Baseline Controlled Study to Evaluate the Safety and Efficacy of Combined EMS and RF Treatments for Non-Invasive Circumference Reduction and Skin Tightening
Phase: NA
Conditions: Non-invasive Circumference Reduction
Sponsor: InMode MD Ltd.

Baseline Controlled Study to Evaluate the Safety and Efficacy of 
Combined EMS and RF Treatments for Non-Invasive 
Circumference Reduction and Skin Tightening 
 
 
Protocol No: DO608715A, Rev. 02 
 
Date: 
September 19, 2019 
 
 

 
Baseline Controlled Study to Evaluate the Safety and Efficacy of Combined EMS 
and RF Treatments for Non-Invasive Circumference Reduction and Skin 
Tightening   
Protocol No: DO608715A      SIRB ID: 7398  Rev. Date:  Sep 19, 2019 
 
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Study Name:  
Baseline Controlled Study to Evaluate the Safety and 
Efficacy of Combined EMS and RF Treatments for Non-
Invasive Circumference Reduction and Skin Tightening   
 
Protocol No.:       DO608715A 
 
Revision No.:  
 
 
Sponsor: 
InMode Ltd. 
Tabor House  
Industrial Park South  
Yokneam 20692 ISRAEL 
POB 44 
Tel +972-4-9097309 
Fax +972-4-9096310 
 
 

 
Baseline Controlled Study to Evaluate the Safety and Efficacy of Combined EMS 
and RF Treatments for Non-Invasive Circumference Reduction and Skin 
Tightening   
Protocol No: DO608715A      SIRB ID: 7398  Rev. Date:  Sep 19, 2019 
 
3 
 
1. Protocol Synopsis 
Study Title 
Baseline Controlled Study to Evaluate the Safety and Efficacy of Combined EMS and RF 
Treatments for Non-Invasive Circumference Reduction and Skin Tightening   
Protocol No 
DO608715A, Rev. 02 
Sponsor 
InMode Ltd.  
Investigational 
Product 
Evolve (InMode EmBody System) with Tite (Embody Plus Handpiece K183450) and Tone 
Applicators  
Study Design 
Prospective, open label clinical study. 
Study Sites 
Dr. Chia 
Dr. Dayan 
Patient Population 
and Sample Size 
Subjects aged 18-65, healthy adults, seeking for non-invasive abdominal circumference 
reduction and skin tightening, male and females.  
Approximately 20 healthy adult volunteers (10 per site), seeking for non-invasive 
abdominal circumference reduction, male and females, 18 to 65 years of age from up to 2 
investigational sites.  
Study Duration 
Eligible subjects will receive up to 3 bi-weekly treatments (once in 2 weeks) with the 
Evolve device utilizing the Tite  and Tone applicators according to the study protocol. 
Study duration for each subject is approximately 8 months (including screening, up to 
three treatments and 3 follow-up visits at 1 months, 3 months and 6 months post last 
treatment. 
Overall study duration will be approximately 14 months, depending on the subject 
recruitment rate. 
Primary 
Objectives 
 
The objective of this trial is to evaluate the safety and efficacy of the Evolve device 
utilizing the Tite and Tone applicators for abdominal non-invasive circumference 
reduction and skin tightening  
Secondary 
Objective 
The secondary objective of this study is subject satisfaction, as measured with a self-
assessment questionnaire and a rating of device and procedure related adverse events. 

 
Baseline Controlled Study to Evaluate the Safety and Efficacy of Combined EMS 
and RF Treatments for Non-Invasive Circumference Reduction and Skin 
Tightening   
Protocol No: DO608715A      SIRB ID: 7398  Rev. Date:  Sep 19, 2019 
 
4 
 
Endpoints  
Primary Effectiveness Endpoint: 
1. The primary efficacy endpoint in this trial is the statistical difference of 
circumference reduction between Control (baseline measurement) and three 
points of follow-up measurement: 4 weeks (1Month) 12 weeks (3Month) and 24 
weeks (6 months) following the last Tx session.  
The primary effectiveness endpoint will be calculated based on those patients 
whose weight remains stable during the study period. A subject is defined as 
having maintained her weight during the treatment period if it remained within 
±3% (inclusive) of baseline for the respective period. 
2. Improvement in in skin appearance comparing pre and at 1, 3 months and 6 
months post last treatment photographs (as assessed by blinded investigators): 
- 
Success is defined by correct identification of the pre and post treatment photos 
as demonstrated in at least 70% or greater of patients completed the treatment 
at 1 month, 3 months and 6 months post treatment. 
- 
At least 2 out of 3 blinded evaluators should agree on the assessment. 
3. Optional: 3D Photographic analysis will be conducted using QuantifiCare System 
at 1 month, 3 months and 6 months follow up visits and compared to the 
baseline. 
4. Investigator assessment of the skin appearance improvement comparing pre and 
post treatment using 0 - 4 -points Likert scale at 1 month, 3 months and 6 months 
follow up visits: 
4 = Significantly marked improvement; 3 = Marked improvement; 2 = Moderate 
improvement; 1 = Slight improvement; 0 = No difference 
Primary Safety Endpoint 
Safety Endpoint Rate of all device and procedure related adverse events (AE's) 
and serious adverse events (SAE's) occurring during the study. 
Secondary Effectiveness Endpoints: 
Subject satisfaction and comfort: 
• 
Improvement assessment will be performed independently by the subject himself 
using 4 points Likert scale questionnaire (Global Aesthetic Improvement Scale), as 
follows: 
- 
4 = Significantly marked improvement; 3 = Marked improvement; 2 = 
Moderate improvement; 1 = Slight improvement; 0 = No difference. 
• 
Subject assessment of satisfaction will be filled out by subjects using a 5-points 
Likert scale, as follows: 
- 
+2 = Very satisfied; +1 = Satisfied; 0 = Indifferent; -1 = Disappointed; -2 = Very 
disappointed. 

 
Baseline Controlled Study to Evaluate the Safety and Efficacy of Combined EMS 
and RF Treatments for Non-Invasive Circumference Reduction and Skin 
Tightening   
Protocol No: DO608715A      SIRB ID: 7398  Rev. Date:  Sep 19, 2019 
 
5 
 
Statement of Compliance 
This study will be conducted in accordance with the Code of Federal Regulations on the Protection of Human 
Subjects (45 CFR Part 46), any other applicable US government research regulations, and institutional 
research policies and procedures. The Principal Investigator will assure that no deviation from, or changes 
to the protocol will take place without prior agreement from the sponsor and documented approval from 
the Institutional Review Board (IRB), except where necessary to eliminate an immediate hazard(s) to the 
trial participants. 
2. Data analysis  
9.1 Analysis Sets 
• 
Safety Analysis Set 
The safety analysis set will include all subjects using Embrace 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. 
9.2 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. 
• 
Subject assessment of comfort will be filled out by subjects using a 5-point Likert 
scale, as follows: 
- 
+2 = Very comfortable; +1 = Comfortable; 0 = Indifferent; -1 = uncomfortable; 
-2 = Pain.