Clinical Study to Evaluate the Safety and Efficacy of the SlimShape Device for Abdominal Fat and Circumference Reduction
Phase: NA
Conditions: Fat Disorder
Sponsor: Syneron Medical

 
 
Syneron Medical Ltd. 
Confidential 
 
Clinical Study to Evaluate the Safety and Efficacy of the SlimShape Device for Abdominal Fat 
and Circumference Reduction 
Protocol # 
DHF22621 
Rev. Date 
October 8, 2017 
Page 1 of 39 
 
 
 
 
 
 
 
 
 
Title: 
Clinical Study to Evaluate the Safety and Efficacy of the SlimShape Device for 
Abdominal Fat and Circumference Reduction 
Protocol Number: 
DHF22621 
Study Type: 
Prospective Clinical Study 
Date: 
September 29, 2016 
 
Study Devices: 
SlimShape 
Sponsor: 
Syneron Medical Ltd. 
Industrial Zone, Tavor Building 
P.O.B. 160 Yokneam Illit, 
20692 Israel 
Project Lead: 
Ruthie Amir MD 
Global Vice President of Clinical & Regulatory Affairs 
ruthiea@syneron.com  
+ 972-73-244-2349 
This document contains confidential information. 
This study will be performed in accordance with applicable regulatory requirements and Good Clinical 
Practice (GCP). This clinical investigation will follow the principles outlined by the International Conference 
on Harmonization (ICH). 
 
This document is the property of Syneron Medical Ltd. No part 
of this document may be reproduced, stored in retrieval system, 
or transmitted in any form or any means, electronic, mechanical, 
photocopying, recording or otherwise without prior written 
permission from Syneron Medical Ltd. 

 
 
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Clinical Study to Evaluate the Safety and Efficacy of the SlimShape Device for Abdominal Fat 
and Circumference Reduction 
Protocol # 
DHF22621 
Rev. Date 
October 8, 2017 
Page 2 of 39 
 
 
Principal Investigator and study site: 
 
Site:_______________________________________ 
 
Principal Investigator’s Signature 
I, _______________________________ have carefully read the foregoing protocol # DHF22621: 
“Clinical Study to Evaluate the Safety and Efficacy of the SlimShape Device for Abdominal Fat and 
Circumference Reduction” and agree that it contains all the necessary information for 
conducting this study safely.  I will conduct this study in strict accordance with this protocol, 
Good Clinical Practices, and local regulatory guidelines, and will attempt to complete the study 
within the time designated.  I will provide copies of the protocol and all other information 
relating to pre-clinical and prior clinical experience submitted by the Sponsor to all personnel 
responsible to me who participate in the study.  I will discuss this information with them to 
assure that they are adequately informed regarding the study product and conduct of the study.  
I agree to keep records on all subject information (case report forms, shipment and product 
return forms and all other information collected during the study) in accordance with GCP and 
Health Canada regulations. 
ACCEPTED AND AGREED: 
_______________________________  
            ____________________ 
Investigator’s Signature                                                                           Date 
_______________________________  
            ____________________ 
Ruthie Amir, M.D.  
 
 
 
 
                 Date 

 
 
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Clinical Study to Evaluate the Safety and Efficacy of the SlimShape Device for Abdominal Fat 
and Circumference Reduction 
Protocol # 
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Rev. Date 
October 8, 2017 
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Table of Contents 
Glossary ........................................................................................................................................... 5 
Table 1- Study Synopsis ................................................................................................................... 6 
Introduction and rationale .............................................................................................................. 8 
Background .................................................................................................................................. 8 
Device Descriptions ..................................................................................................................... 9 
Syneron SlimShape Device ...................................................................................................... 9 
Study design overview ................................................................................................................... 11 
Sutdy Objective ............................................................................................................................. 12 
Primary Objective ...................................................................................................................... 12 
Primary Safety Objective ........................................................................................................... 12 
Secondary Objectives ................................................................................................................ 12 
Primary and Secondary Efficacy Endpoint ............................................................................. 12 
Primary Safety Endpoint ........................................................................................................ 13 
Study population ........................................................................................................................... 13 
Number of Subjects ................................................................................................................... 13 
Subject Withdrawal and Replacement ...................................................................................... 13 
Inclusion Criteria ........................................................................................................................ 13 
Exclusion Criteria ....................................................................................................................... 14 
STUDY PROCEDURES ..................................................................................................................... 15 
Enrollment and Screening ......................................................................................................... 15 
Table 2 – Clinical Evaluation Measurements and Tools ........................................................ 16 
Pre-Treatment Procedures ........................................................................................................ 17 
Screening ............................................................................................................................... 17 
Baseline ................................................................................................................................. 17 
Measurements ...................................................................................................................... 18 
Treatment Procedure ................................................................................................................ 21 
SlimShape Treatment Procedure .......................................................................................... 22 
Post Treatment Procedures ....................................................................................................... 24 
Return Visits .............................................................................................................................. 24 
DATA ANALYSIS.............................................................................................................................. 25 
Recording ................................................................................................................................... 25 
Demography and Baseline Measurements ........................................................................... 25 
Treatment Visit ...................................................................................................................... 25 
Follow-up Visit Measurements .............................................................................................. 25 
Safety ..................................................................................................................................... 25 
Protocol Revisions and/or Deviations ....................................................................................... 25 
ADVERSE EVENTS (AE) ................................................................................................................... 26 
Anticipated Adverse Effects ...................................................................................................... 26 
Unanticipated Adverse Device Effects ...................................................................................... 26 
Reporting Adverse Events (AE) and Serious Adverse Events (SAE) ........................................... 27 

 
 
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Clinical Study to Evaluate the Safety and Efficacy of the SlimShape Device for Abdominal Fat 
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Protocol # 
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Rev. Date 
October 8, 2017 
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Measures taken to protect the rights and welfare of subject............................................... 28 
RISK/BENEFIT ANALYSIS................................................................................................................. 28 
Risks ........................................................................................................................................... 28 
Potential benefits to participating individuals and to society ................................................... 28 
Conclusion: ................................................................................................................................ 29 
ETHICS AND GOOD CLINICAL PRACTICE ........................................................................................ 29 
QUALITY ASSURANCE AND STUDY MONITORING ......................................................................... 29 
Study Monitoring/Auditing/Inspection ..................................................................................... 29 
ADMINISTRATIVE PROCEDURES .................................................................................................... 30 
Supply and Disposition of Study Device .................................................................................... 30 
Control & Disposition of the Investigational Device ................................................................. 30 
Informed Consent ...................................................................................................................... 30 
Monitoring Plan ......................................................................................................................... 31 
Case Report Forms .................................................................................................................... 31 
Record Maintenance ................................................................................................................. 31 
PUBLICATION POLICY..................................................................................................................... 32 
BIBLIOGRAPHY ............................................................................................................................... 33 
Appendix I – Study Summery ........................................................................................................ 34 
Appendix II - Scales ........................................................................................................................ 36 
Appendix III ‐ Photography ............................................................................................................ 37 
Specific photography details: .................................................................................................... 37 
Abdomen: .............................................................................................................................. 37 
Appendix IV - Clinical Trial Acknowledgement .............................................................................. 38 
 

 
 
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Clinical Study to Evaluate the Safety and Efficacy of the SlimShape Device for Abdominal Fat 
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Protocol # 
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Rev. Date 
October 8, 2017 
Page 5 of 39 
 
 
GLOSSARY 
 
ADE 
Adverse Device Effect 
AE 
BMI 
Adverse Event 
Body Mass Index 
CFR 
Code of Federal Regulations 
Cm 
Centimeter 
CRF 
Case Report Form 
FDA 
Food & Drug Administration 
FU 
GCP 
Follow-up 
Good Clinical Practice 
ICF 
Informed Consent Form 
IEC 
Institutional Ethics Committee 
IRB 
Institutional Review Board 
Kg 
Kilogram 
Min 
Minute 
wk 
Weeks 
PI 
Principal Investigator 
USAE 
Unanticipated, serious adverse event 
USADE 
Unanticipated, serious adverse device effect 
SAE 
Serious Adverse Event 
Tx 
US 
Treatment 
Ultrasound 
USI 
Ultrasound Imaging 
W 
Watt (Output Electric Power) 
 
 

 
 
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Clinical Study to Evaluate the Safety and Efficacy of the SlimShape Device for Abdominal Fat 
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Protocol # 
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Rev. Date 
October 8, 2017 
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TABLE 1- STUDY SYNOPSIS 
Proprietary Name 
SlimShape device 
Design 
Prospective, one arm, baseline-controlled, clinical study for the evaluation of the SlimShape 
device for non-invasive abdominal fat and circumference reduction. 
Study subjects will undergo SlimShape treatments on the abdominal area 
Study Population 
Up to 120 healthy adult volunteers, seeking for noninvasive abdominal fat and circumference 
reduction, male and females, 18 to 60 years of age from up to 10 investigational sites. 
Treatment 
and 
Duration 
Eligible subjects will receive up to 3 bi-weekly treatments (2 weeks interval) with the 
SlimShape device utilizing the SlimShape Applicator Belt according to the study protocol. 
The subject will return for 3 follow up visits: four weeks (4wk FU), eight weeks (8wk FU) and 
12 weeks (12wk FU) after the last treatment. 
Each subject will be enrolled for total expected study duration of up to 16 weeks. 
Objective 
The objective of this trial is to evaluate the safety and efficacy of the SlimShape device 
utilizing the SlimShape Applicator Belt for abdominal non-invasive fat and circumference 
reduction 
Primary Objective 
Statistically significant abdominal fat reduction post SlimShape treatments at 12 weeks 
follow-up (12wk FU) versus baseline 
Primary 
Safety 
Objective 
Evaluate the safety of the treatment with the SlimShape device utilizing the SlimShape 
Applicator Belt during all study 
Secondary 
Objectives 
1. Statistically significant abdominal fat reduction post SlimShape treatments as 
measured by Ultrasound device at Pre Tx.3, 4 weeks, and 8 weeks follow-up (4wk FU 
and 8wk FU) versus baseline 
2. Statistically significant abdominal fat reduction post SlimShape treatments as 
measured by calibrated Caliper device at Pre Tx.3, 4 weeks, 8 weeks and 12 weeks 
follow-up (4wk FU, 8wk FU and 12wk FU) versus baseline 
3. Statistically significant abdominal circumference reduction post  SlimShape 
treatment/s at Pre Tx.2, Pre Tx.3, 4 weeks, 8 weeks and 12 weeks follow-up (4wk FU, 
8wk FU and 12wk FU) versus baseline 
4. Investigator satisfaction: 
Satisfaction assessment will be performed by the study investigator using a pre-
defined scale questionnaire. The investigator will answer this questionnaire at each 
follow-up visit (4wk FU, 8wk FU and 12wk FU) 

 
 
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Clinical Study to Evaluate the Safety and Efficacy of the SlimShape Device for Abdominal Fat 
and Circumference Reduction 
Protocol # 
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Rev. Date 
October 8, 2017 
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5. Subject improvement and satisfaction: 
Improvement and satisfaction assessment will be performed independently by the 
subject using a pre-defined scale questionnaire. The subjects will answer this 
questionnaire at each follow-up visit (4wk FU, 8wk FU and 12wk FU) 

 
 
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Clinical Study to Evaluate the Safety and Efficacy of the SlimShape Device for Abdominal Fat 
and Circumference Reduction 
Protocol # 
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Rev. Date 
October 8, 2017 
Page 8 of 39 
 
 
Efficacy Endpoints 
Primary and secondary objectives will be measured using the next efficacy endpoints: 
1. Fat thickness measurements using Ultrasound device 
2. Fat thickness measurements using Caliper 
3. Circumference measurements of the abdominal area using Measuring Tape 
4. Investigator satisfaction using a pre-defined scale 
5. Subject improvement and satisfaction using a pre-defined scale 
6. Photography 
Safety Endpoints 
1. The number, severity and type of any adverse event recorded throughout the study 
and post treatment (immediate and delayed response) 
Statistical 
Methods 
 
 
Descriptive statistics will be used to present changes in the assessments along the study 
course. Circumference measurements and subject assessments’ and satisfaction data will be 
analyzed using two-tailed Wilcoxon Signed Rank test and/or paired t-test (alpha=0.05) to 
analyze the data difference from baseline and longitudinal change.   
INTRODUCTION AND RATIONALE 
Background 
Adipose tissue is a loose type of connective tissue specialized to store lipids. The majority of 
lipids stored in adipose cells are triglycerides formed from imported free fatty acids and glycerol.  
It is not uniformly distributed in the body.  The major adipose depot is subcutaneous (about 80% 
of all body fat).1   In men it normally represents 15-20% of body weight and in women, 20-25% of 
body weight.  A certain amount of body fat is necessary for normal female reproduction and 
health. Subcutaneous adipose tissue helps to shape, cushion and insulate the body and provides 
padding to some organs.  
 
Liposuction is a procedure that can help sculpt the body by removing unwanted fat from specific 
areas.2,3,4  The increasing popularity of this procedure is associated with the evolution of 
techniques and equipment for fat removal, body reshaping and cellulite treatments. Besides the 
traditional suction-assisted lipoplasty, other options include ultrasound-assisted and external 
ultrasound-assisted liposuction, power-assisted liposuction, laser lipolysis as well as low-level 
laser-assisted liposculpture.5  
 

 
 
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Clinical Study to Evaluate the Safety and Efficacy of the SlimShape Device for Abdominal Fat 
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Protocol # 
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Rev. Date 
October 8, 2017 
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The efforts in the search for alternative non-invasive or minimally invasive techniques and new 
tools aim mainly at reducing downtime, and facilitating treatment for reduction of the localized 
fatty tissue areas.6   
 
The SlimShape device is a non-invasive, body countering system based on radiofrequency (RF) 
and vacuum energies. The SlimShape provide a non-invasive approach to achieve a desired 
aesthetic effect (reduction in abdominal fat and circumference). The system is designed to 
enable an automatic, hands-free, full abdominal treatment that is based on a predefined user 
protocol. In addition, the system incorporates a skin-temperature control into the protocol, 
enabling accurate, stable and safer treatment. 
 
Device Descriptions 
Syneron SlimShape Device  
The SlimShape system is comprised of two main parts:  
 
The SlimShape console which houses the system's computer, control panel, electronics, 
discomfort button, cooling system and other power and control devices which operate 
and control the system. 
 
The SlimShape Applicator Belt incorporates an array of vacuum cavities; each cavity 
includes a pair of RF electrodes and a suction pad. Each of the cavities moves 
independently of the others, applying software-controlled vacuum and RF pulses in turn. 
Main Console 
The SlimShape console (Figure 1) incorporates the major modules required to deliver RF energy 
and negative air pressure (vacuum) to the applicator belt assembly, such as: 
 
RF generator 
 
Vacuum pump 
 
Computer 
 
15" LCD control panel with touch-screen technology  

 
 
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Clinical Study to Evaluate the Safety and Efficacy of the SlimShape Device for Abdominal Fat 
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Protocol # 
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Rev. Date 
October 8, 2017 
Page 10 of 39 
 
 
Figure 1:  SlimShape System 
 
The Applicator 
The SlimShape applicator Belt (Figure 2) incorporates a linear array of vacuum cavities; each 
cavity includes a pair of RF electrodes and a suction pad. Each cavity has sufficient mechanical 
degrees of freedom with respect to the neighboring ones, so that when the applicator belt is 
attached to the patient it conforms to the body curvature. The SlimShape applicator is tightened 
to the skin, ensuring vacuum tightness by a strap and buckle mechanism. An array of vacuum, 
air and RF valves/switches will distribute the RF and vacuum energies sequentially between the 
cavities according to a software-controlled routine. Each cavity has temperature sensors that 
enable accurate control of the skin's temperature. 
 
Figure 2: SlimShape Applicator 
 

 
 
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Clinical Study to Evaluate the Safety and Efficacy of the SlimShape Device for Abdominal Fat 
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Protocol # 
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Rev. Date 
October 8, 2017 
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A control button (Figure 3) is available to the patient in order to cease treatment if any 
discomfort is felt during the treatment. The discomfort button is designed to be held in the 
patient's hand during the entire treatment session. The patient should be instructed to press the 
button at any time he/she feels discomfort related to the treatment; this action stops the 
pulsing of vacuum and RF energy. The operator may then adjust the parameters or end the 
treatment session. 
 
Figure 3: Discomfort Button 
SlimShape is an upgraded version of the VelaShape device that is intended for abdominal fat 
reduction. The VelaShape device is cleared by the Food and Drug Administration (FDA). The 
upgraded version, the SlimShape device, is investigational and not yet FDA cleared.  
STUDY DESIGN OVERVIEW 
This study is a prospective, baseline controlled, multi-center, one arm clinical study showing the 
performance and safety of the SlimShape treatment for abdominal non-invasive fat and 
circumference reduction.  
Up to 120 Healthy subjects in up to 10 investigational sites will be enrolled in this study. All 
subjects will undergo an assessment of their general health. During the treatment period, 
subject’s fat thickness and circumference will be measured and up to three successive bi-weekly 
(two weeks interval) treatments will be performed.  
The study subjects will undergo treatments with SlimShape device utilizing the SlimShape 
Applicator Belt. 
During the follow-up period visit will be conducted as follow: 4 weeks (4wk FU), 8 weeks (8wk 
FU) and 12 weeks (12wk FU) post last treatment. Subject’s fat thickness will be measured using 
2 different methods (Calibrated Caliper and Ultrasound Imaging (USI)) and fat reduction will be 
assessed at each post baseline visit. Circumference will be measured in 3 measurements heights 
and circumference reduction will be assessed at each post baseline visit. Additionally, 
investigator and subject questionnaires will be completed.  Finally, photography will be 
performed under visible light conditions of the front, right, left and back view.  Most of the 
assessments will occur at each of the visits to the clinic. 

 
 
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Clinical Study to Evaluate the Safety and Efficacy of the SlimShape Device for Abdominal Fat 
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Protocol # 
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Rev. Date 
October 8, 2017 
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SUTDY OBJECTIVE 
The objective of this trial is to evaluate the safety and efficacy of the SlimShape device utilizing 
the SlimShape Applicator Belt for abdominal non-invasive fat and circumference reduction  
Primary Objective 
Statistically significant abdominal fat reduction as measured by Ultrasound Imaging device post 
SlimShape treatments at 12 weeks follow-up (12wk FU) versus baseline. 
Primary Safety Objective 
Evaluate the safety of the treatment with the SlimShape device utilizing the SlimShape 
Applicator Belt during all study. 
Secondary Objectives 
1. Statistically significant abdominal fat reduction post SlimShape treatments as measured 
by USI device at Pre Tx.3, 4 weeks, and 8 weeks follow-up (4wk FU and 8wk FU) versus 
baseline. 
2. Statistically significant abdominal fat reduction post SlimShape treatments as measured 
by Calibrated Caliper device at Pre Tx.3, 4 weeks, and 8 weeks follow-up (4wk FU and 
8wk FU) versus baseline. 
3. Statistically significant abdominal circumference reduction post SlimShape treatment/s 
at Pre Tx.2, Pre Tx.3, 4 weeks, 8 weeks and 12 weeks follow-up (4wk FU, 8wk FU and 
12wk FU) versus baseline. 
4. Investigator satisfaction: 
Satisfaction assessment will be performed by the study investigator using a pre-defined 
scale questionnaire. The investigator will answer this questionnaire at each follow-up 
visit (4wk FU, 8wk FU and 12wk FU). 
5. Subject improvement and satisfaction: 
Improvement and satisfaction assessment will be performed independently by the 
subject using a pre-defined scale questionnaire. The subjects will answer this 
questionnaire at each follow-up visit (4wk FU, 8wk FU and 12wk FU). 
Primary and Secondary Efficacy Endpoint 
Primary and secondary objectives will be measured using the next efficacy endpoints: 
1. Fat thickness measurements using Ultrasound device 

 
 
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Clinical Study to Evaluate the Safety and Efficacy of the SlimShape Device for Abdominal Fat 
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Protocol # 
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2. Fat thickness measurements using Calibrated Caliper device 
3. Circumference measurements of the abdominal area using Measuring Tape 
4. Investigator satisfaction using a pre-defined scale 
5. Subject improvement and satisfaction using a pre-defined scale 
6. Photography 
Primary Safety Endpoint 
The number, severity and type of any adverse event recorded throughout the study and post 
treatment (discomfort (pain), immediate and delayed response). 
1. Occurrence of expected post treatment immediate response including erythema and 
edema and during all study period based on predefined scale (Table 4). 
2. Number, severity and type of any adverse event recorded throughout the course of the 
study. 
STUDY POPULATION 
Number of Subjects 
This study will be comprised of up to 120 subjects in up to ten (10) investigational sites. Subjects 
who meet all the inclusion and none of the exclusion criteria will be enroll. 
Subject Withdrawal and Replacement 
Subjects enrolled in the study can discontinue their participation at any time for any reason 
without prejudice or reduction in the quality of their medical care.  The investigators or sponsor 
can terminate a subject's participation in this study to protect the subject's health or if the 
subject fails to follow directions resulting in noncompliance to study procedures.  Subjects who 
withdraw or are terminated from the study may be replaced to ensure at least 120 subjects 
have completed the study.  Subjects who fail to complete the treatment will be replaced and will 
not be evaluable.  
Inclusion Criteria 
A subject is eligible to participate in the study if he/she meets all the following inclusion criteria: 
1. Signed informed consent to participate in the study. 
2. Female and male subjects,  18 and  60 years of age at the time of enrolment 
3. Fitzpatrick Skin Type I to VI 
4. BMI interval: 18.5 ≤ BMI ≤ 30 (normal to overweight, but not obese). 
5. If female, not pregnant, lactating and must be either post-menopausal, surgically 
sterilized, or using a medically acceptable form of birth control at least 3 months prior to 

 
 
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Clinical Study to Evaluate the Safety and Efficacy of the SlimShape Device for Abdominal Fat 
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Protocol # 
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Rev. Date 
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enrollment (i.e., oral contraceptives, contraceptive implant, barrier methods with 
spermicide or abstinence). 
6. In addition, negative urine pregnancy test as tested before each treatment and at the 
last visit for women with childbearing potential (e.g. not menopause). 
7. General good health confirmed by medical history and skin examination of the treated 
area. 
8. Willing to follow the treatment and follow-up schedule and post-treatment care 
instructions. 
9. Willing to refrain from a change in diet/ exercise/medication regimen for the entire 
course of the study. 
10. Willing to have photographs and images taken of the treated areas to be used de-
identified in evaluations, publications and presentations. 
Exclusion Criteria 
A subject is not eligible for participation in this study if he/she meets any of the following 
exclusion criteria: 
1. History of hypertension, ischemic heart disease, valvular heart disease, congestive heart 
failure, pacemaker/defibrillator, abdominal aortic aneurism 
2. Current hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positive status, 
blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease 
3. Having or undergoing any form of treatment for active cancer, or having a history of skin 
cancer or any other cancer in the areas to be treated, including presence of malignant or 
pre‐malignant pigmented lesions 
4. Having any active electrical implant anywhere in the body, such as a pacemaker or an 
internal defibrillator 
5. Having a permanent implant in the treated area, such as metal plates or an injected 
chemical substance such as silicone 
6. Having undergone any other surgery in the treated areas within 12 months of treatment 
or during the study, including liposuction  
7. Previous body contouring procedures in the treatment area within 12 months 
8. History of skin disease in the treatment area, known tendency to form keloids or poor 
wound healing 
9. History of epidermal or dermal disorders (particularly if involving collagen or 
microvascularity) 
10. Suffering from significant skin conditions in the treated areas or inflammatory skin 
conditions, including, but not limited to, open lacerations or abrasions and active cold 

 
 
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Clinical Study to Evaluate the Safety and Efficacy of the SlimShape Device for Abdominal Fat 
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sores or herpes sores prior to treatment (duration of resolution as per the Investigator’s 
discretion) or during the treatment course 
11. Allergy to any component of the lotion (VelaSpray Ease) used in this study 
12. Skin lesions in the treatment area other than simple nevi on physical examination (e.g., 
atypical nevus, tattoo, abrasions) including depressed scars in the treatment area 
13. Very poor skin quality (i.e., severe laxity) 
14. Abdominal wall diastasis or hernia on physical examination 
15. Abnormal kidney, liver or coagulation functions, abnormal lipid profile or blood count 
within the last 3 months 
16. Obesity (BMI > 30) 
17. Childbirth within the last 12 months or breastfeeding women. Any acute or chronic 
condition which, in the opinion of the investigator, could interfere with the conduct of 
the study 
18. Unstable weight within the last 6 months (i.e., ± 3% weight change in the prior six 
months) 
19. Inability to comply with circumference measurement procedure (e.g., inability to hold 
breath for the required duration). 
20. Participation in another clinical study involving same anatomical areas within the last 6 
months (or 30 days in case different anatomical areas were treated in previous trial/s). 
21. As per the Investigator’s discretion, any physical or mental condition which might make 
it unsafe for the subject to participate in this study. 
STUDY PROCEDURES 
Enrollment and Screening  
During the first visit, the research staff will screen the subject for eligibility to participate.  The 
inclusion/exclusion criteria will be reviewed, the subject’s medical history, an examination of the 
subject’s skin in the treatment areas will be conducted.   
 
The subject will review the informed consent form and the study will be explained to the subject 
including all risks, potential benefits, procedures, visit requirements, and other alternative 
treatment options.   If the subject qualifies and wishes to participate they will complete the ICF 
with a signature and date.  The original will be retained with subject’s records and a copy will be 
provided to the subject. 
The following measurements will be performed and recorded at the specified times throughout 
the study. 

 
 
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Clinical Study to Evaluate the Safety and Efficacy of the SlimShape Device for Abdominal Fat 
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Protocol # 
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Table 2 – Clinical Evaluation Measurements and Tools 
Measurement 
When to conduct 
Method 
Height 
Baseline 
Scale 
Weight 
Prior to all treatments (Tx.1, Tx.2 & 
Tx.3), and at all follow-ups visits (4wk 
FU, 8wk FU & 12wk FU) 
Scale 
BMI 
Calculation 
Fat thickness 
UltraSound 
measurements 
Baseline, Prior to Tx.3, and at all 
follow-ups visits (4wk FU, 8wk FU & 
12wk FU) 
Ultrasound device 
Fat thickness Caliper 
measurements 
Prior to all treatments (Tx.1, Tx.2 & 
Tx.3), and at all follow-ups visits (4wk 
FU, 8wk FU & 12wk FU). 
Calibrated Caliper 
Circumference 
measurements 
Standardized circumference measuring tape 
Photographs 
Standardized digital photographs 
Urine pregnancy test 
Prior to all treatments (Tx.1, Tx.2 & 
Tx.3), and at the last follow-up visit 
(12wk FU) 
Urine pregnancy test 
Immediate 
response 
assessment 
Immediately after each treatment 
(Tx.1, Tx.2 & Tx.3)  
Post Treatment Side Effect Severity Scale (Table 4) 
Investigator 
satisfaction 
At all follow-up visits (4wk FU, 8wk FU 
and 12wk FU) 
 
Satisfaction Questionnaire (Table 6) 
Subject satisfaction 
Satisfaction Questionnaire (Table 6) 
Subject improvement 
assessment 
Improvement Questionnaire (Table 5) 
Safety 
During treatment and throughout 
study.  
Examination of skin in the treated area, interview 
subjects, Adverse Events form, Occurrence and 
Severity Ratings, as well as relation to treatment, 
action taken and outcome 
 
Baseline/ 
Tx.1
Tx.2
Tx.3
4 Weeks Follow-Up 
(4wk FU Post Tx.3)
8 Weeks Follow-Up 
(8wk FU Post Tx.3)
12 Weeks Follow-Up 
(12wk FU Post Tx.3)
Week 0
Week 2
Week 4
Week 8
Week 12
Week 16
Figure 4: Study Flow-Chart (Visits at the Clinic) 

 
 
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Clinical Study to Evaluate the Safety and Efficacy of the SlimShape Device for Abdominal Fat 
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Protocol # 
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Pre-Treatment Procedures 
It is expected that the screening and baseline procedures will be conducted during the same 
visit as the treatment (prior to the treatment). The treatment visit procedures will take up to 1.5 
hours. 
Screening 
1. ICF - Prior to any study procedures, informed consent will be obtained.  When the 
subject fully understands the possible benefits and risks of the study, the subject will be 
asked to sign and date the informed consent form (ICF).  The subject will be given a copy 
of the signed ICF. 
2. Subject ID - subjects will be assigned a study subject ID number.  
3. Medical History - A medical history will be obtained to determine if the subject meets 
the study criteria, including a list of all prescribed and over the counter medications 
taken within the previous 6 months will be recorded.   
4. Skin Exam - The subject will undergo a routine skin exam to determine if they meet the 
study criteria including the presence of fatty tissue deposits in the treatment area.   
5. BMI – the volunteers’ height and weight will be taken for calculation of BMI. 
6. Pregnancy Screen - Subjects who are capable of becoming pregnant will undergo a urine 
pregnancy test. This will be repeated prior to all treatments, and at the end of the study 
(last FU visit/ 12wk FU).  If the Screening and Treatment procedures are not conducted 
on the same day, the urine pregnancy test will be repeated on the first treatment day.      
7. Scheduling: Subjects will be scheduled to return for the baseline and first treatments 
visit within 14 days following the screening visit. It is preferable the baseline procedures 
and Tx.1 will be conducted immediately after the Screening visit.   
Baseline 
1. Photography – Baseline photographs will be obtained using a consistent camera and 
subject placement settings with a digital imaging system. 
2. BMI – the subject weight and height will be taken if baseline visit occurs on  a different 
day than the screening visit. 

 
 
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Clinical Study to Evaluate the Safety and Efficacy of the SlimShape Device for Abdominal Fat 
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Measurements 
Measure the Fat Thickness at the Treated Area – Calibrated Caliper 
Assess fat thickness at treatment area prior starting the treatment using calibrated caliper. 
 
Measure the Fat Thickness at the Treated Area – Ultrasound Imaging Device 
Ultrasound Imaging (USI) provides a valid way for measuring fat thickness using known 
interfaces observed in any individual. USI is relies on the ability to recognize different sub-skin 
interfaces and correctly identifying them, such as the dermis and the subcutaneous fat layer 
interfaces.   
a) Treated area is defined below the sternum and above the iliac. Mark the rectangle of 
the treated area with white pencil. 
b) Measure 2-4 cm from each edge of the umbilicus (superiorly and inferiorly) and 1.5-3 
cm medially and laterally from the ends of these points (as illustrated in Figure 5, white 
lines). Make sure that the measurement points selected are at least 1 cm from the 
edges of the treatment area (including the width of the USI transducer, see green 
arrows in Figure 5).  
 
Figure 5: Ultrasound Measurements Points  
c) Mark the treated area and the measurements points on the transparency, to ensure 
measurement of the same point in each subsequent visit. 

 
 
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Clinical Study to Evaluate the Safety and Efficacy of the SlimShape Device for Abdominal Fat 
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d) Ultrasound measurements should be obtained from the edges of the measurement 
points, laterally (see Figure 5 above, yellow dashed lines). 
e) Place the applicator on the skin surface at angle of 90⁰ (located the applicator under the 
measurement point line for consistency). 
f) Measurement should include all the area between the dermis and end of the fat tissue 
fascia. At least 2 measurements should be done in each measurement point. 
Marking height of circumference measurement 
The abdominal circumference measurement will be marked at 1cm Above Iliac Height (middle 
height of the treated area circumference). Patient should stand up straight when arms are 
placed at the rear of neck and head is positioned towards the horizon (Figure 7). Elbows will be 
positioned in front of the body (Figure 7). 
The height for the circumference measurement will be marked at the anterior abdomen, at the 
back and at each lateral side of the body. Additional measurements will be taken at: Waist 
Height (upper height of the treated area circumference) and at 1.5inch (3.81cm) Below Navel 
Height (lower height of the treated area circumference) See Figure 6 below. 
 

 
 
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Clinical Study to Evaluate the Safety and Efficacy of the SlimShape Device for Abdominal Fat 
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Protocol # 
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Rev. Date 
October 8, 2017 
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Figure 6: Circumference measurements points 
 
Figure 7: Body poisoning during marking height for circumference measurement 
 
The 1cm Above Iliac Height, Waist Height and 1.5inch (3.81cm) Below Navel Height will be 
measured using the height measuring device (supplied by Syneron Medical). The marking pencil 
will be placed horizontally at the stage of the measurement device during the marking 
procedure. (Figure 7) 
Height of all measurements point will be recorded in the CRF (will used as reference for the 
next visits measurements). As well, the circumference results of each height will be recorded at 
each visit. 
Measuring Circumference 
Abdominal circumference is measured to quantify the treatment effect. This procedure will be 
performed and recorded every visit at the clinic, immediately following the measurement of 
height marking.  
In order to achieve reproducible measurement results, the following requirements should be 
fulfilled: 
1. Patient should be wearing underwear and barefoot during circumference measurement. 
2. Patient should stand up straight when arms are placed at the rear of neck and head is 
positioned towards the horizon. Elbows will be positioned in front of the body (see 
Figure 8A).  
3. The measurement tape (supplied by Syneron Medical) should be in parallel to the floor 
during the measurement (see Figure 8B).  
4. The circumference measurement tape should be placed under the marked reference 
points, in order to maintain repetitive height of the measurement. 

 
 
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Clinical Study to Evaluate the Safety and Efficacy of the SlimShape Device for Abdominal Fat 
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5. Middle measurement should be taken at the level of the 1cm Above Iliac Height. 
Additional two circumference measurements at Waist Height and 1.5inch (3.81cm) 
Below Navel Height will be taken. This height levels should be recorded for follow up 
assessments. 
6. Consecutive measurements should be performed at the same height recorded at 
baseline. In order to assure that the measuring tape is parallel to the floor, several 
reference points should be marked around the treatment area and the measuring tape 
should be placed such that it is aligned with them. 
 
Figure 8: Patient positioning during circumference measurements (A) and measuring device position 
around the abdomen (B) 
 
7. The measurement device should be activated at a constant tension to achieve an exact 
measure of the circumference (use measurement device supplied by Syneron only). 
8. In order to minimize measurement inaccuracies originating from human error, it is 
recommended that, whenever possible, the same operator re-measures the patient at 
approximately at the same hour of day (± 3 hours).  
9. Patients should be under fasting for at least 3 hours prior to circumference 
measurement. 
Treatment Procedure 
Subjects will receive treatments with SlimShape device utilizing the SlimShape Applicator Belt on 
the anterior abdomen. 
Prior to each treatment measurements of weight, fat thickness (by Caliper & Ultrasound), and 
abdominal circumference will be done according to the references from the enrollment visit 
A 
B 

 
 
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(Baseline/ prior to Tx.1). Only patients who are eligible for treatment will be allowed to undergo 
the SlimShape procedure. 
Enrolled subjects will undergo up to 3 successive (according to investigator decision) bi-weekly 
(2 weeks interval) treatments (Tx.1, Tx.2 and Tx.3). Additional three (3) visits in the clinic will be 
occurred to follow-up the abdominal fat and circumference reduction at visits 4, 5 and 6 (4 
weeks, 8 weeks and 12 weeks following last treatment). 
SlimShape Treatment Procedure 
General Treatment Instructions 
1. Place the patient so that he/she is lying on his/her back, with the legs extended. In this 
position, the abdomen is fully accessible and treatment can be easily performed. 
2. Remove any jewelry in the area of the application site. 
3. Ensure that the subject skin in the entire treatment is clean. The skin should be cleaned with 
water and soap and hairs that exist in the treatment areas will be shaved.   
4. Ensure that the applicator belt is clean or wipe with 70% alcohol and allowed to dry. 
5. The choice of treatment settings should take into consideration not only the severity of the 
treated condition (fat layer), but also the subject’s skin type, tendency to bruise, the specific 
anatomical location (abdomen), and comfort. 
6. Immediately prior the treatment, apply a generous amount of the commercial VelaEase 
treatment lotion, RF coupling lotion.  You may need to re-apply the lotion if required. 
7. Position the SlimShape Applicator Belt at the correct/ chosen treatment area (on the 
abdomen). 
8. There should be a complete seal between the applicator and the skin during the treatment 
session.  If you hear air being sucked into the chamber, this indicates that the contact 
between the skin and the belt chambers is not ideal for vacuum creation. This usually means 
that the applicator is not positioned properly at that moment, which tends to happen in 
curved or bony areas, so special attention is required when treating such areas. Changing 
the orientation of the applicator slightly may solve this problem.  
9. The applicator belt chambers should have equal compression/contact with the skin to 
ensure safe and effective RF delivery. 
10. Secure the magnetic pads on the sides of both belts, on both sides of the patient and 
tight the SlimShape belt.  
11. Select the desired treatment protocol. 

 
 
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Clinical Study to Evaluate the Safety and Efficacy of the SlimShape Device for Abdominal Fat 
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Protocol # 
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12. Full operating procedure, software screens and parameters are described in the device user 
manuals and instruction will be provided prior to the start of the study. 
13. Expected post treatment side effects are limited to Erythema (blanchable/non-blanchable), 
Edema, Heat sensation, Hematoma and Pain sensation. 

 
 
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Clinical Study to Evaluate the Safety and Efficacy of the SlimShape Device for Abdominal Fat 
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Post Treatment Procedures 
1. Safety aspect will be assessed before and after each treatment: 
a. Clinical effects - All visible and palpable immediate response will be recorded for 
the entire treatment area using a 4-point severity scale (Table 4) 
b. Adverse Events – Record the number, severity and type of any adverse event 
occurred before, through and after treatments. 
Return Visits 
All subjects will be requested to return to the clinic at the following time-points during the study 
in order to assess the clinical performance of the device: 
 Visit 4: FU1 – 4 weeks (±7 days) post last treatment. 
 Visit 5: FU2 – 8 weeks (±7 days) post last treatment. 
 Visit 6: FU3 – 12 weeks (±7 days) post last treatment. 
At each return visit the following procedures will be conducted and data recorded: 
 
Weight.  
 
Ultrasound fat-thickness measurements. 
 
Caliper fat-thickness measurements. 
 
Circumference measurements. 
 
Skin assessment for clinical effects due the procedures: 
o Post treatment response and adverse events. 
 
Photographs as conducted at baseline. 
 
Satisfaction questionnaire performed by the investigator using the Global 
Aesthetic Improvement (GAI). 
 
Completion of the Subject Follow Up questionnaire: 
o Subjective Improvement and satisfaction performed by the subject using 
the Global Aesthetic Improvement (GAI). 
 
At the final visit a urine pregnancy test will be performed for women with 
childbearing potential. 

 
 
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Clinical Study to Evaluate the Safety and Efficacy of the SlimShape Device for Abdominal Fat 
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Protocol # 
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Rev. Date 
October 8, 2017 
Page 25 of 39 
 
 
DATA ANALYSIS 
Recording 
All data will be recorded on site source documents and transcribed onto Case Report Forms 
(CRFs). The site will be monitored by Syneron staff or designees to assure adherence to the 
clinical trial requirements, subject safety, protocol procedures, and for data accuracy. The Case 
Report Forms and images will be reviewed and retrieved during the monitoring visit.  All source 
documentation will remain in the subject's files at the site. 
Review and Analysis of all data collected will be conducted by the Sponsor or designee as 
described for this protocol with the following data:  
Demography and Baseline Measurements 
Demographic and baseline/screening measurements (e.g., weight, height and digital images) will 
be collected and descriptively presented. 
Treatment Visit 
Skin assessment by the PI, photographs of the treated region, and pain scores will be collected 
used to document any adverse events to assess the device performance. 
Follow-up Visit Measurements 
Follow-up measurements for weight, circumference and digital images will be used for 
comparative measurements with their respective measurement at baseline.  Primary endpoints 
will be evaluated 12 weeks post last treatment. Secondary endpoints may be evaluated at all 
visits.  
Safety 
Safety of device procedure will be evaluated through skin assessments by the PI and research 
staff.  The occurrence and severity of all complications from the start of the study will be 
recoded.   
Protocol Revisions and/or Deviations 
With the exception of emergency situations, no changes or deviations in the conduct of this 
protocol will be permitted without the prior approval of the sponsor. 
The IRB/IEC that granted original approval for the study must be notified of all changes in the 
protocol, and will approve any change or deviation that may increase risk to the subject, and/or 
that may adversely affect the rights of the subject or validity of the investigation. 

 
 
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Clinical Study to Evaluate the Safety and Efficacy of the SlimShape Device for Abdominal Fat 
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Protocol # 
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In the event of an emergency, the Investigator will institute any medical procedures deemed 
appropriate. However, all such procedures must be promptly reported to the sponsor and the 
IRB/IEC. 
ADVERSE EVENTS (AE) 
An adverse event (AE) is any adverse change in health or side effect that occurs in a study 
participant during their participation in the study. 
Anticipated Adverse Effects 
Following treatment with the SlimShape the following local adverse effects could occur 
(anticipated): 
 Purpura  
 Erosion 
 Blister 
 Pain/ soreness 
 Bruising 
 First degree burn 
 Bullae 
 Second degree burn 
An adverse event (AE) is any undesired clinical occurrence in a study subject as indicated by 
signs, symptoms, illnesses, events that develop or worsen in severity in association with the 
study when deemed by the Investigator to be related to use of the device or study procedures. 
The Investigator will document all adverse signs and symptoms regardless of severity or 
frequency that are either volunteered by subjects or observed during the course of the study 
that are related to the device.  The Investigator will also record adverse experiences of subjects 
resulting from concurrent illnesses, reactions to concurrent medications, or progression of 
disease states that the Investigator deems related to the device. Included in the description will 
be the nature of the sign or symptom, the date of onset, whether the event was serious, the 
severity, the relationship to study procedures or investigational device, the action taken, the 
date of resolution, and the outcome. The Principal Investigator will determine the relationship 
of the adverse device effect to the investigational device. 
Unanticipated Adverse Device Effects 
For device studies, part 21 CRF 812.3(s) uses the term unanticipated adverse device effect which 
is defined as any serious adverse effect on health or safety or any life-threatening problem or 
death caused by, or associated with the device, if that effect, problem, or death was not 
previously identified in nature, severity, or degree of incidence in the investigational plan or 
application (including a supplementary plan or application), or any other unanticipated serious 
problem associated with a device that relates to the rights, safety, or welfare of subjects.  

 
 
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Clinical Study to Evaluate the Safety and Efficacy of the SlimShape Device for Abdominal Fat 
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Protocol # 
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Rev. Date 
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Page 27 of 39 
 
Significant device failure may constitute an adverse event if an undesirable experience occurs.  
This definition includes any event resulting from insufficiencies or inadequacies in the 
instructions for use or the deployment of the device, or any event that is a result of a user error. 
All unanticipated adverse effects will be graded as follows: 
Mild: 
Sign or symptom, usually transient, non-life-threatening requiring no special 
treatment and generally not interfering with usual activities. 
Moderate: 
Sign or symptom, non-life-threatening which may be ameliorated by simple 
therapeutic measures, and may interfere with usual activity. 
Major: 
Sign or symptom that is intense or debilitating but non-life-threatening and 
that interferes with usual activities. Recovery is usually aided by therapeutic 
measures and the discontinuation of the study device may be required. 
Severe: 
Any untoward medical occurrence that at any time results in death or life-
threatening illness, resulting in persistent or significant disability/incapacity.   
The relationship of the adverse effect to the study is defined as follows: 
Probable: 
An adverse event has a strong temporal relationship to study device, and 
another etiology is unlikely or significantly less likely. 
Possible: 
An adverse event has a strong temporal relationship to the study device, and 
an alternative etiology is equally or less likely compared to the potential 
relationship to study device.  
Probably not: 
An adverse event has little or no temporal relationship to the study device 
and/or a more likely alternative etiology exists. 
Not related: 
An adverse event has no temporal relationship to study device or has a much 
more likely alternative etiology.  
Reporting Adverse Events (AE) and Serious Adverse Events (SAE) 
Anticipated Adverse Events:  Anticipated adverse events in this study include Purpura, 
blistering, bruising, bullae, erosion, soreness and burn. If an unanticipated adverse event occurs 
at any time during or after the use of the SlimShape device, the Investigator must report it to 
Syneron.  
The Investigator must report all unanticipated adverse device effects that are serious in nature 
to the clinical study monitor immediately or within twenty-four hours by telephone (see below). 
If such an unanticipated adverse device effect is reported after normal working hours, the 
Investigator will leave a voice message at the monitor’s telephone number with accompanying 
report of the unanticipated adverse device effect faxed or sent to the fax number/e-mail 
address below:             

 
 
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Clinical Study to Evaluate the Safety and Efficacy of the SlimShape Device for Abdominal Fat 
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Ruthie Amir, MD, Global VP of Clinical Affairs   
                  
Telephone/Fax No.:      From the U.S.  
011 (972) 73-244-2349 
                                               
 
 
 
011 (972) 54-300-3164 (cell)  
                             E-mail:       
               ruthiea@syneron.com  
 
A written report prepared by the Principal Investigator must follow within five working days to 
both the IRB and to Syneron and should include a full description of the event and sequence. 
Measures taken to protect the rights and welfare of subject 
Research records will be available to study personnel, the sponsor, Ethics Review Committee 
and regulatory agencies as required.  Research records may be used for purposes of medical 
education, after removal of subject names or other identifying information.  In the ICF the 
subjects will be informed that the photographs and video taken of them during the study may 
be made available to the sponsor for marketing and instructional purposes, after removal of 
identifying information.  All images collected will be stored without personal subject identifiers 
at the site and at Syneron. 
RISK/BENEFIT ANALYSIS 
Risks 
Syneron has determined that the SlimShape system is non-significant risk device. As indicated in 
the AE section, the anticipated risks associated with the use of both of the systems are: 
 Purpura  
 Erosion 
 Blister 
 Pain/ soreness 
 Bruising 
 First degree burn 
 Bullae 
 Second degree burn 
Over 2500 subjects worldwide participated in clinical research and underwent treatment with 
the different VelaShape family devices. The SlimShape device will be used in this study was 
previously used in studies and emitted the same acoustic energy. To date, no serious adverse 
events or unanticipated AEs have been reported. The reported AEs relate to skin and 
subcutaneous tissue, confined to the treatment area and were all mild in nature and resolved 
within the study period. 
Potential benefits to participating individuals and to society 
Subjects may or may not benefit from reduction of subcutaneous fatty tissue on the treated 
area via a non-invasive technique resulting in body contouring improvement.  All subjects in the 
treatment groups are expected to have some benefit from the treatment procedures as would 

 
 
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Clinical Study to Evaluate the Safety and Efficacy of the SlimShape Device for Abdominal Fat 
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Protocol # 
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Rev. Date 
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Page 29 of 39 
 
be expected for the commercial devices (SlimShape). Subject will receive all treatment 
procedures at no cost.  This study will benefit the advancement of medicine by generating data 
on safety and efficacy that will aid in the development of an alternative treatment options to 
procedures with higher potential risks subjects, such as liposuction.  The results of this study will 
help to determine whether this device is safe and effective for improvement of localized 
subcutaneous fat. 
Conclusion: 
In light of the potential benefits of non-invasive body contouring relative to its risks, the 
potential benefits associated with the use of the SlimShape System outweigh its risks, 
supporting study initiation. 
ETHICS AND GOOD CLINICAL PRACTICE 
This study will be carried out in compliance with the following: 
 
Syneron Standard Operating Procedures. 
 
Declaration of Helsinki, concerning medical research in humans (Recommendations 
Guiding Physicians in Biomedical Research Involving Human Subjects, Helsinki 1964, 
amended Tokyo, 1975, Venice 1983, and Hong Kong 1989). 
 
US Code of Federal Regulations (Title 21CFR including parts 50, 56 and 812 governing 
informed consent and IRB regulations). 
 
International Conference on Harmonization (ICH) Harmonized Tripartite Guideline for 
Good Clinical Practice (GCP), 1996. 
QUALITY ASSURANCE AND STUDY MONITORING 
Study Monitoring/Auditing/Inspection 
The Study Monitor will be responsible for monitoring the study sites to review the data being 
collected. The sponsor shall implement and maintain quality control and quality assurance 
procedures with written standard operating procedures (SOPs) to ensure that the trial is being 
conducted and data are generated, documented and reported in compliance with the protocol, 
Good Clinical Practice (GCP) and applicable regulatory requirements. Visits will be made prior to 
the initiation of the study, at scheduled intervals throughout the study, and at termination of 
the study. 
Once enrollment and treatments have begun, monitoring visits will take place more frequently 
pending enrollment and study activities.    

 
 
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Clinical Study to Evaluate the Safety and Efficacy of the SlimShape Device for Abdominal Fat 
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Protocol # 
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The sponsor and site will maintain regular phone and e-mail correspondence throughout the 
study to confirm compliance of study procedures.   
 The investigator/institution agrees to allow the monitor and other authorized personnel direct 
access to source data/ documents for trial related monitoring, the clinical supplies 
storage/dispensing area and to provide all documents in the Investigator Regulatory Binder for 
review, and to assist site auditors in their activities if requested. Requests by the Health Canada 
or regulatory agencies of other countries to inspect the study site may be made after adequate 
notification. The investigator may be required to assist the regulatory inspectors in their duties, 
if requested. 
ADMINISTRATIVE PROCEDURES 
Supply and Disposition of Study Device 
The SlimShape device and VelaEase (coupler agents) will be supplied to the participating clinic. 
The device will be maintained by the Sponsor, as needed. Unused equipment or coupler agents 
will be returned to the sponsor at the end of the study.  At the end of all planned treatment 
sessions the devices will be returned to Syneron. 
Control & Disposition of the Investigational Device 
The SlimShape device will be used according to the instructions of the Sponsor and 
manufacturer, Syneron Medical.  At the end of this study, any materials provided specifically for 
use in this study may be returned to the Sponsor, as described in the Clinical Trial Agreement 
and study budget.  
Informed Consent 
The Study Personnel will obtain written Informed Consent prior to the subject’s participation in 
any study procedures.  The Study Personnel will inform the subjects of the experimental 
procedure to be utilized and assure the subjects that their decision regarding participation in the 
study will have no bearing on the quality of medical care received and that their decision 
whether to participate in the study is strictly voluntary.  
 
During the initial interview, the subject will be assured that they are free to change their mind 
and will be allowed to participate in the study or withdraw from the study with no adverse 
effect on their standard medical care.   

 
 
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Clinical Study to Evaluate the Safety and Efficacy of the SlimShape Device for Abdominal Fat 
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Monitoring Plan 
At least 3 monitoring visits are projected during the whole study. The frequency of which will be 
based on enrolment, study activities and the study visit scheduled.  The first visit is scheduled at 
the initiation of the study prior to the first subject treatment in the study.  The second visit is 
scheduled after enrolment and treatment has been initiated and a third visit will be for a close-
out visit for the study.  Interim visits may be conducted as needed to assure compliance to the 
study protocol and regulatory requirements.   The number and frequency of monitoring visits 
may also be increased per the sponsor decision to collect data and images post treatment.  
Case Report Forms 
Paper case report forms will be used in this trial. All protocol-required information collected 
during the study must be entered in the appropriate field of the case report form (CRF). The 
investigator, or designated representative, should complete the appropriate CRF fields as soon 
as possible after information is collected. The information must match the information that 
exists as source documents in the clinic chart, hospital chart, and/or investigator’s files. An 
explanation should be given for all missing data. 
It is the investigator’s responsibility to assure the accurate completion, review, and approval of 
all CRFs and the timely completion and submission of all adverse event forms. 
Record Maintenance 
The investigator shall retain a copy of all study documents in accordance with the FDA 
regulations which specify that records should be kept for a period of two years: 1) following the 
date a marketing application either is approved or disapproved for the use, or 2) following 
notification to FDA that no application is being filed and/or that the study has been 
discontinued.  
If an investigator leaves the study site before record retention obligations have expired, the 
sponsor should be notified in writing of the person designated to retain the study documents 
during and after the study. 
Handling of clinical data.  The data are entered into a secure database that only the sponsor has 
access to.  Admission to the database requires access to a password-protected network secured 
by the Sponsor. This database is maintained by Syneron that performs backups, data 
verification, and application upgrades. All equipment housing the clinical data is located in 
locked rooms or a secure computer network.  The only individuals, who view, extract and 
analyze data for protocol reports and publications are physicians and nurses who are members 
of the study team or Sponsors. Only authorized personnel of the Sponsors have access to 
databases.  
Any paper copies of subject medical records or research records are stored in secure cabinets at 
the study site.  

 
 
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Clinical Study to Evaluate the Safety and Efficacy of the SlimShape Device for Abdominal Fat 
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PUBLICATION POLICY 
The investigator will not publish the study results and will not disclose confidential information 
received from Syneron without prior written agreement from Syneron. Such confidential 
information shall include any and all information relating to this study as described in the 
Clinical Trial Agreement.  In the event that Syneron consents to the publication of data from this 
study, the investigator will provide Syneron manuscripts for review thirty days before 
submission for publication. Syneron will have no editorial rights over manuscripts. The 
investigator will also provide Syneron with advance notice of at least (30) days, of any 
presentation, lecture, abstract session, etc., in which any results from the study will be 
disclosed.  

 
 
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Clinical Study to Evaluate the Safety and Efficacy of the SlimShape Device for Abdominal Fat 
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Protocol # 
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Rev. Date 
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Page 33 of 39 
 
BIBLIOGRAPHY 
 
1. Arner P. OBESITY AND THE ADIPOCYTE, Regional adipocity in man. Journal of 
Endocrinology (1997) 155, 191–192 
2. Illouz YG, de Villiers YT. Body Sculpturing by Lipoplasty. Edinburgh: Churchill Livingstone, 
1989. 
3. Gasparotti M. Superficial liposuction: a new application of the technique for aged and 
flaccid skin. Aesthet Plast Surg (1992) 16, 141–53  
4. Adamo C, Mazzocchi M, Rossi A and Scuderi N. Ultrasonic liposculpturing. extrapolations 
from the analysis of in vivo sonicated adipose tissue. Plast Reconstr Surg (1997) 100, 
220–6 
5. Goldman A. Submental Nd:YAG Laser-Assisted Liposuction. Lasers in Surgery and 
Medicine 38:181–184 (2006). 
6. Hexsel D, Serra M, Mazzuco R, Dal'Forno T, Zechmeister D. Phosphatidylcholine in the 
treatment of localized fat. J. Drugs Dermatol. 2003 Oct;2(5):511-8. 

 
 
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Protocol # 
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Rev. Date 
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Page 34 of 39 
 
 
APPENDIX I – STUDY SUMMERY 
Table 3 - Study Schematics 
 
Screen / 
Baseline* 
Tx.1 
Tx.2 
2 weeks  5 
days 
Tx.3 
2 weeks  
5 days 
4 weeks 
Follow-Up 
(4wk FU) 
7 days 
8 weeks 
Follow-Up 
(8wk FU) 
7 days 
12 weeks 
Follow-Up 
(12wk FU) 
7 days 
Informed Consent 
Process 
X 
 
 
 
 
 

 
 
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Clinical Study to Evaluate the Safety and Efficacy of the SlimShape Device for Abdominal Fat 
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Protocol # 
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Rev. Date 
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Page 35 of 39 
 
 
Eligibility Screening & 
Medical History 
X 
 
 
 
 
 
PERFORM BEFORE TREATMENT 
Photography 
X 
X 
X 
X 
X 
X 
Height 
X 
 
 
 
 
 
Weight (BMI 
calculation) 
X 
X 
X 
X 
X 
X 
Transplant 
Preparation 
X 
 
 
 
 
 
Fat Thickness 
Ultrasound 
Measurement 
(Prior Strapping) 
X 
 
X 
X 
X 
X 
Fat Thickness 
Caliper 
Measurement 
X 
X 
X 
X 
X 
X 
Circumference 
Measurements 
X 
X 
X 
X 
X 
X 
Treatment 
X 
X 
X 
 
 
 
Safety Monitoring 
X 
X 
X 
X 
X 
X 
Subject Questionnaire  
 
 
 
X 
X 
X 
Investigator 
Questionnaire  
 
 
 
X 
X 
X 
Urine Pregnancy Test 
X 
X 
X 
 
 
X 
End of Participation 
(Termination) 
 
 
 
 
 
 
X 

 
 
Syneron Medical Ltd. 
Confidential 
 
Clinical Study to Evaluate the Safety and Efficacy of the SlimShape Device for Abdominal Fat 
and Circumference Reduction 
Protocol # 
DHF22621 
Rev. Date 
October 8, 2017 
Page 36 of 39 
 
 
APPENDIX II - SCALES 
Table 4 - Post Treatment Side Effect Severity Scale 
(0) Absent / None 
 
(1) Mild 
 
(2) Moderate 
 
(3) Severe 
 
 
Table 5 – Global Aesthetic Improvement (GAI) Scale 
(3) Significant improvement 
 
(2) Moderate improvement 
 
(1) Slight improvement 
 
(0) No change 
 
(-1) Slightly worse 
 
(-2) Moderately worse 
 
(-3) Significantly worse 
 
 
Table 6 – Satisfaction Scale 
(2) Very satisfied 
 
(1) Satisfied 
 
(0) No opinion 
 
(-1) Dissatisfied 
 
(-2) Very dissatisfied 
 
 

 
 
Syneron Medical Ltd. 
Confidential 
 
Clinical Study to Evaluate the Safety and Efficacy of the SlimShape Device for Abdominal Fat 
and Circumference Reduction 
Protocol # 
DHF22621 
Rev. Date 
October 8, 2017 
Page 37 of 39 
 
 
APPENDIX III ‐ PHOTOGRAPHY 
At each of the specified time points; photographs of the treated areas should be taken by 
investigator or their designee. 
 
Photographs should be taken in a private room or area of the clinic under controlled 
conditions, including the distance from the camera to the subject, height of the camera, 
background, camera positioning, subject's positioning and lighting in order to achieve 
high-quality before & after sets. 
 
Consistent lighting- Lighting should be projected from about 45º angle in order to 
emphasize the body appearance. 
 
It is important to keep a constant distance between the subject’s feet (use “sticky feet” 
or another way of marking) in order to properly present the effect of the treatment. 
The recommended distance between the feet is ~20 cm, but the main point is not to 
make this distance too small, so the thighs touch each other, or too large. 
 
The disposable underwear should be used for all photographs of all of the anatomical 
areas at all time points. 
 
For consistency purposes, the same person should ideally take all study photographs, 
especially per area and subject.  
 
The digital files should follow a consistent standard naming scheme containing subject 
initials and study ID #, visit or visit date. 
Specific photography details: 
Abdomen:  
Three photographs should be taken at each specified time point 
 
Front 
 
45º from the right side  
 
90º from the right side 
 
45º from the left side  
 
90º from the left side 
The subject’s arms should remain out of the way; it is best to either cross them over each other 
in front of the chest or hold them up at a 90° angle to the body, ensuring that they do not rest 
on the chest or touch the body and that they do not cast a shadow in the photograph.  

 
 
Syneron Medical Ltd. 
Confidential 
 
Clinical Study to Evaluate the Safety and Efficacy of the SlimShape Device for Abdominal Fat 
and Circumference Reduction 
Protocol # 
DHF22621 
Rev. Date 
October 8, 2017 
Page 38 of 39 
 
 
APPENDIX IV - CLINICAL TRIAL ACKNOWLEDGEMENT 
 
I have read and understood the foregoing protocol, and agree to conduct this clinical study as 
outlined herein and in accordance with Good Clinical Practices, as well as with local and 
universal regulations pertaining to clinical trials. 
 
 
 
 
Investigator’s Signature 
 
                                                           Date 
 
Name  
 
 
Clinic  
                                                                                       Street Address 
 
City, State & Zip Code  
                                                           Country 
 
 
Phone # 
 
 
 
Fax #  
 
 
E-mail Address 
 
 
 
 
 

 
 
Syneron Medical Ltd. 
Confidential 
 
Clinical Study to Evaluate the Safety and Efficacy of the SlimShape Device for Abdominal Fat 
and Circumference Reduction 
Protocol # 
DHF22621 
Rev. Date 
October 8, 2017 
Page 39 of 39