Safety and Efficacy of Trim II for Non-invasive Lipolysis and Circumference Reduction of Abdomen
Phase: NA
Conditions: Circumference Reduction of Abdomen
Sponsor: InMode MD Ltd.

 
Safety and Efficacy of Trim II for Non-
invasive Lipolysis and Circumference 
Reduction of Abdomen 
 
NCT05398159 
Last Updated Jun 3 2022 
 

 
Safety and Efficacy of Trim II for Non-invasive Lipolysis and Circumference 
Reduction of Abdomen. 
Protocol No: DO609924A   SIRB ID: 8659  Rev. Date:  Jun 3 2022 
 
2 
 
Study Name:  
Safety and Efficacy of Trim II for Non-invasive Lipolysis 
and Circumference Reduction of Abdomen. 
Protocol No.:        DO609924A 
 
Sponsor: 
InMode Ltd. 
Tavor House, POB 533  
Industrial Park South 
Yokneam, 2069206, Israel 
Tel: +972-4-9096313 
 
 

 
Safety and Efficacy of Trim II for Non-invasive Lipolysis and Circumference 
Reduction of Abdomen. 
Protocol No: DO609924A   SIRB ID: 8659  Rev. Date:  Jun 3 2022 
 
3 
 
Approvals: 
 
Name 
Title 
Signature 
Date 
Written by: 
Dr. Mira Barki 
Clinical Advisor 
 
January 2021 
Approved by: 
Dr. Hela Goren 
VP Clinical Affairs 
 
January 2021 
Approved by: 
Dr. Michael Kreindel 
CTO 
 
January 2021 
 
 
 
Revision Log: 
Revision # 
Date 
Modification 
A 
January 2021 
First Release 
B 
June 2022 
 
 
 
 
 
 
 
 
 
 

 
Safety and Efficacy of Trim II for Non-invasive Lipolysis and Circumference 
Reduction of Abdomen. 
Protocol No: DO609924A   SIRB ID: 8659  Rev. Date:  Jun 3 2022 
 
4 
 
1. Protocol Synopsis 
Study Title 
Safety and Efficacy of Trim II for Non-invasive Lipolysis and Circumference Reduction of 
Abdomen. 
Protocol No 
DO609924A 
Sponsor 
InMode Ltd.  
Investigational 
Product 
Trim II hands free device.  
Study Design 
Prospective, open label clinical study. 
Principle 
Investigator and 
Study Site 
Site 01:  
Site 02:  
Site 03:  
Site 04:  
Site 05:  
 
Patient Population 
and Sample Size 
At least 70 female and male subjects, from 5 investigational sites, aged 18-70 seeking 
non-invasive lipolysis and circumference reduction of abdomen will be enrolled. 
Study Duration 
Eligible subjects will receive 3 bi-weekly treatments (once in 2 weeks) with Trim II hands-
free applicator belt according to the study protocol. 
Trim II hands-free applicator composed of 4 units applied to the abdominal area, using a 
single-use belt.  
Each treatment duration will be 45-60 minutes.       
Study duration for each subject is approximately 6 months (including screening, 3 
treatments and 2 follow-up visits at 1 and 3 months post last treatment).  
Histological samples will be taken from treated area of 8-10 subjects (in total) at baseline 
and at 3 months follow-up visit.  
Overall study duration will be approximately 12 months, depending on the subject 
recruitment rate. 

 
Safety and Efficacy of Trim II for Non-invasive Lipolysis and Circumference 
Reduction of Abdomen. 
Protocol No: DO609924A   SIRB ID: 8659  Rev. Date:  Jun 3 2022 
 
5 
 
Endpoints  
Primary Endpoints: 
• 
Efficacy of the Trim II treatment for lipolysis and abdominal circumference 
reduction. 
Evaluation of change in abdomen circumference using tape measurements in cm 
at the 3 months follow-up visit comparing to baseline.  
Success criteria: Statistically significant reduction in abdominal circumference 
tape measurements at the 3 months follow-up visit compared to baseline  
• 
Safety of the Trim II treatment for lipolysis and abdominal circumference 
reduction.  
The occurrence of adverse events will be followed throughout the whole study. 
Observation, assessment and recording of potential reactions by the investigator. 
Evaluations will be done immediately after each treatment and at the follow-up 
visits. The frequency, severity and causality of reactions will be recorded. 
 
Secondary Endpoints: 
• 
Efficacy of the Trim II treatment for fat and circumference reduction in abdomen, 
as assessed by two blinded evaluators. Evaluation of photographs at baseline and 
3 months follow-up. 
Success criteria: Correct identification of baseline and 3-month follow-up visit 
photographs in at least 70% of treated subjects by two blinded evaluators. 
• 
Change in abdominal fat thickness measured by ultrasound imaging (USI) at the 3 
months follow-up visit comparing to baseline. 
Success criteria: statistically significant change in fat thickness measurements at 
the 3 months follow-up visit compared to baseline. 
• 
Evaluation of change in histological samples at 3 months follow-up visit 
comparing to baseline. 
Success Criteria:  Effect on fat tissue while the dermal and epidermal layers are 
intact with no adverse skin events 
• 
Subject's satisfaction with study treatment at 3 months follow-up visit.  
Subject's satisfaction with the therapy results evaluated through the Subject 
Satisfaction Questionnaire (5-point scale). 
• 
Treatment comfort during the study treatment.  
Subjects will be asked to rate discomfort using Subject's discomfort (pain) level 
after each treatment evaluated using the Therapy Comfort Questionnaire 
Visits 
Each subject will undergo at least 5 study visits including: screening, 3 treatments and 2 
follow-up visits.  Duration of each treatment visit is approximatly 2 hours. 
 
Visit 1:  
Screening, baseline and 1st treatment (can occur on th same day) 

 
Safety and Efficacy of Trim II for Non-invasive Lipolysis and Circumference 
Reduction of Abdomen. 
Protocol No: DO609924A   SIRB ID: 8659  Rev. Date:  Jun 3 2022 
 
6 
 
- 
Screening will be performed to determine subject eligibility as well as 
to collect the required medical information and obtain signed 
Informed Consent 
- 
Baseline abdominal fat thickness measured by ultrasound  
- 
Baseline photographs of treatment area  
- 
Baseline weight and hight (BMI calculation)  
- 
Baseline circumference tape measurement 
- 
Baseline caliper measurement 
- 
Baseline histologies (8 subjects) 
- 
Abdominal 1st treatment will be done using the TRIM II hands-free 
applicators belt according to IFU  
- 
Therapy Comfort Questionnaire 
*  Treatment may occur on the same day of screening or within 3 weeks 
following screening. 
Visits 2-3: 
2nd , 3rd treatments – each 2 weeks following previous visit 
- 
Weight and height (BMI calculation)  
- 
Circumference tape measurement 
- 
Caliper measurement 
- 
Abdominal treatment will be done using the TRIM II hands-free 
applicators belt according to IFU   
- 
Therapy Comfort Questionnaire 
Visit 4: 
Follow-up visit – 1 month following last treatment 
- 
Treatment area will be photographed  
- 
Weight and hight  (BMI calculation)  
- 
Circumference tape measurement 
- 
Caliper measurement 
Visits 5: 
Follow-up visit – 3 months following last treatment 
- 
Treatment area will be photographed  
- 
Weight  and hight (BMI calculation)  
- 
Circumference tape measurement 
- 
Caliper measurement 
- 
Abdominal fat thickness measured by ultrasound 
- 
Histologies (8 subjects) 
- 
Subject's satisfaction  
 
After each treatment and at all visits, skin response and adverse events will be 
recorded.   
Main Eligibility 
Criteria 
Inclusion Criteria 
- 
Female and male subjects, aged 18-70.  
- 
BMI≤ 30. 
- 
Subjects seeking non-invasive lipolysis and circumference reduction of abdomen 
- 
Female should not be pregnant or lactating and must be either post-menopausal, 
surgically sterilized, or using a medically acceptable form of birth control at least 3 

 
Safety and Efficacy of Trim II for Non-invasive Lipolysis and Circumference 
Reduction of Abdomen. 
Protocol No: DO609924A   SIRB ID: 8659  Rev. Date:  Jun 3 2022 
 
7 
 
months prior to enrolment (i.e., oral contraceptives, contraceptive implant, barrier 
methods with spermicide or abstinence). 
- 
In addition, negative urine pregnancy test as tested before each treatment and at the 
last visit for women with childbearing potential (e.g. not menopause). 
- 
General good health confirmed by medical history and skin examination of the 
treated area. 
- 
The subjects should understand the information provided about the investigative 
nature of the treatment, possible benefits and side effects, and sign the Informed 
Consent Form, including permission to use photography. 
- 
The subjects should be willing to comply with the study procedure and schedule, 
including the follow up visits, and will refrain from using any other abdominal 
treatment methods during the entire study period. 
Exclusion Criteria 
- 
Active electrical implant/device in any region of the body, including pacemaker or 
internal defibrillator  
- 
Permanent implant in the treated area such as metal plates, screws or silicon, metal 
piercing or other. 
- 
Current or history of skin cancer, or current condition of any other type of cancer, or 
pre-malignant moles. 
- 
Severe concurrent conditions, such as cardiac disorders, sensory disturbances, 
epilepsy, uncontrolled hypertension, and liver or kidney diseases.  
- 
History of skin disorders, keloids, abnormal wound healing, as well as very dry and 
fragile skin. 
- 
History of bleeding coagulopathies or use of anticoagulants except for low-dose 
aspirin. 
- 
Patients with history of diseases stimulated by heat, such as recurrent Herpes Simplex 
in the treatment area, may be treated only following a prophylactic regimen. 
- 
Impaired immune system due to immunosuppressive diseases such as AIDS and HIV 
or use of immunosuppressive medications.  
- 
Pregnancy and nursing. 
- 
Poorly controlled endocrine disorders, such as Diabetes, or thyroid dysfunction and 
hormonal virilization. 
- 
Isotretinoin (Accutane) within last 6 months. 
- 
Any active condition in the treatment area, such as sores, Psoriasis, eczema, and rash, 
open lacerations, abrasions or lesions, infection in the area to be treated. 
- 
Any surgical procedure in the treatment area within the last 12 months or before 
complete healing.  
- 
Having received treatment with light, laser, RF, or other devices in the treated area 
within 2-3 weeks for non-ablative procedures, and 6-12 weeks for ablative fractional 

 
Safety and Efficacy of Trim II for Non-invasive Lipolysis and Circumference 
Reduction of Abdomen. 
Protocol No: DO609924A   SIRB ID: 8659  Rev. Date:  Jun 3 2022 
 
8 
 
 
 
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. 
laser resurfacing (according to treatment severity) prior to treatment, except special 
recommendations.  
- 
Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g., ibuprofen-containing 
agents) one week before and after each treatment session, as per the practitioner’s 
discretion. 
- 
As per the investigator's discretion, refrain from treating any condition which might 
make it unsafe for the patient. 
- 
Participated in another investigational drug or device study or have completed the 
follow-up phase for any previous study less than 30 days prior to the first evaluation 
in this study. 

 
Safety and Efficacy of Trim II for Non-invasive Lipolysis and Circumference 
Reduction of Abdomen. 
Protocol No: DO609924A   SIRB ID: 8659  Rev. Date:  Jun 3 2022 
 
9 
 
TABLE OF CONTENTS 
1. 
PROTOCOL SYNOPSIS ...................................................................................................... 4 
2. 
INTRODUCTION & STUDY RATIONALE ...........................................................................12 
3. 
DEFINITIONS, ACRONYMS AND ABBREVIATIONS .........................................................12 
4. 
DEVICE DESCRIPTION ......................................................................................................13 
5. 
STUDY OBJECTIVES .........................................................................................................14 
6. 
STUDY ENDPOINTS ...........................................................................................................14 
6.1 
Primary Endpoints ............................................................................................................................................ 14 
6.2 
Secondary Endpoints ........................................................................................................................................ 15 
7. 
STUDY POPULATION ........................................................................................................15 
7.1 
General Considerations .................................................................................................................................... 15 
7.2 
Subject Withdrawal and Replacement ............................................................................................................. 15 
7.3 
Subject Identification ........................................................................................................................................ 16 
7.4 
Inclusion Criteria ............................................................................................................................................... 16 
7.5 
Exclusion criteria ............................................................................................................................................... 16 
8. 
STUDY PROCEDURES .......................................................................................................17 
8.1 
Visit 1: Screening, baseline and 1st treatment .................................................................................................. 17 
8.2 
Visits 2-3:  2nd , 3rd treatments , every 2 weeks following previous visit .......................................................... 19 
8.3 
Visit 4: Follow-up visit – 1 month following last treatment ............................................................................. 20 
8.4 
Visit 5: Follow-up visit – 3 months following last treatment ............................................................................ 20 
8.5 
Table 1 – Clinical Evaluation Measurements and Tools ................................................................................... 21 
9. 
ADVERSE EVENTS REPORTING ......................................................................................21 
9.1 
Definitions ........................................................................................................................................................ 21 
9.2 
Anticipated Adverse Events in this Clinical Evaluation ..................................................................................... 22 

 
Safety and Efficacy of Trim II for Non-invasive Lipolysis and Circumference 
Reduction of Abdomen. 
Protocol No: DO609924A   SIRB ID: 8659  Rev. Date:  Jun 3 2022 
 
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9.3 
Precautions to Minimize Complications ........................................................................................................... 23 
9.4 
Investigator Records ......................................................................................................................................... 23 
9.5 
Investigator Reporting of AEs ........................................................................................................................... 23 
10. 
REGULATORY ASPECTS ..............................................................................................24 
10.1 
Institutional Review Board ........................................................................................................................... 24 
10.2 
Informed Consent ........................................................................................................................................ 24 
10.3 
Protocol and Informed Consent Changes .................................................................................................... 24 
10.4 
Product Supply and Maintenance ................................................................................................................ 24 
10.5 
Privacy of Personal Data .............................................................................................................................. 25 
10.6 
Confidentiality Statement ............................................................................................................................ 25 
11. 
DOCUMENTATION .........................................................................................................25 
11.1 
Case Report Forms (CRFs) ............................................................................................................................ 25 
11.2 
Maintenance and Retention of Records ...................................................................................................... 25 
11.3 
Reports ......................................................................................................................................................... 26 
12. 
MONITORING PLAN .......................................................................................................26 
12.1 
General Considerations ............................................................................................................................... 26 
12.2 
On-Site Visits ................................................................................................................................................ 26 
12.3 
Site Initiation Meeting ................................................................................................................................. 27 
12.4 
Adverse Event Reporting and Follow-up ..................................................................................................... 27 
12.5 
Site Closure Visit .......................................................................................................................................... 27 
13. 
RISK/BENEFIT ANALYSIS .............................................................................................27 
13.1 
Expected Risks: ............................................................................................................................................ 27 
13.2 
Expected Benefits: ....................................................................................................................................... 27 
13.3 
Conclusion: .................................................................................................................................................. 28 
14. 
DATA ANALYSIS ............................................................................................................28 
14.1 
Analysis Sets ................................................................................................................................................. 28 

 
Safety and Efficacy of Trim II for Non-invasive Lipolysis and Circumference 
Reduction of Abdomen. 
Protocol No: DO609924A   SIRB ID: 8659  Rev. Date:  Jun 3 2022 
 
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14.2 
Statistical Analysis ........................................................................................................................................ 28 
15. 
DATA MANAGEMENT PLAN .........................................................................................28 
16. 
REFERENCES ................................................................................................................28 
17. 
INVESTIGATOR STUDY ACKNOWLEDGMENT ............................................................29 
APPENDIX 1.0: TIME AND EVENTS SCHEDULE......................................................................30 
APPENDIX 2.0.  MEASURING FAT THICKNESS AT THE TREATED AREA USING 
ULTRASOUND IMAGING (USI) DEVICE ....................................................................................31 
APPENDIX 3.0: PHOTOGRAPHY ..............................................................................................32 
APPENDIX 4.0: CIRCUMFERENCE MEASUREMENTS ............................................................33 
APPENDIX 5.0: SCALES ............................................................................................................35 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Safety and Efficacy of Trim II for Non-invasive Lipolysis and Circumference 
Reduction of Abdomen. 
Protocol No: DO609924A   SIRB ID: 8659  Rev. Date:  Jun 3 2022 
 
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2. Introduction & Study Rationale  
Unwanted excess fat is a common medical and aesthetic concern.  Surgical interventions may yield 
definitive results of fat reduction and body contouring, however invasive modalities require long recovery 
time and may be associated with significant risks.   
A variety of non-invasive body treatments are available for medical aesthetic indications such as 
circumference reduction and fat lipolysis. These include devices based on optical energy such as lasers and 
Intense Pulsed Light (IPL), devices based on ultrasound technologies, radiofrequency (RF), Cryolipolysis, 
suction- massage, or combined technologies.      
 
Non-invasive modification of the adipocyte by the various energies involves one of several mechanisms such 
as thermal augmentation of normal fat metabolic pathways, thermal destruction, cavitational destruction, 
or creation of a temporary adipocyte cell membrane pore1. As a non-invasive option, these technologies 
have been developed to reduce cellulite and body circumference with minimal recovery time and risks2.   
Through these mechanisms, the final result is that the sizes of the adipocytes are either temporarily or 
permanently reduced and/or the number of adipocytes is reduced, which will result in a measurable 
reduction of fat and circumference of the treated area. 
 
RF technology for fat related indications is vastly used and clinically studied. RF delivers a thermal stimulus 
to the skin and subcutaneous adipose tissue causing neocollagenesis and thickening of the dermis and 
enhancement of lipolysis - fat cell metabolism, resulting in reduction of adipose tissue volume and 
circumferences3.  
 
Electrical muscle stimulation (EMS) also known as Neuromuscular Electrical Stimulation (NMES), or 
“electromyostimulation”, is the application of current to elicit a muscle contraction. There are a few 
studies that investigate the effect of NMES on abdominal muscles4-7. Alon and colleagues5-7 found that 
NMES applied to the abdominal musculature was well tolerated and strengthened muscles by about 14% 
to 22%.  
The Trim II combines Bi-polar RF and EMS energies alternated via a touch screen, in a hands-free 
applicator composed of 4 units.  
The current prospective study is intended to evaluate the safety and efficacy of the Trim II   device for 
non-invasive lipolysis and circumference reduction of the abdomen. 
3. Definitions, Acronyms and Abbreviations  
RF -  
Radiofrequency 
IPL – Intense Pulsed Light 
EMS -    Electrical Muscle Stimulation 

 
Safety and Efficacy of Trim II for Non-invasive Lipolysis and Circumference 
Reduction of Abdomen. 
Protocol No: DO609924A   SIRB ID: 8659  Rev. Date:  Jun 3 2022 
 
13 
 
NMES - Neuromuscular Electrical Stimulation  
USI – Ultrasound Imaging 
AE - 
Adverse Events 
SAEs -  Serious Adverse Events  
UADEs - Unanticipated Adverse Device Effects 
ICF – Informed Consent Form 
CRF- Case Report Form 
4. Device Description 
The Trim II applicator is a hands-free medical aesthetic device applying combined bi-polar RF energy and 
muscle activation. 
The non invasive bi-polar RF treatment is targeting the dermal and subdermal tissues. The EMS repeatedly 
contracts muscles by passing electrical currents through electrodes contacting the treated body area.  
The RF and EMS energies are applied automatically in alternating manner to the treatment area during 
the same treatment session. The application is controlled by software. The TRIM II device includes a belt 
and 4 applicator units, which contain RF and EMS emitting electrodes.   
Each unit has electrodes and a cable connected to the system. Figure 1 demonstrates the TRIM II 
applicator unit.  
 
Figure 1. TRIM II applicator 
Each applicator comprises the following parts:  

 
Safety and Efficacy of Trim II for Non-invasive Lipolysis and Circumference 
Reduction of Abdomen. 
Protocol No: DO609924A   SIRB ID: 8659  Rev. Date:  Jun 3 2022 
 
14 
 
Pulse generator 
Generates bi-phasic electrical pulses with controlled intensity and 
structure 
Electrodes 
EMS pulses delivered between electrodes 1, 2, 3 having one 
polarity and electrodes 4, 5, 6 have another polarity 
RF energy is delivered between electrodes 1-6 having one polarity 
and electrodes 7-9 having opposite polarity. 
 Each electrode has embedded temperature sensor. 
Connector 
Connector 10 connects the applicator to the cable 
 
Trim II hands-free applicator units are applied to the abdominal area using a single-use adjustable belt set. 
The belts enable an easy and comfortable setting of the applicator units onto the patient skin. 
The System provides individual adjustment of RF and EMS intensity level to achieve maximum efficacy, 
safety and comfort for each patient. The System provides enhanced safety while minimizing possible side 
effects by constantly monitoring RF parameters. 
Another safety feature is a hand-held switch (Figure 2) that interrupts the treatment process and switches 
the system to pause state until the operator re-enables it. The patient can use the hand-held switch to 
pause the treatment if the discomfort becomes excessive. 
5. Study Objectives 
The Primary Objective of this trial is to evaluate the safety and efficacy of the Trim II treatment for 
lipolysis and abdominal circumference reduction.  
6. Study Endpoints 
6.1 Primary Endpoints 
• 
Efficacy of the Trim II treatment for lipolysis and abdominal circumference reduction. 
Evaluation of change in abdomen circumference using tape measurements in cm at the 3 months 
follow-up visit comparing to baseline.  
Success criteria: Statistically significant reduction in abdominal circumference tape measurements at 
the 3 months follow-up visit compared to baseline. 
* 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. 
  

 
Safety and Efficacy of Trim II for Non-invasive Lipolysis and Circumference 
Reduction of Abdomen. 
Protocol No: DO609924A   SIRB ID: 8659  Rev. Date:  Jun 3 2022 
 
15 
 
• 
Safety of the Trim II treatment for lipolysis and abdominal circumference reduction.  
The occurrence of adverse events will be followed throughout the whole study. Observation, 
assessment and recording of potential reactions by the investigator. 
Evaluations will be done immediately after each treatment and at the follow-up visits. The frequency, 
severity and causality of reactions will be recorded. 
6.2 Secondary Endpoints 
• 
Efficacy of the Trim II treatment for fat and circumference reduction in abdomen, as assessed by two 
blinded evaluators. Evaluation of photographs at baseline and 3 months follow-up. 
Success criteria: Correct identification of baseline and 3-month follow-up visit photographs in at least 
70% of treated subjects by two blinded evaluators. 
• 
Change in abdominal fat thickness measured by ultrasound imaging (USI) at the 3 months follow-up 
visit comparing to baseline. 
Success criteria: statistically significant change in fat thickness measurements at the 3 months follow-
up visit compared to baseline. 
• 
Evaluation of change in histological samples at 3 months follow-up visit comparing to baseline. 
Success Criteria: Effect on fat tissue with no adverse effect in dermal tissue  
• 
Subject's satisfaction with study treatment at 3 months follow-up visit.  
Subject's satisfaction with the therapy results evaluated through the Subject Satisfaction 
Questionnaire (5-point scale) as follows: +2 = Very satisfied; +1 = Satisfied; 0 = Indifferent; -1 = 
Disappointed; -2 = Very disappointed. 
• 
Therapy comfort during the study treatment.  
Subjects will be asked to classify skin reactions (subjective evaluation) and will rate discomfort using 
visual analog pain scale from 0 (no pain) to 10 (intolerable pain) immediately after each treatment 
session. 
7. Study Population 
7.1 General Considerations 
The study will recruit at least 70 female and male subjects aged 18-70 of skin seeking non-invasive lipolysis 
and circumference reduction, in 5 sites.  
Treatment area: abdomen 
Eligible subjects will be screened. Investigators will screen subjects based on the inclusion/exclusion 
criteria described below after a written informed consent is signed. 
7.2 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 

 
Safety and Efficacy of Trim II for Non-invasive Lipolysis and Circumference 
Reduction of Abdomen. 
Protocol No: DO609924A   SIRB ID: 8659  Rev. Date:  Jun 3 2022 
 
16 
 
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 that at least 70 subjects have completed the study.  Subjects who fail to 
complete the treatment will be replaced and will not be evaluable. 
7.3 Subject Identification 
A unique subject identification code will be assigned when an individual subject is qualified for enrolment. 
Subject identification details will be coded using subject’s initials, site number and subject case number. 
Subject initials will be composed of the first letter of given name, first letter of middle name and first 
letter of family name (for example, ADS for Adam Daniel Smith) and a three-digit sequential number. The 
investigator will complete subject identification on a confidential site log, which will be used for the 
purposes of traceability. 
An example is provided below: 
ADS 101 
In any case, other identification details (i.e. full names, phone numbers, etc,) will not be filled in any way 
in the Case Report Files. The identification log will be kept in the study file only. 
7.4 Inclusion Criteria 
- 
Female and male subjects, aged 18-70.  
- 
BMI≤ 30. 
- 
Subjects seeking non-invasive lipolysis and circumference reduction of abdomen 
- 
Female should not be pregnant or lactating and must be either post-menopausal, surgically sterilized, 
or using a medically acceptable form of birth control at least 3 months prior to enrolment (i.e., oral 
contraceptives, contraceptive implant, barrier methods with spermicide or abstinence). 
- 
In addition, negative urine pregnancy test as tested before each treatment and at the last visit for 
women with childbearing potential (e.g. not menopause). 
- 
General good health confirmed by medical history and skin examination of the treated area. 
- 
The subjects should understand the information provided about the investigative nature of the 
treatment, possible benefits and side effects, and sign the Informed Consent Form, including 
permission to use photography. 
- 
The subjects should be willing to comply with the study procedure and schedule, including the follow 
up visits, and will refrain from using any other abdominal treatment methods during the entire study 
period. 
7.5 Exclusion criteria 
- 
Active electrical implant/device in any region of the body, including pacemaker or internal defibrillator  
- 
Permanent implant in the treated area such as metal plates, screws or silicon, metal piercing or other. 

 
Safety and Efficacy of Trim II for Non-invasive Lipolysis and Circumference 
Reduction of Abdomen. 
Protocol No: DO609924A   SIRB ID: 8659  Rev. Date:  Jun 3 2022 
 
17 
 
- 
Current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant 
moles. 
- 
Severe concurrent conditions, such as cardiac disorders, sensory disturbances, epilepsy, uncontrolled 
hypertension, and liver or kidney diseases.  
- 
History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin. 
- 
History of bleeding coagulopathies or use of anticoagulants except for low-dose aspirin. 
- 
Patients with history of diseases stimulated by heat, such as recurrent Herpes Simplex in the 
treatment area, may be treated only following a prophylactic regimen. 
- 
Impaired immune system due to immunosuppressive diseases such as AIDS and HIV or use of 
immunosuppressive medications.  
- 
Pregnancy and nursing. 
- 
Poorly controlled endocrine disorders, such as Diabetes, or thyroid dysfunction and hormonal 
virilization. 
- 
Isotretinoin (Accutane) within last 6 months. 
- 
Any active condition in the treatment area, such as sores, Psoriasis, eczema, and rash, open 
lacerations, abrasions or lesions, infection in the area to be treated. 
- 
Any surgical procedure in the treatment area within the last 12 months or before complete healing.  
- 
As per the practitioner's discretion, refrain from treating any condition which might make it unsafe for 
the patient 
- 
Participated in another investigational drug or device study or have completed the follow-up phase for 
any previous study less than 30 days prior to the first evaluation in this study. 
8. Study Procedures 
Each subject will undergo at least 5 study visits including: screening, 3 treatments and 2 follow-up visits.  
Duration of each treatment visit is approximatly 2 hours. 
 
The Time and Events Schedule is provided in Appendix 1.0.  
8.1 Visit 1: Screening, baseline and 1st treatment 
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 RF and EMS technologies 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.  
- 
Having received treatment with light, laser, RF, or other devices in the treated area within 2-3 weeks 
for non-ablative procedures, and 6-12 weeks for ablative fractional laser resurfacing (according to 
treatment severity) prior to treatment, except special recommendations.  
- 
Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g., ibuprofen-containing agents) one week 
before and after each treatment session, as per the practitioner’s discretion. 

 
Safety and Efficacy of Trim II for Non-invasive Lipolysis and Circumference 
Reduction of Abdomen. 
Protocol No: DO609924A   SIRB ID: 8659  Rev. Date:  Jun 3 2022 
 
18 
 
The subject will review the informed consent form and the study will be explained to the subject including 
risks, potential benefits, procedures, visit requirements, and other alternative treatment options. If the 
subject qualifies and wishes to participate, he/she 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. Subjects will 
then be screened for study eligibility according to inclusion and exclusion criteria. 
The following Demographic and Baseline Measurements will be performed: 
Screening: 
- 
Demographic data including gender, age, race, skin type (Fitzpatrick scale). 
- 
ICF - Prior to any study procedures, informed consent will be obtained.  When the subject fully 
understands the possible benefits and risks of the study, the subject will be asked to sign and date the 
informed consent form (ICF).  The subject will be given a copy of the signed ICF. 
- 
Subject ID - subjects will be assigned a study subject ID number.  
- 
Medical History - A medical history will be obtained to determine if the subject meets the study 
criteria, including a list of all prescribed and over the counter medications taken within the previous 6 
months will be recorded.   
- 
Pregnancy Screen - Subjects who are capable of becoming pregnant will undergo a urine pregnancy 
test. This will be repeated prior to all treatments, and at the end of the study (last FU visit, 3-month 
FU).   
- 
Weight and hight (BMI calculation)  
- 
Pregnancy Urine Test prior to the treatment  
 
Baseline: 
 
- 
Baseline abdominal fat thickness measured by ultrasound. Appendix 2.0 
- 
Baseline photographs of treatment area - Photography – Baseline photographs will be obtained using 
a consistent camera and subject placement settings with a digital imaging system. Appendix 3.0 
- 
Baseline circumference tape measurement. Appendix 4.0 
- 
Baseline caliper measurement 
- 
Baseline histologies (8 subjects – at selected sites).  
 
Treatment:  
- 
1st abdominal treatment will be done using the TRIM II hands-free applicators belt according to IFU  
- 
Subject Comfort Assessment  
- 
*  Treatment may occur on the same day of screening or within 3 weeks following screening. 
- 
If the Screening and Treatment procedures are not conducted on the same day, the urine pregnancy 
test will be repeated on the first treatment day. 
 
Treatment procedure:  
• 
Treatment will be conducted according to instructions in the operator manual and company 
guidelines. 

 
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• 
Place the patient in the position, that the treatment area is fully accessible and treatment can be 
easily performed. 
• 
Remove any jewellery in the area of the application site. 
• 
Ensure that the subject skin in the entire treatment is clean. The skin should be cleaned with 
water and soap and long/coarse hairs in the treatment area should be shaved.   
• 
The choice of treatment settings should take into consideration not only the severity of the 
treated condition, but also the subject’s comfort. 
• 
Ensure that the skin is clean and dry. Long and dense hairs may affect the treatment and should 
be shaved according to PI discretion. 
• 
Thin layer of conductive ultrasound gel should be applied to the electrodes or to the treated area. 
• 
Belt will be used to attach the units to the treatment area.  
• 
Application of the device near the thorax may increase risk of cardiac fibrillation. 
• 
Avoid application of device over the head, eyes, across the mouth and front of neck. 
• 
The caregiver shouldn’t leave the patient unattended during treatment 
• 
The skin should be observed for excessive erythema or edema. If observed, stop the treatment 
and move to another treatment zone. 
• 
The patient can use the Hand-held switch to pause the treatment if the discomfort becomes 
excessive. Activate the treatment by entering Active mode. 
• 
Set RF power: Always start with a lower setting level (20 energy level) to check the patient’s 
tolerance to the treatment parameters. Increase the settings gradually. Check that skin 
temperature starts rising after a few cycles. 
• 
Set Cut-off temperature: Start with 40.5°-41° gradually increasing to 43° according to patient 
comfort.  
• 
EMS power level to be set according to patient tolerance, starting at 5 intensity levels. Increase 
gradually to see muscle contraction.  
• 
The longer the treatment time, the better the results. The treatment will last approximately 45-60 
minutes according to subject’s comfort.  
• 
Slight erythema and edema are a typical immediate response. However, when there is excessive 
tissue reaction, stop treatment. For excessive heat sensation, you may decrease the parameters.   
 
After treatment: 
• 
Observation, assessment and recording of adverse events will be conducted. 
• 
Subject will complete Therapy Comfort Questionnaire 
 
8.2 Visits 2-3:  2nd , 3rd treatments , every 2 weeks following previous visit 
- 
Pregnancy Urine Test prior to the treatment   
- 
Weight  and hight (BMI calculation)  
- 
Circumference tape measurement 
- 
Caliper measurement 
- 
Abdominal treatment will be done using the TRIM II hands-free applicators belt according to IFU   

 
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- 
Therapy Comfort Questionnaire 
8.3 Visit 4: Follow-up visit – 1 month following last treatment 
- 
Caliper measurement 
8.4 Visit 5: Follow-up visit – 3 months following last treatment 
- 
Treatment area will be photographed  
- 
Pregnancy Urine Test prior to the treatment   
- 
Weight and hight (BMI calculation)  
- 
Circumference tape measurement 
- 
Caliper measurement 
- 
Abdominal fat thickness measured by ultrasound 
- 
Histologies (8 subjects) 
- 
Subject's satisfaction  
 
After each treatment and at all visits, any adverse events will be recorded.   
- 
Treatment area will be photographed  
- 
Weight and hight (BMI calculation)  
- 
Circumference tape measurement 

 
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8.5 Table 1 – Clinical Evaluation Measurements and Tools  
Measurement 
When to conduct 
Method 
Height 
Baseline, Prior to every treatment and 
at follow-up’s visits 
Scale 
Weight 
Scale 
BMI 
Calculation 
Circumference  
Baseline, Prior to every treatment and 
at follow-up’s visits 
Tape Measurement (Appendix 4.0) 
Caliper 
Baseline, Prior to every treatment and 
at follow-up’s visits 
Caliper 
Photographs 
Baseline, and at follow-up’s visits 
Standardized digital photographs (Appendix 3.0) 
Urine pregnancy test 
Baseline, Prior to every treatment and 
at last follow-up visit (3 months) 
Urine pregnancy test 
Ultrasound imaging 
Baseline and last follow-up visit 
Abdominal US (Appendix 4.0) 
Histology (8 subjects) 
Baseline and last follow-up visit 
Biopsies taken from treatment areas 
Therapy Comfort  
After every treatment 
Therapy Comfort Questionnaire (Appendix 5) 
Immediate response 
assessment 
Immediately after each treatment  
Complete in CRF  
Subject satisfaction 
Last follow-up visit 
Subject Satisfaction Questionnaire (Appendix 5) 
Safety- AE 
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  
9. Adverse Events Reporting  
9.1 Definitions 
Adverse Event: 
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. 
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 

 
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• 
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 (Table 2): 
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 (Table 3): 
Most Probably Related: 
Follows a reasonable temporal sequence from study device 
delivery/retrieval and cannot be reasonably explained by known 
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 
9.2 Anticipated Adverse Events in this Clinical Evaluation 
Possible Trim II adverse effects include but are not limited by:  
• 
Pain  

 
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• 
Excessive redness (erythema) 
• 
Swelling (edema) 
• 
Muscles spasm 
• 
Treatment area infection 
• 
Skin irritation and burns beneath the electrodes have been reported with the use of pain 
• 
Skin burn 
• 
Pigmentation change 
• 
Scar 
*Erythema and edema lasting not longer than 24h is typical skin reaction to the treatment. 
*Skin irritation and burns beneath the electrodes have been reported with the use of powered muscle 
stimulators. 
 
9.3 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 above-mentioned risks. 
9.4 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 
9.5 Investigator Reporting of AEs 
The Investigator will report all serious adverse events (SAEs) to InMode Ltd by telephone as soon as becoming 
aware of them. A written follow-up report will be emailed or faxed to InMode 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 
Ltd by telephone within 24 hours. A written follow-up written report will be emailed or faxed to InMode Ltd 
within 5 working days and will include the following information: 
1. Nature of adverse effect. 

 
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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 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. 
10. Regulatory Aspects 
10.1 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, GA 30339, Toll-Free: (888) 636-1062, Phone: (770) 690-9491, Fax: (770) 690-9492 before the start 
of the study.  
10.2 Informed Consent 
An Informed Consent that includes all 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 or 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 in accordance 
with ICH E6R2 guidance. A copy of the IRB approved ICF will also be provided to the subject.  
10.3 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. 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. 
10.4 Product Supply and Maintenance  
The device will be maintained by the Sponsor, as needed. It will be supplied to the participating clinic. The 
device will be used according to the instructions of the Sponsor and manufacturer, InMode.  At the end of 

 
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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. 
10.5 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 subject 
number and study 2-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. 
10.6 Confidentiality Statement 
This document contains confidential information that must not be disclosed to anyone other than the 
Sponsor, the Investigator Team, regulatory authorities, and members of the Research Ethics Committee.   
11. Documentation 
11.1 Case Report Forms (CRFs) 
Paper case report forms will be used in this trial. All protocol-required information collected during the 
study must be entered in the appropriate field of the case report form (CRF). The investigator, or 
designated representative, should complete the appropriate CRF fields as soon as possible after 
information is collected. The information must match the information that exists as source documents in 
the clinic chart, hospital chart, and/or investigator’s files. An explanation should be given for all missing 
data. 
It is the investigator’s responsibility to assure the accurate completion, review, and approval of all CRFs 
and the timely completion and submission of all adverse event forms. 
11.2 Maintenance and Retention of Records 
Investigators will maintain all study related documentation for a period of five years following: 1) 
marketing authorization for device commercialization, or 2) sponsor’s withdrawal of submission for 
approval, or 3) completion of the study, if the investigational device is already approved for 
commercialization. 
Printouts provided on thermal paper should be immediately photocopied for long-term storage. 
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. 

 
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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. 
11.3 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. 
12. Monitoring Plan 
12.1 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 Ltd procedures detail monitoring procedures and 
monitor responsibilities.  
The study will be monitored by the sponsor periodically at the site, per Sponsor discretion.  
12.2 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. Some ‘visits’ may be performed using a video/conference call and will not be actual physical visits. 

 
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12.3 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.  Suitability of potential study subjects will also be evaluated prior to their inclusion. 
12.4 Adverse Event Reporting and Follow-up 
Monitoring of adverse events, their follow up and outcomes will take place at each study visit. 
12.5 Site Closure Visit 
A Site Closure Visit will be conducted to ensure that all used and unused investigational devices have been 
returned to the Sponsor, all relevant documentation is filed and archived under the Investigator’s 
responsibility according to regulations. 
13. Risk/Benefit Analysis  
13.1 Expected Risks: 
As indicated in section 9.2 possible Trim II applicator adverse effects include but are not limited by:  
• 
Pain  
• 
Excessive redness (erythema) 
• 
Swelling (edema) 
• 
Muscles spasm 
• 
Treatment area infection 
• 
Skin burn 
• 
Pigmentation change 
• 
Scar 
*Erythema and edema lasting not longer than 24h is typical skin reaction to the treatment. 
*Skin irritation and burns beneath the electrodes have been reported with the use of powered muscle 
stimulators. 
 
These risks are minimal when compared to other methods of lipolysis and circumference reduction that 
are being utilized (such us surgical liposuction).  
13.2 Expected Benefits:  
The expected benefit of using the Trim II is achieving the desired lipolysis and circumference reduction via 
a non-invasive technique. As previously indicated, individuals seeking body contouring are currently most 
likely to do so via liposuction. It is obvious that the low risk profile of the Trim II greatly benefits the 
individual seeking such treatments as it significantly minimizes the risks associated with the procedure.  

 
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13.3 Conclusion:  
It can therefore be claimed that the expected benefits associated with the use of the Trim II outweigh its 
risks. 
14. Data analysis  
14.1 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. 
14.2 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. 
15. Data Management Plan 
Case Report Forms and questionnaires will be retrieved by Monitors after source data verification and 
resolution of monitoring queries. Documents will be delivered to InMode Ltd onsite data management 
facility where forms will be logged in, and then data will be entered using a double entry method.  
16. References 
1. Mulholland RS, Paul MD, Chalfoun C. Noninvasive Body Contouring with Radiofrequency, Ultrasound, 
Cryolipolysis, and Low-Level Laser Therapy. Clin Plastic Surg 2011 38: 503–520. 
2. 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. 
3. Adatto MA, Adatto-Neilson RM, Morren G. Reduction in adipose tissue volume using a new high-power 
radiofrequency technology combined with infrared light and mechanical manipulation for body 
contouring. Lasers Med Sci 2014 29:1627–1631. 
4. Dalia M. Kamel, PhD, Amel M Yousif, PhD Neuromascular Electrical Stimulation and Strength Recovery 

 
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Protocol No: DO609924A   SIRB ID: 8659  Rev. Date:  Jun 3 2022 
 
29 
 
of Postnatal Diastasis Recti Abdominis Muscles. Ann Rehabil Med 2017;41(3):465-474 pISSN: 2234-
0645 • eISSN: 2234-0653  
5. Alon G, McCombe SA, Koutsantonis S, Stumphauzer LJ, Burgwin KC, Parent MM, et al. Comparison of 
the effects of electrical stimulation and exercise on abdominal musculature. J Orthop Sports Phys Ther 
1987;8:567-73 
6. Alon G, Frederickson R, Gallager L, Rehwoldt CT, Guillen M, Putnam Pement ML, et al. Electrical 
stimulation of the abdominals: the effects of three versus five weekly treatments. J Clin Electrophysiol 
1992;4:511 
7. Alon G, Taylor DJ. Electrically elicited minimal visible titanic contraction and its effect on abdominal 
muscles strength and endurance. Eur J Phys Med Rehab 1997;7:2-6 
 
17. Investigator Study Acknowledgment 
Investigator’s Statement: 
 
I have read and understand the foregoing protocol and any corresponding amendments entitled: 
“Safety and Efficacy of Trim II for Non-invasive Lipolysis and Circumference Reduction of Abdomen”, 
Study No.: DO609924A and agree to conduct the Study as outlined herein. 
 
 
Investigator’s Name (Please print) 
 
 
 
 
Investigator’s Title 
 
 
 
 
 
 
 
 
 
 
 
 
Investigator’s Signature  
 
 
 
 
 
Date 
 
 

 
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Appendix 1.0: Time and Events Schedule  
Visit type 
Procedure 
Visit 1* 
Screening 
Baseline 
Measures  
Visit 2 
Tx1 (same 
day or 
within 21 
days after 
screening) 
Visit 3 
Tx2 (14 days after 
Tx1 +/- 2 days) 
Visit 4 
Tx3 (14 days 
after Tx2 +/- 
2 days) 
Visit 5 
1 Month 
Follow-up 
(30 days 
after Tx3 +/- 
7 days) 
Visit 6 
3 Month Follow-
up 
(90 days after Tx3 
+/- 10 days) 
Medical History and 
Demographics 
 
 
 
 
 
 
Physical Exam  
 
 
 
 
 
 
Skin type 
 
 
 
 
 
 
Pregnancy Screening 
 
  
 
 
 
 
Inclusion/Exclusion 
Criteria 
 
 
 
 
 
 
Informed Consent 
 
 
 
 
 
 
Photos  
 
 
 
 
 
 
BMI/Height/Weight 
 
 
 
 
 
 
Circumference 
 
 
 
 
 
 
Caliper 
 
 
 
 
 
 
Ultrasound 
 
 
 
 
 
 
Histology-8 subjects (At 
selected sites) 
 
 
 
 
 
 
Treatment 
 
 
 
 
 
 
Subject’s Comfort  
 
 
 
 
 
 
Subject’s Satisfaction  
 
 
 
 
 
 
Skin response and AE 
 
 
 
 
 
 
Concomitant Medication 
 
 
 
 
 
 
Study End 
 
 
 
 
 
 
* Screening and 1st treatment may occur on the same day and up to 3 weeks interval 
 

 
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Appendix 2.0.  Measuring Fat Thickness at the Treated Area using Ultrasound 
Imaging (USI) Device  
 
• 
At screening visit, the therapist will mark the rectangle of the treatment area according to the 
applicators setting with white pencil. 
• 
Two US measurement points will be selected and images will be captured (according to the 
applicators positioning) 
• 
A transparency will be created at baseline for each patient, with treated area, identification marks 
(umbilicus, spots/moles) and the measurements points marked, to ensure USI of the same point at 
baseline and FU visit. 
• 
US probe should be applied to measure abdominal subcutaneous fat in the area of the two 
measurement points (identified according to the transparency).  
• 
Each measurement of fat later thickness should be repeated 2 times and an average value will be 
recorded. 
 

 
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Appendix 3.0: Photography 
At each of the specified time points; photographs of the treated areas should be taken by investigator or 
their designee. 
• 
Photographs should be taken in a private room or area of the clinic under controlled conditions, 
including the distance from the camera to the subject, height of the camera, background, camera 
positioning, subject's positioning and lighting in order to achieve high-quality before & after sets. 
• 
Consistent lighting- Lighting should be preferably projected from about 45º angle in order to 
emphasize the treatment area appearance. 
• 
For consistency purposes, the same person should ideally take all study photographs. 
• 
The digital files should follow a consistent standard naming scheme containing subject initials and 
study ID #, visit or visit date. 
Specific photography details: 
Area: Abdomen:  
Five photographs should be taken at each specified time point 
• 
Front 
• 
45º from the right side  
• 
90º from the right side 
• 
45º from the left side  
• 
90º from the left side 
The subject’s arms should remain out of the way; it is best to either cross them over each other in front of 
the chest or hold them up at a 90° angle to the body, ensuring that they do not rest on the chest or touch 
the body and that they do not cast a shadow in the photograph. 
 

 
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Appendix 4.0: Circumference Measurements  
The following steps are necessary to achieve consistent measurements:  
• 
The measurement tape should be parallel to the floor during the measurement  
• 
Prior to circumference measurement, mark the area to be treated in order to perform the 
measurements within the defined area for treatment. The area to be measured must be at 
height that includes the area to be treated.  
• 
Baseline measurement should be taken at the level of the widest part of area (most 
protruding convexity) – horizontal midline. This height level should be recorded for follow 
up assessments. Two additional measurements will be taken at 2 inches/5cm above this 
baseline and 2 inches/5 cm below it.  
• 
The consecutive measurements should be performed at the same height recorded at 
enrollment. In order to assure that measuring tape is parallel to the floor, several reference 
points should be marked around the treatment area and the measuring tape should be 
placed such that it is aligned with them.  
• 
The tape should be placed under the reference points in order to maintain repetitive height 
of the measurement  
• 
The measurement device should be placed at a constant tension to achieve an exact 
measurement of the circumference  
• 
The same trained evaluator will preferably perform the circumference measurement to 
avoid bias in results. In case that evaluator is not available, another trained person will 
perform the procedure.  
The circumference measurement: 
• 
Position the subject next to a fixed height measuring device. Such a device could be a 
wooden/metal measurement stick, fixed perpendicular to the floor. 
• 
Alternatively, a medical height measuring device will be employed.  
• 
The height reference line should be at the widest part of the marked treatment area 
(horizontal mid-line).  
• 
This height should be kept as the reference in the follow up throughout all measurements 
of the same treatment area. 
• 
In order to ensure a reproducible posture, position the subject as close as possible to the 
measurement stick. 
• 
Arms will be crossed over the chest with hands placed in the opposite axillae. The head will 
be held up with eyes level and looking straight ahead. 

 
Safety and Efficacy of Trim II for Non-invasive Lipolysis and Circumference 
Reduction of Abdomen. 
Protocol No: DO609924A   SIRB ID: 8659  Rev. Date:  Jun 3 2022 
 
34 
 
• 
Have the subject rotate slowly to produce the height reference line. This line should be 
marked on the skin as the subject rotates. Make sure that the height reference points cover 
the entire length of the circumference, at front, back and two sides.  
• 
In the subject file, record the height of the horizontal mid-line of the treatment area (the 
distance from the floor). This will enable the operator to re-measure the subject at the same 
height in the follow up visits for the evaluation of the change in the circumference. 
• 
Place the measurement tape at the widest part of the marked area. The measurement tape 
should be placed below the reference line. 
• 
Record the measured circumference in the subject file 
• 
Measure circumference at 2 inches/5 cm above the horizontal midsection of the marked 
treatment area 
• 
Measure circumference at 2 inches/5 cm below the horizontal midsection of the marked 
treatment area. 
 
 

 
Safety and Efficacy of Trim II for Non-invasive Lipolysis and Circumference 
Reduction of Abdomen. 
Protocol No: DO609924A   SIRB ID: 8659  Rev. Date:  Jun 3 2022 
 
35 
 
Appendix 5.0: Scales 
Subject Satisfaction Questionnaire  
Satisfaction Rate  
Score 
Very Satisfied 
+2 
Satisfied 
+1 
Indifferent 
0 
Disappointed  
-1 
Very Disappointed 
-2 
Subject Therapy Comfort Questionnaire 
Comfort Rate  
Score 
Very Comfortable 
+2 
Comfortable 
+1 
Indifferent 
0 
Uncomfortable 
-1 
Pain 
-2 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Safety and Efficacy of Trim II for Non-invasive Lipolysis and Circumference 
Reduction of Abdomen. 
Protocol No: DO609924A   SIRB ID: 8659  Rev. Date:  Jun 3 2022 
 
36 
 
Appendix 6.0:  Calliper  measurements 
• 
Take two measurements next to the belly button from both sides. If measurements are not the same, 
record the average  
• 
Pull out the fold of skin with the underlying layer of fat  
• 
Place the jaws of the caliper on the pulled skinfold 
• 
Release the trigger of the caliper so the entire force of the jaws is on the skinfold  
• 
Keep holding firmly the fold of skin with the fingers so that the caliper is measuring just the thickness of 
the fold of skin  
• 
When the caliper is placed on the skinfold it may move a little and slow down after a few seconds, then 
the measurement should be taken.  
• 
Note the reading on the scale before releasing any pressure off the calipers. 
• 
Maintain consistency with regards to type of caliper used, landmark site measured