Clinical Study to Evaluate the Safety and Efficacy of the UltraShape Power Device Using the U-Sculpt Power Transducer for Abdominal Fat and Circumference Reduction
Phase: NA
Conditions: Excess Abdominal Fat
Sponsor: Syneron Medical

 
 
Syneron Medical Ltd. 
Confidential 
 
Clinical Study to Evaluate the Safety and Efficacy of the UltraShape Power Device Using the 
U-Sculpt Power Transducer for Abdominal Fat and Circumference Reduction 
Protocol # 
DHF21621 
Rev. Date 
April 05, 2016 
Page 1 of 37 
 
 
 
 
 
 
 
 
Title: 
Clinical Study to Evaluate the Safety and Efficacy of the UltraShape Power Device 
Using the U-Sculpt Power Transducer for Abdominal Fat and Circumference 
Reduction 
Protocol Number: 
DHF21621 
Study Type: 
Prospective Clinical Study 
Date: 
April 05, 2016 
 
Study Devices: 
UltraShape Power 
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. 

 
 
Syneron Medical Ltd. 
Confidential 
 
Clinical Study to Evaluate the Safety and Efficacy of the UltraShape Power Device Using the 
U-Sculpt Power Transducer for Abdominal Fat and Circumference Reduction 
Protocol # 
DHF21621 
Rev. Date 
April 05, 2016 
Page 2 of 37 
 
Principal Investigator and study site: 
Site 1: 
Site 2: 
Site 3: 
Site 4: 
Site 5: 
Site 6: 
Site 7: 
Site 8: 
Site 9: 
Site 10: 
 
Principal Investigator’s Signature 
I, _______________________________ have carefully read the foregoing protocol # DHF21621: 
“Clinical Study to Evaluate the Safety and Efficacy of the UltraShape Power Device Using the U-
Sculpt Power Transducer 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 
 
 

 
 
Syneron Medical Ltd. 
Confidential 
 
Clinical Study to Evaluate the Safety and Efficacy of the UltraShape Power Device Using the 
U-Sculpt Power Transducer for Abdominal Fat and Circumference Reduction 
Protocol # 
DHF21621 
Rev. Date 
April 05, 2016 
Page 3 of 37 
 
Table of Contents 
Glossary ........................................................................................................................................... 5 
Table 1- Study Synopsis ................................................................................................................... 6 
Introduction and rationale .............................................................................................................. 7 
Background .................................................................................................................................. 7 
Device Descriptions ..................................................................................................................... 8 
Syneron UltraShape Power Device .......................................................................................... 8 
Study design overview ................................................................................................................... 11 
Sutdy Objective ............................................................................................................................. 11 
Primary Objective ...................................................................................................................... 11 
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 ................................................................................................................ 22 
UltraShape Power Treatment Procedure .............................................................................. 23 
Post Treatment Procedures ....................................................................................................... 23 
Return Visits .............................................................................................................................. 23 
DATA ANALYSIS.............................................................................................................................. 24 
Recording ................................................................................................................................... 24 
Demography and Baseline Measurements ........................................................................... 24 
Treatment Visit ...................................................................................................................... 24 
Follow-up Visit Measurements .............................................................................................. 24 
Safety ..................................................................................................................................... 25 
Protocol Revisions and/or Deviations ....................................................................................... 25 
ADVERSE EVENTS (AE) ................................................................................................................... 25 
Anticipated Adverse Effects ...................................................................................................... 25 
Unanticipated Adverse Device Effects ...................................................................................... 26 
Reporting Adverse Events (AE) and Serious Adverse Events (SAE) ........................................... 27 
Measures taken to protect the rights and welfare of subject............................................... 27 
RISK/BENEFIT ANALYSIS................................................................................................................. 27 
Risks ........................................................................................................................................... 27 

 
 
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Clinical Study to Evaluate the Safety and Efficacy of the UltraShape Power Device Using the 
U-Sculpt Power Transducer for Abdominal Fat and Circumference Reduction 
Protocol # 
DHF21621 
Rev. Date 
April 05, 2016 
Page 4 of 37 
 
Potential benefits to participating individuals and to society ................................................... 28 
Conclusion: ................................................................................................................................ 28 
ETHICS AND GOOD CLINICAL PRACTICE ........................................................................................ 28 
QUALITY ASSURANCE AND STUDY MONITORING ......................................................................... 29 
Study Monitoring/Auditing/Inspection ..................................................................................... 29 
ADMINISTRATIVE PROCEDURES .................................................................................................... 29 
Supply and Disposition of Study Device .................................................................................... 29 
Control & Disposition of the Investigational Device ................................................................. 29 
Informed Consent ...................................................................................................................... 30 
Monitoring Plan ......................................................................................................................... 30 
Case Report Forms .................................................................................................................... 30 
Record Maintenance ................................................................................................................. 30 
PUBLICATION POLICY..................................................................................................................... 31 
BIBLIOGRAPHY ............................................................................................................................... 32 
Appendix I – Study Summery ........................................................................................................ 33 
Appendix II - Scales ........................................................................................................................ 34 
Appendix III - Pain assessment ...................................................................................................... 35 
Appendix IV ‐ Photography ............................................................................................................ 36 
Specific photography details: .................................................................................................... 36 
Abdomen: .............................................................................................................................. 36 
Appendix V - Clinical Trial Acknowledgement ............................................................................... 37 
 
 
 

 
 
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Clinical Study to Evaluate the Safety and Efficacy of the UltraShape Power Device Using the 
U-Sculpt Power Transducer for Abdominal Fat and Circumference Reduction 
Protocol # 
DHF21621 
Rev. Date 
April 05, 2016 
Page 5 of 37 
 
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 
W 
Watt (Output Electric Power) 
 
 
 
 

 
 
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Clinical Study to Evaluate the Safety and Efficacy of the UltraShape Power Device Using the 
U-Sculpt Power Transducer for Abdominal Fat and Circumference Reduction 
Protocol # 
DHF21621 
Rev. Date 
April 05, 2016 
Page 6 of 37 
 
TABLE 1- STUDY SYNOPSIS 
Proprietary Name 
UltraShape Power device utilizing the U-Sculpt Power Transducer 
Design 
Prospective, one arm, baseline-controlled, clinical study for the evaluation of the UltraShape 
Power treatment using the U-Sculpt Power Transducer for non-invasive abdominal fat and 
circumference reduction. 
Study subjects will undergo UltraShape Power 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 3 bi-weekly treatments (2 weeks interval) with the UltraShape 
Power device utilizing the U-Sculpt Power Transducer 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 (Third Treatment). 
Each subject will be enrolled for total expected study duration of 16 weeks. 
Objective 
The objective of this trial is to evaluate the safety and efficacy of the UltraShape Power 
device utilizing the U-Sculpt Power Transducer for abdominal non-invasive fat and 
circumference reduction 
Primary Objective 
Statistically significant abdominal fat reduction post UltraShape Power treatments at 12 
weeks follow-up (12wk FU) versus baseline 
Primary 
Safety 
Objective 
1. Evaluate the safety of the treatment with the UltraShape Power device utilizing the 
U-Sculpt Power Transducer during all study 
2. Comfort level during treatment: 
Comfort assessment will be performed independently by the subject himself using 
NSR scale. The subjects will answer this questionnaire after each treatment (Tx.1, 
Tx.2 and Tx.3) 
Secondary 
Objectives 
3. Statistically significant abdominal fat reduction post UltraShape Power treatments as 
measured by Ultrasound device at Pre Tx.3, 4 weeks, and 8 weeks follow-up (4wk FU 
and 8wk FU) versus baseline 
4. Statistically significant abdominal fat reduction post UltraShape Power treatments as 
measured by calibrated Caliper 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 
5. Statistically significant abdominal circumference reduction post  UltraShape Power 
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 
6. 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 UltraShape Power Device Using the 
U-Sculpt Power Transducer for Abdominal Fat and Circumference Reduction 
Protocol # 
DHF21621 
Rev. Date 
April 05, 2016 
Page 7 of 37 
 
7. Subject improvement and satisfaction: 
Improvement and satisfaction assessment will be performed independently by the 
subject himself using a pre-defined scale questionnaire. The subjects will answer this 
questionnaire at each follow-up visit (4wk FU, 8wk FU and 12wk FU) 
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 calibrated 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) 
2. Pain assessment using NSR scale 
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 

 
 
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Clinical Study to Evaluate the Safety and Efficacy of the UltraShape Power Device Using the 
U-Sculpt Power Transducer for Abdominal Fat and Circumference Reduction 
Protocol # 
DHF21621 
Rev. Date 
April 05, 2016 
Page 8 of 37 
 
ultrasound-assisted liposuction, power-assisted liposuction, laser lipolysis as well as low-level 
laser-assisted liposculpture.5  
 
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.  New minimally invasive technologies include subcutaneous injection of 
phosphatidylcholine. This drug was initially used in emergencies and in the treatment of 
atheroma plaques in cardiac diseases.  Recently, it has also been used in the treatment of 
localized fat deposits, with mixed reviews.6   
 
The UltraShape® Contour I VER 3.1 is a device cleared by the Food and Drug Administration (FDA 
– K133238) and Health Canada (HC). The UltraShape, the next generation of Contour I VER 3.1, is 
a commercial device cleared by the CE, Health Canada and by the Food and Drug Administration 
(FDA – K141708) which uses focused ultrasound to produce localized mechanical motion within 
fat tissues and cells for the purpose of producing mechanical cellular membrane disruption. It is 
intended for reduction in abdominal circumference. 
 
The UltraShape Power System delivers focused ultrasound energy that can disrupt 
subcutaneous adipose tissue (SAT) to provide a non-invasive approach to achieve a desired 
aesthetic effect. It is intended for non-invasive reduction in abdominal circumference. This study 
intends to assess UltraShape Power device utilizing the U-Sculpt Power transducer performance. 
 
Device Descriptions 
Syneron UltraShape Power Device  
General: Tissue selectivity is achieved by a proprietary knowledge of ultrasound parameters 
ensuring specific destruction of the fat cells only within the target area. All other types of tissue, 
such as blood vessels, muscles and peripheral nerves remain intact. There are no thermal 
effects. Fat cell destruction is achieved by ultrasound-induced mechanical effects during a very 
short exposure time. 
 
The UltraShape Power system comprised of two main parts: 
 
The Main console 
 
Transducer 
 

 
 
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Clinical Study to Evaluate the Safety and Efficacy of the UltraShape Power Device Using the 
U-Sculpt Power Transducer for Abdominal Fat and Circumference Reduction 
Protocol # 
DHF21621 
Rev. Date 
April 05, 2016 
Page 9 of 37 
 
Main Console 
The Pulser 
The main console contains: the Pulser, Touch Screen, PC, Cooling System, Power supply Module 
and Video Camera. The main console hardware and software enable operation of the 
Transducer Unit. 
The Pulser is responsible for producing high power electrical signals for feeding the Transducer 
Unit, with the ability to control operating frequencies, burst length, duty cycle and on-line 
output power. The Pulser has communication interfaces with the PC, the Power Supply Module 
(PSM), the Distributer Board (DSB), the Transducer and the cooling system. The Pulser is 
comprised of a CPU unit and Pulse generator. The Pulser uses transducer-unique parameters 
and "Power Level" (high \ medium \ low) selected by the user to send the relevant electric signal 
to the transducer. 
Touch Screen and PC 
The operator interfaces with the UltraShape Power system using its Touch Screen.  
The Touch Screen interface allows the user to command and control the system using dedicated 
software. The Touch Screen interfaces with the Pulser, the camera and external USB. The Touch 
Screen operates the system's tracking system that uses a video camera in order to monitor the 
position of the transducer over the patient’s body. The System database is managed by the 
Touch Screen. 
Cooling system 
Inside the Transducer there is a cooling element (TEC). The cooling system evacuates heat from 
the hot side of the TEC, by circulating water into the system's radiator. 
Power Supply Module 
The Power Supply Module (PMS) provides the input power to the system sub-units. The Power 
Supply Module receives external AC voltage and converts it into DC: Low Voltage and High 
Voltage. The PSM is controlled by the Pulser and the DSB. 
Video Camera 
The system includes a video camera as a part of its tracking system. The camera captures the 
image of the treatment area, enabling the operator to monitor the procedure and track the 
treated area and transducer position. 
Distributor Board (DSB) 
The Distributor Board is responsible for distribution of DC voltages to the system's sub-units. 
The DSB is controlled by the Pulser. The DSB gathers feedback signals from the Cooling system 
and returns it to the Pulser. 

 
 
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Clinical Study to Evaluate the Safety and Efficacy of the UltraShape Power Device Using the 
U-Sculpt Power Transducer for Abdominal Fat and Circumference Reduction 
Protocol # 
DHF21621 
Rev. Date 
April 05, 2016 
Page 10 of 37 
 
Transducer 
The transducers are electro-mechanical devices that convert electrical signals into mechanical 
(acoustical) energy. Functionality of the transducer is based on piezoelectric ceramics, whose 
characteristics are to change their physical dimensions when electrical voltage is applied. When 
an alternating voltage, with a certain frequency, is applied across the piezoelectric element, it 
causes it to oscillate with the same frequency, thus producing ultrasound waves. The spherical 
shape of the piezoelectric element enables focusing of the ultrasonic wave, which enables the 
ultrasound waves to be focused into a narrow focal region (which is actually the target region). 
The UltraShape Power system supports use of the "U-Sculpt Power” (Isppa 660 W/cm2) and the 
“VDF Power” (Isppa 550 W/cm2) Transducers. 
 
Figure 1:  UltraShape Power System 
 
Accessories needed for the UltraShape Power Treatment 
Reusable Straps 
Gather skin and fat at the area to be treated. Straps are supplied at 3 sizes. 
Parker Gel  
Used as a coupler agent between skin surface and the ultrasonic transducer   
Ultrasound Device 
Measure fat thickness at treatment area prior starting the treatment. 

 
 
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Clinical Study to Evaluate the Safety and Efficacy of the UltraShape Power Device Using the 
U-Sculpt Power Transducer for Abdominal Fat and Circumference Reduction 
Protocol # 
DHF21621 
Rev. Date 
April 05, 2016 
Page 11 of 37 
 
Calibrated Caliper 
Assess fat thickness at treatment area prior starting the treatment. 
Circumference measuring tape 
Assess circumference reduction  
Height Measuring Device(Seca) 
Measure circumference at the same height in the subsequent visits  
A3 Transpaernt Paper (B ledger size) 
Assure repeatable marking of treatment area at each treatment visit 
STUDY DESIGN OVERVIEW 
This study is a prospective, baseline controlled, multi-center, one arm clinical study showing the 
performance and safety of the UltraShape Power 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 three successive bi-weekly (two 
weeks interval) treatments will be performed.  
The study subjects will undergo treatments with UltraShape Power device utilizing the U-Sculpt 
Power Transducer. 
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 (Tx.3). Subject’s fat thickness will be measured 
in two different methods (Caliper & Ultrasound) 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. 
SUTDY OBJECTIVE 
The objective of this trial is to evaluate the safety and efficacy of the UltraShape Power device 
utilizing the U-Sculpt Power Transducer for abdominal non-invasive fat and circumference 
reduction  
Primary Objective 
Statistically significant abdominal fat reduction as measured by Ultrasound device post 
UltraShape Power treatments at 12 weeks follow-up (12wk FU) versus baseline. 

 
 
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Clinical Study to Evaluate the Safety and Efficacy of the UltraShape Power Device Using the 
U-Sculpt Power Transducer for Abdominal Fat and Circumference Reduction 
Protocol # 
DHF21621 
Rev. Date 
April 05, 2016 
Page 12 of 37 
 
Primary Safety Objective 
1. Evaluate the safety of the treatment with the UltraShape Power device utilizing the U-
Sculpt Power Transducer during all study. 
2. Comfort level during treatment: 
Comfort assessment will be performed independently by the subject himself using NSR 
scale; the subjects will answer this questionnaire after each treatment (Tx.1, Tx.2 and 
Tx.3). 
Secondary Objectives 
1. Statistically significant abdominal fat reduction post UltraShape Power 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 UltraShape Power treatments as 
measured by calibrated Caliper 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. 
3. Statistically significant abdominal circumference reduction post UltraShape Power 
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 himself 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 
2. Fat thickness measurements using calibrated 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 

 
 
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Clinical Study to Evaluate the Safety and Efficacy of the UltraShape Power Device Using the 
U-Sculpt Power Transducer for Abdominal Fat and Circumference Reduction 
Protocol # 
DHF21621 
Rev. Date 
April 05, 2016 
Page 13 of 37 
 
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. 
3. Discomfort (pain) level using a 10-point visual analog scale will also be recorded after 
each benign pigmented lesion clearance treatment– by Numerical Scale Response (NSR), 
according to Appendix IIIAppendix III - Pain assessment. 
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. Abdominal fat thickness of at least 1.5 cm (measured by calibrated caliper). 
5. BMI interval: 22 ≤ BMI ≤ 30 (normal to overweight, but not obese). 
6. 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 
enrollment (i.e., oral contraceptives, contraceptive implant, barrier methods with 
spermicide or abstinence). 

 
 
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Clinical Study to Evaluate the Safety and Efficacy of the UltraShape Power Device Using the 
U-Sculpt Power Transducer for Abdominal Fat and Circumference Reduction 
Protocol # 
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Rev. Date 
April 05, 2016 
Page 14 of 37 
 
7. In addition, negative urine pregnancy test as tested before each treatment and at the 
last visit for women with bearing potential (e.g. not menopause). 
8. General good health confirmed by medical history and skin examination of the treated 
area. 
9. Willing to follow the treatment and follow-up schedule and post-treatment care 
instructions. 
10. Willingness to refrain from a change in diet/ exercise/medication regimen for the entire 
course of the study. 
11. 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. 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 
sores or herpes sores prior to treatment (duration of resolution as per the Investigator’s 
discretion) or during the treatment course 
10. 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 

 
 
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Clinical Study to Evaluate the Safety and Efficacy of the UltraShape Power Device Using the 
U-Sculpt Power Transducer for Abdominal Fat and Circumference Reduction 
Protocol # 
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Rev. Date 
April 05, 2016 
Page 15 of 37 
 
11. Very poor skin quality (i.e., severe laxity) 
12. Abdominal wall diastasis or hernia on physical examination 
13. Abnormal kidney, liver or coagulation functions, abnormal lipid profile or blood count 
within the last 3 months 
14. Obesity (BMI > 30) 
15. 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 
16. Unstable weight within the last 6 months (i.e., ± 3% weight change in the prior six 
months) 
17. Inability to comply with circumference measurement procedure (e.g., inability to hold 
breath for the required duration). 
18. Abdominal fat thickness lower than 2.5 cm after strapping. 
19. 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). 
20. 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 UltraShape Power Device Using the 
U-Sculpt Power Transducer for Abdominal Fat and Circumference Reduction 
Protocol # 
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Rev. Date 
April 05, 2016 
Page 16 of 37 
 
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 
measurement 
Baseline, Prior to Tx.3, and at all 
follow-ups visits (4wk FU, 8wk FU & 
12wk FU) 
Ultrasound device. 
Fat thickness Caliper 
measurement 
Prior to all treatments (Tx.1, Tx.2 & 
Tx.3), and at all follow-ups visits (4wk 
FU, 8wk FU & 12wk FU). 
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 
Treatment-associated 
pain 
Immediately after each treatment 
(Tx.1, Tx.2 & Tx.3)  
Subject will be asked to rank/ assess pain level 
during treatment based on the Numerical Scale 
Response  (NSR scale) - Appendix IIIAppendix III 
- Pain assessment 
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) 
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 2: Study Flow-Chart (Visits at the Clinic) 
 
 

 
 
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U-Sculpt Power Transducer for Abdominal Fat and Circumference Reduction 
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April 05, 2016 
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Pre-Treatment Procedures 
Screening and Baseline procedures may be conducted on the same visit day as the treatment, 
prior to the treatment.  It is expected that the screening and baseline procedures will be 
conducted during the same visit and the treatment visit procedures will take up to 2 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 at visits 2 and 3 (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 
treatment day.      
7. Scheduling: Subjects will be scheduled to return for the baseline and 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 is a different day than 
the screening visit. 

 
 
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U-Sculpt Power Transducer for Abdominal Fat and Circumference Reduction 
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Rev. Date 
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Measurements 
Measure the Fat Thickness at the Treated Area – Calibrated Caliper 
The procedure can be performed only in areas where the fat thickness is ≥1.5 cm as measured 
by a skin fold caliper (or ≥3.0 cm as measured by a pinch test), and ≥2.5 cm as measured by a 
skin fold caliper after strapping.  
Marking Area for Treatment and Sequence of Treatments 
The mark of area to be treated should be copied to a transparent template (at size of A3 paper) 
to ensure consistent marking of the same area for same patient during the subsequent visits.  
During copying the treatment area to the transparent template, the following signs will be 
marked on transparency (Figure 3) 
a) Margins of area to be treated (A in Figure 3) 
b) Subject's identification code (B in Figure 3) 
c) Location of navel (C in Figure 3) 
d) Sides of right and left (D in Figure 3)  
At the subsequent treatment sessions, this transparent template will be placed according to 
these signs on the abdomen, and the line of treatment area will be re-marked.  
 
Figure 3: Marked area of treatment is copied to transparent template, which includes: (A) margin of 
area to be treated   (B) Subject's code   (C) location of navel (blue central circle)   (D) right and left side. 
The left picture demonstrates the procedure on patient. 
 
 

 
 
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Rev. Date 
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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) Divide the treatment area into 4 sub areas: 
1. Right Upper 
2. Right Lower 
3. Left Upper 
4. Left Lower 
b) Locate each sub area mid-point and measure 
 
Figure 4: Ultrasound Measurements Points  
c) Mark the measurements points on the transparency (made while marking the treatment 
area), to measure the same point in each subsequent visit. 
d) Place the applicator on the skin surface at angle of 90⁰ (located the applicator under the 
measurement point line for consistency). 
e) Measurement should include all the area between the dermis and end of the fat tissue 
fascia. 
Marking height of circumference measurement 
The abdominal midsection for circumference (=Midline) measurement will be marked at the 
widest region within the defined area for treatment (see Figure 5). Patient should stand up 
straight when arms are placed at the rear of neck and head is positioned towards the horizon 
(Figure 6). Elbows will be positioned in front of the body (Figure 6). 
The height for the circumference measurement will be marked at the anterior abdomen, at the 
back and at each lateral side of the body (Figure 7). Additional measurements will be taken at 2 
cm above midsection (=2cm above Midline) measurement and 2 cm below midsection (=2cm 
below Midline) measurement. 

 
 
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U-Sculpt Power Transducer for Abdominal Fat and Circumference Reduction 
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Rev. Date 
April 05, 2016 
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Figure 5: Circumference measurement will be done at the widest region within the defined area for 
treatment (white arrow) 
 
Figure 6: Body poisoning during marking height for circumference measurement 
 
 
Figure 7: Height of circumference measurement will be marked at the anterior abdomen, at the back 
and at each lateral side of the body. 
 
The height of midsection will be measured using the height measuring device (supplied by 
Syneron Medical) (Figure 8). The marking pencil will be placed horizontally at the stage of the 
measurement device (Figure 8) during the marking procedure.  

 
 
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Height of midsection area and circumference results will be recorded in the CRF (will used as 
reference for the next visits measurements). 
 
Figure 8: Mark pencil will be placed horizontally at the stage of measurement device 
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 9A).  
3. The measurement tape (supplied by Syneron Medical) should be in parallel to the floor 
during the measurement (see Figure 9B).  
4. The circumference measurement tape should be placed under the marked reference 
points, in order to maintain repetitive height of the measurement. 
5. Midline measurement should be taken at the level of the widest part within the defined 
area for treatment (Figure 5) – horizontal midsection. This height level should be 
recorded for follow up assessments. Additional two measurements at 2 cm above and 2 
cm below the horizontal midsection (=Midline) will be taken. 
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. 

 
 
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U-Sculpt Power Transducer for Abdominal Fat and Circumference Reduction 
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Rev. Date 
April 05, 2016 
Page 22 of 37 
 
 
Figure 9: 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 
measurement 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 UltraShape Power device utilizing the U-Sculpt Power 
Transducer on the anterior abdomen. 
Prior to each treatment measurements of weight, fat thickness (both by Ultrasound and 
Caliper), and abdominal circumference will be done according to the references from the 
enrollment visit (Baseline/ prior to Tx.1). Only patients who are eligible for treatment will be 
allowed to undergo the UltraShape Power procedure. 
Enrolled subjects will undergo 3 successive 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). 
A 
B 

 
 
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U-Sculpt Power Transducer for Abdominal Fat and Circumference Reduction 
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Rev. Date 
April 05, 2016 
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UltraShape Power Treatment Procedure 
The subject abdomen will be gathered using reusable straps (supplied by Syneron Medical), to 
gather the fat area for treatment according to the instruction written in the User Manual.  
 According to size of the treatment area, the UltraShape Power device will determine the total 
number of FTZs to be delivered during treatment. While the recommended minimal number of 
ultrasound FTZs to be delivered per subject at a whole single treatment will be defined / 
determined by the system according to the subject physical characteristic and treated area size. 
Prior to admitting the FTZs (pulses) Parker acoustic gel will be applied and on the treated area 
and used as a coupler agent between the ultrasonic U-Sculpt Power Transducer and the skin 
surface. 
Perform the UltraShape Power utilizing the U-Sculpt Power Transducer treatment according to 
the instruction in the User Manual. 
Expected post treatment side effects are limited to Erythema (blanchable/non-blanchable), 
Edema, Heat sensation and pain sensation. 
Post Treatment Procedures 
1. Pain assessment – immediately after each treatment the subjects will be asked to rank 
the pain sensation during treatment using Numerical Scale Response (NSR; see 
Appendix III) for the UltraShape Power procedure 
2. 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. 

 
 
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Clinical Study to Evaluate the Safety and Efficacy of the UltraShape Power Device Using the 
U-Sculpt Power Transducer for Abdominal Fat and Circumference Reduction 
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Rev. Date 
April 05, 2016 
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 
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 bearing 
potential. 
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 (Tx.3). Secondary endpoints may be evaluated at 
all visits.  

 
 
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Clinical Study to Evaluate the Safety and Efficacy of the UltraShape Power Device Using the 
U-Sculpt Power Transducer for Abdominal Fat and Circumference Reduction 
Protocol # 
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Rev. Date 
April 05, 2016 
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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. 
 
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 UltraShape Power the following local adverse effects could occur 
(anticipated): 
 Purpura  
 Erosion 
 Blister 
 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 

 
 
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Clinical Study to Evaluate the Safety and Efficacy of the UltraShape Power Device Using the 
U-Sculpt Power Transducer for Abdominal Fat and Circumference Reduction 
Protocol # 
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Rev. Date 
April 05, 2016 
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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.  
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.  

 
 
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U-Sculpt Power Transducer for Abdominal Fat and Circumference Reduction 
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Rev. Date 
April 05, 2016 
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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 UltraShape Power 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:             
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 UltraShape Power 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 
 soreness 
 Bruising 
 First degree burn 

 
 
Syneron Medical Ltd. 
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Clinical Study to Evaluate the Safety and Efficacy of the UltraShape Power Device Using the 
U-Sculpt Power Transducer for Abdominal Fat and Circumference Reduction 
Protocol # 
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Rev. Date 
April 05, 2016 
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 Bullae 
 Second degree burn 
Over 1000 subjects worldwide participated in clinical research and underwent treatment with 
the different UltraShape devices. The UltraShape Power 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 
be expected for the commercial devices (UltraShape Power). 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 UltraShape Power 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. 

 
 
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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.    
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 UltraShape Power device and Parker Gel (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 UltraShape Power 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.  

 
 
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Clinical Study to Evaluate the Safety and Efficacy of the UltraShape Power Device Using the 
U-Sculpt Power Transducer for Abdominal Fat and Circumference Reduction 
Protocol # 
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Rev. Date 
April 05, 2016 
Page 30 of 37 
 
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.   
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.  

 
 
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Clinical Study to Evaluate the Safety and Efficacy of the UltraShape Power Device Using the 
U-Sculpt Power Transducer for Abdominal Fat and Circumference Reduction 
Protocol # 
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Rev. Date 
April 05, 2016 
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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.  
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.  

 
 
Syneron Medical Ltd. 
Confidential 
 
Clinical Study to Evaluate the Safety and Efficacy of the UltraShape Power Device Using the 
U-Sculpt Power Transducer for Abdominal Fat and Circumference Reduction 
Protocol # 
DHF21621 
Rev. Date 
April 05, 2016 
Page 32 of 37 
 
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. 
 
 

 
 
Syneron Medical Ltd. 
Confidential 
 
Clinical Study to Evaluate the Safety and Efficacy of the UltraShape Power Device Using the 
U-Sculpt Power Transducer for Abdominal Fat and Circumference Reduction 
Protocol # 
DHF21621 
Rev. Date 
April 05, 2016 
Page 33 of 37 
 
APPENDIX I – STUDY SUMMERY 
Table 3 - Study Schematics 
 
Screen / 
Baseline* 
Tx.1 
Tx.2 
5 days 
Tx.3 
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 
 
 
 
 
 
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 
Marking of the 
Treatment Areas 
X 
X 
X 
 
 
 
Transplant 
Preparation 
X 
 
 
 
 
 
Fat Thickness 
Ultrasound 
Measurement 
(Prior Strapping) 
X 
 
X 
X 
X 
X 
Fat Thickness 
Caliper 
Measurement 
(Prior Strapping) 
X 
X 
X 
X 
X 
X 
Fat Thickness 
Caliper 
Measurement 
(Prior Strapping) 
X 
X 
X 
 
 
 
Circumference 
Measurements 
X 
X 
X 
X 
X 
X 
Treatment 
X 
X 
X 
 
 
 
Subject Pain Assessment 
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 UltraShape Power Device Using the 
U-Sculpt Power Transducer for Abdominal Fat and Circumference Reduction 
Protocol # 
DHF21621 
Rev. Date 
April 05, 2016 
Page 34 of 37 
 
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 
(0) No change 
 
(1) Slight improvement 
 
(2) Moderate improvement 
 
(3) Significant improvement 
 
 
Table 6 – Satisfaction Scale 
(0) Dissatisfied 
 
(1) No Opinion 
 
(2) Satisfied 
 
(3) Very Satisfied 
 
 
 
 

 
 
Syneron Medical Ltd. 
Confidential 
 
Clinical Study to Evaluate the Safety and Efficacy of the UltraShape Power Device Using the 
U-Sculpt Power Transducer for Abdominal Fat and Circumference Reduction 
Protocol # 
DHF21621 
Rev. Date 
April 05, 2016 
Page 35 of 37 
 
APPENDIX III - PAIN ASSESSMENT 
 
Immediately after treatment the subject will be asked to rate treatment related pain. Pain will 
be assessed post treatment based on the Numerical Scale Response (NSR). The subject will be 
presented a scale (below) with words along a horizontal line and asked to make a mark along 
the scale to rate their pain from no pain to worst possible pain.  A number will be derived by the 
research staff by measuring up to the point the subject has indicated versus the entire line.  
 
 
 
 
 

 
 
Syneron Medical Ltd. 
Confidential 
 
Clinical Study to Evaluate the Safety and Efficacy of the UltraShape Power Device Using the 
U-Sculpt Power Transducer for Abdominal Fat and Circumference Reduction 
Protocol # 
DHF21621 
Rev. Date 
April 05, 2016 
Page 36 of 37 
 
APPENDIX IV ‐ 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 UltraShape Power Device Using the 
U-Sculpt Power Transducer for Abdominal Fat and Circumference Reduction 
Protocol # 
DHF21621 
Rev. Date 
April 05, 2016 
Page 37 of 37 
 
APPENDIX V - 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