Clinical Evaluation of Safety and Efficacy of the CelluTite Treatment
Phase: NA
Conditions: Cellulite of Thighs
Sponsor: InMode MD Ltd.

 
Cover Letter: 
 
Enclosed bellow documents are part of the Clinical Trial 
NCT03769649 
 
Study Name:  
Clinical Evaluation of Safety and 
Efficacy of The CelluTite Treatment 
 
Revision Date:  August 15, 2019 
 
 

 
Clinical Evaluation of Safety and Efficacy of The CelluTite Treatment 
Protocol No:           DO608110C 
IRB ID:                  7030   
Rev. Date: August 15, 2019 
 
2 
 
 
 
 
Study Name:  
Clinical Evaluation of Safety and Efficacy of The 
CelluTite Treatment 
 
Protocol No.:     DO608110 
 
Revision No.:  
4 
 
Sponsor: 
InMode MD Ltd. 
Tabor House  
Industrial Park South  
Yokneam 20692 ISRAEL 
POB 44 
Tel +972-4-9097309 
Fax +972-4-9096310 
 
 

 
Clinical Evaluation of Safety and Efficacy of The CelluTite Treatment 
Protocol No:           DO608110C 
IRB ID:                  7030   
Rev. Date: August 15, 2019 
 
3 
 
 
Approvals: 
 
Name 
Title 
Signature 
Date 
Written by: 
Maria Shusterman 
 
 
 
 
Approved by: 
 
 
 
 
Approved by: 
 
 
 
 
 
Revision Log: 
Revision # 
Date 
Modification 
A 
October 2018 
First Release 
B 
November 
 
C 
November 
 
4 
August 2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Clinical Evaluation of Safety and Efficacy of The CelluTite Treatment 
Protocol No:           DO608110C 
IRB ID:                  7030   
Rev. Date: August 15, 2019 
 
4 
 
1. Protocol Synopsis 
Study Title 
Evaluation of Safety and Efficacy of The CelluTite Treatment 
Protocol No 
DO608110C 
Sponsor 
InMode MD Ltd.  
Device 
InMode RF system CelluTite RFAL hand piece HP172248. 
Morpheus8 Applicator  
Study Design 
Prospective single centre, open label clinical study. 
Study Objectives 
 
The aim of the study is to evaluate the safety and efficacy of cellulite treatment with 
HP172248 and Morpheus8. 
Study Sites 
Dr. Bruce Katz, 60 E 56th St #2, New York, NY 10022, USA 
 
Patient Population 
and Sample Size 
Approximately 10 female subjects , aged 18-70 having grade II and mild/moderate grade 
III cellulites.  
Treatment areas 
Exterior (lateral) and posterior thighs  
Optional: Buttocks with Morpheus Applicator only 
Study Duration 
Study duration for each subject is approximately seven months (including screening, one 
treatment and four follow-up visits at 1 week, 1 month, 3 months and 6 months post 
treatment.  
Overall study duration will be approximately 12 months, depending on the subject 
recruitment rate. 
 Efficacy Endpoints  Photographs evaluation: Photos from all time points (baseline and follow-up visits) will be 
evaluated by the treating physician and 2 blinded independent evaluators. 
Optional: Photos will be taken using QuantifiCare (imaging specializing in skin evaluations 
in clinical trials) at baseline and 6M FU visit. 
Evaluation goals are rating the degree of cellulite according to Clinician Reported 
Photonumeric Cellulite Severity Scale (CR-PCSS). 

 
Clinical Evaluation of Safety and Efficacy of The CelluTite Treatment 
Protocol No:           DO608110C 
IRB ID:                  7030   
Rev. Date: August 15, 2019 
 
5 
 
Safety Endpoint 
Observation, assessment and recording of adverse events. 
Evaluations will be done immediately after treatments and at all follow-up visit. The 
frequency, severity and causality of all adverse events will be recorded. 
Possible treatment adverse effects include but are not limited by:  
- 
Discomfort or pain  
- 
Excessive skin redness (erythema)  
- 
Excessive skin swelling (edema) 
- 
Bruising 
- 
Damage to natural skin texture (crust, blister, burn) 
- 
Change of pigmentation (hyper- and hypo-pigmentation) 
- 
Scarring 
- 
Excessive Bleeding 
- 
Surface Irregularity 
- 
Numbness 
- 
Seroma 
- 
Severe and persistent reactions are reportable as adverse events. 
  
Each subject will undergo at least 5 study visits including screening, 1 treatment and 4 
follow-up visits. 
Visit 1: 
- 
Screening will be performed to determine subject eligibility as well as 
to collect all of the required medical information and obtain signed 
Informed Consent. 
- 
Baseline photos will be performed. 
- 
Treatment may occur on the same day of screening or within 3 weeks 
following screening.  
Visit 2: 
Follow-up visit – 1 week following treatment. 
Safety follow-up to insure that patient recovery is proper. 
Photos and assessments will be performed. 
Visit 3: 
Follow-up visit – 1 month following treatment. 
Photos and assessments will be performed. 
Visit 4: 
Follow-up visit – 3 months following treatment. 
Photos and assessments will be performed. 
Visit 5: 
Follow-up visit – 6 months following treatment. 
Photos and assessments will be performed. 
- 
After the treatment and at all visits, adverse events will be recorded. 
- 
Duration of the screening and treatment visit is approximatly 2-3 hours and the 
follow-up visit is approximatly 1 hour.  
Main Eligibility 
Criteria 
Inclusion Criteria 
- 
Female subjects aged 18-70 having mild/moderate grade cellulites.  

 
Clinical Evaluation of Safety and Efficacy of The CelluTite Treatment 
Protocol No:           DO608110C 
IRB ID:                  7030   
Rev. Date: August 15, 2019 
 
6 
 
- 
The patients should understand the information provided about the treatment, 
possible benefits and side effects, and sign the Informed Consent Form, (including the 
permission to use photography). 
- 
The patients should be willing to comply with the study procedure and schedule, 
including the follow up visit, and will refrain from using any other aesthetic treatment 
methods in the treatment area for the last 6 months and during the entire study 
period.  
Exclusion Criteria: 
- 
Body fat layer thinner than 5mm. 
- 
Pacemaker or internal defibrillator, or any other active electrical implant anywhere in 
the body. 
- 
Superficial permanent implant in the treated area such as metal plates and screws, 
metal piercing, silicone implants or an injected chemical substance.  
- 
Current or history of skin cancer (remission of 5 years), or current condition of any 
other type of cancer, or pre-malignant moles.  
- 
Severe concurrent conditions, such as cardiac disorders, epilepsy, uncontrolled 
hypertension, and liver or kidney diseases. 
- 
Pregnancy and nursing. 
- 
History of bleeding coagulopathies or use of anticoagulants. 
- 
Impaired immune system due to immunosuppressive diseases such as AIDS and HIV 
or use of immunosuppressive medications.  
- 
Poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction and 
hormonal virilization. 
- 
Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash. 
- 
History of skin disorders, keloids, abnormal wound healing, as well as very dry and 
fragile skin. 
- 
Use of Isotretinoin (Accutane®) within 6 months prior to treatment. 
- 
Any surgery or treatment such as laser or chemicals in treated area within 3-6 months 
prior to treatment or before complete healing. 
- 
Allergies, in particular to anesthesia. 
- 
Mental disorders such as Body Dysmorphic Disorder (BDD). 
- 
As per the practitioner's discretion, refrain from treating any condition that might 
make it unsafe for the patient.  
 
 
 

 
Clinical Evaluation of Safety and Efficacy of The CelluTite Treatment 
Protocol No:           DO608110C 
IRB ID:                  7030   
Rev. Date: August 15, 2019 
 
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TABLE OF CONTENTS 
1. 
PROTOCOL SYNOPSIS ......................................................................................... 4 
2. 
INTRODUCTION & STUDY RATIONALE ............................................................. 10 
3. 
DEFINITIONS, ACRONYMS AND ABBREVIATIONS .......................................... 10 
4. 
DEVICE DESCRIPTION ........................................................................................ 11 
5. 
STUDY OBJECTIVES .......................................................................................... 12 
6. 
STUDY ENDPOINTS ............................................................................................ 12 
6.1 
Efficacy Endpoints ...........................................................................................................................12 
6.2 
Safety Endpoint ...............................................................................................................................15 
7. 
STUDY POPULATION .......................................................................................... 16 
7.1 
General Considerations...................................................................................................................16 
7.2 
Inclusion Criteria .............................................................................................................................17 
7.3 
Exclusion criteria .............................................................................................................................17 
8. 
STUDY DESIGN ................................................................................................... 17 
8.1 
Screening and Baseline (Visit 1) ......................................................................................................18 
8.2 
Treatment .......................................................................................................................................18 
8.3 
Follow up visits (Visits 4-5) ..............................................................................................................20 
9. 
EFFICACY AND SAFETY EVALUATIONS .......................................................... 20 
9.1 
Efficacy Measures ...........................................................................................................................20 
9.2 
Safety Measures .............................................................................................................................20 
10. 
SUBJECT COMPLIANCE ................................................................................. 21 
10.1 
Subject Discontinuation or Withdrawal .....................................................................................21 
10.2 
Compensation for Study Participation .......................................................................................21 

 
Clinical Evaluation of Safety and Efficacy of The CelluTite Treatment 
Protocol No:           DO608110C 
IRB ID:                  7030   
Rev. Date: August 15, 2019 
 
8 
 
11. 
RISK / BENEFIT ANALYSIS ............................................................................. 22 
11.1 
Potential Risks ............................................................................................................................22 
11.2 
Benefits ......................................................................................................................................22 
12. 
ADVERSE EVENTS REPORTING .................................................................... 23 
12.1 
Definitions ..................................................................................................................................23 
Adverse Event: ..........................................................................................................................................23 
Serious Adverse Event (SAE):....................................................................................................................23 
Unanticipated Adverse Event: ..................................................................................................................23 
AE Severity: ...............................................................................................................................................23 
12.2 
Anticipated Adverse Events in this Clinical Evaluation...............................................................24 
12.3 
Precautions to Minimize Complications.....................................................................................25 
12.4 
Investigator Records ..................................................................................................................25 
12.5 
Investigator Reporting of AEs .....................................................................................................25 
13. 
REGULATORY ASPECTS ................................................................................ 26 
13.1 
Institutional Review Board .........................................................................................................26 
13.2 
Protocol ......................................................................................................................................26 
13.3 
Informed Consent ......................................................................................................................26 
13.4 
Protocol and Informed Consent Changes ..................................................................................26 
13.5 
Product Accountability ...............................................................................................................27 
13.6 
Privacy of Personal Data ............................................................................................................27 
14. 
DOCUMENTATION ........................................................................................... 27 
14.1 
Documentation List ....................................................................................................................27 
14.2 
Case Report Forms (CRFs) ..........................................................................................................27 
14.3 
Protocol Modifications ...............................................................................................................28 
14.4 
Maintenance and Retention of Records ....................................................................................28 
14.5 
Reports .......................................................................................................................................29 

 
Clinical Evaluation of Safety and Efficacy of The CelluTite Treatment 
Protocol No:           DO608110C 
IRB ID:                  7030   
Rev. Date: August 15, 2019 
 
9 
 
15. 
MONITORING PLAN ........................................................................................ 29 
15.1 
General Considerations ..............................................................................................................29 
15.2 
On-Site Visits ..............................................................................................................................29 
15.3 
Site Initiation Meeting ................................................................................................................30 
15.4 
Adverse Event Reporting and Follow-up ....................................................................................30 
15.5 
Site Closure Visit .........................................................................................................................30 
16. 
DATA ANALYSIS. ............................................................................................ 30 
16.1 
Analysis Sets ...............................................................................................................................30 
16.2 
Statistical Analysis ......................................................................................................................30 
17. 
REFERENCES .................................................................................................. 30 
18. 
INVESTIGATOR STUDY ACKNOWLEDGMENT ............................................. 32 
APPENDIX I: TIME AND EVENTS SCHEDULE ........................................................... 33 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Clinical Evaluation of Safety and Efficacy of The CelluTite Treatment 
Protocol No:           DO608110C 
IRB ID:                  7030   
Rev. Date: August 15, 2019 
 
10 
 
2. Introduction & Study Rationale  
Cellulite affects 85–98% of post-pubertal females of all races. While not a pathologic condition, 
it remains an issue of cosmetic concern to a great number of individuals. Cellulite describes the 
orange peel or cottage cheese-type dimpling of skin seen most commonly on the thighs and 
buttocks. It is prevalent in women of all races but is more common in Caucasian females. 
Cellulite can be located in any area of the body that contains subcutaneous adipose tissue 
Although cellulite may be found in any area where excess adipose tissue is deposited, obesity is 
not necessary for its presence. 
The desire for minimally invasive safe and less traumatic cellulite treatments has grown 
substantially in recent years. Minimally invasive, temperature-controlled radiofrequency (RF)-
based technology offers an optimal energy-based alternative.  
Radiofrequency-assisted lipolysis (RFAL) technology was introduced by InMode Ltd., Israel about 
10 years ago. RF energy is applied to the treatment area using a handpiece with 2 electrodes. An 
internal active electrode emitting coagulative thermal energy targets the deep soft tissues, as 
well as releases tissue in dimples by cutting fibrous septa with spatula-shaped tip. 
The external electrode is larger compared to the internal electrode, thus having relatively low 
energy density that creates nonablative RF heating. RF flows between the internal and the 
external electrode placed on the skin, heating the tissue in between the electrodes and causing 
a thermo coagulative effect. The treatment stimulates contraction and collagen formation and 
simultaneously coagulates and liquifies adipose tissue with profound contraction of the fibro- 
septal network (FSN)1-4.  The RFAL technology became a well-established alternative for body3,4, 
face and neck2,5-7 rejuvenation treatments using RFAL based handpieces.  
InMode RF technology with a few handpieces was cleared by the FDA for electro-coagulation 
and hemostasis (K171593, K163190, K151793). 
 
The InMode system with the Morpheus8 Handpiece (K180189) is designed for delivering RF 
energy to the skin surface in a fractional manner. The energy is delivered to the skin through 
bipolar arrays of 24 insulated pins and results in localized heating and ablation of the skin that is 
in direct contact with the pins non-insulated tip. Ablation of the skin promotes skin renewal 
while untreated skin between the pins enables faster healing of the tissue. There is also the 
contribution of non-ablative, non-coagulating dermal matrix heating that occurs in the skin that 
is not subject to fractional ablation. 
 
This prospective study is intended to evaluate the safety and efficacy of a new CelluTite RFAL 
handpiece combined with Morpheus8 handpiece for the treatment of cellulite. 
3. Definitions, Acronyms and Abbreviations  
RF -  
 
 
 
Radiofrequency 

 
Clinical Evaluation of Safety and Efficacy of The CelluTite Treatment 
Protocol No:           DO608110C 
IRB ID:                  7030   
Rev. Date: August 15, 2019 
 
11 
 
RFAL -   
 
 
Radiofrequency-assisted lipolysis  
AE - 
 
 
       Adverse Events 
SAEs -   
 
 
Serious Adverse Events  
UADEs -  
 
 
Unanticipated Adverse Device Effects  
HP -                             Handpiece 
4. Device Description 
The InMode RF™ System is employing radiofrequency (RF) energy for use in dermatological and 
general surgical procedures for electrocoagulation and hemostasis. The System operates when 
Handpiece is connected.  
The InModeRF System with CelluTite HP provides individual adjustment of treatment 
parameters to achieve maximum efficiency and safety for the specific treatment. 
The System provides enhanced safety while minimizing possible side effects by monitoring RF 
parameters and tissue temperature.  
The System incorporates the following safety features. All personnel operating the System 
should be familiar with these features. 
 
• 
System has unique password to avoid device operation by non-authorized personnel. 
• 
The RF energy cannot be activated unless the applicator and footswitch have been 
connected to the System.  
• 
An audible tone indicates energy activation. 
• 
During activation, the System performs a self-test of the hardware. 
• 
Hardware is tested every 10ms to ensure proper operation of electrical circuit. 
• 
Tissue impedance monitoring prevents accidental energy emission to the patient. 
• 
Skin surface is monitored during the treatment. RF energy delivery is terminated when 
skin temperature accidentally reaches the Cut-off level. 
• 
System starts at a low setting. 
• 
Internal and skin surface temperature and impedance are constantly monitored. 
 
The InMode System with the Morpheus8 HP is designed to deliver radiofrequency energy to the 
skin in a non-homogeneous fractional manner, via an array of 24-electrode pins. The array 
delivers bipolar RF energy to the skin, resulting in heating of skin around the electrodes contact, 
to temperatures leading to electrocoagulation and homeostasis of small portions of the skin. 
The procedure is carried out while leaving untouched areas in-between the pin electrodes. This 

 
Clinical Evaluation of Safety and Efficacy of The CelluTite Treatment 
Protocol No:           DO608110C 
IRB ID:                  7030   
Rev. Date: August 15, 2019 
 
12 
 
maintains the integrity of the treated skin and serves as a reservoir of cells that accelerate and 
promote the healing process. 
  
The System provides individual adjustment of treatment parameters to achieve maximum 
efficiency and safety for each patient and applications. 
The Morpheus8 HP contains the following safety features: 
• 
System has a password to avoid device operation by non-authorized personnel. 
• 
The power electronics cannot be activated unless the applicator and footswitch have been 
connected to the System.  
• 
An audible tone indicates energy activation. 
• 
During activation, the system performs a self-test of the hardware. 
• 
Hardware is tested every 10ms to ensure proper operation of electrical circuit. 
• 
System starts at a low setting. 
5. Study Objectives 
The objective of this clinical study is to evaluate the safety and efficacy of treatment with 
CelluTite RFAL HP and Morpheus8 HP. 
6. Study Endpoints 
6.1 Efficacy Endpoints 
Photographs evaluation:  Photographs should always be taken under the same settings, 
including distance, angle, background, lighting and body position. Angles to include front, back 
and side views (90º angles and 30º angles).  
Photos from all time points (baseline before treatment and at follow-up visits) will be evaluated 
by the treating physician and 2 independent evaluators. 
Optional: Photos will be taken using QuantifiCare (imaging specializing in skin evaluations in 
clinical trials) at baseline and 6M FU visit 
Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS)8: This 5-point 
photonumeric scale rates cellulite severity from "0" (none) to "4" (severe) from a clinician's 
perspective in two main clinical morphologic features of cellulite (categories): (A) number of 
evident dimples (Figure 1); and (B) severity of linear undulations (contour irregularities) (Figure 
2).  

 
Clinical Evaluation of Safety and Efficacy of The CelluTite Treatment 
Protocol No:           DO608110C 
IRB ID:                  7030   
Rev. Date: August 15, 2019 
 
13 
 
Table 1. Cellulite Severity Scale 
 
0 
1 
2 
3 
4 
Number of evident 
dimples 
(A) None/no 
dimples 
(B) 1 dimple 
(C)2 dimples 
(D) 3 dimples 
(E) 4 or more 
dimples 
Severity of linear 
undulations (contour 
irregularities) 
(A) None—no 
depressions or 
raised areas 
(B) superficial: 
generalized, 
small 
depressions 
with no 
protuberances;  
(C) mild: pattern 
of mild linear 
undulations 
with alternating 
areas of 
protuberances 
and depressions 
(D) moderate: 
pattern of 
moderate linear 
undulations with 
alternating areas 
of protuberances 
and depressions  
(E) severe: severe 
generalized linear 
undulations with 
alternating areas of 
protuberances and 
depressions 

 
Clinical Evaluation of Safety and Efficacy of The CelluTite Treatment 
Protocol No:           DO608110C 
IRB ID:                  7030   
Rev. Date: August 15, 2019 
 
14 
 
Figure 1. Number of evident dimples 
 
 
 
 
 
 

 
Clinical Evaluation of Safety and Efficacy of The CelluTite Treatment 
Protocol No:           DO608110C 
IRB ID:                  7030   
Rev. Date: August 15, 2019 
 
15 
 
Figure 2. Severity of linear undulations (contour irregularities) 
 
 
6.2 Safety Endpoint 
Observation, assessment and recording of adverse events. Evaluations will be done immediately 
after treatment and at all follow-up visits. The frequency, severity and causality of all adverse 
events will be recorded. 
Possible CelluTite adverse effects include but are not limited by:  
- 
Discomfort or pain  
- 
Excessive skin redness (erythema)  

 
Clinical Evaluation of Safety and Efficacy of The CelluTite Treatment 
Protocol No:           DO608110C 
IRB ID:                  7030   
Rev. Date: August 15, 2019 
 
16 
 
- 
Excessive skin swelling (edema) 
- 
Ecchymosis 
- 
Damage to natural skin texture (crust, blister, burn) 
- 
Change of pigmentation (hyper- and hypo-pigmentation) 
- 
Scarring 
- 
Very slight risk of infection 
- 
Incision port scarring 
- 
Surface Irregularity 
- 
Numbness 
- 
Seroma 
- 
Side effects related to anesthesia 
Possible Morpheus8 adverse effects include but are not limited by:  
- 
Discomfort or pain  
- 
Excessive skin redness (erythema)  
- 
Excessive skin swelling (edema) 
- 
Damage to natural skin texture (crust, blister, burn) 
- 
Change of pigmentation (hyper- and hypo-pigmentation) 
- 
Localized infection 
- 
Scarring 
Erythema lasting not longer than 24h and edema for 1-3 weeks is a typical skin reaction to the 
Morpheus8 treatment.  
Crusting from the ablated dots will exfoliate naturally after 1-3 weeks. 
Adverse events will be classified as Mild, Moderate, and Severe. 
The duration of the adverse event until it subsides will also be recorded. 
7. 
Study Population 
7.1 General Considerations 
The study will recruit approximately 70 female subjects, between the ages of 18-70, having 
small body areas with adipose tissue, seeking cellulite treatments.  
Treatment areas include Exterior (Lateral) and posterior thighs  
Optional: Buttocks treated with Morpheus Applicator only 
Eligible subjects will be screened. Investigators will screen subjects based on the 
inclusion/exclusion criteria described below after a written informed consent is signed. 

 
Clinical Evaluation of Safety and Efficacy of The CelluTite Treatment 
Protocol No:           DO608110C 
IRB ID:                  7030   
Rev. Date: August 15, 2019 
 
17 
 
7.2 Inclusion Criteria 
- 
Female subjects aged 18-70 having mild/moderate grade cellulites.  
- 
The patients should understand the information provided about the treatment, possible 
benefits and side effects, and sign the Informed Consent Form, (including the permission to 
use photography). 
- 
The patients should be willing to comply with the study procedure and schedule, including 
the follow up visit, and will refrain from using any other aesthetic treatment methods in the 
treatment area for the last 6 months and during the entire study period.  
7.3 Exclusion criteria 
- 
Body fat layer thinner than 5mm. 
- 
Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the 
body. 
- 
Superficial permanent implant in the treated area such as metal plates and screws, metal 
piercing, silicone implants or an injected chemical substance.  
- 
Current or history of skin cancer (remission of 5 years), or current condition of any other 
type of cancer, or pre-malignant moles.  
- 
Severe concurrent conditions, such as cardiac disorders, epilepsy, uncontrolled 
hypertension, and liver or kidney diseases. 
- 
Pregnancy and nursing. 
- 
History of bleeding coagulopathies or use of anticoagulants. 
- 
Impaired immune system due to immunosuppressive diseases such as AIDS and HIV or use 
of immunosuppressive medications.  
- 
Poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction and 
hormonal virilization. 
- 
Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash. 
- 
History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile 
skin. 
- 
Use of Isotretinoin (Accutane®) within 6 months prior to treatment. 
- 
Any surgery or treatment such as laser or chemicals in treated area within 3-6 months prior 
to treatment or before complete healing. 
- 
Allergies, in particular to anesthesia. 
- 
Mental disorders such as Body Dysmorphic Disorder (BDD). 
- 
As per the practitioner's discretion, refrain from treating any condition that might make it 
unsafe for the patient. 
8. 
Study Design 
The study is a prospective, open label clinical study.  
Approximately 70  subjects will be recruited for the study.  
 

 
Clinical Evaluation of Safety and Efficacy of The CelluTite Treatment 
Protocol No:           DO608110C 
IRB ID:                  7030   
Rev. Date: August 15, 2019 
 
18 
 
Treatment areas include Exterior (Lateral) and posterior thighs  
Optional: Buttocks treated with Morpheus Applicator only 
The treatment will be conducted according to the guidelines in the operator manual.  
The treatment efficacy will be evaluated by comparing 1, 3 and 6 months follow-up photos and 
cellulite grade to baseline.  
 
Each subject will undergo 5-6 study visits including screening, treatment and 4 follow-up visits. 
 
The Time and Events Schedule is provided in Appendix I.  
8.1 Screening and Baseline (Visit 1)  
Screening visit will be performed in order to determine subject eligibility and to collect all required 
demographic and baseline clinical information. Study procedures and available treatment 
options, including the CelluTite RFAL and Fractional RF technology will be described in detail to 
the subject. Subject will be assured that the decision regarding participation in the study is strictly 
voluntary and that they are free to change their mind at any stage. Subjects who decide to 
participate in the study will sign the Informed Consent form and Photo Release form prior to any 
study related procedure.  
 
Subjects will then be screened for study eligibility according to inclusion and exclusion criteria. 
   
The following Demographic and Baseline Measurements will be performed: 
- 
Demographic data including gender, age, race, skin type (Fitzpatrick scale). 
- 
Medical history and concomitant medication usage.  
- 
Baseline photos and assessments will be taken. 
8.2 Treatment  
The CelluTite HP treatment may occur on the same day of screening and baseline visit (or within 
3 weeks following screening).  
 
Treatment area: Treatment areas include exterior (lateral) and posterior thighs Optional: 
Buttocks treated with Morpheus Applicator only 
Treatment procedure 
- 
Treatment will be conducted according to instructions in the operator manual and company 
guidelines. 

 
Clinical Evaluation of Safety and Efficacy of The CelluTite Treatment 
Protocol No:           DO608110C 
IRB ID:                  7030   
Rev. Date: August 15, 2019 
 
19 
 
- 
Local anesthesia should be injected, incisions should be created for tumescent and internal 
electrode insertion and tumescent anesthesia should be applied. Make two or three 
incisions for each side. One on the low side of the thigh and 1 or 2 on the top area. 
- 
Sterile water–based gel, such as ultrasound gel should be applied to the skin surface to 
insure good contact of external electrode. 
- 
Insert CelluTite cannula to the most distal protrusion. 
- 
Treat protrusion area to reach internal cut off. Treat depressed areas without energy to 
mechanically release septa and elevate the dimples. 
- 
Treat only in one plane at the depth of 7-20mm depending on fat thickness and severity of 
cellulite. 
- 
Use 40oC external cut-off and 60oC internal cut-off. Higher setting (40oC/70oC) can be used 
for depth 15-20mm. 
- 
Cannula should be inserted to the intended tissue and good contact of return electrode with 
skin surface should be ensured.  
- 
While RF is applied, footswitch should be pressed.   
- 
Treat all dimples/depressions  in the treatment area. 
- 
Treat all marked areas uniformly.  
- 
After RFAL heating, no or minimal aspiration is recommended. Aspiration is performed with 
slow cannula movement to take liquified fat out without additional mechanical destruction 
of tissue. However, aggressive external “milking” of melted fat out of the treatment zone 
should be performed through the incision port to reduce risk of seroma and level of 
inflammation. Even pressure should be applied when milking the treatment area to achieve 
outcomes that are uniform in contour. 
- 
Endpoint of the CelluTite treatment is achievement of temperature cut-off. 
- 
Set Morpheus8 hand piece with BODY treatment depth and energy level of 40 in Fixed 
mode and double stack with 2 consecutive pulses on the same spot. Apply 2 passes of 
Morpheus8 with 50% overlap to all treated area. 
If subject has grade III cellulite and dimples are present: 
.1 Step 1: Release bands/dimples with the CelluTite handpiece exercising caution not to reach 
maximum cutoff temperature. 
- 
Step 2: Set Morpheus8 hand piece with BODY treatment depth and energy level of 40 in 
Fixed mode and double stack with 2 consecutive pulses on the same spot. Apply 2 passes of 
Morpheus8 with 50% overlap to all treated area.Step 3: Harvest Fat and Fat Transfer - 
additional procedure called fat grafting and/or EVL (Expansion Vibration Lipofilling) might be 
performed to further expand and even the area of concern. During this procedure the 
physician will remove unwanted fat from a "donor" zone and add it to another zone of the 
thigh. If subjects meet the criteria for this procedure it will be discussed during the 
screening. 
- 
Loose closing of the incision port with a suture provides drainage of treated area after the 
treatment. 
- 
Compressing garments must be applied at least for 1-2 weeks following the treatment. 

 
Clinical Evaluation of Safety and Efficacy of The CelluTite Treatment 
Protocol No:           DO608110C 
IRB ID:                  7030   
Rev. Date: August 15, 2019 
 
20 
 
- 
Optional: Apply topical anesthesia on Buttocks area and treat with Morpheus Applicator 
only. Set Morpheus8 hand piece with BODY treatment depth and energy level of 40 in Fixed 
mode and double stack with 2 consecutive pulses on the same spot. Apply 2 passes of 
Morpheus8 with 50% overlap to all treated area. 
After treatment, observation, assessment and recording of adverse events will be conducted. 
8.3 Follow up visits (Visits 2-5) 
Four follow up visits will be conducted and 1 week, 1Month, 3 Months and 6 months post last 
treatment. 
 
The follow up visits will include the following assessments: 
- 
Camera photos  
- 
Cellulite evaluation 
- 
AE evaluation recording 
- 
Concomitant medication recording 
9. 
Efficacy and Safety Evaluations 
9.1 Efficacy Measures  
The below assessments will be conducted at baseline and follow-up visits. 
Photos from all time points (baseline before treatment and at follow-up visits) will be evaluated 
by the treating physician and 2 blinded independent evaluators.  
Evaluation goals are rating the degree of cellulite.  
9.2 Safety Measures  
Observation, assessment and recording of adverse events. Evaluations will be done immediately 
after treatment and at all follow-up visits, to determine if adverse events develop or persist. The 
frequency, severity and causality of all adverse events will be recorded. 
Possible CelluTite adverse effects include but are not limited by:  
- 
Discomfort or pain  
- 
Excessive skin redness (erythema)  
- 
Excessive skin swelling (edema) 
- 
Ecchymosis 
- 
Damage to natural skin texture (crust, blister, burn) 
- 
Change of pigmentation (hyper- and hypo-pigmentation) 
- 
Scarring 

 
Clinical Evaluation of Safety and Efficacy of The CelluTite Treatment 
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IRB ID:                  7030   
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21 
 
- 
Very slight risk of infection 
- 
Incision port scarring 
- 
Surface Irregularity 
- 
Numbness 
- 
Seroma 
- 
Side effects related to anesthesia 
 
Possible Morpheus8 adverse effects include but are not limited by:  
- 
Discomfort or pain  
- 
Excessive skin redness (erythema)  
- 
Excessive skin swelling (edema) 
- 
Damage to natural skin texture (crust, blister, burn) 
- 
Change of pigmentation (hyper- and hypo-pigmentation) 
- 
Localized infection 
- 
Scarring 
Erythema lasting not longer than 24h and edema for 1-3 weeks is a typical skin reaction to the 
Morpheus8 treatment.  
Crusting from the ablated dots will exfoliate naturally after 1-3 weeks. 
Adverse events will be classified as Mild, Moderate, and Severe. 
The duration of the adverse event until it subsides will also be recorded. 
10. Subject Compliance  
10.1 Subject Discontinuation or Withdrawal 
Subjects will be suspended temporarily or terminated from the study whenever considered 
necessary for their welfare.   
The investigator may withdraw a subject if, in his judgment, it is in the best interest of the subject, 
if the subject cannot comply with the protocol, or if a Serious Adverse Event occurred.  
Each subject must complete the 6 months follow-up visit in order to remain in the study.  
If a subject withdraws, the reason must be recorded in the CRF Exit Form and signed by the 
Investigator.  
10.2 Compensation for Study Participation 
There is no cost to subject for participation and any potential stipend will be clearly explained in 
the ICF.   

 
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11. Risk / Benefit Analysis  
11.1 Potential Risks 
Risk is the product of the likelihood that an adverse medical event will occur times the severity of 
the event.  The main potential risks of using the CelluTite an Morpheus8 handpieces are specified 
below. 
 
Possible CelluTite adverse effects include but are not limited by:  
- 
Discomfort or pain  
- 
Excessive skin redness (erythema)  
- 
Excessive skin swelling (edema) 
- 
Ecchymosis 
- 
Damage to natural skin texture (crust, blister, burn) 
- 
Change of pigmentation (hyper- and hypo-pigmentation) 
- 
Scarring 
- 
Very slight risk of infection 
- 
Incision port scarring 
- 
Side effects related to anesthesia 
- 
Surface Irregularity 
- 
Numbness 
- 
Seroma 
Possible Morpheus8 adverse effects include but are not limited by:  
- 
Discomfort or pain  
- 
Excessive skin redness (erythema)  
- 
Excessive skin swelling (edema) 
- 
Damage to natural skin texture (crust, blister, burn) 
- 
Change of pigmentation (hyper- and hypo-pigmentation) 
- 
Localized infection 
- 
Scarring 
Erythema lasting not longer than 24h and edema for 1-3 weeks is a typical skin reaction to the 
Morpheus8 treatment.  
Crusting from the ablated dots will exfoliate naturally after 1-3 weeks. 
11.2 Benefits 
Subjects may experience cellulite improvement. Each individual may get different level of clinical 
aesthetic results. 

 
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12. Adverse Events Reporting  
12.1 Definitions 
Adverse Event: 
An Adverse Event (AE) is any untoward medical occurrence (sign, symptom, illness, abnormal 
laboratory value, or other medical event) in a subject. This definition does not imply that there is a 
relationship between the adverse event and the device. (Significant device failure may constitute 
an adverse event if an undesirable experience occurs).  
An Adverse Device Effect (ADE) is any untoward and unanticipated response to a medical device. 
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. 
Serious Adverse Event (SAE):  
A serious adverse event (SAE) is any adverse event that: 
• 
Led to death 
• 
Led to a serious deterioration in the health of the subject that resulted in a life-
threatening illness or injury 
• 
Resulted in a permanent impairment of a body structure or a body function 
• 
Required in-subject hospitalization or prolongation of existing hospitalization 
• 
Resulted in medical or surgical intervention to prevent permanent impairment to body 
structure or a body function 
• 
Led to fatal distress, a congenital abnormality, birth defect or death 
Unanticipated Adverse Event: 
An unanticipated adverse event is any serious, device-related adverse event, if that event was not 
previously identified in the risk analysis and Informed Consent form in nature, severity, or 
frequency. 
 
AE Severity: 
Adverse events are graded according to severity as follows: 
Mild 
Sign or symptom, usually transient, requiring no special treatment and 
generally not interfering with usual activities. 
Moderate 
Sign or symptom, which may be ameliorated by simple therapeutic 
measures; yet, may interfere with usual activity. 
Severe 
Sign or symptom that are intense or debilitating and that interfere with 
usual activities. Recovery is usually aided by therapeutic measures.   
 
Relationship to Device: 
The relationship of the adverse event to the treatments or procedures is defined as follows: 
Most Probably Related 
Follows a reasonable temporal sequence from study device 
delivery/retrieval and cannot be reasonably explained by known 

 
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characteristics of the subject’s clinical data or the surgical 
procedure applied. 
Possibly Related: 
Follows a reasonable temporal sequence from study device 
delivery/retrieval but could have been produced by the subject’s 
clinical state or by the surgical procedures regardless of the study 
device. 
Probably not Related: 
Temporal association is such that the study device is not likely to 
have had any reasonable association with the observed event. 
Unrelated 
No relationship to study device activation is perceived 
12.2 Anticipated Adverse Events in this Clinical Evaluation 
Possible CelluTite adverse effects include but are not limited by:  
- 
Discomfort or pain  
- 
Excessive skin redness (erythema)  
- 
Excessive skin swelling (edema) 
- 
Ecchymosis 
- 
Damage to natural skin texture (crust, blister, burn) 
- 
Change of pigmentation (hyper- and hypo-pigmentation) 
- 
Scarring 
- 
Very slight risk of infection 
- 
Incision port scarring 
- 
Side effects related to anesthesia 
- 
Surface Irregularity 
- 
Numbness 
- 
Seroma 
Possible Morpheus8 adverse effects include but are not limited by:  
- 
Discomfort or pain  
- 
Excessive skin redness (erythema)  
- 
Excessive skin swelling (edema) 
- 
Damage to natural skin texture (crust, blister, burn) 
- 
Change of pigmentation (hyper- and hypo-pigmentation) 
- 
Localized infection 
- 
Scarring 
Erythema lasting not longer than 24h and edema for 1-3 weeks is a typical skin reaction to the 
Morpheus8 treatment.  
Crusting from the ablated dots will exfoliate naturally after 1-3 weeks. 

 
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12.3 Precautions to Minimize Complications 
A list of warning and precautions is provided in the Operator Manual which is provided to site 
personnel. 
Additionally, the exclusion criteria listed in this protocol further reduce the abovementioned risks. 
12.4 Investigator Records  
The Investigator will report all Adverse Events which occur with each subject throughout the study 
and follow-up period and will record them in the CRF Adverse Events Investigation Form. The 
Investigator will categorize Adverse Events according to: 
• 
Serious or non-serious 
• 
Severity  
• 
Anticipated or unanticipated  
• 
Relationship to device use 
12.5 Investigator Reporting of AEs 
The Investigator will report all serious adverse events (SAEs) to InMode MD Ltd by telephone as 
soon as becoming aware of them. A written follow-up report will be emailed or faxed to InMode 
MD Ltd and the reviewing IRB within 24 hours and will include the following information: 
1. 
Nature of AE 
2. 
Statement regarding the degree to which it is considered device related, and rationale. 
3. 
Results of any diagnostic tests that were performed. 
4. 
Description of any treatment implemented. 
5. 
Statement of subject’s current clinical status. 
6. 
Investigator’s signature and date. 
Non-serious adverse events that are unanticipated and may be device related will be reported to 
the InMode MD Ltd by telephone within 24 hours. A written follow-up written report will be 
emailed or faxed to InMode MD Ltd within 5 working days and will include the following 
information: 
1. Nature of adverse effect. 
2. Statement as to why it is considered unanticipated. 
3. Statement as to the degree to which it is considered device related, and rationale. 
4. Results of any diagnostic tests that were performed. 
5. Description of any treatment implemented. 
6. Statement of subject’s current clinical status. 
7. Investigator’s signature and date. 
All other Adverse Events will be reported in writing to InMode MD Ltd in writing within 5 working 
days of the Investigator becoming aware of them.  
The Investigator will continue to clinically monitor the AE, with laboratory tests where appropriate, 
until it is resolved, stabilized or there is a return to baseline. 

 
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13. Regulatory Aspects 
13.1 Institutional Review Board  
The study protocol, informed Consent forms (all versions), and any specific advertising will be 
submitted to and approved by Sterling Institutional Review Board (IRB), at 6300 Powers Ferry Road 
· Suite 600-351, Atlanta, Georgia 30339, Toll-Free: (888) 636-1062, Phone: 770-690-9491, Fax: (770) 
690-9492 before the start of the study. A form must be signed by the chairman or designee of the 
IRB noting the approvals. This notification will be provided to the sponsor. 
 
13.2 Protocol 
Protocols will be noted as approved by the Investigator by placement of his signature on the 
Investigator’s Signature Page. The protocol and Informed Consents will be provided, and the site 
shall assure IRB approval prior to any study related activities. 
 
13.3 Informed Consent 
An Informed Consent that includes all of the relevant elements currently required by FDA or state 
regulations will be provided to each prospective study patient at screening and before enrolling 
into the study. The type and method of study, any potential or possible hazards, and the patient’s 
right to withdraw from the study at any time will be explained to the patients by the Investigator 
of designee.  Once the Investigator is assured that an individual candidate understands the 
implications of participating in this study, the patient will be asked to give Consent by signing and 
dating in the appropriate areas of the Informed Consent form. The Investigator or Designee will 
also sign and date the form. A copy of the IRB approved IC form will also be provided to InMode 
MD Ltd.  
 
13.4 Protocol and Informed Consent Changes 
Changes to the protocol or Informed Consent Form will be implemented as amendments to the 
original document and approved by the IRB. The approvals will be processed in accordance with 
the established IRB procedures. Copies of all protocol and IC amendments/revisions, along with 
letters noting IRB approval, will be submitted to InMode MD Ltd, as this may affect safety.  Any 
addenda, amendment or revision that substantially alters the study design or increases potential 
risk to the patient requires the patient’s Consent to continue in the study. 
 

 
Clinical Evaluation of Safety and Efficacy of The CelluTite Treatment 
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13.5 Product Accountability 
All device and related materials receipt, inventory, dispensing, and reconciliation records will be 
maintained in compliance with Federal Regulations.    Upon completion or termination of the study 
the site will be responsible for retaining all partial and unused products under FDA regulations. 
 
13.6 Privacy of Personal Data 
The subject's name and personal data will remain confidential and will not be published in any 
way. All reports and communications relating to study subjects will identify the subject only by 
his/her case number and study 3-letter code. The Study staff will complete subject identification 
in a confidential enrolment log, which will be used for the purposes of traceability and follow-up. 
This will be treated with strict adherence to professional standards of confidentiality and will be 
filed under adequate security and restricted accessibility 
14. Documentation 
14.1 Documentation List 
Accurate, complete and timely documentation is essential to the successful conduct of this study. 
The following documents will be created and maintained: 
1. 
Informed Consent Forms (ICFs). 
2. 
Case Report Forms (CRFs). 
3. 
Adverse effect reports to sponsor. 
4. 
Adverse effect reports to IRB. 
5. 
Inventory Log.  
6. 
Monitoring logs. 
7. 
IRB approval for protocol. 
8. 
IRB approval for informed Consent. 
9. 
Final report to Sponsor and IRB. 
10. Records of protocol deviations. 
11. Record of protocol amendments. 
12. 1 copy of each protocol revisions. 
13. 1 copy of each CRF revision. 
14. Clinical Trial Agreement. 
15. All correspondence relating to study. 
14.2 Case Report Forms (CRFs) 
CRFs will be designed for recording the required demographic and clinical information and the 
variables to be analysed, as described by this protocol. 

 
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CRFs will be completed by the authorized Investigator or a designee who will be properly trained 
on study procedures and data recording requirements. Upon completion, the CRFs will be signed 
by the Principal Investigator. 
CRFs will be provided by the sponsor, one CRF per subject, each one numbered.  
Study data will be recorded directly onto the CRF as soon as it is collected. The following data will 
be recorded pre-procedure, during the procedure, and post-procedure on the CRFs: 
1. 
Baseline Data Form – to be used for screening subjects for inclusion in the study and to record 
subject’s demographic data and medical history. 
2. 
Training Form – to be used for recording relevant training information. 
3. 
Treatment Visit Forms – to be used to record procedural details, procedural complications, 
technical performance of the device, test results and other relevant information related to the 
procedure and device. 
4. 
Unscheduled Visit Form – to be used to record procedural details, procedural complications, 
technical performance of the device, and other relevant information related to the procedure 
and device during an unscheduled visit to site. 
5. 
Termination Form - to be used to record all details regarding the termination of the subject, 
whether a result of study completion or premature withdrawal. 
6. 
Exit Form – To be completed after all study procedures, follow-up and completion of AE 
investigation for the subject. 
7. 
Adverse Event Investigation Form – to be used to report all AE, if occurred. 
14.3 Protocol Modifications 
An amendment to the protocol may be proposed by an Investigator or the Sponsor. The 
amendment will be prepared and approved by the Sponsor according to the Sponsor's Procedure. 
Significant amendment will be submitted to the IRB for approval before implementation. 
If for any unexpected reason it is necessary to deviate from the procedures stated above, the 
protocol deviation should be discussed with the Sponsor representative. It must be approved by 
the Investigator and Sponsor representative.  The deviation and reasons for it will be described in 
the appropriate Protocol Deviation Form, signed and filed in the relevant section of the Sponsor 
Study File following approval. 
A copy of the document must be filed in the Investigator Study File. 
Any deviation must be noted in the Study Report. If a deviation has any implication of impact on 
the study objectives it must also be included in the summary. 
 
14.4 Maintenance and Retention of Records 
Investigators will maintain all study related documentation for a period of two years following: 1) 
marketing authorization for device commercialization, or 2) sponsor’s withdrawal of submission for 
approval, or 3) completion of the study. 

 
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All printouts and records of tests and procedures are to be kept in a secure and safe place 
throughout the study.  Once the study is completed, the records will be kept as required by local 
regulations, but in no case less than the period defined above. 
The Investigator will not relocate or dispose of any study documents before obtaining sponsor’s 
written permission. 
Documentation should be kept so as to make its retrieval easy should an audit take place. 
All study documentation will be kept locked under the Investigator’s responsibility. 
14.5 Reports 
Study reports include a Final Report that will be issued by the Sponsor. Report format will be 
designed by the Sponsor. 
All study reports will be signed by the Principal Investigators approving its contents, analysis, results 
and conclusions.  
AE related reporting requirements are specified above. 
15. Monitoring Plan 
15.1 General Considerations 
Monitoring functions will be performed in compliance with Good Clinical Practices, EN ISO 14155, 
and as outlined in 21CRF§812.43(d) and 21CRF§812.46. InMode MD Ltd procedures detail 
monitoring procedures and monitor responsibilities.  
The study will be monitored periodically, per Sponsor discretion and site monitoring plan, for the 
purposes of: a) verifying compliance to the protocol and applicable regulations, and b) verifying 
correspondence of CRF data to original entries in source files.  
15.2 On-Site Visits 
Periodic on-site monitoring visits are intended to assess the Investigator’s adherence to the 
protocol, maintenance of records and reports, and review of source documents for accuracy, 
completeness, and legibility, and monitoring of Adverse Events. 
During periodic visits the monitor is required to: 
• 
Assess the progress of the study towards meeting study objectives. 
• 
Identify any concerns that stem from observations of device performance and/or review of 
the subject’s CRF, study management documents, and informed Consent documents.  
• 
Monitor AE reporting and investigations. 
Reports of on-site visits will be submitted by the monitor and will include, as applicable, resolution 
of concerns, completion of appropriate follow-up activities, completion of assigned tasks, and 
corrective actions. Visits may be performed using a video conference or phone call and will not be 
actual physical visits. 

 
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15.3 Site Initiation Meeting 
A Site Initiation visit will take place prior to initiation of study procedures.  All study related 
documents and procedures will be explained to all staff involved in the study to ensure 
understanding of the study requirements.   
15.4 Adverse Event Reporting and Follow-up 
Monitoring of adverse events, their follow up and outcomes will take place at each study visit. 
15.5 Site Closure Visit 
Upon approval of the Final Report, a Site Closure Visit will be conducted to ensure that all used and 
unused devices have been returned to the Sponsor, all relevant documentation is filed and archived 
under the Investigator’s responsibility according to regulations. 
16.  Data analysis.  
16.1 Analysis Sets 
- 
Safety Analysis Set 
The safety analysis set will include all subjects using treatment procedures at least a single time. 
- 
Performance Analysis Set 
Performance analysis set will consist of all subjects providing at least one post treatment 
performance measurement. 
- 
Treatment of Missing Values 
Only observed data will be used; i.e. missing data will not be imputed. 
 
16.2 Statistical Analysis  
Means, and standard deviations for each characteristic will be calculated.  Paired sample t-test will 
be computed to assess changes in before treatment and follow-up scores. Statistical significance 
will be calculated and two-tail significance level of 0.05 will be used. All analyses will be conducted 
using IBM SPSS 21.0. 
17. References  
1. Paul M, Blugerman G, Kreindel M, Mulholland RS. Three dimensional radiofrequency 
tissue tightening: a proposed mechanism and applications for body contouring. Aesth 
Plast Surg. 2011;35(1):87-95. 

 
Clinical Evaluation of Safety and Efficacy of The CelluTite Treatment 
Protocol No:           DO608110C 
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Rev. Date: August 15, 2019 
 
31 
 
2. Mulholland RS. Nonexcisional, minimally invasive rejuvenation of the neck. Clin Plast 
Surg. 2014;41:11–31. 
3. Chia CT, Theodorou SJ, Hoyos AE, Pitman GH. Radiofrequency-assisted liposuction 
compared with aggressive superficial, subdermal liposuction of the arms: a bilateral 
quantitative comparison. Plast Reconstr Surg Glob Open. 2015;3(7):e459. 
4. Theodorou SJ, Del Vecchio D, Chia CT. Soft tissue contraction in body contouring with 
radiofrequency-assisted liposuction: a treatment gap solution. Aesth Surg J 2018, Vol 
38(S2) S74–S83.  
5. Ahn DH, Mulholland RS, Duncan D, et al. Non-excisional face and neck tightening using a 
novel subdermal radiofrequency thermocoagulative device. J Cosmet Dermatol Sci Appl. 
2011;1:8845–8851. 
6. Divaris M, Blugerman G, Paul MD. Face expressive lifting (FEL): an original surgical 
concept combined with bipolar radiofrequency. Eur J Plast Surg. 2013;DOI 
10.1007/s00238-013-0908-2. 
7. Keramidas E, Rodopoulou S. Radiofrequency-assisted liposuction for neck and lower face 
adipodermal remodeling and contouring. Plast Reconstr Surg Glob Open. 2016;4(8):e850. 
8. Barry E. DiBernardo, MD; Gordon H. Sasaki, MD; Bruce E. Katz, MD; Joseph P. Hunstad, 
MD, FACS; Christine Petti, MD, FACS; and A. Jay Burns, MD A Multicenter Study for 
Cellulite Treatment Using a 1440-nm Nd:YAGWavelength Laser with Side-Firing Fiber. 
Aesthetic Surgery Journal 2016, Vol 36(3) 335–343 

 
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18. Investigator Study Acknowledgment 
 
Investigator's Statement: 
 
I have read and understand the foregoing protocol and any corresponding amendments 
entitled: “Clinical Evaluation of Safety and Efficacy of The CelluTite Treatment.”, Study 
No.: DO608110C, and agree to conduct the Study as outlined herein. 
 
 
Investigator's Name (Please print)  
 
 
 
 
 
Investigator's Title 
 
 
 
 
 
 
 
 
 
 
 
 
Investigator's Signature  
 
 
 
 
 
 
 
 
 
Date 

 
Clinical Evaluation of Safety and Efficacy of The CelluTite Treatment 
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Rev. Date: August 15, 2019 
 
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Appendix I: Time and Events Schedule 
 
 
Visit type 
 
Procedure 
Visit 1* 
Screening 
Baseline 
Measures & 
 1st Treatment 
Visit 2 
1 Week 
Follow-up 
 
Visit 3 
1 Month 
Follow-up 
 
Visit 4 
3 Months 
Follow-up 
 
Visit 5 
6 Months 
Follow-up 
 
Medical History and 
Demographics 
 
 
 
 
 
Inclusion/Exclusion Criteria 
 
 
 
 
 
Informed Consent 
 
 
 
 
 
Photos  
 
 
 
 
 
Optional: QuantifiCare 
Photos 
 
 
 
 
 
Treatment 
 
 
 
 
 
Investigator Assessments 
 
 
 
 
 
AE**Query 
 
 
 
 
 
Concomitant Medication 
 
 
 
 
 
Study End 
 
 
 
 
 
 
* Screening and treatment may occur on the same day and up to 3 weeks interval 
** AE – Adverse Events