Clinical Evaluation of the Levita Robotic Platform
Phase: NA
Conditions: Bariatric Surgery Candidate, Cholelithiases, Other Disease
Sponsor: Levita Magnetics

 
 
CONFIDENTIAL 
 
 
Page 1 of 30 
 
 
 
 
 
 
Clinical Evaluation of the Levita Robotic Platform  
 
 
 
Protocol Number: CP007 
Revision: A 
January 12, 2021 
 
 
 
 
 
 
Sponsor: Levita Magnetics  
 
Alberto Rodriguez-Navarro, MD  
 
Title: CEO and Founder 
 
Email: CP007@levita.com 
 
Telephone: +1 (650) 204-0529 
 
 
 
 
Sponsor Signature:____________________________ 
 
Sponsor Name: Alberto Rodriguez-Navarro, MD 
 
 
 
 
 
 
 
 
CONFIDENTIALITY STATEMENT 
This study is confidential in nature. All information related to this study is considered 
proprietary and should not be made available to those not directly involved in this study. 
Authorized recipients of this information include Investigators and co-Investigators, 
other health care personnel necessary to conduct the study, and Clinical Investigation 
Ethics Committees and Institutional Review Boards. The personnel provided with data 
from this study are hereby informed of its confidential and proprietary nature. Release of 
these data to individuals other than those listed above requires the prior written 
permission of Levita Magnetics. 
 
 

 
 
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PROTOCOL REVIEW PAGE 
 
 
STUDY TITLE: 
Clinical evaluation of the Levita Robotic Platform  
 
PROTOCOL: 
CP007 
 
REVISION: 
A 
 
Investigator’s Statement: I agree to conduct this clinical study in accordance with the 
design and specific provisions of this protocol; modifications to the study or protocol are 
acceptable only with a protocol amendment approved by the Study Sponsor and Ethics 
Committee (EC) if required.  I agree to await EC approval for the protocol and informed 
consent before initiating the study, to obtain informed consent from subjects prior to 
their enrollment in the study, to collect and record data as required by this protocol and 
case report forms, submit all reports as required by this protocol, provide the requested 
financial information, and to maintain study documentation for the period of time 
detailed in this protocol. 
 
Investigator Signature 
Date of Signature 
 
 
Investigator Name: 
 
 
 
 
 
 

 
 
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Protocol Synopsis 
 
Title: 
Clinical Evaluation of the Levita Robotic Platform  
Study Objective: 
The purpose of this study is to evaluate the safety and 
feasibility of the Levita Robotic Platform (LRP) used with the 
Levita Magnetic Surgical System (MSS). 
Study Design: 
Prospective, multi-center, single-arm, open label study 
designed to assess the safety and feasibility of the use of the 
Levita Robotic Platform with the Levita Magnetic Surgical 
System in laparoscopic procedures. 
Enrollment Size 
and Number of 
Sites: 
Up to 100 subjects in up to 5 clinical sites in Chile 
Subject Population: All patients at least 18 years of age presenting for elective 
laparoscopic surgery are potential candidates. 
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 LRP or both. 
Feasibility 
Outcomes: 
Ability to utilize the Levita MSS with the LRP as intended in 
laparoscopic procedures.  The following outcomes will be 
considered in this feasibility study: 
1. The LRP is able to engage, move, and decouple with the 
MSS as intended / controlled by the surgeon 
2. The LRP 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 LRP. 
4. The MSS or the LRP cannot be successfully used and 
due to a MSS or LRP performance issue the procedure 
must be converted to an open procedure. 
Inclusion Criteria: 
Subjects must meet ALL of the following inclusion criteria to 
be eligible for participation in the study: 
• Subject is at least 18 years of age 
• Subject is scheduled to undergo elective laparoscopic 
procedure  
• Subject signs a written Informed Consent  Form (ICF) to 
participate in the study prior to any study required 
procedures 

 
 
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Exclusion Criteria: 
Subjects must be EXCLUDED from participation in this study 
if ANY of the following exclusion criteria are met: 
• Subjects with pacemakers, defibrillators, or other 
electromedical implants 
• Subjects with ferromagnetic implants 
• Subjects with significant comorbidities: cardiovascular, 
neuromuscular, chronic obstructive pulmonary disease, 
and urological disease (renal failure) 
• Subjects with a clinical history of impaired coagulation 
confirmed by abnormal blood tests 
• Subject has an anatomical abnormality or disease of 
intended target tissue noted after initiation of index 
procedure that would prevent device use  
• Subject is pregnant or wishes to become pregnant during 
the length of study participation  
• Subject is not likely to comply with the follow-up 
evaluation schedule 
• Subject is participating in a clinical trial of another 
investigational drug or device 
Study Duration / 
Follow-up Period 
Subjects will be followed for 30 days post-procedure, with 
follow-up visits at hospital discharge and at 7 and 30 days 
post-procedure. 
Clinical Sites and 
Site  
Principal 
Investigators*: 
Francisco Riquelme, MD 
Hospital Salvador 
Santiago, Chile 
 
Ignacio Robles, MD  
Hospital de la FACH 
Santiago, Chile 
 
Clinica INDISA 
Santiago, Chile 
Sponsor: 
Levita Magnetics  
Alberto Rodriguez-Navarro, MD  
Title: CEO and Founder 
Email: CP007@levita.com 
Telephone: +1 (650) 204-0529 
*Additional Investigators and Clinical Sites will be listed in a study report or separate 
document. 
 

 
 
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Investigator Agreement and Certification 
Clinical Evaluation of the Levita Robotic Platform  
 
I agree to participate in the clinical investigation of the Levita Robotic Platform and 
Magnetic Surgical System sponsored by Levita Magnetics (hereinafter “Study Sponsor”). I 
agree to conduct this investigation according to the requirements of the investigational plan 
provided by the Study Sponsor and in accordance with Good Clinical Practice requirements 
as outlined in ISO 14155 and conditions imposed by the reviewing Ethics Committee (EC). I 
agree to ensure informed consent is appropriately obtained from all subjects prior to 
inclusion in this study. 
 
I understand that this investigation may be monitored by the Study Sponsor and/or a 
designee employed by Study Sponsor. 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. 
 
I understand that this investigation, protocol, and trial results are confidential and I agree 
not to disclose any such information to any person other than a representative of Study 
Sponsor or regulatory authority without the prior written consent of Study Sponsor. 
 
I will provide financial information by completing a Levita Financial Disclosure Form and 
update it as necessary. 
 
Accepted by 
Principal Investigator Signature 
Printed name 
date 
Co-Investigator Signature 
Printed name 
date 
Co-Investigator Signature 
Printed name 
date 
 
 

 
 
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Table of Contents 
1 INTRODUCTION ........................................................................................................ 8 
1.1 
BACKGROUND AND RATIONALE ................................................................................. 8 
2 SURGICAL SYSTEM DEVICE DESCRIPTION ......................................................... 9 
3 INDICATION FOR USE ............................................................................................ 11 
4 STUDY PURPOSE AND OBJECTIVE ..................................................................... 11 
5 STUDY ENDPOINTS ................................................................................................ 12 
5.1 
SAFETY OUTCOMES ............................................................................................... 12 
5.2 
FEASIBILITY OUTCOMES ......................................................................................... 12 
5.3 
OTHER ASSESSMENTS ........................................................................................... 12 
6 STUDY DESIGN ....................................................................................................... 12 
6.1 
OVERVIEW ............................................................................................................ 12 
6.2 
SAMPLE SIZE AND NUMBER OF CENTERS ................................................................. 13 
6.3 
STUDY DURATION .................................................................................................. 13 
7 STUDY PROCEDURES ........................................................................................... 13 
7.1 
SUBJECT ELIGIBILITY, PRE-SCREENING, AND EXCLUSIONS ....................................... 13 
7.2 
ENROLLMENT AND WRITTEN INFORMED CONSENT .................................................... 14 
7.3 
SCREENING/BASELINE EVALUATION ........................................................................ 14 
7.4 
PROCEDURE .......................................................................................................... 14 
7.5 
POST-PROCEDURE / HOSPITAL DISCHARGE ............................................................. 15 
7.6 
FOLLOW-UP ........................................................................................................... 15 
7.7 
UNPLANNED FOLLOW-UP VISITS ............................................................................. 15 
7.8 
EARLY DISCONTINUATION / WITHDRAWAL ................................................................ 16 
7.9 
LOST TO FOLLOW-UP SUBJECTS ............................................................................. 16 
8 RISK / BENEFIT ANALYSIS .................................................................................... 16 
8.1 
BENEFITS .............................................................................................................. 16 
8.2 
RISKS ................................................................................................................... 16 
8.3 
MINIMIZATION OF RISK AND MONITORING PROCEDURES ........................................... 17 
9 STATISTICAL SECTION .......................................................................................... 18 
9.1 
STATISTICAL METHODS .......................................................................................... 18 
9.2 
SAMPLE SIZE JUSTIFICATION .................................................................................. 18 
10 DATA MANAGEMENT ........................................................................................... 18 
10.1 
DATA COLLECTION ................................................................................................. 18 
10.2 
DATA PROCESSING ................................................................................................ 19 
11 MONITORING AND QUALITY CONTROL PROCEDURES .................................. 19 
11.1 
CONTROL OF SYSTEMIC ERROR/ BIAS ..................................................................... 19 
11.2 
MONITORING AND AUDITING ................................................................................... 19 

 
 
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11.3 
DEVICE ACCOUNTABILITY ....................................................................................... 20 
12 ADVERSE EVENTS ............................................................................................... 21 
12.1 
DEFINITIONS .......................................................................................................... 21 
12.2 
ADVERSE EVENT REPORTING ................................................................................. 22 
12.3 
ADVERSE EVENT SEVERITY .................................................................................... 23 
12.4 
EVENT RELATIONSHIP ............................................................................................ 23 
12.5 
SUBJECT DEATH .................................................................................................... 25 
12.6 
DEVICE DEFICIENCY ............................................................................................... 25 
13 STUDY ADMINISTRATION .................................................................................... 25 
13.1 
STATEMENT OF COMPLIANCE .................................................................................. 25 
13.2 
ETHICS COMMITTEE (EC) APPROVAL ...................................................................... 25 
13.3 
INFORMED CONSENT .............................................................................................. 26 
13.4 
AMENDING THE PROTOCOL ..................................................................................... 27 
13.5 
PROTOCOL DEVIATIONS/VIOLATIONS AND MEDICAL EMERGENCIES ........................... 27 
13.6 
PRE-STUDY DOCUMENTATION REQUIREMENTS ........................................................ 27 
13.7 
RECORD RETENTION .............................................................................................. 28 
13.8 
CRITERIA FOR TERMINATING STUDY ........................................................................ 28 
13.9 
CRITERIA FOR SUSPENDING/TERMINATING AN INVESTIGATIONAL SITE ........................ 28 
13.10 SPONSOR RESPONSIBILITIES .................................................................................. 28 
13.11 INVESTIGATOR RESPONSIBILITIES ............................................................................ 29 
14 REFERENCES ....................................................................................................... 30 
15 REVISION HISTORY .............................................................................................. 30 
 
APPENDIX 1: INFORMED CONSENT FORM 
 
 

 
 
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1 
INTRODUCTION 
1.1 
Background and Rationale 
Since the introduction of minimally invasive surgery (MIS) in the 1980’s, 
laparoscopy has become the preferred approach for 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 (LRP) 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 LRP 
replaces the commercially available surgical support arm that is currently 
used with the MSS.  
 
The safety and effectiveness of the MSS has been demonstrated for the 
retraction of the gallbladder during cholecystectomy (Rivas et al.). This pivotal 

 
 
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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 
Levita Robotic Platform when used with the Magnetic Surgical System for 
laparoscopic procedures. 
 
2 
SURGICAL SYSTEM DEVICE DESCRIPTION 
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 1). 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.  
 
 
Figure 1. Magnetic Grasper Device 

 
 
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The Magnetic Controller mounted on the robotic arm (Figure 2) 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 LRP 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 LRP 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 Levita Robotic Platform (Figure 3) includes two robotic arms, control unit(s), 
and control software. A handheld and/or foot-operated control pad allow for LRP 
control by the surgeon or surgical assistant. One arm of the LRP attaches the 
Magnetic Controller using the arm mount of the Magnetic Controller and the 
second robotic arm attaches a conventional laparoscopic camera. 
 
     

 
 
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Figure 3. Levita Robotic Platform. One arm is mobilizing the External 
Magnetic Controller (external magnet) and the second arm is mobilizing a 
conventional laparoscopic camera. 
 
The LRP is certified to international electrical safety and software standards for 
use in medical products. The design of the LRP 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 LRP is 
provided non-sterile to the user, and must be placed in an off-the-shelf sterile bag 
prior to use.   
 
3 
INDICATION FOR USE 
The Magnetic Surgical System 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 in a hands-free manner.   
 
4 
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. 
 

 
 
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5 
STUDY ENDPOINTS 
The following endpoints will be evaluated in all subjects who undergo 
laparoscopic procedures using the Robotic Platform and Magnetic Surgical 
System.  
5.1 
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 LRP or both. 
5.2 
Feasibility Outcomes 
Ability to utilize the Levita MSS with the LRP as intended in laparoscopic 
procedures.  The following outcomes will be considered in this feasibility 
study: 
1. The LRP is able to engage, move, and decouple with the MSS as 
intended / controlled by the surgeon 
2. The LRP 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 LRP. 
4. The MSS or the LRP cannot be successfully used and due to a 
MSS or LRP performance issue the procedure must be converted 
to an open procedure.  
5.3 
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) 
• 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 
 
6 
STUDY DESIGN 
6.1 
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 Levita 

 
 
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Robotic Platform with the Levita Magnetic Surgical System in laparoscopic 
procedures. 
6.2 
Sample Size and Number of Centers 
The study will be conducted at up to five (5) clinical sites with a target 
maximum of 100 subjects in which the Robotic Platform and Levita Magnetic 
Surgical System is used for laparoscopic procedures. 
6.3 
Study Duration 
Enrollment of subjects in this study is anticipated to take up to 12 months. 
Clinical follow-up evaluations will be conducted at discharge, and 7 and 30 
days following surgery. The total study duration is expected to be 
approximately 13 months. 
 
7 
STUDY PROCEDURES 
7.1 
Subject Eligibility, Pre-Screening, and Exclusions 
All subjects 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. 
7.1.1 
Inclusion Criteria 
Subjects must meet ALL of the following inclusion criteria to be eligible 
for participation in the study: 
1. Subject is at least 18 years of age 
2. Subject is scheduled to undergo elective laparoscopic 
procedure  
3. Subject signs a written Informed Consent  Form (ICF) to 
participate in the study prior to any study required procedures 
7.1.2 
Exclusion Criteria 
Subjects must be EXCLUDED from participation in this study if ANY of 
the following exclusion criteria are met: 
1. Subjects with pacemakers, defibrillators, or other 
electromedical implants 
2. Subjects with ferromagnetic implants 
3. Subjects with significant comorbidities: cardiovascular, 
neuromuscular, chronic obstructive pulmonary disease, and 
urological disease (renal failure) 

 
 
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4. Subjects with clinical history of impaired coagulation confirmed 
by abnormal blood tests 
5. Subject has an anatomical abnormality or disease of intended 
target tissue noted after initiation of index procedure that 
would prevent device use  
6. Subject is pregnant or wishes to become pregnant during the 
length of study participation  
7. Subject is not likely to comply with the follow-up evaluation 
schedule 
8. Subject is participating in a clinical trial of another 
investigational drug or device 
7.2 
Enrollment and Written Informed Consent 
Patients who pass initial pre-screening will be asked to sign the Informed 
Consent Form (See Appendix 1) before any study-specific tests or 
procedures are performed. The Investigator will inform the potential subject of 
the elements of the clinical study, including risks, potential benefits and 
required follow-up procedures, prior to obtaining the potential subject’s 
informed consent.  Enrollment may be non-sequential per the discretion of the 
study surgeon. 
7.3 
Screening/Baseline Evaluation 
The Screening visit will occur within 30 days prior to the laparoscopic 
procedure. 
 
The following evaluations are required at the time of subject screening 
/baseline: 
• Demographic Information: gender, race, age, weight, and height, and 
smoking status 
• Medical / Surgical History 
• Pre-operative blood draw for determination of coagulation disorders 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 procedure, a second 
urine pregnancy test is required within 7 days of the index procedure. 
7.4 
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 

 
 
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• 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 
7.5 
Post-Procedure / Hospital Discharge 
Before hospital discharge the following data will be collected: 
• Length of hospital stay (time from admittance to post-anesthesia care unit 
until hospital discharge) 
• Length of time spent in Post Anesthesia Care Unit (PACU) 
• Adverse events, if any 
7.6 
Follow-up  
All subjects will be asked to return to the investigational site at 7 days and 
again at 30 days post-procedure according to the study schedule described in 
Table 1.   Subjects will be queried about adverse events at these study visits.  
Study visits should be scheduled as closely as possible to the earlier part of 
the time period to allow for rescheduling if needed due to last minute 
schedule changes. Visits not completed within the specified time period will 
be regarded as deviations.  
 
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. 
  
 
 
7.7 
Unplanned Follow-up Visits 
Subjects returning for unscheduled visits will be reported on the Unscheduled 
Visit case report form.  

 
 
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7.8 
Early Discontinuation / Withdrawal  
All subjects will be informed of their right to withdraw from the clinical study at 
any time without penalty or loss of benefits to which the subject is otherwise 
entitled. Additionally, the Investigator may prematurely discontinue any 
subject’s participation in the study if the Investigator feels that the subject can 
no longer fully comply with the requirements of the study or if any of the study 
procedures are deemed potentially harmful to the subject. The reason for 
early discontinuation will be documented in the source documents and the 
Study Termination case report form. 
7.9 
Lost to Follow-up Subjects 
Every attempt will be made to have all subjects complete the follow-up visit 
schedule. A subject will not be considered lost to follow-up unless efforts to 
obtain compliance are unsuccessful. At a minimum, the effort to obtain follow-
up information will include three attempts to make contact via telephone or 
email and if unsuccessful, then a certified letter from the Investigator will be 
sent to the subject’s last known address. In general, the study Site 
Coordinator should attempt to contact the subject as soon as possible after 
each missed visit to reschedule the visit. 
 
8 
RISK / BENEFIT ANALYSIS 
8.1 
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.  
8.2 
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 petechaie 
• Vascular injury 
• Gastro-intestinal injury 
• Organ perforation 
• Need for extended surgery 

 
 
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• Additional surgical intervention due to any of the above factors (includes 
reoperation) 
 
These adverse events do not include all adverse events, which occur with 
surgery in general, but are important considerations particular to laparoscopic 
instrumentation. 
 
8.3 
Minimization of Risk and Monitoring Procedures 
Levita Magnetics has attempted to mitigate risks as much as possible through 
product design and development 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 LRP. 
 
Risks will be further mitigated through selection of qualified physicians with 
competence in minimally invasive surgery, appropriate training, and study 
monitoring. 
• Investigators who participate in the study will be experienced and skilled in 
laparoscopic 
surgical 
techniques. 
Additionally, 
Investigators, 
in 
conjunction with the investigational site, will have adequate resources for 
participation in a clinical study. 
• The study has been designed to ensure treatment and follow-up of 
subjects are consistent with current medical practice. 
• Each Investigator will ensure oversight and approval of the study by the 
Ethics Committee (EC) prior to initiation of the clinical study at his/her 
investigational site. 
• 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. 

 
 
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• 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. 
 
9 
STATISTICAL SECTION 
9.1 
Statistical Methods 
This study is not planned to provide statistical data but to provide initial 
outcomes for safety and feasibility of the LRP used with the MSS. 
 
Descriptive tables may be produced for baseline characteristics including 
demographics and medical history and for study outcomes. 
9.2 
Sample Size Justification 
This is a single-arm, multi-center, investigational study to understand the 
safety and feasibility of the use of the LRP with the MSS.  A sample size of 
100 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 100 subjects will provide appropriate information regarding 
the safety and feasibility of the LRP and MSS in laparoscopic procedures.    
 
10 
DATA MANAGEMENT 
10.1 Data Collection 
Data will be collected on paper case report forms (CRF) supplied by the 
Sponsor. The Site Principal Investigator is responsible for the accuracy and 
completeness of all study documentation. 
 
Corrections to the CRF must be 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 NCR 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 

 
 
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information sent to the Sponsor must be redacted of personal identification 
information. 
 
A unique study number will be assigned to each subject. All information 
recorded on the CRF about the subject will be recorded with the study 
number on it. The main database will contain only the study number to 
identify the subject. The code with subject name and study number will be 
maintained in a secured designated location at the site and will be inspected 
by study monitors and auditors. Any computerized data will be password 
protected. 
 
Levita Magnetics or its designee will be responsible for database design and 
management for this study. 
10.2 Data Processing 
Prior to data entry, monitoring, as detailed below, may be completed.  In 
association with data entry, the data will be reviewed for further 
inconsistencies or incongruities.  If warranted, a data clarification form or 
communication will be used to query the Investigator.  
 
11 
MONITORING AND QUALITY CONTROL PROCEDURES 
11.1 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.  
11.2 Monitoring and Auditing 
Monitoring visits to the clinical sites may be made periodically during the 
study, 
to 
ensure 
that 
all 
aspects 
of 
the 
current, 
approved 
protocol/amendment(s) are followed. 
 
Prior to the enrollment of any subject in this study, site study personnel will be 
trained to 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.  
 
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 

 
 
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• Protocol amendments have been approved by the EC and 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 
 
The Investigator or designee must, upon request, provide to the Monitor or 
regulatory authority the necessary study records for a thorough review of the 
study’s progress. These records include, but are not limited to, case 
report forms and original documents and records such as hospital and 
clinic charts, consent forms, laboratory records, and pharmacy dispensing 
records. 
 
The Monitor will provide a written report to the Sponsor after each on-site 
visit. The report will identify the personnel participating in the visit, the 
activities performed, any protocol deviations, and any action items/corrective 
actions identified. 
 
If compliance problems or protocol deviations are noted, the Sponsor will 
recommend corrective action. If the response from the Investigator is not 
adequate, the Sponsor will terminate the site’s participation in the study and 
notify the regulatory authorities (if applicable). 
 
The study may also be subject to a quality assurance audit by 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. 
11.3 Device Accountability 
Access to investigational devices shall be controlled and used only in the 
clinical investigation and according to the protocol. 
 
The Sponsor shall keep records to document the physical location of all 
investigational devices from shipment (or hand-carried) to the sites until return 
or disposal. 
 

 
 
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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. 
 
12 
ADVERSE EVENTS 
12.1 Definitions 
12.1.1 Adverse Event (AE) 
AEs are any untoward medical occurrence, unintended disease or injury, 
or untoward clinical signs (including abnormal laboratory findings) in 
which subjects, users or other persons, whether or not related to the 
investigational medical device.  This definition includes events related to 
the procedures involved.  For users or other persons, this definition is 
restricted to events related to investigational medical devices. 
 
All adverse events, regardless of relationship to the device, must be 
recorded on the case report forms provided. Adverse events that occur 
during this study should be treated by established standards of care. 
 
Adverse events shall be assessed and documented at the time of the 
procedure and at all study follow-up visits. Each Investigator shall 
provide source documentation as requested by the Sponsor to facilitate 
reporting and adjudication of these events. 
12.1.2 Serious Adverse Event (SAE) 
An adverse event is considered a SAE if it: 
• Led to death 
• Led to a serious deterioration in the health of the subject, that either 
resulted in: 
a) A life-threatening illness or injury, or 
b) A permanent impairment of a body structure or a body function, or 
c) In-patient 
hospitalization, 
or 
prolongation 
of 
existing 
hospitalization, or  

 
 
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d) medical or surgical intervention to prevent permanent life-
threatening illness or injury or permanent impairment to body 
structure or a body function. 
• Led to fetal distress, fetal death or a congenital abnormality 
 
Planned hospitalization for a pre-existing condition, without serious 
deterioration in health, is not considered a serious adverse event. 
12.1.3 Serious Adverse Device Effect (SADE) 
A serious adverse device effect is defined as an adverse event related to 
the use of an investigational medical device that has resulted in any of 
the consequences characteristic of a serious adverse event.   
 
12.1.4 Unanticipated Serious Adverse Device Effect (USADE) 
An USADE is a serious adverse device effect which by its nature, 
incidence, severity or outcome has not been identified in the current 
version of the investigational plan. 
12.2 Adverse Event Reporting 
Any adverse event that occurs during the course of the study must be 
reported using the Adverse Event (AE) Form in the CRFs and the Investigator 
must sign each report. The Investigator must determine whether the adverse 
event is serious or unanticipated, its intensity, and the relationship of each 
adverse event to the investigational device or procedure.    
 
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 (CP007@levita.com).  At a minimum, 
the AE CRF should be provisionally completed, scanned and sent via email. 
The Sponsor will contact the site for additional information, if required. 
 
For any adverse event that is ongoing at the time of the initial report, periodic 
follow-up information is required until the adverse event is resolved or is not 
expected to change. The site should submit relevant follow-up information 
related to the adverse event as soon as it is available. 
 
Depending upon the nature and seriousness of the adverse event, the 
Sponsor may request the Investigator to provide copies of the subject’s 
medical records (such as the subject’s laboratory tests and hospital records, 
Investigator summaries, etc.) to document the adverse event. The Sponsor is 

 
 
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available to respond to any medical issues that arise during the conduct of 
this study. 
 
The Investigator will report all serious adverse events, including unanticipated 
serious adverse device effects, to the EC according to the EC requirements. 
A copy of this EC communication should be sent to the Sponsor. 
 
The Sponsor will ensure that safety reporting for the study is conducted in 
compliance with all pertinent requirements and regulations. 
12.3 Adverse Event Severity 
The Investigator must determine the severity of the adverse event according 
to the following definitions: 
 
Mild The adverse event is noticeable to the subject, but 
does not interfere with routine activity; the symptoms 
are easily tolerated and transient in nature. 
 
Moderate The adverse event interferes with routine activity but 
responds to symptomatic therapy or rest; the 
symptoms are poorly tolerated and sustained. 
 
Severe The adverse event significantly limits the subject’s 
ability 
to 
perform 
routine 
activities 
despite 
symptomatic therapy. The adverse event requires 
medical 
or 
surgical 
treatment 
or 
results 
in 
hospitalization. 
 
Life-Threatening The subject is at immediate risk of death. 
12.4 Event Relationship 
The following lists the potential event attribution categories. 
12.4.1 Device Related 
An adverse event is considered device-related when the clinical event 
has a reasonable time sequence associated with use of the 
investigational device and is unlikely to be attributed to concurrent 
disease or other procedures or medications. It is reasonable to believe 
that the device directly caused or contributed to the adverse event. 
 
The Investigator will evaluate the relationship of the adverse event to the 
MSS and/or LRP 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. 

 
 
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Page 24 of 30 
 
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. 
12.4.2 Procedure-Related 
An adverse event is considered to be procedure-related when it is 
reasonable to believe that the event is associated with the index 
procedure and is not specific to the investigational device. Other 
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 

 
 
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Page 25 of 30 
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. 
 
12.5 Subject Death 
Any subject death during the investigation must be reported to Levita 
Magnetics within 24 hours of Investigator’s knowledge of the death. The 
Adverse Event CRF must be completed and include a complete description of 
the relevant details of the death. A copy of the death records, death 
certificates and an autopsy report (if performed) are required to be sent to the 
Sponsor. In addition, subject death must be reported to the EC in accordance 
with EC requirements. 
12.6 Device Deficiency 
All device deficiencies related to the identity, quality, durability, reliability, 
safety or performance (includes malfunctions, use errors, and inadequate 
labeling) of the device shall be documented. Sponsor will assess all device 
deficiencies that could have led to a serious adverse device effect. 
 
In the event of a suspected malfunction or device deficiency, the 
investigational device should be returned to the Sponsor for analysis. 
Instructions for returning the investigational device will be provided by the 
Sponsor. 
 
13 
STUDY ADMINISTRATION 
13.1 Statement of Compliance 
The clinical investigations will be in accordance with the ethical principles of 
the Declaration of Helsinki (59th WMA General Assembly, Seoul, October 
2008) and ICH-GCP Guidelines.  The clinical investigation shall not 
commence until approval by the EC.  Any additional requirements imposed by 
the EC or regulatory authority shall be followed. The Sponsor shall maintain a 
Clinical Trial Liability Policy with an insurance company. 
13.2 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 

 
 
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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. 
 
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. 
13.3 Informed Consent 
Written informed consent is mandatory and must be obtained from all 
subjects as per local regulations, prior to their participation in the study. A 
template Informed Consent is provided in Appendix 1. 
 
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. 
 
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 

 
 
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change to the content of subject information and/or to the consent form. The 
Investigator will inform the subject of changes in a timely manner, and will ask 
the subject to confirm his/her continuation in the study by signing a revised 
consent form. 
 
Any revised informed consent form and other written information provided to 
subjects must receive approval from the EC and Sponsor prior to use. 
13.4 Amending the Protocol 
This protocol is to be followed exactly, and will only be altered by written 
amendments. Amendments must be approved by all parties responsible for 
approving the protocol prior to implementation. The Informed Consent and 
CRFs will be reviewed to ensure these are amended if necessary. 
 
Administrative changes that do not affect the benefit/risk ratio or scientific 
validity of the study (e.g., editorial changes for clarity) may be made with just 
approval from the Sponsor and will be documented as a protocol revision. 
13.5 Protocol Deviations/Violations and Medical Emergencies 
A protocol deviation or violation is a failure to comply with the requirements of 
the clinical study as specified in the protocol. Examples of protocol deviations 
include late visits, missed visits, and required follow-up testing not completed. 
An example of a protocol violation includes enrollment of a study subject who 
fails to meet inclusion/exclusion criteria as specified in the protocol or failure 
to obtain informed consent. Each Investigator shall conduct this clinical study 
in accordance with the study protocol and any conditions required by the 
reviewing EC. 
 
Deviations/violations from clinical protocol requirements will be reviewed and 
evaluated on an ongoing basis and, as necessary, appropriate corrective 
actions put into place. Levita Magnetics accepts the right of the Investigator to 
deviate from the protocol in an emergency when necessary to safeguard the 
life or the physical well-being of a study subject but such deviation must be 
reported within 24 hours of implementation to the EC and Sponsor.  
13.6 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) 

 
 
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13.7 Record Retention 
The Investigator will maintain all essential trial documents and source 
documentation that support the data collected on the study subjects in 
compliance with ICH/GCP guidelines. Documents must be retained until at 
least 2 years have elapsed since the date the investigation is completed or 
terminated or the records are no longer required to support a regulatory 
submission 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. 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. 
13.8 Criteria for Terminating Study 
Levita Magnetics reserves the right to terminate the study but intends only to 
exercise this right for valid scientific or 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: 
• The discovery of an unexpected, significant, or unacceptable risk to 
subjects enrolled in the study. 
• A decision on the part of Levita Magnetics to suspend or discontinue 
further regulatory submissions for the device. 
13.9 Criteria for Suspending/Terminating an Investigational Site 
Levita Magnetics reserves the right to stop the enrollment of subjects at an 
investigational site at any time after the study initiation visit if no subjects have 
been enrolled or if the center has multiple or severe protocol violations 
without justification or fails to follow remedial actions. 
 
Possible reasons for suspending/terminating a study center include: 
• Failure to obtain written Informed Consent. 
• Failure to report SAE or USADE to Levita Magnetics within 24 hours of 
knowledge. 
• Failure to complete data forms prior to the scheduled monitoring visits. 
• Loss of (or unaccounted for) investigational product inventory. 
13.10 Sponsor Responsibilities 
The Sponsor, Levita Magnetics, is responsible for selecting qualified 
Investigators and providing them with the information and materials 
necessary to conduct this trial appropriately, ensuring appropriate monitoring 
of the investigation, that EC review and approval are obtained, and ensuring 

 
 
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that the Investigators and the reviewing EC are promptly notified of significant 
new information about this investigation. 
 
Specifically, the Sponsor will be responsible for: 
• Securing compliance with the clinical protocol, Investigators’ agreement, 
and local regulations; 
• Conducting evaluations of all adverse events; 
• Controlling the distribution of the device(s) under investigation; 
• Maintaining records and reports; 
• Analyzing and reporting data; 
• Designating appropriately qualified medical personnel to be available to 
advise on study related medical questions or problems 
 
13.11 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. 
• Be 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. 
• Control any investigational device(s) stored at their site. 
• Be aware of, and comply with, GCP and applicable regulatory 
requirements. 
• Permit monitoring and auditing by the Sponsor, and inspection by the 
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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14 
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Ghezzi TL, Corleta OC. 30 Years of Robotic Surgery.  World J Surg 
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15 
REVISION HISTORY 
Revision 
Date 
Description of Change 
A 
12 January 2021 
  Initial release