Prospective, Multi-center, Single-arm, Open Label Study Designed to Assess the Safety and Feasibility of the Use of the Dual Robotic Arm Accessory With the Levita Magnetic Surgical System in Laparoscopic Procedures
Phase: NA
Conditions: Bariatric Surgery Candidate, Cholelithiases, Other Disease
Sponsor: Levita Magnetics

 
 
 
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Prospective, multi-center, single-arm, open label study 
designed to assess the safety and feasibility of the use of the 
Dual Robotic Arm Accessory with the Levita Magnetic 
Surgical System in laparoscopic procedures 
 
 
 
 
 
 
Investigational Product: 
Dual Robotic Arm Accessory (DRAA) 
Protocol Name: 
MARS in GI 
Protocol Number: 
CP008 
 
 
 
 
 
 
 
 
 
 
 
 
 
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: 
CP008@levita.com 
 
 
Manufacturer and Sponsor Address: 
Levita Magnetics Corp. 
 
4055A Campbell Avenue 
Menlo Park, CA 94025 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 on Harmonization Harmonized Tripartite Guideline for 
Good Clinical Practice E6 (ICH GCP E6). 
 
All applicable laws and regulations, including, without limitation, data privacy laws 
and regulations. 
 
SIGNATURES 
 
 
 
 
 
 
13-Sep-2022 
Dr. Alberto Rodríguez Navarro, CEO Levita 
Magnetics 
Fecha  
 
 
 
 
 
17-Sep-2022 
Matthew Kroh MD, Medical Expert- Cleveland 
Clinic 
 
Date 
 
 
 
 
 

 
 
 
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Investigator Agreement and Certification 
Clinical Evaluation of the Dual Robotic Arm Accessory  
 
 
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 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. 
 
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. 
 

 
 
 
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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 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 
specimens in accordance with the protocol. I further agree not to originate or use the 
name of Levita Magnetics and/or Dual Robotic Arm Accessory (DRAA), 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 the use of the 
Dual Robotic Arm Accessory with the Levita Magnetic 
Surgical System in laparoscopic procedures 
Protocol Number:  
CP008 
Investigational 
Device:  
Levita Dual Robotic Arm Accessory (DRAA)  
 
Device Description: The Dual Robotic Arm Accessory (DRAA) for the MSS comprises 
two collaborative robotic arms, which along with their controllers 
and control software, are intended for use in medical 
applications, and additional adaptors, for 1) attaching the 
Magnetic Controller of the commercially available Levita 
Magnetics MSS to one robotic arm and 2) attaching a 
commercially available camera and endoscope to the second 
robotic arm. 
 
The design of the robotic arms, referred to as the Scope Arm and 
the Magnet Arm, includes several redundant safety features that 
make them well suited for use with the MSS in the operating 
room environment, including hardware and software safety 
controls. 
 
When mounted on the Scope Arm, an endoscope can be pivoted 
and translated as controlled by the user, while maintaining 
minimal motion at the point where the endoscope enters the 
patient’s body via a standard trocar. Similarly, when mounted on 
the Magnet Arm, the Magnetic Controller can be moved to 
different positions on or away from the abdominal wall. 
Study Objective: 
The purpose of this study is to evaluate the safety and 
feasibility of the Dual Robotic Arm Accessory (DRAA) used 
with the Levita Magnetic Surgical System (MSS).  
Study Design: 
Prospective, multi-center, single-arm, open label study. 
Enrollment Size 
and Number of 
Sites: 
Up to 50 subjects will be competitively enrolled in up to 3 
clinical sites in Chile. 

 
 
 
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Subject Population: All patients at least 18 years of age presenting for elective 
laparoscopic surgery are potential candidates. 
Rationale: 
Levita has developed a Robotic Platform (DRAA) to assist in 
external management of the controlling magnet and the 
laparoscopic camera, which would give better control of surgical 
tools to the surgeon. The DRAA replaces the commercially 
available surgical support arm that is currently used with the 
MSS. 
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.  If device 
related, AEs will be further characterized as to relationship to 
the MSS the DRAA or both. 
Feasibility 
Outcomes: 
Ability to utilize the Levita MSS with the DRAA as intended in 
laparoscopic procedures.  The following outcomes will be 
considered in this feasibility study: 
1. The DRAA is able to engage, move, and decouple with 
the MSS as intended / controlled by the surgeon 
2. The DRAA is able to provide adequate endoscopic 
visualization via a conventional endoscopic system as 
intended / controlled by the surgeon 
3. The procedure is successfully performed with the MSS 
and DRAA. 
4. The MSS or the DRAA cannot be successfully used 
and due to a MSS or DRAA performance issue the 
procedure must be converted to an open 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 laparoscopic procedure  
Willing and able to provide a written Informed Consent  
Form (ICF) to participate in the study prior to any study 
required procedures 
Exclusion Criteria: 
Individuals 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 
Significant comorbidities: cardiovascular, neuromuscular, 
chronic obstructive pulmonary disease, and urological 
disease (renal failure) 

 
 
 
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Clinical history of impaired coagulation confirmed by 
abnormal blood tests 
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 
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 Tisne 
Santiago, Chile 
 
Ignacio Robles, MD  
Hospital de la FACH 
Santiago, Chile 
 
Pablo Marín, MD 
Clínica Colonial 
Santiago, Chile 
Medical Expert: 
Matthew Kroh, MD 
Cleveland Clinic, OH, 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 
1.2 
SPONSOR PROTOCOL APPROVAL ......................................................................... 3 
2 ABBREVIATIONS / ACRONYMS ............................................................................ 11 
3 INTRODUCTION ...................................................................................................... 12 
3.1 
BACKGROUND AND RATIONALE .......................................................................... 12 
4 SURGICAL SYSTEM DEVICE DESCRIPTION ....................................................... 13 
5 INDICATION FOR USE  AND INTENDED USE ...................................................... 16 
6 STUDY PURPOSE AND OBJECTIVE ..................................................................... 17 
7 STUDY ENDPOINTS ................................................................................................ 17 
7.1 
SAFETY OUTCOMES .......................................................................................... 17 
7.2 
FEASIBILITY OUTCOMES .................................................................................... 17 
7.3 
OTHER ASSESSMENTS ...................................................................................... 17 
8 STUDY DESIGN ....................................................................................................... 18 
8.1 
OVERVIEW ....................................................................................................... 18 
8.2 
SAMPLE SIZE AND NUMBER OF CENTERS ............................................................ 18 
8.3 
STUDY DURATION ............................................................................................. 18 
9 STUDY PROCEDURES ........................................................................................... 18 
9.1 
SUBJECT ELIGIBILITY, PRE-SCREENING, AND EXCLUSIONS .................................. 18 
9.2 
SCREENING/BASELINE EVALUATION ................................................................... 19 
9.3 
PROCEDURE ..................................................................................................... 20 
9.4 
POST-PROCEDURE / HOSPITAL DISCHARGE ........................................................ 20 
9.5 
FOLLOW-UP ...................................................................................................... 20 
9.6 
UNPLANNED FOLLOW-UP VISITS ........................................................................ 20 
9.7 
EARLY DISCONTINUATION / WITHDRAWAL ........................................................... 20 
9.8 
LOST TO FOLLOW-UP SUBJECTS ........................................................................ 21 
9.9 
STUDY EXIT ...................................................................................................... 21 
9.10 STUDY SCHEDULE OF ASSESSMENTS ................................................................. 21 
TABLE 1: SCHEDULE OF ASSESSMENTS ......................................................................... 21 
10 RISK / BENEFIT ANALYSIS .................................................................................. 22 
10.1 BENEFITS ......................................................................................................... 22 
10.2 RISKS .............................................................................................................. 22 
10.3 MINIMIZATION OF RISK AND MONITORING PROCEDURES ...................................... 22 
11 STATISTICAL ANALYSIS ..................................................................................... 24 
11.1 STATISTICAL METHODS ..................................................................................... 24 

 
 
 
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11.2 SAMPLE SIZE JUSTIFICATION ............................................................................. 24 
11.3 SAFETY VARIABLES ........................................................................................... 24 
11.4 SAFETY ............................................................................................................ 24 
11.5 DEMOGRAPHICS ............................................................................................... 24 
11.6 HANDLING MISSING DATA .................................................................................. 24 
11.7 INTERIM ANALYSIS ............................................................................................ 25 
12 DATA MANAGEMENT ........................................................................................... 25 
12.1 DATA COLLECTION ............................................................................................ 25 
12.2 DATA PROCESSING ........................................................................................... 25 
12.3 FINAL CLINICAL STUDY REPORT ........................................................................ 26 
12.4 PUBLICATION POLICY ........................................................................................ 26 
13 MONITORING AND QUALITY CONTROL PROCEDURES .................................. 26 
13.1 CONTROL OF SYSTEMIC ERROR/ BIAS ................................................................ 26 
13.2 MONITORING AND AUDITING .............................................................................. 26 
13.3 DEVICE ACCOUNTABILITY .................................................................................. 28 
14 ADVERSE EVENTS ............................................................................................... 28 
14.1 DEFINITIONS ..................................................................................................... 28 
14.2 ADVERSE EVENT REPORTING ............................................................................ 29 
14.3 ADVERSE EVENT SEVERITY ............................................................................... 30 
14.4 EVENT RELATIONSHIP ....................................................................................... 31 
14.5 SUBJECT DEATH ............................................................................................... 32 
14.6 DEVICE DEFICIENCY .......................................................................................... 33 
15 STUDY ADMINISTRATION .................................................................................... 33 
15.1 STATEMENT OF COMPLIANCE ............................................................................. 33 
15.2 ETHICS COMMITTEE (EC) APPROVAL ................................................................. 33 
15.3 INFORMED CONSENT ......................................................................................... 34 
15.4 PROTECTION OF PATIENT CONFIDENTIALITY ....................................................... 35 
15.5 AMENDING THE PROTOCOL ................................................................................ 35 
15.6 PROTOCOL DEVIATIONS/VIOLATIONS AND MEDICAL EMERGENCIES ...................... 35 
15.7 PRE-STUDY DOCUMENTATION REQUIREMENTS ................................................... 36 
15.8 RECORD RETENTION ......................................................................................... 36 
15.9 SITE CLOSE-OUT .............................................................................................. 37 
15.10 STUDY SUSPENSION OR EARLY TERMINATION ..................................................... 37 
15.11 CRITERIA FOR SUSPENDING/TERMINATING AN INVESTIGATIONAL SITE ................... 37 
15.12 SPONSOR RESPONSIBILITIES ............................................................................. 38 
15.13 INVESTIGATOR RESPONSIBILITIES ....................................................................... 39 
16 REFERENCES ....................................................................................................... 41 
17 REVISION HISTORY .............................................................................................. 41 
 
 
 

 
 
 
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2 ABBREVIATIONS / ACRONYMS  
Abbreviations 
Definitions 
AE 
Adverse Event 
CDC 
Center for Disease Control and Prevention 
CFR 
Code of Federal Regulations 
CRF  
Case Report Form  
CRO 
Contract Research Organization 
EC 
Ethics Committee  
EUA 
Emergency Authorization Use 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
GDP 
Good Documentation Practice  
HHS 
United States Department of Health and Human Services 
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 
LAR 
Legal Authorized Representative 
LOS 
Length of Stay 
DRAA 
Dual Robotic Arm Accessory 
MC 
Magnetic Controller 
MIS 
Minimally Invasive Surgery 
MSS 
Magnetic Surgical System 
N/A 
Not Applicable 
N/D 
Not Done 
NSR 
Non-significant Risk 
OR 
Operating Room 
PACU 
Post Anesthesia Care Unit 
PD 
Protocol Deviation 
PHI 
Protected Health Information 
PI 
Principal Investigator 
PP 
Per Protocol 
RA 
Robotic Arm 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event  
SD 
Standard Deviation 
SDV 
Source Document Verification  
SOC 
Standard of Care 
SOP 
Standard Operating Procedures 
SID 
Subject Identification Number 
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 intra-abdominal 
procedures. With limited access to the surgical field, one of the key 
requirements of laparoscopic surgery 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 can block or obscure the 
surgical view. A number of surgical instruments (graspers or 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, leading to potentially increased 
complications. These complications include risk of postoperative pain, 
additional scars, injury to major blood vessels and bowel, infection, incision-
related hernias, and chronic incisional pain, among others.  
 
To maximize the benefits of MIS, robotic surgery was developed more than 30 
years ago. However, the use of the robotic technology has not resulted in 
demonstrated clinical benefit and the same number of incisions are typically 
required in robotic procedures (Tan et al; Leal and Campos). Nevertheless, one 
of the advantages of a robotic platform is that the surgeon has full control of all 
instruments during the surgery.  
 
One of the goals of MIS is a reduction in the number of abdominal incisions, 
resulting in 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 developed the 
Levita® Magnetic Surgical System (MSS) for tissue/organ mobilization. The 
MSS allows the surgeon to move tissue/organs out of the visual field without 
requiring a dedicated incision/port for the tool.   
 
Laparoscopic procedures often require several clinical team members to 
manage the instruments and camera. Ideally only one clinician, who would 
provide direct control of all the internal surgical tools, would be required.  This 
would both improve the operating environment and reduce the cost of the 
procedure by decreasing the number of required personnel.  
 
Recently, Levita has developed a Robotic Platform (DRAA) to assist in external 
management of the controlling magnet which would reduce required personnel 
and give control of all surgical tools to the same surgeon. The DRAA replaces 
the commercially available surgical support arm that is currently used with the 
MSS.  
 

 
 
 
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The safety and effectiveness of the MSS 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. The MSS has also been used 
successfully for liver mobilization in bariatric procedures at Duke Regional 
Medical Center in a series of 40 patients (Davis et al.)  As use of the MSS for 
laparoscopic procedures expands additional data collection is ongoing to detail 
clinician’s experiences with this system in various other laparoscopic 
procedures.   
 
This current study is intended to evaluate the safety and feasibility of the Dual 
Robotic Arm Accessory when used with the Magnetic Surgical System for 
laparoscopic procedures. 
 
4 SURGICAL SYSTEM DEVICE DESCRIPTION 
 
The Dual Robotic Arm Accessory (DRAA) for the MSS, pictured below in Figure 
1, comprises two collaborative robotic arms, which along with their controllers 
and control software, are intended for use in medical applications, and additional 
adaptors, for 1) attaching the Magnetic Controller of the commercially available 
Levita Magnetics MSS to one robotic arm and 2) attaching a commercially 
available camera and endoscope to the second robotic arm. 
 
The design of the robotic arms, referred to as the Scope Arm and the Magnet 
Arm, includes several redundant safety features that make them well suited for 
use with the MSS in the operating room environment, including hardware and 
software safety controls.  
 
When mounted on the Scope Arm, an endoscope can be pivoted and translated 
as controlled by the user, while maintaining minimal motion at the point where 
the endoscope enters the patient’s body via a standard trocar. Similarly, when 
mounted on the Magnet Arm, the Magnetic Controller can be moved to different 
positions on or away from the abdominal wall. 
 
 

 
 
 
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Figure 1. Diagram of Dual Robotic Arm Accessory: the Magnet RA (on far cart) 
is holding the Magnetic Controller (MC) of the Magnetic Surgical System; the 
Scope RA (on near cart) is holding a commercially available endoscope 
 
 
The MSS is composed of three components: the Detachable Grasper, the 
Delivery/Retrieval Shaft (together, the “Magnetic Grasper Device”), and an 
external Magnetic Controller mounted on a Robotic Platform. 
  
The Detachable Grasper and Delivery/Retrieval Shaft make up the Magnetic 
Grasper Device (Figure 2). 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 operated by hand and is 
inserted into the abdominal cavity through a ≥ 10 mm laparoscopic trocar port. The 
Magnetic Grasper Device is single-use, disposable, and provided sterile to the 
user.  
 

 
 
 
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Figure 2. Magnetic Grasper Device 
 
The Magnetic Controller mounted on the robotic arm (Figure 3) emits a magnetic 
field that attracts the Detachable Grasper. Once the Detachable Grasper is 
attached to the desired tissue/organ and detached from the Delivery/Retrieval 
Shaft, the robot arm brings the Magnetic Controller to the external surface of the 
abdominal wall so that it can magnetically couple to the internal Detachable 
Grasper under control of the surgeon, the DRAA moves the Magnetic Controller 
along the surface of the abdomen. When the Magnetic Controller moves, the 
Detachable Grasper follows, thus retracting the internal tissue/organ to a location 
of the surgeon’s choice. The external Magnetic Controller and the DRAA is re-
usable, provided non-sterile to the user, and must be placed in an off-the-shelf 
sterile bag prior to use.   
 
 
 
 
 
       Figure 3. Magnetic Controller 
 
 
The Dual Robotic Arm Accessory (Figure 4) includes two robotic arms, control 
unit(s), and control software. A handheld and/or foot-operated control pad allow 

 
 
 
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for DRAA control by the surgeon or surgical assistant. One arm of the DRAA 
attaches the Magnetic Controller using the arm mount of the Magnetic Controller 
and the second robotic arm attaches a conventional laparoscopic camera. 
 
     
 
 
Figure 4. DRAA. One arm is mobilizing the External Magnetic Controller 
(external magnet) and the second arm is mobilizing a conventional 
laparoscopic camera. 
 
The DRAA is certified to international electrical safety and software standards for 
use in medical products. The design of the DRAA includes several redundant 
safety features which make it well suited for use with the MSS in the operating 
room environment. These features include hardware and software safety controls 
including requirement for an enabling switch, an emergency stop, and controls for 
the workspace, velocity and axis torque of the robot.  As noted, the DRAA is 
provided non-sterile to the user. While no portions of the DRAA are in direct patient 
contact, the Robot Arms are in the sterile field. Therefore, prior to use, the Robot 
Arms must be draped in off the shelf sterile bags (such as the Mayo Stand Cover 
CFI-708).   
 
5 INDICATION FOR USE  AND INTENDED USE 
 
The Magnetic Surgical System is already commercial approved as a class II 
device, is designed to grasp, hold, retract, mobilize, or manipulate soft tissue and 
organs in minimally invasive procedures.  The Robotic Platform is an accessory 
designed to facilitate use of the Magnetic Surgical System and an Endoscopic 
Camera in a hands-free manner.   
 

 
 
 
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The Dual Robotic Arm Accessory (DRAA) is intended to assist in accurate control 
of the Magnetic Surgical System and a commercially available endoscope. It is 
intended for use by trained and qualified surgeons, who are familiar with this device 
prior to surgery, in an operating room environment in accordance with the 
representative specific procedures set forth in the Instructions for Use.   
 
6 STUDY PURPOSE AND OBJECTIVE 
 
The purpose of this study is to evaluate the safety and feasibility of the Robotic 
Platform used with the Levita Magnetic Surgical System in laparoscopic 
procedures. 
 
7 STUDY ENDPOINTS 
 
The following endpoints will be evaluated in all subjects who undergo laparoscopic 
procedures using the Robotic Platform and Magnetic Surgical System.  
 
7.1 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.  If device related, AEs will be further characterized as 
to relationship to the MSS the DRAA or both. 
7.2 Feasibility Outcomes 
Ability to utilize the Levita MSS with the DRAA as intended in laparoscopic 
procedures.  The following outcomes will be considered in this feasibility 
study: 
• The DRAA is able to engage, move, and decouple with the MSS as 
intended / controlled by the surgeon 
• The DRAA is able to provide adequate endoscopic visualization via a 
conventional endoscopic system as intended / controlled by the surgeon 
• The procedure is successfully performed with the MSS and DRAA. 
• The MSS or the DRAA cannot be successfully used and due to a 
MSS or DRAA performance issue the procedure must be converted 
to an open 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) 
• Number of required surgeons 
• Estimated blood loss 
• MSS and Robotic Platform malfunctions 
• Patient and Surgeon satisfaction with the system 
 
8 STUDY DESIGN 
 
8.1 Overview 
This feasibility study is a prospective, multi-center, single-arm, open label 
study designed to assess the safety and feasibility of the use of the Dual 
Robotic Arm Accessory with the Levita Magnetic Surgical System in 
laparoscopic procedures. 
8.2 Sample Size and Number of Centers 
The study will be conducted at up to three (3) clinical sites with a target 
maximum of 50 subjects in which the Robotic Platform and Levita Magnetic 
Surgical System is used for laparoscopic procedures. 
8.3 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, 7 days, and 30 
days following surgery. The total study duration is expected to be approximately 
13 months. 
 
9 STUDY PROCEDURES 
9.1 Subject Eligibility, Pre-Screening, and Exclusions 
All individuals presenting for elective laparoscopic procedures are potential 
candidates and will be screened for eligibility. Study clinicians will select 
subjects based on knowledge/experience.  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 
Participants must meet ALL of the following inclusion criteria to be eligible 
for participation in the study: 
1. At least 18 years of age 
2. Scheduled to undergo elective laparoscopic procedure  

 
 
 
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3. Willing and able to provide a written Informed Consent  Form 
(ICF) to participate in the study prior to any study required 
procedures 
9.1.2 Exclusion Criteria 
Individuals must be EXCLUDED from participation in this study if ANY of 
the following exclusion criteria are met: 
1. Individuals with pacemakers, defibrillators, or other 
electromedical implants 
2. Individuals with ferromagnetic implants 
3. Individuals with significant comorbidities: cardiovascular, 
neuromuscular, chronic obstructive pulmonary disease, and 
urological disease (renal failure) 
4. Individuals with clinical history of impaired coagulation 
confirmed by abnormal blood tests 
5. Anatomical abnormality or disease of intended target tissue 
noted after initiation of index procedure that would prevent 
device use  
6. The individual is pregnant or wishes to become pregnant 
during the length of study participation  
7. Individual is not likely to comply with the follow-up evaluation 
schedule 
8. Is participating in a clinical trial of another investigational drug 
or device 
9. Is a 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 laparoscopic 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 
• Urine pregnancy test for women of childbearing potential.  Note that 
if the screening test is more than 1 week prior to the index 

 
 
 
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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 (IFU). 
 
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  
• Number of required surgeons 
• Conversion to open surgical procedure 
• The need for an additional surgical tool to mobilize the intended organ 
or tissue 
• Estimated blood loss 
• Video recording of the overall procedure 
• Adverse events 
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 Table 
1: Schedule of Assessments.   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.  
 
 
 
 
 
9.6 Unplanned Follow-up Visits 
Subjects returning for unscheduled visits will be reported on the Unscheduled 
Visit case report form.  
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 

 
 
 
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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 as soon as possible 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 
& 
Discharge 
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 
 
√ 
 
 
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. 
 

 
 
 
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10 RISK / BENEFIT ANALYSIS 
10.1 Benefits 
Possible benefits of the use of the Levita Magnetic Surgical System and 
Robotic Platform 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, faster recovery, and reduced 
intraoperative labor required.  
10.2 Risks 
There are risks associated with use of the Levita Magnetic Surgical System and 
Robotic Platform 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 of the MSS which included in vivo 
performance testing, human factors testing, non-clinical performance testing, 
clinical testing of the MSS in other surgical procedures, biocompatibility testing, 
sterilization validation, reprocessing validation and shelf-life validation. 
Additionally, careful labeling, IFU and training are provided as detailed below 
for the MSS and DRAA. 
 
Risks will be further mitigated through selection of qualified physicians with 
competence in minimally invasive surgery, appropriate training, and study 
monitoring. 

 
 
 
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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. 
 
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 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 may 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 ANALYSIS 
11.1 Statistical Methods 
This study is not planned to provide statistical data but to provide initial 
outcomes for safety and feasibility of the DRAA used with the MSS. 
 
Descriptive tables may be produced for baseline characteristics including 
demographics and medical history and for study outcomes. 
11.2 Sample Size Justification 
This is a single-arm, multi-center, investigational study to understand the safety 
and feasibility of the use of the DRAA with the MSS.  A sample size of 50 
subjects was planned to allow use of the system in a number surgeons and a 
number of different types of laparoscopic procedures. It is expected that 
enrollment of 50 subjects will provide appropriate information regarding the 
safety and feasibility of the DRAA and MSS in laparoscopic procedures.    
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. If device related, AEs will be further characterized as to 
relationship to the MSS the DRAA or both. 
11.4 Safety  
All adverse events for participants in the safety population will be reported.   
● Serious Adverse Events 
● Non-serious Adverse Events Device Related Adverse Event  
● 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). 
11.6 Handling Missing Data 
Only subjects with non-missing data for safety will be used. 
 

 
 
 
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11.7 Interim Analysis 
Interim analysis will not be conducted for this study. 
 
12 DATA MANAGEMENT 
12.1 Data Collection 
Data will be collected on paper case report forms (CRF) supplied by the 
Sponsor. A CRF will be completed for every subject who signs a written 
Informed Consent Form and is enrolled in the study. The Site Principal 
Investigator is responsible for the accuracy and completeness of all study 
documentation. 
 
Corrections to the CRF must be made 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 No Carbon Required paper (or equivalent) so 
that both the site and monitor/Sponsor will have copies of the CRFs.  One of 
the three copies 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. 
12.2 Data Processing 
Prior to data entry, monitoring, as detailed below, may 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.  
 

 
 
 
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The Monitor shall generate queries for data errors and discrepancies 
discovered in their review of source documents. When queries are necessary, 
the Monitor will 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 (GCPs), clinical protocol and other study requirements.  
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 the protocol and the device including the IFU.  Additionally, the 
procedure for obtaining informed consent and the procedure for reporting 
adverse events will be reviewed.  
 

 
 
 
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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: 
• Qualified subjects are appropriately consented  
• Regulatory and study documents are complete and current 
• The protocol is appropriately followed 
• Protocol 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, and accounted for 
 
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 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 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. 

 
 
 
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13.3 Device Accountability 
The device is investigational and not approved for commercial use. 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-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 or malfunctioning investigational devices, if 
applicable 
• Date of disposal, 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 
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.  

 
 
 
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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" 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 
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 (CP008@levita.com).  At a minimum, 

 
 
 
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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 adverse events, including serious and 
unanticipated serious adverse device effects, to the reviewing EC according to 
the 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. 
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. 

 
 
 
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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 
MSS and/or DRAA 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. 
 
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. 

 
 
 
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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. 
 
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 allowance of study enrollment, 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 
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 

 
 
 
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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. 
 
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 

 
 
 
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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. 
• Failure to report SAE or USADE to Levita Magnetics within 24 hours of 
knowledge. 

 
 
 
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•  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 Instructions for Use 
• 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  
• Protocol Signature Page 
• Appropriate insurance certificates (as necessary) e.g., CLIA/CAP  

 
 
 
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• 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. 
• 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. 
• 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. 
• 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. 

 
 
 
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• 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 
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Schimpke S, Guerron AD. Magnetic surgery for liver retraction: An Incision-less 
approach for less invasive bariatric surgery.  SAGES Annual Meeting Abstract 
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Ghezzi TL, Corleta OC. 30 Years of Robotic Surgery.  World J Surg 
2016;40(10):2550-7. doi:10.1007/s00268-016-3543-9 
 
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. 
 
Tan A, Ashrafian H, Alasdair JS, Mason SE, Harling L, Athanasiou T, Darzi A. 
Robotic surgery: disruptive innovation or unfulfilled promise?  A systematic review 
and meta-analysis of the first 30 years. Surg Endosc 2016;30(10):4330-52 
doi:10.1007/s00464-01604752-x 
 
17 REVISION HISTORY 
Revision 
Date 
Description of Change 
A 
 13 September 2022 
   Initial release