Pilot Study to Evaluate VelaShape III & UltraShape Power Combined Treatment for Thigh Circumference Reduction
Phase: NA
Conditions: Circumference Reduction
Sponsor: Syneron Medical

 
 
Confidential 
 
Pilot Study to Evaluate VelaShape III & UltraShape Power Combined Treatment for 
Thigh Circumference Reduction 
Protocol # 
DHF24451 
Rev. Date 
October 6, 2017 
Page 1 of 39 
 
 
 
 
 
 
 
 
Title: 
Pilot Study to Evaluate VelaShape III & UltraShape Power Combined 
Treatment for Thigh Circumference Reduction. 
Protocol Number: 
DHF24451 
Study Type: 
Prospective Clinical Study 
Date: 
October 6, 2017  
Study Devices: 
VelaShape III and UltraShape Power 
Sponsor: 
Syneron Candela 
530 Boston Post Road  
Wayland, MA 01778  
United States 
 
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 Candela. 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 Candela. 

 
 
Confidential 
 
Pilot Study to Evaluate VelaShape III & UltraShape Power Combined Treatment for 
Thigh Circumference Reduction 
Protocol # 
DHF24451 
Rev. Date 
October 6, 2017 
Page 2 of 39 
 
 
Table of Contents 
Glossary ........................................................................................................................................... 5 
Introduction and rationale .............................................................................................................. 7 
Background .................................................................................................................................. 7 
Device Descriptions ..................................................................................................................... 8 
VelaShape Device .................................................................................................................... 8 
UltraShape Power Device ........................................................................................................ 9 
Study Design Overview .................................................................................................................. 10 
Objective........................................................................................................................................ 11 
Primary Endpoint ....................................................................................................................... 12 
Secondary Endpoints ................................................................................................................. 12 
Study population ........................................................................................................................... 12 
Number of Subjects ................................................................................................................... 12 
Subject Withdrawal and Replacement ...................................................................................... 12 
Inclusion Criteria ........................................................................................................................ 13 
Exclusion Criteria ....................................................................................................................... 13 
STUDY PROCEDURES ..................................................................................................................... 14 
Enrollment and Screening ......................................................................................................... 14 
Pre-Treatment Procedures ........................................................................................................ 16 
Screening ............................................................................................................................... 16 
Baseline ................................................................................................................................. 17 
Measurements ...................................................................................................................... 17 
VelaShape - General Treatment Procedure .......................................................................... 19 
Treatment Using the VContour Applicator to the Inner Thigh .............................................. 20 
Treatment Using the VSmooth Applicator to the Lateral Thigh ............................................ 23 
UltraShape Power General Treatment Procedure ................................................................ 24 
Treatment Procedure ................................................................................................................ 25 

 
 
Confidential 
 
Pilot Study to Evaluate VelaShape III & UltraShape Power Combined Treatment for 
Thigh Circumference Reduction 
Protocol # 
DHF24451 
Rev. Date 
October 6, 2017 
Page 3 of 39 
 
Post-treatment Procedures ....................................................................................................... 25 
Return Visits .............................................................................................................................. 26 
DATA ANALYSIS.............................................................................................................................. 27 
Recording ................................................................................................................................... 27 
Demography and Baseline Measurements ........................................................................... 27 
Treatment Visit ...................................................................................................................... 27 
Follow-up Visit Measurements .............................................................................................. 27 
Safety ..................................................................................................................................... 27 
Protocol Revisions and/or Deviations ....................................................................................... 28 
ADVERSE EVENTS (AE) ................................................................................................................... 28 
Anticipated Adverse Effects ...................................................................................................... 28 
Unanticipated Adverse Device Effects ...................................................................................... 29 
Reporting Adverse Events (AE) and Serious Adverse Events (SAE) ........................................... 30 
Measures taken to protect the rights and welfare of subject............................................... 30 
RISK/BENEFIT ANALYSIS................................................................................................................. 31 
Risks ........................................................................................................................................... 31 
Potential benefits to participating individuals and to society ................................................... 31 
Conclusion: ................................................................................................................................ 31 
ETHICS AND GOOD CLINICAL PRACTICE ........................................................................................ 32 
QUALITY ASSURANCE AND STUDY MONITORING ......................................................................... 32 
Study Monitoring/Auditing/Inspection ..................................................................................... 32 
ADMINISTRATIVE PROCEDURES .................................................................................................... 33 
Supply and Disposition of Study Device .................................................................................... 33 
Control & Disposition of the Investigational Device ................................................................. 33 
Informed Consent ...................................................................................................................... 33 
Monitoring Plan ......................................................................................................................... 33 
Case Report Forms .................................................................................................................... 33 
Record Maintenance ................................................................................................................. 34 
PUBLICATION POLICY..................................................................................................................... 34 

 
 
Confidential 
 
Pilot Study to Evaluate VelaShape III & UltraShape Power Combined Treatment for 
Thigh Circumference Reduction 
Protocol # 
DHF24451 
Rev. Date 
October 6, 2017 
Page 4 of 39 
 
References ..................................................................................................................................... 35 
Appendix I – Study Summary ........................................................................................................ 36 
Appendix II - Scales ........................................................................................................................ 37 
Appendix III - Pain assessment ...................................................................................................... 38 
Appendix IV ‐ Photography ............................................................................................................ 39 
 
 
 

 
 
Confidential 
 
Pilot Study to Evaluate VelaShape III & UltraShape Power Combined Treatment for 
Thigh Circumference Reduction 
Protocol # 
DHF24451 
Rev. Date 
October 6, 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 
W 
Watt (Output Electric Power) 
 
 
 
 
 
 

 
 
Confidential 
 
Pilot Study to Evaluate VelaShape III & UltraShape Power Combined Treatment for 
Thigh Circumference Reduction 
Protocol # 
DHF24451 
Rev. Date 
October 6, 2017 
Page 6 of 39 
 
Table 1- Study Synopsis 
Proprietary Name 
VelaShape III and UltraShape Power Devices  
Design 
Prospective, one-arm, baseline-controlled pilot study for the evaluation of the 
VelaShape III combined with UltraShape Power treatment for non-invasive 
circumference reduction to the thighs. 
Study Population 
Up to 40 healthy adult volunteers seeking noninvasive circumference reduction of 
thighs. Male and females, 18 to 60 years of age enrolled at up to two investigational 
sites.  
Treatment and 
Duration 
Eligible subjects will receive 3 bi-weekly treatments to the thighs at 2-week intervals, 
with the VelaShape III and UltraShape Power devices according to the study protocol.  
Each subject will return for 3 follow up visits: four weeks (4wk FU), 8 weeks (8wk FU) 
and 12 weeks (12wk FU) after the last treatment (Tx.3), for total expected study 
duration of 16 weeks. 
Objective 
The objective of this trial is to evaluate the safety and efficacy of the VelaShape III 
combined with UltraShape Power for circumference reduction of the thighs.  
Primary Objective 
1. Statistically significant circumference reduction post combined VelaShape III and 
UltraShape Power treatments at 12 weeks follow-up (12wk FU) versus baseline. 
2. Evaluate the safety of the combined treatment with the VelaShape III and 
UltraShape Power devices. 
Secondary 
Objectives 
3. Circumference reduction post combined treatments Pre-Tx.2, Pre-Tx.3 and all 
follow-up visits (4wk FU, 8wk FU and 12wk FU) versus baseline. Statistically 
significant reduction post combined treatment at the follow-up visits only.  
4. Investigator satisfaction assessment will be performed independently, using a 5- 
point Likert scale questionnaire, at each follow-up visit (4wk FU, 8wk FU and 12wk 
FU). 
5. Subject satisfaction assessment will be performed independently by the subject, 
using a 5- point Likert scale questionnaire, at each follow-up visit (4wk FU, 8wk FU 
and 12wk FU). 
6. Comfort level during treatment: Comfort assessment will be performed 
independently by the subject using a 10-point NSR scale. The subjects will answer 
this questionnaire regarding each device separately and combined after each 
treatment (Tx.1, Tx.2 and Tx.3).  
Efficacy Endpoints 
Primary and secondary objectives will be assessed using the following efficacy 
endpoints: 

 
 
Confidential 
 
Pilot Study to Evaluate VelaShape III & UltraShape Power Combined Treatment for 
Thigh Circumference Reduction 
Protocol # 
DHF24451 
Rev. Date 
October 6, 2017 
Page 7 of 39 
 
1. Circumference measurements of the treatment area 
2. Investigator satisfaction 
3. Subject satisfaction 
4. Pain assessment 
5. Photography 
Safety Endpoints 
Number, severity and type of any adverse events 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 and 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   
 

 
 
Confidential 
 
Pilot Study to Evaluate VelaShape III & UltraShape Power Combined Treatment for 
Thigh Circumference Reduction 
Protocol # 
DHF24451 
Rev. Date 
October 6, 2017 
Page 8 of 39 
 
The VelaShape device is a commercial device cleared by the Food and Drug Administration (FDA) 
under 510(k) K071872 indicated for the relief of minor muscle aches and pain, relief of muscle 
spasm, temporary improvement of local blood circulation, temporary reduction in the appearance 
of cellulite, and for temporary reduction of thighs circumferences.  It combines controlled infrared 
(IR) light and conducted bipolar radiofrequency (RF) energies with mechanical manipulation. The 
VelaShape II, the next generation VelaShape, is a CE-cleared device since 2009, which also 
combines controlled infrared (IR) light and conducted bipolar radiofrequency (RF) energies with 
mechanical manipulation.  The VelaShape II device has 65W RF energy. 
The VelaShape III, the newest generation VelaShape, is a device based on the CE-cleared 
VelaShape II and FDA-cleared Transcend device (K120510). All devices combine controlled 
infrared (IR) light and conducted bipolar radiofrequency (RF) energies with vacuum.  The 
VelaShape III device is indicated for relief of minor muscle aches and pain, relief of muscle spasm, 
temporary improvement of local blood circulation, temporary reduction in the appearance of 
cellulite, and for temporary reduction of thighs and abdomen circumference. 
The VelaShape III device has 150W RF energy. 
 
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 newest generation UltraShape device, 
UltraShape Power, includes a small transducer (U-Sculpt Power), and is FDA-cleared (K170370) 
for lipolysis (breakdown of fat) to provide a non-invasive approach to achieve a desired aesthetic 
effect. It is intended for non-invasive reduction in abdominal circumference and fat reduction in 
the flanks and thighs. 
 
Device Descriptions 
VelaShape Device 
The newest generation, VelaShape III, is composed of a console to which two applicators, 
VContour and VSmooth, are connected via an umbilical cable. Each applicator incorporates an 
operation panel to enable the operator remote control of the system in addition to the system’s 
touch screen operation panel. Prior to treatment, the applicators are fitted with a replaceable 
cap, which keeps the skin from coming into direct contact with the applicator during the 
treatment. These caps can be cleaned between treatments for reuse for the same subject, since 
multiple treatments are typical. During treatment with the VelaShape III device, the applied 

 
 
Confidential 
 
Pilot Study to Evaluate VelaShape III & UltraShape Power Combined Treatment for 
Thigh Circumference Reduction 
Protocol # 
DHF24451 
Rev. Date 
October 6, 2017 
Page 9 of 39 
 
suction repeatedly pulls the skin into a chamber in the middle of the cap. There, the skin is 
exposed to the combined elōs technology (electro optical synergy - IR light and RF) using gentle 
vacuum suction with or without mechanical manipulation.  
 
The VSmooth applicator contains rotating elements that create a massaging motion. The system 
enables the user to adjust the RF energy, optical energy and vacuum levels, thereby utilizing the 
optimal treatment parameters for each subject/anatomical area. 
 
 
Figure 1: VelaShape III Device 
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 Ultrasonic Transducer: The ultrasonic transducer is an electro-mechanical device that 
converts an electrical signal into mechanical (acoustical) energy. Its functionality is based on 
piezoelectric ceramics that has the property of changing size when a voltage is applied. Thus, 
applying an alternating voltage frequency across such piezoelectric element causes it to oscillate 
in the same frequency, producing sound waves. The spherical shape of that piezoelectric element 
enables the focusing of the ultrasound waves into a narrow focal region, which is the target 
region. The transducer is comprised of a Polyethylene membrane, which was approved by 
biocompatibility testing and in vitro and in vivo verification tests.  
 

 
 
Confidential 
 
Pilot Study to Evaluate VelaShape III & UltraShape Power Combined Treatment for 
Thigh Circumference Reduction 
Protocol # 
DHF24451 
Rev. Date 
October 6, 2017 
Page 10 of 39 
 
  
Figure 2:  UltraShape Power System 
Accessories needed for the UltraShape Power Treatment 
Small transducer (U-Sculpt Power) 
will be used to deliver the ultrasonic energy to the body. 
Reusable Straps 
Gather skin and fat in the area to be treated.  
Parker Gel  
Used as a coupler agent between skin surface and the ultrasonic transducer.   
Calibrated Caliper 
Assess fat thickness at treatment area prior to 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, pilot study to evaluate the performance and 
safety of the combined VelaShape III and UltraShape Power treatment for non-invasive 
circumference reduction of the thighs.  
Guided Tracking System 
Graphical User Interface 
U-Sculpt Power 
Transducer 

 
 
Confidential 
 
Pilot Study to Evaluate VelaShape III & UltraShape Power Combined Treatment for 
Thigh Circumference Reduction 
Protocol # 
DHF24451 
Rev. Date 
October 6, 2017 
Page 11 of 39 
 
Up to 40 healthy subjects from up to two investigational sites will be enrolled in this study. All 
subjects will undergo an assessment of their general health. All subjects will receive treatment for 
circumference reduction with VelaShape III combined with UltraShape Power for the thighs. 
Eligible subjects will receive 3 bi-weekly treatments, at 2-week intervals, to thighs with the 
VelaShape III combined with UltraShape Power devices.  Each of the three treatments (Tx.1, Tx.2 
and Tx.3) include the following steps, as shown in Table 2. 
 
Table 2: Combined Treatment by area 
Step 
Thigh Treatment 
1 
VelaShape III (VContour applicator to inner thigh) – 10 minutes at time on 
temperature 
2 
VelaShape III (VSmooth applicator to lateral thigh) -– 10 minutes at time on 
temperature 
3 
Ultrashape Power to inner and outer thighs – FTZs applied per User Guide 
 
The subject will return for 3 follow up visits: four weeks (4wk FU), 8 weeks (8wk FU) and 12 weeks 
(12wk FU) after last treatment (Tx.3). The total expected study duration for each subject is 16 
weeks. 
 
At baseline and before each treatment (Tx.1, Tx.2 and Tx.3) and at follow-ups (4wk FU, 8wk FU, 
12wk), the subject’s weight, circumference and fat thickness (using caliper) will be measured. 
Photography will be performed under visible light conditions of the front, right and left sides of 
the thighs. 
 
After each treatment (Tx.1, Tx.2 and Tx.3), the comfort assessment will be performed by the subject 
using the NSR scale. The subjects complete the questionnaire regarding each device separately and 
combined.
 
In addition, at each follow-up visit (4wk FU, 8wk FU, and 12wk FU), the subject and investigator 
questionnaires will be completed.  
 
OBJECTIVE 
The objective of this trial is to evaluate the safety and efficacy of the VelaShape III combined with 
UltraShape Power for circumference reduction of the thighs. 

 
 
Confidential 
 
Pilot Study to Evaluate VelaShape III & UltraShape Power Combined Treatment for 
Thigh Circumference Reduction 
Protocol # 
DHF24451 
Rev. Date 
October 6, 2017 
Page 12 of 39 
 
Primary Endpoint 
1. Statistically significant circumference reduction post combined VelaShape III and 
UltraShape Power treatments at 12 weeks follow-up (12wk FU) versus baseline. 
2. Number, severity and type of adverse events following combined treatment with the 
VelaShape III and UltraShape Power devices (immediate and delayed response), as 
recorded throughout the study. 
 
Secondary Endpoints 
1. Circumference reduction post combined VelaShape III and UltraShape Power treatments 
at Pre-Tx.2, Pre-Tx.3 and all follow-up visits (4wk FU, 8wk FU and 12wk FU) versus 
baseline. Statistically significant circumference reduction post combined treatment at the 
follow-up visits only.  
2. Investigator satisfaction assessment will be performed independently, using a 5-point 
Likert scale questionnaire, at each follow-up visit (4wk FU, 8wk FU and 12wk FU).  
3. Subject satisfaction assessment will be performed independently by the subject, using a 
5-point Likert scale questionnaire, at each follow-up visit (4wk FU, 8wk FU and 12wk FU). 
4. Comfort level during treatment: Comfort assessment will be performed independently by 
the subject using a 10-point NSR scale. The subjects will complete this questionnaire 
regarding each device separately and combined after each treatment (Tx.1, Tx.2 and 
Tx.3).  
 
STUDY POPULATION 
Number of Subjects 
This study will enroll and be comprised of up to 40 subjects, who meet all the inclusion and none 
of the exclusion criteria, from up to two investigational sites. The subject will receive treatment 
for circumference reduction of thighs. 
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 60 subjects have completed 
the study.  Subjects who fail to complete the treatment may be replaced and will not be evaluable.  

 
 
Confidential 
 
Pilot Study to Evaluate VelaShape III & UltraShape Power Combined Treatment for 
Thigh Circumference Reduction 
Protocol # 
DHF24451 
Rev. Date 
October 6, 2017 
Page 13 of 39 
 
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 enrollment. 
3. Fitzpatrick Skin Type I to VI. 
4. 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. Female subjects 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). 
7. In addition, negative urine pregnancy test as tested before each treatment and at the last 
visit for women with child-bearing potential (e.g. not menopausal). 
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. Known 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. 

 
 
Confidential 
 
Pilot Study to Evaluate VelaShape III & UltraShape Power Combined Treatment for 
Thigh Circumference Reduction 
Protocol # 
DHF24451 
Rev. Date 
October 6, 2017 
Page 14 of 39 
 
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. Known photosensitivity. 
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 
sores or herpes sores prior to treatment (duration of resolution as per the Investigator’s 
discretion) or during the treatment course. 
11. 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. 
12. Very poor skin quality (i.e., severe laxity). 
13. Abdominal wall diastasis or hernia on physical examination. 
14. Abnormal kidney, liver or coagulation functions, abnormal lipid profile or blood count 
within the last 3 months. 
15. Obesity (BMI > 30). 
16. Pregnant, childbirth within the last 12 months or breastfeeding women.  
17. 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. Abdominal fat thickness lower than 2.5 cm after strapping. 
21. Participation in another clinical study within the last 6 months. 
22. 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.   

 
 
Confidential 
 
Pilot Study to Evaluate VelaShape III & UltraShape Power Combined Treatment for 
Thigh Circumference Reduction 
Protocol # 
DHF24451 
Rev. Date 
October 6, 2017 
Page 15 of 39 
 
 
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 (Table 3). 
Table 3- Clinical Evaluation Measurements and Tools 
Measurement 
When to conduct 
Method 
Height 
Baseline 
Scale 
Weight 
Prior to all treatments and at all follow-
ups visits (Tx.1, Tx.2, Tx.3. 4wk FU, 8wk 
FU and 12wk FU) 
Scale 
BMI 
Calculation 
Circumference 
measurements 
Standardized circumference measuring tape 
Fat thickness: Caliper 
measurement 
Caliper 
Photographs 
Standardized digital photographs 
Urine pregnancy test 
Prior to each treatment, and at the last 
follow-up visit (Tx.1, Tx.2, Tx.3, 12wk 
FU) 
Urine pregnancy test 
Pregnancy inquiry 
At each visit (at treatments visits- prior 
to treatment) 
Pregnancy inquiry 
Treatment-associated 
pain 
Immediately after treatment (Tx.1, 
Tx.2, Tx.3) the subject will be asked to 
assess the pain level during treatment  
Numerical Scale Response (NSR) 
Immediate Response 
Assessment 
Immediately after treatment the 
investigator should assess the post-
treatment immediate response  
Post-treatment Side Effect Severity Scale (Table 9) 
Subject satisfaction  
At all follow-up visits: 4wk FU, 8wk FU 
and 12wk FU 
Subject Satisfaction Questionnaires (Table 10, 
Table 11) 
Investigator 
satisfaction  
Investigator Satisfaction Questionnaire (Table 10) 
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 

 
 
Confidential 
 
Pilot Study to Evaluate VelaShape III & UltraShape Power Combined Treatment for 
Thigh Circumference Reduction 
Protocol # 
DHF24451 
Rev. Date 
October 6, 2017 
Page 16 of 39 
 
 
Figure 3: Study Flow-Chart (Visits at the Clinic) 
Pre-Treatment Procedures 
 It is expected that the screening and baseline procedures will be conducted during the same visit 
as the treatment. All visit procedures should take up to 2 hours. 
Screening 
1. ICF - Prior to any study–related activities, 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. 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.   
3. Skin Exam - The subject will undergo a routine skin exam to determine if he/she meets 
the study criteria including the presence of fatty tissue deposits in the treatment area.   
4. BMI – the volunteers’ height and weight will be taken for calculation of BMI. 
5. Pregnancy Screen – female subjects who can become 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).  If the Screening and Treatment procedures are not conducted on the same 
day, the urine pregnancy test will be repeated on the treatment day.   
6. Scheduling: Subjects will be scheduled to return for the baseline and treatments visit 
within 14 days following the screening visit. It is preferable that the baseline procedures 
and Tx.1 will be conducted immediately after the Screening visit. 
 
 
 
  

 
 
Confidential 
 
Pilot Study to Evaluate VelaShape III & UltraShape Power Combined Treatment for 
Thigh Circumference Reduction 
Protocol # 
DHF24451 
Rev. Date 
October 6, 2017 
Page 17 of 39 
 
Baseline 
1. Subject ID - Prior to treatment, subjects will be assigned a study subject number.  
2. Photography – Baseline photographs will be obtained using a digital imaging system with 
standardized consistent camera settings. 
3. BMI – the subject weight and height will be taken if baseline visit is a different day than 
the screening visit. 
Measurements 
Measure the Fat Thickness at the Area to be treated  
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 UltraShape Power Treatment  
The mark of the area to be treated should be copied to a transparent template (for each side: 
Right and Left) 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 according to the following table (Table 4): 
Table 4- Marking the intended area to be treat by UltraShape 
Step 
Thigh Treatment 
1 
The thigh area will be marked on the transparency. Each thigh (left 
and right) will be marked separately. 
2 
Mark the Subject's identification code on the transparency for each 
thigh (left and right) separately. 
3 
Define the thigh (right or left) on the transparency. 
Separate transparency for each side. 
 
At the subsequent treatment sessions, this transparent template will be placed according to these 
signs on the treated area, and the line of treatment area will be re-marked. 
Marking height circumference and circumference measurement  
Patients should stand up straight when arms are placed at the rear of the neck and the head is 
positioned towards the horizon. Elbows will be positioned in front of the body (Figure 4). 
 

 
 
Confidential 
 
Pilot Study to Evaluate VelaShape III & UltraShape Power Combined Treatment for 
Thigh Circumference Reduction 
Protocol # 
DHF24451 
Rev. Date 
October 6, 2017 
Page 18 of 39 
 
 
Figure 4: Body positioning during marking height for circumference measurements 
 
The height of midsection will be measured using the height measuring device (supplied by 
Syneron Candela). The marking pencil will be placed horizontally at the edge of the measurement 
device during the marking procedure (Table 5). 
 
Table 5- Thigh Circumference Measurements  
Step 
Measurement 
1) Mark the 
midsection for 
circumference 
(=Midline) 
measurement 
for left and right 
thighs 
separately. 
 

 
 
Confidential 
 
Pilot Study to Evaluate VelaShape III & UltraShape Power Combined Treatment for 
Thigh Circumference Reduction 
Protocol # 
DHF24451 
Rev. Date 
October 6, 2017 
Page 19 of 39 
 
Step 
Measurement 
2) The height for 
the 
circumference 
measurement 
will be marked 
for each thigh 
separately. 
 
3) Measure the 
circumference 
of each thigh 
separately with 
the 
Circumference 
Measuring 
Tape. 
 
 
 
For each treatment area, the measurements will be taken at 2 cm above midsection (=2cm above 
Midline) measurement and 2 cm below midsection (=2cm below Midline) measurement. 
 
The height of the midsection thigh (will be used as a reference for all study visit measurements) 
and the circumference measurements will be recorded in the CRF. 
VelaShape - General Treatment Procedure 
1. Ensure that the subject is in a comfortable position for the procedure. 
2. Remove any jewelry in the treatment area. 
3. Ensure that the treatment area skin is clean. The skin should be cleaned with water and soap, 
and hair in the treatment area should be shaved.   
4. Ensure that the treatment applicator/ applicator cap is clean. If not, it should be wiped with 
70% alcohol and allowed to dry. 
 

 
 
Confidential 
 
Pilot Study to Evaluate VelaShape III & UltraShape Power Combined Treatment for 
Thigh Circumference Reduction 
Protocol # 
DHF24451 
Rev. Date 
October 6, 2017 
Page 20 of 39 
 
5. Prior to treating the entire area, a test should be performed in a small section within the area 
to assess the skin for unwanted affects.  
6. 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 (i.e. thigh), and comfort. 
7. There should be a complete seal between the applicator and the skin during the treatment 
session.  In curved or bony areas, careful attention is required when treating. A slight change 
in the orientation of the applicator may solve the problem. 
8. Always hold the applicator perpendicular to the skin surface, so that the compression/contact 
with the skin is consistent for each application. 
9. Full operating procedure, software screens and parameters are described in the device User 
Manuals. Instructions will be provided prior to the start of the study. 
10. Always hold the applicator so that both electrodes have equal compression/contact with the 
skin to ensure safe and effective RF delivery. 
11. Before the treatment, apply a thin layer of the commercial VelaEase treatment lotion 
(Appendix 5).  You may need to re-apply the lotion, if the indicators on the applicator blink 
continuously for more than a few pulses, indicating bad coupling. 
Treatment Using the VContour Applicator to the Inner Thigh 
1. Select the appropriate zone for treatment of circumference reduction using the 
Medium Cover; define the size of the targeted sub-area, large, medium or small, 
And divide it into segments: 
• Large size sub-area (25 x 20 cm) will be divided into 20 segments. 
• Medium size sub-area (15 x 20cm) will be divided into 12 segments. 
• Small size sub-area (10 x 20 cm) will be divided into 8 segments. 
 
2. Each segment of the sub-area is the size of the Medium Cover (5 x 5cm). 

 
 
Confidential 
 
Pilot Study to Evaluate VelaShape III & UltraShape Power Combined Treatment for 
Thigh Circumference Reduction 
Protocol # 
DHF24451 
Rev. Date 
October 6, 2017 
Page 21 of 39 
 
 
Figure 5: Sub-Area Divided into Segments 
3. Set the following parameters:  
• 
The target RF level is level “3”.  If safety concerns arise or if the subject reports too 
much pain, use lower RF levels. 
• 
The target vacuum level start is “1” gradually increased to level “2” and then to “3” 
over the treatment course. 
• 
In some cases, the skin is very lax and is pulled deep into the treatment chamber of 
the replaceable cap; to prevent adverse effects, use level vacuum “1” in these cases. 
The treatment will be performed with the large VelaShape applicator size (45mm x 
25mm) or the small VelaShape applicator size with the appropriate tip size.  
4. Cycle 1: 
a. Starting with Section A1 to A20, each segment will undergo 5 consecutive stacking 
pulses in a “horizontal snake-like” treatment technique (see illustration below). 
b. After all segments are pulsed 5 times, another cycle of 4 consecutive pulses, then 
3 consecutive pulses and then 2 consecutive pulses should performed. 
c. Continue treating each sub-area from A1 to A20 with 2 consecutive stacking 
pulses until the surface temperature reaches 450C or the patient is unable to 
tolerate more heat, whichever comes first. 
 

 
 
Confidential 
 
Pilot Study to Evaluate VelaShape III & UltraShape Power Combined Treatment for 
Thigh Circumference Reduction 
Protocol # 
DHF24451 
Rev. Date 
October 6, 2017 
Page 22 of 39 
 
 
Figure 6:  Cycle 1 treatment order  
 
5. Cycle 2: 
d. In this cycle, the same sub-area set (A1-A20) will be started and continued with 
two consecutive stacking pulses using the “vertical snake-like” treatment 
technique (see illustration below) until the surface temperature reaches 450C or 
the patient is unable to tolerate more heat.  
 
Figure 7 : Cycle 2 treatment order  
 
6. Cycle 3:  
e. In this cycle, the same sub-area set (start from sub-area A1 to A20) will be started 
and continue with 2 consecutive stacking pulses using the “horizontal snake-like” 
treatment technique until the surface temperature reaches 450C or the patient is 
unable to tolerate more heat. 
A1 
A2 
A3 
A4 
A5 
A10 
A9 
A8 
A7 
A6 
A11 
A12 
A13 
A14 
A15 
A20 
A19 
A18 
A17 
A16 
Cycle 1 “horizontal snake-like” 
A1 
A2 
A3 
A4 
A5 
A10 
A9 
A8 
A7 
A6 
A11 
A12 
A13 
A14 
A15 
A20 
A19 
A18 
A17 
A16 
Cycle 2 “vertical snake-like” 

 
 
Confidential 
 
Pilot Study to Evaluate VelaShape III & UltraShape Power Combined Treatment for 
Thigh Circumference Reduction 
Protocol # 
DHF24451 
Rev. Date 
October 6, 2017 
Page 23 of 39 
 
7. Cycle 4:  
f. If the total time duration of Cycles # 1, 2 and 3 is less than 10 minutes at time on 
temperature (450C), then continue with the “Vertical Snake-Like” treatment 
technique (see Figures 4-7) and apply one pulse per sub-area until the 10-minute 
treatment duration for all four cycles is reached. 
 
8. Treatment time: The large size sub-area (25 x 20 cm) set includes 20 segments (A1-A20), the 
medium size sub-area (15 x 20 cm) set includes 12 segments (A1-A12) and the small size sub-
area (10 x 20 cm) set includes 8 segments (A1-A8). The 3-4 consecutive cycles should take at 
least 12 minutes (2 minutes to temperature + 10 minutes treatment time at temperature). 
Treatment Using the VSmooth Applicator to the Lateral Thigh 
1. Mark treatment areas that are 20 x 25 cm in size. Within each of these areas mark four 
elliptical overlapping segments according to the following illustration below 
 
Figure 8: VSmooth Treatment Area Segmentation 
2. Attach the Large Electrode cover to the VSmooth applicator. 
3. Select treatment parameters on the screen or on the applicator: 
a. IR = 1 
b. RF =3 
c. Vacuum = 1 
4. It is recommended to maintain the RF level at 3 in all cycles to achieve optimal results. 
5. You may increase the IR and Vacuum levels from 1 -> 2 -> 3 based on patient tolerance, and 
only in areas with minimal laxity. 
6. Apply a thin, lightly visible layer of VelaSpray Ease lotion at the beginning of each cycle. 
7. Start treating according to Table 6 below. 

 
 
Confidential 
 
Pilot Study to Evaluate VelaShape III & UltraShape Power Combined Treatment for 
Thigh Circumference Reduction 
Protocol # 
DHF24451 
Rev. Date 
October 6, 2017 
Page 24 of 39 
 
Table 6 - Cellulite Mode Protocol 
Step 
Segment 
Mode/ Routine 
Illustration 
Step 1 
A 
Circular horizontal Clock-Wise manner in gliding 
technique until temperature reached. 
 
Step 2 
B 
Circular horizontal Clock-Wise manner in gliding 
technique until temperature reached. 
 
Step 3 
C 
Circular vertical Clock-Wise manner in gliding 
technique until temperature reached. 
 
Step 4 
D 
Circular vertical Clock-Wise manner in gliding 
technique until temperature reached. 
 
Step 5 
All 
Treat all sub-areas in “Horizontal Snake-Like” 
manner using gliding technique. 
 
Step 6 
All 
Treat all sub-areas in “Vertical Snake-Like” 
manner using gliding technique. 
 
UltraShape Power General Treatment Procedure 
Thigh treatment: The subject treatment area will be gathered using taping, to gather the fat area 
for treatment according to the instructions provided in the User Manual.  
Note: Make sure that the gel remains are removed from the treatment area prior to the 
UltraShape Power treatment. 
The UltraShape Power device will determine the total number of FTZs to be delivered during 
treatment according to the size of the treatment area. 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. 

 
 
Confidential 
 
Pilot Study to Evaluate VelaShape III & UltraShape Power Combined Treatment for 
Thigh Circumference Reduction 
Protocol # 
DHF24451 
Rev. Date 
October 6, 2017 
Page 25 of 39 
 
 
Prior to applying the FTZs, Parker acoustic gel will be applied on the treated area and used as a 
coupling agent between the ultrasonic transducer and the skin surface. 
UltraShape Power treatment should be performed according to treatment instruction in the 
UltraShape Power User Manual. 
Expected post treatment side effects are limited to erythema (blanchable/non-blanchable), 
edema, heat and/or pain sensation. 
Treatment Procedure 
Eligible subjects will receive 3 bi-weekly treatments, at 2-weeks interval, to the thighs with the 
VelaShape III and UltraShape Power devices. Each of the three treatments (Tx.1, Tx.2 and Tx.3) 
includes the following steps, as shown in Table 7. 
 
Table 7- VelaShape III and UltraShape Power Treatment to the Thighs  
Step 
Thigh Treatment 
1 
Pretreatment Measurements: weight, circumference, fat thickness 
(caliper) and photos of the treated area 
2 
~12 minutes/lateral thigh of VelaShape III using VSmooth applicator 
3 
~12 minutes/inner thigh of VelaShape III using VContour applicator 
4 
Clean the thigh treatment area from VelaShape spray 
5 
Gathering method: Taping 
6 
Ultrashape Power using small U-Sculpt Power transducer to the lateral and 
inner thigh 
7 
Clean the thigh treatment area from the gel 
Comments 
Move to other thigh only after completing all steps for one thigh 
Post-treatment Procedures 
Pain assessment – immediately after each treatment subjects will be asked to assess the pain 
sensation experienced during treatment using a Numerical Scale Response (NSR; see  

 
 
Confidential 
 
Pilot Study to Evaluate VelaShape III & UltraShape Power Combined Treatment for 
Thigh Circumference Reduction 
Protocol # 
DHF24451 
Rev. Date 
October 6, 2017 
Page 26 of 39 
 
Appendix III - Pain assessment) for each treatment phase: 
a. VelaShape III 
b. UltraShape Power 
2. Clinical effects - All visible and palpable immediate response will be recorded for the 
entire treatment area using a 4-point severity scale (Table 9). 
3. Safety aspects will be assessed before and after each treatment: 
a. Adverse Events – Record the number, severity and type of any adverse event 
occurring before, during and after treatments. 
4. Subject will also be provided with the following instructions for care of the treated areas 
in the informed consent form. 
a. Temporary skin erythema (redness) and edema (swelling), as well as heat and 
tightening sensations, may occur up to a few hours after the treatment, but 
normally do not last longer. If the subject feels significant discomfort longer than 
that time, cool/cold compress (but not ice packs) may be applied for relief. Over- 
the-counter pain medication such as Tylenol may be used. 
b. On the evening after the treatment, subjects should wash the treated areas 
gently with lukewarm water and avoid very hot or cold water in these areas. 
Generally, subjects may use their regular soaps after treatment, as long as these 
are not scrub soaps or exfoliants. 
c. The treated areas should also not be exposed to potential mechanical damage 
(e.g., kickboxing, massage) at least 48 hours post-treatment. 
d. Tanning of any sort (sun exposure, tanning beds, and artificial sunless tanning 
lotions) is not allowed in the treated areas during the entire course of the study 
since it might cause hyperpigmentation. 
e. Subjects will be instructed to use a high factor sunscreen with SPF of at least 30 
and to protect the treated areas from direct sunlight for the entire period of the 
study. 
Return Visits 
All subjects will be requested to return to the clinic at the following time-points during the study 
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.  

 
 
Confidential 
 
Pilot Study to Evaluate VelaShape III & UltraShape Power Combined Treatment for 
Thigh Circumference Reduction 
Protocol # 
DHF24451 
Rev. Date 
October 6, 2017 
Page 27 of 39 
 
• 
Caliper measurements. 
• 
Circumference measurements. 
• 
Photographs as conducted at baseline visit. 
• 
Completion of study questionnaires: 
o Investigator satisfaction using the 5- Point Likert Scale. 
o Subject satisfaction using the 5- Point Likert Scale. 
• 
Pregnancy inquiry prior to each treatment and at the final follow-up visit, a urine 
pregnancy test will be performed for women with child-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.  
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.   

 
 
Confidential 
 
Pilot Study to Evaluate VelaShape III & UltraShape Power Combined Treatment for 
Thigh Circumference Reduction 
Protocol # 
DHF24451 
Rev. Date 
October 6, 2017 
Page 28 of 39 
 
Protocol Revisions and/or Deviations 
Except for 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 VelaShape III and/or UltraShape Power the following local adverse 
effects could occur (anticipated): 
➢ Purpura  
➢ Hyperpigmentation 
➢ Blister 
➢ Hypopigmentation 
➢ Bruising 
➢ Soreness 
➢ Bullae 
➢ First-degree burn 
➢ Erosion 
➢ Pain 
➢ Damage to natural skin 
structure 
(scratching, 
crusting) 
➢ Second-degree burn 
➢ Excessive skin redness (erythema) 
➢ Hair removal (pulling) 
 
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 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 

 
 
Confidential 
 
Pilot Study to Evaluate VelaShape III & UltraShape Power Combined Treatment for 
Thigh Circumference Reduction 
Protocol # 
DHF24451 
Rev. Date 
October 6, 2017 
Page 29 of 39 
 
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.  
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.  

 
 
Confidential 
 
Pilot Study to Evaluate VelaShape III & UltraShape Power Combined Treatment for 
Thigh Circumference Reduction 
Protocol # 
DHF24451 
Rev. Date 
October 6, 2017 
Page 30 of 39 
 
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, hyperpigmentation, hypopigmentation, soreness, pain, erythema, 
damage to natural skin structure and burn. If an unanticipated adverse event occurs at any time 
during or after the use of the VelaShape III and UltraShape devices, 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 emailed to the address below:     
         
Mark Lakernik, M.D., Clinical Consultant 
Cell Number: 1-416-456-9330 
Fax Number:  1-877-597-5640              
 
 
               
E-mail: markl@syneron-candela.com 
 
A written report prepared by the Principal Investigator must follow within five working days to 
both the IRB and to Syneron Candela 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. 
 
 

 
 
Confidential 
 
Pilot Study to Evaluate VelaShape III & UltraShape Power Combined Treatment for 
Thigh Circumference Reduction 
Protocol # 
DHF24451 
Rev. Date 
October 6, 2017 
Page 31 of 39 
 
RISK/BENEFIT ANALYSIS 
Risks 
Syneron has determined that the VelaShape III and the UltraShape Power systems are 
non-significant risk devices. As indicated in the AE section, the anticipated risks associated with 
the use of both of the systems are: 
➢ Purpura  
➢ Hyperpigmentation 
➢ Blister 
➢ Hypopigmentation 
➢ Bruising 
➢ Soreness 
➢ Bullae 
➢ First-degree burn 
➢ Erosion 
➢ Pain 
➢ Hair pulling 
➢ Second-degree burn 
➢ Erythema 
➢ Damage 
to 
natural 
skin 
structure 
(scratching, crusting) 
 
Over 2,000 subjects worldwide participated in clinical research and underwent treatment with 
the different VelaShape or UltraShape devices. The VelaShape III and UltraShape Power devices 
that will be used in this study were previously used in clinical studies and emitted the same RF or 
acoustic energy, respectively. 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 or moderate in nature and resolved within the study period. 
Potential benefits to participating individuals and to society 
Subjects may or may not benefit from circumference reduction, reduction of subcutaneous fatty 
tissue in the treated area via a non-invasive technique resulting in body contouring, or from skin 
laxity and texture 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 
(VelaShape III and 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: 
Considering the potential benefits of non-invasive circumference and fat reduction relative to its 
risks, the potential benefits associated with the use of the VelaShape III and UltraShape Power 
Systems outweigh its risks, supporting study initiation. 

 
 
Confidential 
 
Pilot Study to Evaluate VelaShape III & UltraShape Power Combined Treatment for 
Thigh Circumference Reduction 
Protocol # 
DHF24451 
Rev. Date 
October 6, 2017 
Page 32 of 39 
 
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.    
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. 

 
 
Confidential 
 
Pilot Study to Evaluate VelaShape III & UltraShape Power Combined Treatment for 
Thigh Circumference Reduction 
Protocol # 
DHF24451 
Rev. Date 
October 6, 2017 
Page 33 of 39 
 
ADMINISTRATIVE PROCEDURES 
Supply and Disposition of Study Device 
If required the VelaShape III device, UltraShape Power device, and VelaSpray ease lotion, Parker 
Gel (coupling agents) will be supplied to the participating clinic. The device will be maintained by 
the Sponsor, as needed. Unused equipment or coupling 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 Candela. 
Control & Disposition of the Investigational Device 
The VelaShape III and UltraShape Power devices will be used according to the instructions of the 
manufacturer, Syneron Medical Ltd.  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.   
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 

 
 
Confidential 
 
Pilot Study to Evaluate VelaShape III & UltraShape Power Combined Treatment for 
Thigh Circumference Reduction 
Protocol # 
DHF24451 
Rev. Date 
October 6, 2017 
Page 34 of 39 
 
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.  
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.  

 
 
Confidential 
 
Pilot Study to Evaluate VelaShape III & UltraShape Power Combined Treatment for 
Thigh Circumference Reduction 
Protocol # 
DHF24451 
Rev. Date 
October 6, 2017 
Page 35 of 39 
 
REFERENCES 
 
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. 
 
 

 
 
Confidential 
 
Pilot Study to Evaluate VelaShape III & UltraShape Power Combined Treatment for 
Thigh Circumference Reduction 
Protocol # 
DHF24451 
Rev. Date 
October 6, 2017 
Page 36 of 39 
 
APPENDIX I – STUDY SUMMARY 
Table 8 - Study Schematics 
 
 
 
 
Screening / 
Baseline 
Tx.1 
 
Tx.2 
2wk4 
days 
 
Tx.3 
4wk4 
days 
 
4 weeks 
(7 days) 
Follow-up 
from last 
Tx. (4wk 
FU) 
 
8 weeks  
(7 days) 
Follow-up 
from last 
Tx. (8wk 
FU)   
 
12 weeks 
(7 days)  
Follow-up 
from last 
Tx. (12wk 
FU)   
 
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 
Caliper 
Measurement 
(without 
Strapping/Taping) 
X 
X 
X 
X 
X 
X 
Caliper 
Measurement (with  
Strapping/Taping) 
X 
X 
X 
 
 
 
Marking of the 
Treatment Areas 
X 
X 
X 
 
 
 
Reference height 
measurement 
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 
Investigator Satisfaction  
 
 
 
X 
X 
X 
Subject Satisfaction 
 
 
 
X 
X 
X 
Urine Pregnancy Test 
X 
X 
X 
 
 
X 
End of Participation 
(Termination) 
 
 
 
 
 
X 

 
 
Confidential 
 
Pilot Study to Evaluate VelaShape III & UltraShape Power Combined Treatment for 
Thigh Circumference Reduction 
Protocol # 
DHF24451 
Rev. Date 
October 6, 2017 
Page 37 of 39 
 
APPENDIX II - SCALES 
Table 9 - Post Treatment Side Effect Severity Scale 
(0) Absent / None 
 
(1) Mild 
 
(2) Moderate 
 
(3) Severe 
 
 
 
Table 10 –Investigator and Subject Satisfaction Scale with Treatment Outcome 
(2) Very Satisfied 
 
(1) Satisfied 
 
(0) No Opinion 
 
(-1) Unsatisfied 
 
(-2) Very Unsatisfied 
 
 
Table 11 –Subject Treatment Recommendation Scale 
(2) Highly recommend 
 
(1) Recommend 
 
(0) No Opinion 
 
(-1) Do not recommend 
 
(-2) Definitely do not recommend 
 
 
 
 
 
 
 
 
 
 

 
 
Confidential 
 
Pilot Study to Evaluate VelaShape III & UltraShape Power Combined Treatment for 
Thigh Circumference Reduction 
Protocol # 
DHF24451 
Rev. Date 
October 6, 2017 
Page 38 of 39 
 
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.  
 
 
 
 
 

 
 
Confidential 
 
Pilot Study to Evaluate VelaShape III & UltraShape Power Combined Treatment for 
Thigh Circumference Reduction 
Protocol # 
DHF24451 
Rev. Date 
October 6, 2017 
Page 39 of 39 
 
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 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 that the thighs touch each other, 
or too large. 
• 
The disposable underwear should be used for all photographs of treatment areas 
at each study visit. 
• 
For consistency purposes, the same person should ideally take all study 
photographs, particularly for the same area and subject.  
• 
Small plain labels (with the date, subject ID, subject initials, Investigator name, 
and identity of the specific area photographed, if necessary) should be placed in 
the same location within each frame at each photography time point. The label 
should not cover the treated area. 
• 
All digital files should follow a consistent standard naming scheme. 
Specific photography details: 
Four photographs of each thigh (angles below) should be taken at each specified time point: 
• 
Front of the thigh 
• 
90º from the front (right side of the body)  
• 
90º from the front (left side of the body) 
• 
Back of the thigh 
Subjects’ 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 the arms do not rest 
on the chest or touch the body and that they do not cast a shadow in the photograph.