if scheduled, by Levita 
Magnetics. 
• 
Willing to perform and be capable of performing treatment procedures 
as outlined in this protocol. 
• 
Comply with all required elements of this protocol (e.g., perform testing 
and follow-up as specified, especially during personnel transitions). 
• 
Agree to obtain written Informed Consent before any study specific 
procedures are performed. 
• 
Conduct or supervise the trial as written in the clinical protocol (e.g., 
perform testing and follow-up as specified, especially during personnel 
transitions). 
• 
Agree to obtain written Informed Consent before any study specific 
procedures are performed and ensure the rights, safety, and welfare of 
human subjects in the study. 
• 
Control any investigational device(s) stored at their site. 
• 
Understand the investigational device, including potential risks and 
side effects. 

 
 
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• 
Be aware of, and comply with, GCP and applicable regulatory 
requirements. 
• 
Permit monitoring and auditing by the Sponsor, and inspection by the 
appropriate 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. 
• 
Ensure that all associates and study team members are informed 
about their duties and obligations. 
• 
Monitor and report all adverse events, protocol violations, and 
unanticipated problems that occur during the study. 
• 
Maintain accurate study records, submit data to Sponsor, if applicable, 
and make the data available for monitoring and inspection. 
• 
Complete Data Forms for each subject. 
• 
Maintain the study EC approval, and inform Sponsor of withdrawal of 
EC approval. 
• 
Submit progress reports and final reports to EC and/or Sponsor. 
• 
Notify the Sponsor and/or EC of any study protocol deviations (PDs) or 
Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE) 
or Unanticipated Adverse Device Effect (UADE) within 24 hours of 
knowledge of the event. 
• 
Maintaining study records per 21 CFR 812.140(a) and ICH E6 (R1) 
and ICH E6(R2). 
 
 
Each Investigator will provide a completed Financial Disclosure statement 
confirming that they have no personal financial interest connected to the study 
or Sponsor, prior to study initiation and upon request at later time points in the 
study if needed. 
 
The Investigator is responsible for maintaining study records for every subject 
participating in the study.  The study center will also maintain original source 
documents from which study-related data are derived. 
 
 
 
 
 
 
 
 
 
 

 
 
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16 
REFERENCES 
 
Luengas R, Galindo J, Castro M, Marambio A, Watkins G, Rodríguez del Rey M, 
Davanzo C, Portenier D, Guerron AD. First prospective clinical trial of reduced 
incision bariatric procedures using magnetic liver retraction. American Society for 
Bariatric Surgery. Elsevier, 1550-7289/2020.  
 
Welsh LK, Davalos G, Diaz R, Narvaez A, Perez JE, Castro M, Kuchibhatla M, 
Risoli T, Portenier  and Guerron AD. Magnetic Liver Retraction Decreases 
Postoperative Pain and Length of Stay in Bariatric Surgery Compared to 
Nathanson Device. Journal of Laparoendoscopic & Advanced Surgical 
Techniques Volume 00, Number 00, 2020. DOI: 10.1089/lap.2020.0388.  
 
Davis MJ, Davalos G, Ortega C, Sugong C, Schimpke S, Jain-Spagler K, Yoo J, 
Seymour K, Sudan R, Portenier D, Guerron AD. Magnetic Liver Retraction: an 
Incision-Less Approach for Less Invasive Bariatric Surgery. Obesity Surgery. DOI 
10.1007/s11695-018-03655-w.  
 
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. 
 
 
17 
REVISION HISTORY 
Revision 
Date 
Description of Change 
A 
04 January 2024 
   Initial release 
B 
19 June 2024 
Addition of Interim Analysis to 
section 11.7 and changes to 
protocol number from CP009 to 
LVT009.