Prospective Clinical Study for the Evaluation of the Efficacy and Safety of the BeShape One Device for Non-invasive Waist Circumference Reduction
Phase: NA
Conditions: Dermatological Non-Disease
Sponsor: BeShape Technologies Ltd.

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PROSPECTIVE CLINICAL STUDY FOR THE EVALUATION OF THE 
EFFICACY AND SAFETY OF THE BESHAPE ONE DEVICE FOR NON-
INVASIVE WAIST CIRCUMFERENCE REDUCTION. 
 
BeShape Technologies Ltd.  
 
Product: BeShape OneTM 
 
Protocol Number: CTP-BSO-001 
Development Phase: Clinical Validation 
Sponsor:  
BeShape Technologies Ltd. 
Hataas 20, Kfar Saba 
Israel 
Protocol Approval Date: 3-Nov-2022 
Current protocol Version: 5.1 
 
 
 
 
This clinical study will be conducted in accordance with current Good Clinical Practice (GCP) as 
directed by the provisions of the International Conference on Harmonization (ICH); Israel 
Ministry of Health; United States (US) Code of Federal Regulations (CFR) and the Sponsor’s 
Standard Operating Procedures (SOPs). 
This document contains confidential and proprietary information (including confidential 
commercial information pursuant to 21CFR§20.61) and is a confidential communication of 
BeShape Technologies Ltd. (the “Sponsor”). The recipient agrees that no information contained 
herein may be published or disclosed without written approval from the Sponsor. 
 
 
 
 
 
 

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TABLE OF CONTENTS 
TABLE OF CONTENTS .................................................................................................................................... 2 
PROTOCOL SYNOPSIS .................................................................................................................................... 4 
1 
INTRODUCTION........................................................................................................................... 8 
2 
DEVICE DESCRIPTION ............................................................................................................. 10 
2.1 
General Device Description .......................................................................................................... 10 
3 
INTENDED USE AND INDICATIONS FOR USE ..................................................................... 10 
4 
RATIONALE FOR STUDY ......................................................................................................... 10 
5 
STUDY OBJECTIVES AND ENDPOINTS ................................................................................ 11 
5.1 
Primary Endpoint .......................................................................................................................... 11 
5.2 
Secondary Endpoints ..................................................................................................................... 11 
5.3 
Exploratory Endpoint .................................................................................................................... 11 
5.4 
Safety Endpoint ............................................................................................................................. 11 
6 
SELECTION OF STUDY POPULATION ................................................................................... 11 
6.1 
Inclusion Criteria:.......................................................................................................................... 12 
6.2 
Exclusion Criteria.......................................................................................................................... 12 
6.3 
Informed Consent .......................................................................................................................... 13 
7 
STUDY DESIGN .......................................................................................................................... 13 
8 
ADMINISTRATION OF TREATMENT ..................................................................................... 13 
9 
STUDY PROCEDURES............................................................................................................... 14 
9.1 
Overview ....................................................................................................................................... 14 
9.2 
Screening ....................................................................................................................................... 14 
9.3 
Baseline ......................................................................................................................................... 15 
9.4 
Treatment ...................................................................................................................................... 15 
9.5 
Follow-Up ..................................................................................................................................... 15 
9.6 
Clinical Assessments ..................................................................................................................... 15 
9.6.1 
Patient Improvement using the Global Aesthetic Improvement Scale ........................... 15 
9.6.2 
Patient Satisfaction using a 5-point Likert Scale ............................................................ 15 
9.6.3 
Investigator Satisfaction using the Clinical Global Aesthetic Scale ............................... 15 
9.6.4 
Pain Rating Scale ........................................................................................................... 15 
9.6.5 
Abdominal Fat Thickness Measurements ....................................................................... 15 
10 
PATIENT COMPLETION / WITHDRAWAL ............................................................................. 16 
10.1 
Completion .................................................................................................................................... 16 
10.2 
Withdrawal from the study ............................................................................................................ 16 
11 
STATISTICAL CONSIDERATIONS .......................................................................................... 16 
11.1 
Study Design and Objectives ........................................................................................................ 16 
11.2 
Study Endpoints ............................................................................................................................ 16 
11.2.1 
Primary Endpoint ........................................................................................................... 16 
11.2.2 
Secondary Endpoints ...................................................................................................... 16 
11.2.3 
Exploratory Endpoint ..................................................................................................... 17 
11.2.4 
Safety Endpoints ............................................................................................................ 17 
11.3 
Statistical Hypothesis .................................................................................................................... 17 
11.4 
Sample Size Determination ........................................................................................................... 17 
11.5 
Analysis Data Sets......................................................................................................................... 17 
11.5.1 
Safety Analysis Set ......................................................................................................... 17 
11.5.2 
Full Analysis Set (FAS) ................................................................................................. 17 

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11.5.3 
Per Protocol (PP) Analysis Set ....................................................................................... 17 
11.6 
Statistical Methods ........................................................................................................................ 17 
11.6.1 
Randomization ............................................................................................................... 17 
11.6.2 
Disposition of Subjects/Data .......................................................................................... 17 
11.6.3 
Demographic and Baseline Characteristics .................................................................... 18 
11.6.4 
Efficacy Analyses ........................................................................................................... 18 
11.6.5 
Safety Analyses .............................................................................................................. 18 
12 
SAFETY, ADVERSE EVENT AND DEVICE DEFICIENCY REPORTING ............................ 18 
12.1 
Definitions ..................................................................................................................................... 18 
12.2 
Definition of Adverse Event Severity ........................................................................................... 20 
12.3 
Definition of Relationship to Investigational Device .................................................................... 20 
12.4 
Management of Adverse Events ................................................................................................... 21 
12.4.1 
Adverse Events Assessments ......................................................................................... 21 
12.4.2 
Adverse Event Documentation ....................................................................................... 21 
12.4.3 
Reporting of SAE and/or UADE .................................................................................... 21 
12.5 
Management of Device Deficiencies ............................................................................................ 21 
12.5.1 
Device Deficiency Assessment ...................................................................................... 21 
12.5.2 
Device Deficiency Documentation ................................................................................. 21 
12.5.3 
Reporting of Device Deficiencies .................................................................................. 22 
13 
RISK / BENEFIT ANALYSIS ..................................................................................................... 22 
13.1 
Risks .............................................................................................................................................. 22 
13.2 
Benefits ......................................................................................................................................... 23 
14 
ETHICAL ASPECTS .................................................................................................................... 23 
14.1 
Study-Specific Design Considerations .......................................................................................... 23 
14.2 
Regulatory Ethics Compliance ...................................................................................................... 23 
14.2.1 
Statement of Compliance ............................................................................................... 23 
14.2.2 
Investigators Responsibilities ......................................................................................... 24 
14.2.3 
Independent Ethics Committee or Institutional Review Board ...................................... 24 
14.2.4 
Informed Consent ........................................................................................................... 25 
14.2.5 
Privacy of Personal Data ................................................................................................ 25 
15 
ADMINISTRATIVE REQUIREMENTS ..................................................................................... 26 
15.1 
Protocol Amendments ................................................................................................................... 26 
15.2 
Protocol Deviations ....................................................................................................................... 26 
15.3 
Regulatory Documentation ........................................................................................................... 26 
15.3.1 
Regulatory Approval/Notification .................................................................................. 26 
15.3.2 
Required Pre-study Documentation ............................................................................... 26 
15.3.3 
Patient Identification Register and Patient Screening Log ............................................. 27 
15.3.4 
Case Report Form Completion ....................................................................................... 27 
15.3.5 
Record Retention and Storage ........................................................................................ 27 
15.3.6 
Device Accountability .................................................................................................... 28 
15.3.7 
Packaging and Labeling ................................................................................................. 28 
15.4 
Monitoring Procedures .................................................................................................................. 28 
15.5 Use of Information and Publication .............................................................................................. 29 
15.6 
Study Registration in a publicly accessible database .................................................................... 30 
APPENDIX A – TIME & EVENTS SCHEDULE 
APPENDIX B – PHOTOGRAPHY 
 

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PROTOCOL SYNOPSIS 
Protocol Number 
CTP-BSO-001 
Protocol Title 
Prospective clinical study for the evaluation of the efficacy and 
safety of BeShape One device for non-invasive waist 
circumference reduction. 
Location(s) 
2 primary care clinics in Europe and North America 
Study Design 
Open-Label, prospective, multicenter, one arm, baseline-
controlled study 
Investigational 
Product  
BeShape One 
Device Description 
The BeShape One Device is a non-invasive, high-intensity non 
focused ultrasound device intended for non-invasive waist 
circumference reduction. The device includes two treatment 
chambers which apply homogeneous, selective and uniform 
heating of the entire volume of fat cells.  
 
Study overview 
Study subjects will be consecutively screened and enrolled into 
the study.  
The study will consist of a single BeShape One treatment and a 
follow up period (12 weeks) 
Eligible subjects will receive 1 treatment with the BeShape 
One device. Treatment will take approximately 1 hour. 
Subjects will be followed for 12 weeks, FU visits occurring at 
6- and 12-weeks post treatment. 
 
Study Population 
Adult volunteers, seeking non-invasive abdominal fat and 
circumference reduction, male and females, 18 to 65 years of 
age. 
Study Objectives 
To evaluate the safety and efficacy of the BeShape One device 
for non-invasive waist circumference reduction. 
Inclusion Criteria 
1. Female and male subjects ≥18 and ≤65 years of age.  
2. Abdominal fat thickness of at least 1.5 cm.  
3. 18.5 ≤ BMI ≤ 33  
4. Women of childbearing potential (i.e., not post-menopausal 
or surgically sterilize) must have a negative urine 

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pregnancy test. Participating women of childbearing 
potential must be using a medically acceptable form of 
birth control for at least 3 months prior to enrollment. 
5. Understand the study and volunteer to sign the informed 
consent. 
6. Willing to follow the treatment and follow up schedule and 
post-treatment care instructions. 
7. Willing to refrain from a change in diet, exercise or 
medication regimen for the duration of the study.  
8. Willing to have de-identified images of the treated areas 
taken for possible use in publications and presentations. 
Exclusion Criteria 
1. Pregnant women, intending to become pregnant during the  
study, less than 12 months after delivery, breastfeeding, or  
less than 6 weeks after completing breastfeeding; 
2. Participation in a clinical study of another investigational 
device or drug involving the same anatomical site within 
the last 3 months, or, if it does not involve the same 
anatomical site, at the discretion of the researcher. 
3. Subjects with significant systemic disease, such as ongoing 
hyperlipidemia, diabetes mellitus, hepatitis or other liver 
disease, HIV-positive status, blood coagulopathy or 
excessive bleeding, autoimmune or connective tissue 
disease, and malignant neoplasms; undergoing chronic 
steroid or immunosuppressive therapy. 
4.  Subject having or undergoing any form of treatment for 
active cancer, or having a history of skin cancer or any 
other cancer in the areas to be treated, including presence 
of malignant or pre‐malignant pigmented lesions. 
5. An implanted pacemaker or any other implantable active 
device anywhere in the body. 
6. Subjects with thyroid disease and / or metabolic syndrome. 
7. Unstable weight within the last 6 months (i.e. + 3% weight 
change in the past six months). 
8. Local skin pathologies or natural structure loss in the treated 
area (hernia) and / or loss of sensation or dysesthesia in 
the treated area. 
9. Previous body contouring procedures in the treatment area 
within the past 12 months. 
10. History of abdominal surgery, including laparoscopic 
procedures. 
11. Caesarean section within 12 months. 
12. Any permanent or temporary implant in the treatment area 
such as metal plates or an injected chemical substance 

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such as silicone. 
13. Actively expressed psychiatric or psychological state. 
14. Abnormal kidney, liver or coagulation functions, 
abnormal lipid profile or blood count within the last 3 
months. 
15. Any condition that, at the researcher's discretion, renders 
the subject unsuitable for participation in a clinical 
research study. 
Duration of Study 
Up to 4 months (including screening period and two follow up 
visits at 6 and 12 weeks after the treatment)  
Primary Endpoint 
To evaluate the reduction in waist circumference following 
treatment with the BeShape One device at the final 12-week 
follow-up visit compared to baseline. 
Secondary 
Endpoints 
1. Waist circumference reduction at 6 week follow up visit 
compared to baseline 
2. Subject improvements measured independently by the 
Global Aesthetic Improvement scale at each follow up visit 
(6 wk and 12 wk). 
3. Subject satisfaction using a 5-point Likert scale at each 
follow up visit (6 wk and 12 wk).  
4. Investigator satisfaction using the Clinical Global Aesthetic 
Improvement scale at each follow up visit (6 wk and 12 
wk). 
5. Subject comfort/pain level, assessed after treatment using a 
pain scale. 
Exploratory 
Endpoints 
To evaluate the reduction in abdominal fat thickness at 6- and 
12-weeks post treatment. 
Safety Endpoint 
Number, severity and type of adverse events recorded 
throughout the study and post treatment phase (immediate and 
delayed response). 
Study Sponsor 
BeShape Technologies Ltd. 
Hataas 20, Kfar Saba 
Israel 
 

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Abbreviations 
Abbreviation 
Description 
CRF 
Case Report Form 
FDA 
US Food and Drug Administration 
GCP 
Good Clinical Practice 
BMI 
Body Mass Index 
SAT 
Subcutaneous Adipose Tissue 
US 
Ultrasound 
TD 
Transducers 
TEC 
Thermoelectric Coolers 
VAS 
Visual Analogue Scale 
AE 
Adverse Event 
SAE 
Serious Adverse Event 
HIPAA 
Health Insurance Portability and Accountability Act 
ICF 
Informed Consent Form 
IEC 
Independent Ethics Committee 
IRB 
Institutional Review Board 
PE 
Physical Examination 
PI 
Principal Investigator 
SOP 
Standard Operating Procedure 
WHO 
World Health Organization 
W 
Watt (Output Electric Power) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1 INTRODUCTION 
A growing number of people seek cosmetic solutions for the removal of excess weight. 
These solutions include surgical trends of abdominoplasties, Brachioplasty and 
liposuction procedures. The latter is used for the removal of excess fat tissues in specific 
body areas for body shaping, combined with several modifications including ultrasound 
(US) and laser (Brown SA, 2009).  Due to limitations and complications resulting in 
death, there has been a significant decrease in the performance of these procedures 
(Garcia O, 2013), and during this period, a significant number of noninvasive body 
contouring devices have been introduced to the aesthetic surgery market. Many 21st-
century aesthetic surgery patients now seek noninvasive or minimally invasive procedures 
with minimal downtime in exchange for limited aesthetic outcomes. Current nonsurgical 
procedures employ mechanical vacuum massage, lasers, radiofrequency, ultrasound, or 
low-level energy infrared light (Sasaki GH, 2014). Some of these devices may create a 
temporary effect but are unable to present any scientific or preclinical evidence (histology 
or gross pathology) of fat cell disruption. 
Currently, a significant number of noninvasive in-use devices are ultrasonic energy-
based. The use of ultrasonic energy in aesthetic body contouring, dating back to the late 
1980s, popularized the concept of ultrasound-assisted liposuction (UAL), and introduced 
the techniques to the USA in 1993 (Garcia O, 2013; Manstein D L.H., 2008). 
US used for body sculpting can be divided into two broad categories: relatively low-
frequency nonthermal ultrasound and high intensity focused thermal ultrasound. With 
nonthermal US, a low frequency is chosen to increase the likelihood of cavitation while 
generating little heat through absorption mechanisms. The high-intensity focused 
ultrasound (HIFU) can be highly focused to conﬁne the cavitation effects to the focal 
zone of the ultrasonic beam. Thermal HIFU delivers high frequency (2MHz) ultrasonic 
energy to subcutaneous tissue, producing heat capable of disrupting adipose tissue and 
thermally modifying collagen (Jewell, 2011).  
The early generations of US devices for use in body contouring were associated with 
increased complication rates, which were mostly attributed to the high ultrasonic energy 
output associated with these devices (Garcia O, 2013; Manstein D, 2008). 
The ultrasonic energy used by the LipoSonix system (Solta Medical, Inc., Hayward, CA, 
USA) is an example of High-Frequency Thermal Ultrasound, which is generated by an 
internally focused transducer and focuses the ultrasonic waves so they converge at a 
speciﬁed depth and location (Ter Haar G, 2007) at temperatures reaching 60-650C. 
Clinical trials conducted with the LipoSonix device explored its effects on waist 
circumference utilizing a standardized waist measuring technique. Results showed 
statistically significant decrease in waist circumference reduction. Safety of the device 
was also evaluated. There were no unanticipated adverse device events, and clinical 
laboratory tests did not reveal any abnormalities (Mark L. Jewell, 2011) 

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In contrast to HIFU technology, the BeShape technology makes use of high intensity non-
focused US, utilizing continuous wave (CW) ultrasonic energy to the adipose tissue at a 
temperature of 480C. There is far less information regarding the effects of non-focused 
and weakly focused US on adipose tissue and its ability to disrupt fat cells. Non-focused 
US has typically been used for US physiotherapy, where changes in cellular activity and 
cell membrane permeability have been reported (Garcia O, 2013). 
A unique feature of the BeShape OneTM is the vacuum feature. The activated vacuum 
effectively fixes the target tissue in the treated area inside the cup-shaped chamber of the 
device applicator. This tissue fixation in the applicator allows the transmission of the 
ultrasound energy parallel to the body surface, rather than perpendicular, thereby 
reducing US energy exposure to the underlying muscles and internal organs.  
An example of a device utilizing vacuum to achieve its desired affects in lipolysis 
(breakdown of fat) is the Zeltiq CoolSculpting System (Allergan + Zeltiq Aesthetics, 
Pleasanton, CA USA). It is a thermoelectric cooling and heating device using 
Cryolipolysis technology to target fat cells. Similar to BeShape's technology, the device 
includes a cup-shaped applicator with two cooling panels that is applied to the treatment 
area. The tissue is drawn into the handpiece under moderate vacuum and the selected 
temperature is modulated by thermoelectric elements and controlled by sensors that 
monitor the heat flux out of the tissue (Nils Krueger, 2014). The vacuum applicator draws 
tissue into the applicator cup and holds the tissue against the cooling surfaces of the 
applicator. Clinical findings with the Zeltiq CoolSculpting system utilizing vacuum and 
surface applicators demonstrated that use of the device safely and effectively induced 
cold-assisted lipolysis with colder temperatures down to -15°C, resulting in shorter 
duration treatment. 
The purpose of the current clinical study is to evaluate the safety and effectiveness of 
treatment with the investigational high-intensity non-focused BeShape One US device on 
waist circumference reduction. 
 
 
 
 
 
 
 
 
 
 
 
 
 

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2 DEVICE DESCRIPTION 
2.1 General Device Description 
The BeShape OneTM system consists of hardware and software, these elements are 
integrated in the BeShape OneTM console and applicator/handpiece. BeShape OneTM is 
supplied as a kit, with a console and 2 applicators. 
The console is floor-standing and portable. It is controlled by a touch screen. 
The BeShape One device applicator is a mechanical hand piece with an internal 
rectangular bathtub-shaped chamber and contains the US transducers. The applicator uses 
a vacuum during the procedure that draws adipose tissue into the inner cup-shaped 
chamber, thereby providing heating of the subcutaneous adipose tissue.  
 
3 INTENDED USE AND INDICATIONS FOR USE 
The BeShape One Device is a high-intensity non-focused ultrasound device intended 
for non-invasive waist circumference reduction in adult population. 
 
4 RATIONALE FOR STUDY 
A growing number of people seek cosmetic solutions for the removal of excess weight. 
Surgical solutions such as abdominoplasties, Brachioplasty and liposuction procedures 
are available but these include limitations and complications sometimes even resulting in 
death. Therefore, there has been a significant decrease in the performance of these 
invasive procedures (Garcia O, 2013) and nonsurgical solutions are at need. 
 
Although no nonsurgical procedure has been accepted as the gold standard as of yet, 
cryolipolysis is considered to be both safe and effective, with a high patient satisfaction 
rate of up to 73% after one treatment. This rate is comparable with that of HIFU and 
acoustic wave therapy (62.3% and 64%, respectively). However, the latter modalities are 
associated with either a higher rate of adverse events and pain or a high number of up to 
eight treatments necessary to achieve the desired effect (Nils Krueger, 2014) . 
 
The noninvasive BeShape One device offers an alternative approach for waist 
circumference reduction using a high intensity non-focused US technology. The current 
proposed study will evaluate the safety and efficacy of the BeShape One device in 
effectively reducing waist circumference in adult population.  
 
 

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5 STUDY OBJECTIVES AND ENDPOINTS 
The objective of the study is evaluating the safety and efficacy of the BeShape One 
device for non-invasive waist circumference reduction. 
 
5.1 
Primary Endpoint 
To evaluate the reduction in waist circumference following BeShape treatment at the final 
follow-up visit compared to baseline. 
 
5.2 
Secondary Endpoints 
The secondary objectives of the study are as follows: 
• Waist circumference reduction at 6 week follow up visits compared to baseline,. 
• Subject improvement as measured independently by the Global Aesthetic 
Improvement scale at each follow up visit (6 wk and 12 wk). 
• Subject satisfaction using a 5-point Likert scale at each follow up visit (6 wk and 12 
wk). 
• Investigator satisfaction using the Clinical Global Aesthetic Improvement scale at 
each follow up visit (6 wk and 12 wk). 
• Subject comfort/pain level, assessed after treatment using a pain scale. 
 
5.3 
Exploratory Endpoint 
To evaluate the reduction in abdominal fat thickness at 6- and 12-weeks post treatment. 
 
5.4 
Safety Endpoint 
Number, severity and type of adverse events recorded throughout the study and post 
treatment phase (immediate and delayed response), including skin reactions (erythema, 
edema, irritation, etc.). 
 
 
6 SELECTION OF STUDY POPULATION 
The intention is to enroll 70 patients who meet all eligibility criteria. Evaluation of the 
study participant inclusion/exclusion criteria will be based on the review of clinical 
medical records and documented patient interviews conducted by the investigator or 
under the direction of the investigator. 
 
To be enrolled in the study, patients must meet ALL of the inclusion criteria and NONE 
of the exclusion criteria designated below. 
 

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6.1 
Inclusion Criteria: 
 
1. Female and male subjects ≥18 and ≤65 years of age.  
2. Abdominal fat thickness of at least 1.5 cm.  
3. 18.5 ≤ BMI ≤ 33  
4. Women of childbearing potential (i.e., not post-menopausal or surgically sterilize) 
must have a negative urine pregnancy test. Participating women of childbearing 
potential must be using a medically acceptable form of birth control for at least 3  
months prior to enrollment. 
5. Understand the study and volunteer to sign the informed consent. 
6. Willing to follow the treatment and follow up schedule and post-treatment care 
instructions. 
7. Willing to refrain from a change in diet, exercise or medication regimen for the 
duration of the study. 
8. Willing to have de-identified images of the treated areas taken for possible use in 
publications and presentations. 
6.2 
Exclusion Criteria 
1. Pregnant women, intending to become pregnant during the study, less than 12 months  
after delivery, breastfeeding, or less than 6 weeks after completing breastfeeding; 
2. Participation in another clinical study of another investigational device or drug 
involving the same anatomical site within the last 3 months, or, if it does not involve 
the same anatomical site, at the discretion of the researcher. 
3. Subjects with significant systemic disease, such as ongoing hyperlipidemia, diabetes 
mellitus, hepatitis or other liver disease, HIV-positive status, blood coagulopathy or 
excessive bleeding, autoimmune or connective tissue disease, and malignant 
neoplasms; undergoing chronic steroid or immunosuppressive therapy. 
4. Subject having or undergoing any form of treatment for active cancer, or having a 
history of skin cancer or any other cancer in the areas to be treated, including 
presence of malignant or pre‐malignant pigmented lesions. 
5. An implanted pacemaker or any other implantable active device anywhere in the body. 
6. Subjects with thyroid disease and / or metabolic syndrome. 
7. Unstable weight within the last 6 months (i.e. + 3% weight change in the past six 
months). 
8. Local skin pathologies or natural structure loss in the treated area (hernia) and / or loss 
of sensation or dysesthesia in the treated area. 
9. Previous body contouring procedures in the treatment area within the past 12 months. 
10. History of abdominal surgery, including laparoscopic procedures. 
11. Caesarean section within 12 months. 
12. Any permanent or temporary implant in the treatment area such as metal plates or an 
injected chemical substance such as silicone. 
13. Actively expressed psychiatric or psychological state. 
14. Abnormal kidney, liver or coagulation functions, abnormal lipid profile or blood 
count within the last 3 months. 

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15. Any condition that, at the researcher's discretion, renders the subject unsuitable for 
participation in a clinical research study. 
 
6.3 
Informed Consent 
Written informed consent will be obtained from each study patient prior to enrollment 
into the study.  A written informed consent (approved by BeShape Technologies Ltd. and 
the Ethics Committee) must be signed and dated by the patient (or legally authorized 
representative, if appropriate), and the investigator.  Patients will be given a copy of the 
signed informed consent document.  The signed informed consent will be retained with 
the study records at the site. It is the responsibility of the Investigator to assure that 
informed consent is obtained from each patient in accordance with GCP guidelines. 
Subjects may withdraw their consent to participate in the study at any time without 
prejudice. The investigator may withdraw a subject if, in his clinical judgement, it is in 
the best interest of the subject or if the subject cannot comply with the protocol. 
 
7 STUDY DESIGN 
This study is a prospective, baseline controlled, multi-center, one arm clinical study 
aimed to assess the efficacy and safety of the BeShape OneTM device for waist 
circumference reduction. 
All subjects will undergo an assessment of their general health. A single treatment 
utilizing the BeShape OneTM device will be administered.  
During the follow-up period, visits will be conducted as follows: 6 weeks (6wk FU), and 
12 weeks (12wk FU) post treatment. Subject’s waist circumference will be measured at 
baseline (before treatment) and at each of the follow up visits. Circumference reduction 
will be assessed at each post baseline visit. Additionally, investigator and subject 
assessments will be completed at each follow up visit. Photography of the treatment areas 
will be performed under visible light conditions of the front, right, left and back view of 
the subjects at the baseline visit (before first treatment) and at the last follow-up visit 
(12wk FU). 
 
8 ADMINISTRATION OF TREATMENT 
Subjects will receive one treatment with the BeShape OneTM device on the anterior 
abdomen. Prior to the treatment, measurements of weight and waist circumference will be 
performed.  
Before starting the procedure using the BeShape OneTM device, the administrator should 
clean the entire treatment area with a wet wipe and hairs should be shaved. Conductive 
castor oil will be applied to the treatment areas to ensure full contact between the 
applicator and the skin. Prior to treatment, it is necessary for the operator to ensure that all 
treatment areas are in close contact with the cup-shaped applicator chamber. Following 
visual confirmation of proper contact with the tissue, the skin will be marked as a 

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treatment area using a skin marking pen. Subjects will receive treatment on at least 4 
abdomen/flanks treatment areas and up to 6 treatment areas, at the discretion of the 
investigator. During the procedure, subjects will lie in the supine position in order to 
provide the best access to the treatment area.  
Upon completion of treatment, the treated area will be freed from the applicator. The 
administrator should check for any immediate skin reaction and record any outstanding 
findings on the CRF before proceeding to the next area of treatment.  
Immediately after completion of the procedure (after all treatment areas have been 
treated), the following evaluations and measurements will be performed: 
* 
Assessment of adverse events, including any skin reaction (erythema, edema, 
irritation, etc.) or any other side effects; 
* 
Pain assessment. 
 
All findings will be recorded on the Adverse Events form.  
 
9 STUDY PROCEDURES 
9.1 
Overview 
Patient visits may occur within a + 2 days deviation from the scheduled time.  
Efficacy rating scales to be used in the study include:  
• Waist circumference measurement  
• Abdominal fat thickness measurements  
• Global Aesthetic Improvement scale (GAI) 
• Clinical Global Aesthetic Improvement scale (CGAI) 
Safety evaluations will include a pain scale and adverse event monitoring throughout the 
study. Number, severity and type of adverse events will be recorded throughout treatment 
and follow-up phases. 
9.2 
Screening 
During the first visit, the research staff will screen the subject for eligibility to participate. 
The inclusion/exclusion criteria will be reviewed, the subject’s medical history and a 
physical examination of the subject’s general health including vital signs will be 
performed. In addition, there will also be an examination of the subject’s skin in the 
treatment area.  
The subject will review the informed consent form and the study will be explained to the 
subject including all risks, potential benefits, procedures, visit requirements, and other 
alternative treatment options. If the subject qualifies and wishes to participate, they will 
complete the ICF with a signature and date. The original will be retained with subject’s 
records and a copy will be provided to the subject.  

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9.3 
Baseline 
Baseline assessments will include height, weight and waist circumference measurements 
and obtaining photographs of the treatment area.  
 
9.4 
Treatment 
A single treatment will be administered at the baseline visit, following completion of 
baseline measurements and photographs. Clinical and safety assessments will be 
administered prior to and following the treatment. 
 
9.5 
Follow-Up 
Follow up visits will occur 6- and 12-weeks post treatment. Clinical and safety 
assessments will be performed at each of the follow up visits. 
 
9.6 
Clinical Assessments 
 
9.6.1 
Patient Improvement using the Global Aesthetic Improvement Scale 
Patient improvement assessment will be performed independently by the subject using 
pre-defined scale questionnaire. The subjects will answer this questionnaire at each 
follow-up visit (6wk FU, and 12wk FU). 
 
9.6.2 
Patient Satisfaction using a 5-point Likert Scale 
Patient satisfaction assessment will be performed independently by the subject using pre-
defined scale questionnaire. The subjects will answer this questionnaire at each follow-up 
visit (6wk FU, and 12wk FU). 
 
9.6.3 
Investigator Satisfaction using the Clinical Global Aesthetic Scale 
Satisfaction assessment will be performed by the study investigator using a pre-defined 
scale questionnaire. The investigator will answer this questionnaire at each follow-up visit 
(6wk FU, and 12wk FU)  
 
9.6.4 
Pain Rating Scale 
The subjects will rate their pain at the treatment visit.  
 
9.6.5 
Abdominal Fat Thickness Measurements 
Abdominal fat thickness will be assessed at the treatment area prior to starting the 
treatment and following the treatment.  
 

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10 PATIENT COMPLETION / WITHDRAWAL 
10.1 
Completion 
A subject will be considered to have completed the study if the they complete the 
treatment as well as both follow up visits. 
 
10.2 
Withdrawal from the study 
A subject will be withdrawn from the study for any of the following reasons: 
• Withdrawal of consent  
• Subject is not compliant with requirements of the study, including inclusion and 
exclusion criteria. 
• The investigator believes that for safety reasons (e.g. an adverse event) it is in the 
best interest of the patient to stop the study. 
• The study is prematurely stopped or halted (e.g. clinical halt) 
Subjects enrolled in the study can discontinue their participation at any time for any 
reason without prejudice or reduction in the quality of their medical care. The 
investigators or sponsor can terminate a subject's participation in this study to protect the 
subject's health or if the subject fails to follow directions resulting in noncompliance to 
study procedures. Subjects who fail to complete the study will be replaced and will not be 
considered evaluable. 
 
11 STATISTICAL CONSIDERATIONS 
11.1 Study Design and Objectives 
This study is a prospective, baseline controlled, multi-center, one arm study.  The purpose 
of this study is to evaluate the performance and safety of the BeShape One device for 
waist circumference reduction. 
11.2 Study Endpoints 
11.2.1 
Primary Endpoint 
The primary endpoint is the change from baseline to 12 weeks after treatment in waist 
circumference. 
11.2.2 
Secondary Endpoints 
The secondary endpoints are 
• Change from baseline to 6 weeks after treatment in waist circumference. 
• Global Aesthetic Improvement scale at 6 weeks and 12 weeks following treatment 
measuring subject rated improvement. 
• Satisfaction scale at 6 weeks and 12 weeks following treatment measuring subject 
rated satisfaction. 
• Clinical Global Aesthetic Improvement scale at 6 weeks and 12 weeks following 
treatment measuring investigator rated improvement. 
• Pain score after treatment measuring subject comfort/pain level. 

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11.2.3 
Exploratory Endpoint 
Change from baseline to 6 weeks and 12 weeks after treatment of abdominal fat thicknes. 
11.2.4 
Safety Endpoints 
The incidence, severity and type of adverse events recorded throughout the study and post 
treatment phase, including skin reactions (erythema, edema, irritation, etc.). 
Safety will also be assessed with vital signs. 
11.3 Statistical Hypothesis 
The null hypothesis of this study is that there is no difference between the mean decrease 
from baseline of waist circumference 12 weeks after treatment. 
The alternative hypothesis is that there is a difference in the mean decrease from baseline 
of waist circumference 12 weeks after treatment. 
  
11.4 Sample Size Determination 
A total samples size of 70 subjects should be enrolled into the study. 
 
11.5 Analysis Data Sets 
11.5.1 
Safety Analysis Set 
All subjects who received treatment will be included in the safety analysis set. The safety 
analysis set will be used for the summary and analyses of all safety endpoints. 
11.5.2 
Full Analysis Set (FAS) 
The full analysis set (FAS) includes all eligible subjects who are enrolled in the study, 
received treatment and have at least one post treatment waist circumference measurement.  
The FAS will be used for the summary and analyses of the primary, secondary and 
exploratory endpoints. 
11.5.3 
Per Protocol (PP) Analysis Set 
The per protocol (PP) analysis set will consist of all subjects from the FAS without any 
major protocol violations.  The PP analysis set will be used for a sensitivity analysis of 
the primary endpoint. 
11.6 Statistical Methods 
11.6.1 
Randomization 
This is a one arm study thus no randomization will be performed. 
11.6.2 
Disposition of Subjects/Data 
The numbers of subjects who were enrolled will be provided. A list of discontinued 
subjects together with the reasons for discontinuation will be presented. 

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11.6.3 
Demographic and Baseline Characteristics 
Demographic and baseline characteristics including age, gender, race, ethnicity, height, 
weight and BMI will be tabulated. Continuous variables will be summarized by a mean, 
standard deviation, minimum, median and maximum, and categorical variables by a count 
and percentage.  
11.6.4 
Efficacy Analyses 
All efficacy analyses will be performed on the FAS.  All efficacy endpoints will be listed 
by subject and presented descriptively. 
11.6.5 
Safety Analyses 
All safety analyses will be performed on the Safety Analysis Population.  The safety 
assessment will be based on the incidence, severity and relationship to treatment of the 
adverse events. 
All Serious Adverse Events (SAEs) will be listed and discussed on a subject-by-subject 
basis. 
Vital signs will be presented descriptively by visit.   
 
12 SAFETY, ADVERSE EVENT AND DEVICE DEFICIENCY REPORTING 
Timely, accurate, and complete reporting and analysis of safety information from clinical 
studies are crucial for the protection of subjects, investigators, and the sponsor and are 
mandated by regulatory agencies worldwide. The sponsor has established Standard 
Operating Procedures (SOPs) in conformity with regulatory requirements worldwide to 
ensure appropriate reporting of safety information. All clinical studies conducted by the 
sponsor or of its affiliates will be conducted in accordance with those procedures. 
 
12.1 
Definitions 
The definitions provided below are in compliance with ISO 14155 (2020-07 third edition) 
and 21 CFR 812.3  
• Adverse Event (AE) 
An adverse event is any untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs in subjects, users or other persons, whether or not related to the 
investigational medical device and whether anticipated or unanticipated.   
This definition includes any occurrence that is new in onset or aggravated in severity or 
frequency from the baseline condition, or abnormal results of diagnostic procedures, 
including laboratory test abnormalities. 
This definition also includes events related to the control and to the procedures involved. 
Note: The sponsor collects adverse events starting with the signing of the informed 
consent. 
 

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• Adverse Device Effect (ADE) 
An adverse event related to the use of an investigational medical device. 
This definition includes adverse events resulting from insufficient or inadequate 
instructions for use, deployment, implantation, installation or operation or any 
malfunction of the investigational device.  
This definition includes any event resulting from use error or from intentional misuse of 
the investigational device.  
• Serious Adverse Event (SAE) 
An adverse event that led to any of the following: 
o 
death  
o 
serious deterioration in the health of the subject, users or other persons as 
defined by one or more of the following:  
o a life-threatening illness or injury or a permanent impairment of a body 
structure or  
o a body function including chronic diseases or  
o in-patient or prolonged hospitalization or  
o medical or surgical intervention to prevent life-threatening illness or injury 
or permanent impairment to a body structure or function 
o 
foetal distress, foetal death, a congenital abnormality, or birth defect including  
physical or mental impairment 
Note: Medical and scientific judgment should be exercised in deciding whether expedited 
reporting is also appropriate in situations other than those listed above. For example, 
important medical events may not be immediately life threatening or result in death or 
hospitalization but may jeopardize the subject or may require intervention to prevent one 
of the outcomes listed in the definition above. Any adverse event is considered a serious 
adverse event if it is associated with clinical signs or symptoms judged by the investigator 
to have a significant clinical impact. 
• Serious Adverse Device Effect (SADE) 
An adverse device effect (ADE) that has resulted in a ny of the consequences 
characteristic of a serious device event (SAE). 
• Unanticipated Serious Adverse Device Effect (USADE) 
A serious adverse device effect (SADE) which by its nature, incidence, severity or 
outcome has not been identified in the current version of the risk assessment. 
Note: Anticipated serious adverse device effect (ASADE) is an effect which by its nature, 
incidence, severity or outcome has been identified in the current version of the risk 
assessment. 
• Device Deficiency (DD) 
Inadequacy of a medical device with respect to its identity, quality, durability, reliability, 
usability, safety and performance.  

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This definition includes malfunctions, use errors and inadequacy in the information 
supplied by the manufacturer including labeling.  
This definition includes device deficiencies related to the investigational device or 
control. 
 
12.2 
Definition of Adverse Event Severity 
For all adverse events, the severity of the adverse event will be determined by the 
investigator, using the following terms: 
• Mild 
A mild adverse event is one in which the subject is aware of the event, but it is easily 
tolerated without intervention.  
• Moderate  
A moderate adverse event is one that causes sufficient discomfort to interfere with usual 
activities. 
• Severe  
A severe adverse event is one that results in the inability to perform usual activities. 
 
12.3 
Definition of Relationship to Investigational Device 
For all adverse events, the relationship to study device and/or procedure will be 
determined by the investigator, using the following terms: 
• Probably related: 
Follows a reasonable temporal sequence from study device delivery / retrieval, and 
cannot be reasonably explained by known characteristics of the patient’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 patient’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. 
• Not related:   
No relationship to study device activation is perceived. 
 

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12.4 
Management of Adverse Events 
12.4.1 
Adverse Events Assessments 
Should the subject experience an adverse event, an assessment of the situation will be 
initiated by the study staff, the PI will be notified and appropriate course of action will be 
determined. The sponsor will be contacted as appropriate. The AE will be documented 
and reported per the sponsor SOPs, IRB and regulation requirements. 
12.4.2 
Adverse Event Documentation 
The adverse event will be recorded in the Case Report Forms and will include the 
following information: 
• Type of effect (AE, ADE, SAE, UADE, ASADE, SADE) 
• Date of onset and resolution 
• Severity 
• Seriousness (yes/no) 
• Relationship to device/procedure 
• Anticipated (yes/no) 
• Treatment given and/or action taken 
12.4.3 
Reporting of SAE and/or UADE 
All SAE's, SADE, ASADE and UADE will be reported in writing to the PI, sponsor and 
IRB within 72 hours of knowledge of the event.  
If the event resulted in death of a subject, the event will be reported to the PI, sponsor and 
IRB within 24 hours of knowledge of the event.  
In case of an UADE, the sponsor will immediately conduct an evaluation. The results of 
the evaluation will be reported to the regulatory authorities, IRB and PI within 10 days 
after the sponsor first receives notice of the effect. 
 
12.5 
Management of Device Deficiencies 
12.5.1 
Device Deficiency Assessment 
All DD of an investigational device will be documented throughout the study and 
managed by the sponsor in accordance with written SOPs for the control of a non-
conforming product. The sponsor will take, where applicable, appropriate corrective and 
preventive actions to protect the safety of subjects, users and other persons. Device 
deficiencies of the control, if applicable, will also be documented. 
12.5.2 
Device Deficiency Documentation 
The PI will record any observed device deficiency on a device deficiency form. The form 
may or may not be part of the CRFs. 
The sponsor will review all device deficiencies and determine and document in writing 
whether they could have led to a serious adverse device effect. 

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12.5.3 
Reporting of Device Deficiencies 
The PI will report to the sponsor, IRB and regulatory authorities (if applicable) device 
deficiencies that could have led to a serious adverse device effect within 72 hours of 
knowledge of the event.  
 
13 RISK / BENEFIT ANALYSIS 
13.1 
Risks 
The BeShape One Device is a high-intensity non focused ultrasound device intended for 
non-invasive waist circumference reduction in adult population. The risks to patients 
resulting from potential device hazards and associated with the study procedures/devices 
have been analyzed using the Risk Management Standard - ISO 14971. The different 
types of hazards were identified and evaluated using risk assessment numerical 
parameters. Applicable controls for the risks were analyzed. After the implementation of 
appropriate risk control measures, the level of risk was re-evaluated and found to be 
acceptable. Below is a summary of some of the key hazards and applicable control 
measures. 
 
Patient Injury Risk: The BeShape One device may cause over-heating related patient 
injuries such as skin burns, blistering and erythema. 
Patient Injury Risk Mitigation: The over-heating related injuries are mitigated by an 
inherent device design cooling mechanism and controlling mechanism that stops 
activation of the device at a predetermined time. In addition, mitigation is achieved by 
comprehensive software validation ensuring correct device algorithm output, including 
constant monitoring of the energy level during treatment and cooling water and 
therapeutic heating temperature control. The device has also been tested in pre-clinical 
settings, demonstrating and proving the safety of the device. 
 
Biocompatibility Risk: The device components and/or materials may present a 
biocompatibility risk (irritation, allergic reaction, etc.) if they contact the patients' body.  
Biocompatibility Risk Mitigation: The risk of biocompatibility is mitigated as all the 
materials that come in contact with the skin human are known to be biocompatible. The 
device is non-invasive and only comes in contact with the outer skin surface. 
 
Use Risk: The operator may perform the treatment incorrectly (due to use error or SW 
bug) and/or apply excessive treatment duration, potentially causing patient injury.  
Use Risk Mitigation: The BeShape One device includes a floor standing portable console 
and touch screen which indicates if the acoustic energy is turned on or off. The user can 
stop the acoustic energy transmission at any time by pressing the on/off button or the 
emergency button. Furthermore, prior to each treatment a system test is performed. 
Comprehensive software validation, proper operator training, proper instructions for use 
and electrical safety testing are additional mitigations for this use risk.  
  

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Performance Risk: The BeShape One device may lead to ineffective treatment due to 
vacuum mechanism failure. 
Performance Risk Mitigation: This risk is mitigated by real time monitoring of the 
vacuum level and software control on energy transmission coupled to vacuum formation. 
The system is configured to stop its operation if good skin contact is not established. 
Further mitigations include pre-clinical studies and SW validation.  
 
System Failure Risk: The BeShape One device may fail to operate due to system 
malfunction.  
System Failure Risk Mitigation: The BeShape Once device is calibrated during 
manufacturing. In addition, the manufacturer supplies it with a tissue-mimicking phantom 
for periodic user tests.  
 
In summary, there are no anticipated severe risks or serious adverse device effects. There 
are no contraindications for use in the proposed study or study population. There may be 
other risks to the subject that are associated with the device or procedure which are 
unforeseeable at this time.  
 
13.2 
Benefits 
 
Subjects may or may not benefit from circumferential waist reduction of the treated area 
resulting in body contouring improvement via the investigational device. Subjects will 
receive all treatment procedures at no cost. This study will benefit the advancement of 
medicine by generating data on safety and efficacy that will aid in the development of an 
alternative treatment options to procedures with higher potential risks, such as 
liposuction. The results of this study will help to determine whether this device is safe and 
effective for improvement of waist circumference reduction. 
 
14 ETHICAL ASPECTS 
14.1 
Study-Specific Design Considerations 
Subjects/cases will be carefully screened using the study eligibility criteria prior to 
enrollment in the study.  
 
14.2 
Regulatory Ethics Compliance 
14.2.1 
Statement of Compliance 
The study will be conducted in compliance the Declaration of Helsinki, ISO 14155, 21 
CFR 50 and 21 CFR 812 for non-significant risk device studies, applicable regulatory 
requirements and ICH Good Clinical Practice (GCP) guidelines. The study will be 
conducted in accordance with this protocol and any regional or national regulations, as 
appropriate. The study will not commence until the approval from the IRB has been 

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received and will be conducted in compliance with the conditions set forth in the IRB 
approval.  
14.2.2 
Investigators Responsibilities 
The investigator is responsible for ensuring that the clinical study is performed in 
accordance with the protocol, current ICH guidelines on GCP, and applicable regulatory 
requirements. 
GCP is an international ethical and scientific quality standard for designing, conducting, 
recording, and reporting studies that involve the participation of human subjects. 
Compliance with this standard provides public assurance that the rights, safety, and well-
being of study subjects are protected, consistent with the principles that originated in the 
Declaration of Helsinki, and that the clinical study data are credible. 
14.2.3 
Independent Ethics Committee or Institutional Review Board 
Before the start of the study, the investigator will provide the IEC/IRB with current and 
complete copies of the following documents: 
• Final protocol and if applicable, amendments 
• Informed consent form  
• Investigator's Brochure (or equivalent information) and amendments 
• Investigator's curriculum vitae or equivalent information (unless not required, as 
documented by IEC/IRB) 
• Information regarding funding, name of the sponsor, institutional affiliations, and 
other potential conflicts of interest 
• Any other documents that the IEC/IRB requests to fulfill its obligation 
This study will be undertaken only after IEC/IRB has given full approval of the final 
protocol, amendments (if any), and informed consent and after the sponsor has received a 
copy of this approval. This approval letter must be dated and must clearly identify the 
documents being approved. 
During the study the investigator will send the following documents to the IEC/IRB for 
their review and approval, where appropriate: 
• Protocol amendments 
• Investigator's Brochure amendments or new edition(s) 
• Summaries of the status of the study (at least annually or at intervals stipulated in 
guidelines of the IEC/IRB) 
• Reports of any serious adverse events, if applicable 
• Deviations from or changes to the protocol  
• Notification if new investigator is responsible for the study at the site 
• Any other requirements of the IEC/IRB 
At least once a year the IEC/IRB will be asked to review and re-approve this clinical 
study. This request and approval should be documented in writing. At the end of the 

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study, the investigator (or sponsor where required) will notify the IEC/IRB about the 
study completion. 
14.2.4 
Informed Consent 
Each subject must give written consent according to local requirements after the nature of 
the study has been fully explained. The consent form must be signed before performance 
of any study-related activity. The consent form used must be approved by both the 
sponsor and by the reviewing IEC/IRB. The informed consent should be in accordance 
with principles set forth in the Declaration of Helsinki, current ICH and GCP guidelines, 
applicable regulatory requirements, and sponsor policy. 
Before entry into the study, the investigator or an authorized member of the 
investigational staff must explain to potential subjects the aims, methods, reasonably 
anticipated benefits, and potential hazards of the study, and any discomfort it may entail. 
Subjects will be informed that their participation is voluntary and that they may withdraw 
consent to participate at any time. They will be informed that choosing not to participate 
will not affect the care the subject will receive for the treatment for his/her disease. 
Subjects will be told that alternative treatments are available if they refuse to take part 
and that such refusal will not prejudice future treatment. Finally, they will be told that 
their records may be accessed by health authorities without violating the confidentiality of 
the subject, to the extent permitted by the applicable law(s) or regulations. By signing the 
informed consent form the subject is authorizing such access. 
The subject will be given sufficient time to read the informed consent form and the 
opportunity to ask questions. After this explanation and before entry into the study, 
consent should be appropriately recorded by name of the subject, subject's signature and 
date of signature. After having obtained the consent, a copy of the informed consent form 
must be given to the subject. If the subject or legally acceptable representative is unable 
to read or write, an impartial witness should be present for the entire informed consent 
process (which includes reading and explaining all written explanations) and should 
personally date and sign the inform consent form after the oral consent of the subject or 
legally acceptable representative is obtained. 
14.2.5 
Privacy of Personal Data 
The collection and processing of personal data from patients enrolled in this study will be 
limited to those data that are necessary to investigate the efficacy, safety, quality, and 
utility of the investigational product(s) used in this study. This data must be collected and 
processed with adequate precautions to ensure confidentiality and compliance with 
applicable data privacy protection laws and regulations. 
 
 
 
 

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15 ADMINISTRATIVE REQUIREMENTS 
15.1 
Protocol Amendments 
The investigator will not modify this protocol without a formal amendment. Protocol 
amendments must not be implemented without prior IEC/IRB approval, or when the 
relevant competent authority has raised any grounds for non-acceptance, except when 
necessary, to eliminate immediate hazards to the patients in which case the amendment 
must be promptly submitted to the IEC/IRB and relevant competent authority. When the 
change(s) involves only logistic or administrative aspects of the study, the IRB (and IEC 
where required) only needs to be notified. 
15.2 
Protocol Deviations 
Investigators are not allowed to deviate from the protocol except under emergency 
circumstances. Deviations from the protocol to protect the rights, safety and well being of 
the subjects may proceed without prior approval of the sponsor and the IRB. Such 
deviations shall be documented and reported to the sponsor and the IRB as soon as 
possible but within 5 working days of the occurrence of such a deviation. In any other 
case, the investigator or other physician in attendance will contact the appropriate sponsor 
representative by fax or telephone regarding any situations requiring a departure from the 
protocol. If possible, contact will be made before implementing any departure from the 
protocol. In all cases contact with the sponsor must be made as soon as possible in order 
to discuss the situation and agree on an appropriate course of action. Any protocol 
deviation needs to be recorded in the CRF, source documents and protocol deviation form 
and should describe the deviation and the circumstances requiring it. 
15.3 
Regulatory Documentation 
15.3.1 
Regulatory Approval/Notification 
This protocol and any amendment(s) must be submitted to the appropriate regulatory 
authorities in each respective country, if applicable. A study may not be initiated at a site 
until all local regulatory requirements are met.  
15.3.2 
Required Pre-study Documentation 
The following documents must be available and maintained during the study: 
• Approved Study Protocol and amendment(s) 
• A copy of the dated and signed written IEC/IRB approval of the protocol and any 
amendments. This approval must clearly identify the specific protocol by title and 
number and must be signed by the chairman or authorized designee. 
• An approved informed consent form 
• Regulatory authority approval or notification, if applicable 
• Documentation of investigator qualifications (e.g., curriculum vitae) 
• Completed financial disclosure form  
• Signed and dated clinical trial agreement, which includes the financial agreements 
• Other documentation required by local regulations 

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15.3.3 
Patient Identification Register and Patient Screening Log 
The investigator agrees to complete a subject/case identification register to permit easy 
identification of each subject/case during and after the study. The subject/case 
identification register will be treated as confidential. To ensure patient confidentiality, no 
copy will be made. All reports and communications relating to the study will identify 
subject/case by initials and assigned number only. The investigator will also complete a 
subject/case enrollment log, which reports all subject/case who were determined eligible 
for inclusion in the study. 
15.3.4 
Case Report Form Completion 
All data relating to the study will be recorded on source documents/CRFs and then 
entered into an EDC with electronic CRFs (eCRFs). The case report forms and/or pre-
templated source documents will only include a subject number and initials. Data will be 
collected in English. A black or blue pen will be used to record data on the source 
documents/CRFs. The source documents and eCRFs are to be completed at the time of 
the data collection. Recorded information should be legible and complete. Erroneous 
entries should be crossed out, corrected with the change, initialed and dated by the 
individual making the correction. Every effort should be made to ensure that all measures 
are recorded on the source documents and eCRFs. The investigator must verify that all 
data entries on the source documents and in the eCRFs are accurate and correct. The EDC 
will include electronic CRFs and will be used to process the data collected during the 
study. The development, validation, handling, maintenance, security measures, change 
control, data backup, retention, recovery, user access, blinding etc. will be performed per 
sponsor SOPs and regulatory requirements.  
15.3.5 
Record Retention and Storage 
In compliance with the ICH/GCP guidelines, the investigator/institution will maintain all 
source documents and eCRFs that support the data collected from each patient, as well as 
all study documents as specified in ISO 14155 Annex E, Essential clinical investigation 
documents, and all study documents as specified by the applicable regulatory 
requirement(s). The investigator/institution will take measures to prevent accidental or 
premature destruction of these documents. 
Essential documents must be retained and stored for at least 2 years after the last approval 
of a marketing application ICH region and until there are no pending or contemplated 
marketing applications in an ICH region or until at least 2 years have elapsed since the 
formal discontinuation of clinical development of the investigational products. These 
documents will be retained for a longer period if required by regulatory requirements or 
by an agreement with the sponsor. It is the responsibility of the sponsor to inform the 
investigator/institution as to when these documents no longer need to be retained. 
If the responsible investigator retires, relocates, or for other reasons withdraws from the 
responsibility of keeping the study records, custody must be transferred to a person who 

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will accept the responsibility. The sponsor must be notified in writing of the name and 
address of the new custodian. Under no circumstance shall the investigator relocate or 
dispose of any study documents before having obtained written approval from the 
sponsor. 
If it becomes necessary for the sponsor or the appropriate regulatory authority to review 
any documentation relating to this study, the investigator must permit access to such 
report. 
15.3.6 
Device Accountability 
A Device Accountability Log will be maintained for the sponsor's equipment (smart 
phones and software) documenting date of receipt, description of device (including type, 
model#, serial number or unique code, quantity and software version) and date of return 
for used and unused products. Device usage will be recorded in the CRF for each subject. 
15.3.7 
Packaging and Labeling 
This study will utilize an investigational device and FDA cleared devices as controls. The 
sponsor is responsible for packaging and labeling of the device for delivery to the study 
site. FDA cleared devices do not require special labeling. Investigational devices or its 
immediate package shall bear a label with the following statement:  
"CAUTION – Investigational device. Limited by Federal (or United States) law to 
investigational use." 
The label or other labeling shall describe all relevant contraindications, hazards, adverse 
effects, interfering substances or devices, warnings and precautions. It is the investigator's 
responsibility to ensure appropriate labeling is visible and remains intact throughout the 
life of the study. The instructions for use (IFU) will be provided as separate documents 
from this protocol. 
15.4 
Monitoring Procedures 
The sponsor is responsible for all monitoring-related procedures. The monitoring 
activities will be performed based on a written monitoring plan and will include, but not 
be limited to, descriptions of monitor qualifications, training, visit reports and reviews, 
follow up on monitoring findings and corrective actions. 
The monitoring requirements for an NSR device study is identified in 21 CFR 812.2(b) 
Abbreviated requirements. For monitoring an NSR device study, the requirement is to 
comply with 21 CFR 812.46 with respect to monitoring: 
• Compliance to the signed agreement between the investigator and sponsor 
• The study follows the protocol and any amendments that apply 
• Compliance to any conditions of the approval imposed by the IRB or FDA 
 
In addition, the monitor will verify that: 
• The conditions for the study continue to be acceptable 

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• Accurate, complete and current records are maintained and required reports are 
written 
• Any adverse effects are documented and reported to the sponsor and IRB as 
appropriate 
• Source data is verified and corrections are made to any inconsistencies or missing 
data found 
• Findings of non-compliance or required modifications are reviewed with the 
investigator and is presented in a written report or follow up letter 
• A monitoring report is written at the end of each monitoring visit and/or the clinical 
study 
15.5 
Use of Information and Publication 
All information, including but not limited to information regarding BeShape One TM or 
the sponsor's operation (e.g., patent application, manufacturing processes, basic scientific 
data, prior clinical data, and formulation information) supplied by the sponsor to the 
investigator and not previously published, and any data generated as a result of this study, 
are considered confidential and remains the sole property of the sponsor. The investigator 
agrees to maintain this information in confidence and use this information only to 
accomplish this study, and will not use it for other purposes without the sponsor's prior 
written consent. 
The investigator understands that the information developed in the clinical study will be 
used by the sponsor in connection with the continued development of the BeShape One 
TM system, and thus may be disclosed as required to other clinical investigators or 
regulatory agencies. To permit the information derived from the clinical studies to be 
used, the investigator is obligated to provide the sponsor with all data obtained in the 
study. 
The results of the study will be reported in a Clinical Study Report generated by the 
sponsor and will contain all data from all investigational sites. Any work created in 
connection with performance of the study and contained in the data that can benefit from 
copyright protection (except any publication by the investigator as provided for below) 
shall be the property of the sponsor as author and owner of copyright in such work. 
The sponsor shall have the right to publish such data and information without approval 
from the investigator. If an investigator wishes to publish information from the study, a 
copy of the manuscript must be provided to the sponsor for review at least 30 days before 
submission for publication or presentation. Expedited reviews will be arranged for 
abstracts, poster presentations, or other materials. If requested by the sponsor in writing, 
the investigator will withhold such publication for up to an additional 90 days to allow for 
filing of a patent application. In the event that issues arise regarding scientific integrity or 
regulatory compliance, the sponsor will review these issues with the investigator. The 
sponsor will not mandate modifications to scientific content and does not have the right to 
suppress information. The investigator will recognize the integrity of a multicenter study 
by not publishing data derived from the individual site until the combined results from the 

Protocol CTP-BSO-001                                                                  Ver.5.1 3 Nov 2022 Redacted Oct 2024 
 
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complete study have been published in full, within 12 months after conclusion, 
abandonment, or termination of the study publication. Authorship of publications 
resulting from this study will be based on generally accepted criteria for major medical 
journals. 
15.6 
Study Registration in a publicly accessible database 
The description and information of the clinical study will be registered in a publicly 
accessible database prior to recruitment of the first subject and will be updated throughout 
the conduct of the study. Results will be entered at completion of the clinical study.