Clinical Evaluation of the Safety and Efficacy of a 1060nm Diode Laser for Non-invasive Fat Reduction of the Abdomen
Phase: NA
Conditions: Fat Atrophy
Sponsor: Venus Concept

 
Diode Laser for Non‐invasive Fat Reduction of the Abdomen 
IRBVerCsioonnd1i.t0ions 
Protocol #CS1317 
19 September 2018 
Satisfied at the Protocol 
Level 
Oct 11, 2018 
Clinical Evaluation of the Safety and Efficacy of a 
1060 nm Diode Laser for Non‐invasive Fat Reduction 
of the Abdomen 
Protocol Identifying Number: CS1317 
Funded by: Venus Concept Ltd. 
Version Number: v 1.0 
19 September 2018 
NCT03756350 
 
 
 
 
 
 
 
Sponsor Contact 
 
Paul Cardarelli 
Senior Director, Product Marketing and Clinical Affairs 
Address: Venus Concept Ltd. 
255 Consumers Rd., Suite 110 
Toronto, Ontario M2J 1R4 
Canada 
Telephone 888‐907‐0115 
E‐mail: pcardarelli@venusconcept.com 
 
 
 
 
  
24/09/18 
 
 
Signature of Sponsor Representative 
Date: (DD/MM/YYYY 
20182493 

ii 
 
Table of Contents 
LIST OF ABBREVIATIONS........................................................................................................................... 1 
STATEMENT OF COMPLIANCE ................................................................................................................. 2 
PROTOCOL SUMMARY ............................................................................................................................... 3 
SCHEMATIC OF STUDY DESIGN ............................................................................................................... 4 
1 
KEY ROLES ...................................................................................................................................... 5 
2 
INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE ...................... 5 
2.1 
Background Information ........................................................................................................... 5 
2.2 
Rationale .................................................................................................................................. 5 
2.3 
Potential Risks and Benefits .................................................................................................... 6 
2.3.1 
Known Potential Risks ........................................................................................... 6 
2.3.2 
Known Potential Benefits ....................................................................................... 6 
3 
OBJECTIVES AND PURPOSE ......................................................................................................... 7 
4 
STUDY DESIGN AND ENDPOINTS ................................................................................................. 7 
4.1 
Description of the Study Design ............................................................................................... 7 
4.2.1 
Primary EndpointS ................................................................................................. 7 
4.2.2 
Secondary Endpoints ............................................................................................. 7 
5 
STUDY ENROLLMENT AND WITHDRAWAL ................................................................................... 8 
5.1 
Participant Inclusion Criteria .................................................................................................... 8 
5.2 
Participant Exclusion Criteria ................................................................................................... 8 
5.3 
Strategies for Recruitment and Retention ................................................................................ 9 
5.4 
Participant Withdrawal or termination ...................................................................................... 9 
5.4.1 
Reasons for Withdrawal or Termination ................................................................. 9 
5.4.2 
Handling of Participant Withdrawals or termination ............................................... 9 
5.5 
Premature Termination or Suspension of Study ...................................................................... 9 
6 
STUDY device ................................................................................................................................. 11 
6.1 
Study device and Control Description .................................................................................... 11 
6.1.1 
Acquisition ............................................................................................................ 11 
6.1.2 
Device Specific Considerations ........................................................................... 11 
6.2 
Study device Accountability Procedures ................................................................................ 11 
7 
STUDY PROCEDURES AND SCHEDULE ..................................................................................... 11 
7.1 
Study Procedures/Evaluations ............................................................................................... 11 
7.1.1 
Study specific procedures .................................................................................... 11 
7.2 
Laboratory Procedures/Evaluations ....................................................................................... 12 
7.2.1 
Clinical Laboratory Evaluations ............................................................................ 12 
7.3 
Study Schedule ...................................................................................................................... 12 
7.3.1 
Screening ............................................................................................................. 12 
7.3.2 
Enrollment/Baseline ............................................................................................. 13 
7.3.3 
Follow-up .............................................................................................................. 14 
7.3.4 
Final Study Visit ................................................................................................... 14 
7.3.5 
Early Termination Visit ......................................................................................... 15 
7.3.6 
UNSCHEDULED Visit .......................................................................................... 15 
7.3.6 
Schedule of Events Table .................................................................................... 15 
7.4 
Justification for Sensitive Procedures .................................................................................... 15 
7.5 
Concomitant Medications, Treatments, and Procedures ....................................................... 16 
7.6 
Prohibited Medications, Treatments, and Procedures ........................................................... 16 

iii 
 
7.7 
Prophylactic Medications, Treatments, and Procedures ....................................................... 16 
7.8 
Rescue Medications, Treatments, and Procedures ............................................................... 16 
8 
ASSESSMENT OF SAFETY ........................................................................................................... 17 
8.1 
Specification of Safety Parameters ........................................................................................ 17 
8.1.1 
Definition of Adverse Events (AE) ....................................................................... 17 
8.1.2 
Definition of Serious Adverse Events (SAE) ........................................................ 17 
8.1.3 
Definition of Unanticipated Problems (UP) .......................................................... 17 
8.2 
Classification of an Adverse Event ........................................................................................ 18 
8.2.1 
Severity of Event .................................................................................................. 18 
8.2.2 
Relationship to Study Agent ................................................................................. 18 
8.2.3 
Expectedness....................................................................................................... 18 
8.3 
Time Period and Frequency for Event Assessment and Follow-Up ...................................... 18 
8.4 
Reporting Procedures ............................................................................................................ 19 
8.4.1 
Adverse Event Reporting ..................................................................................... 19 
8.4.2 
Serious Adverse Event Reporting ........................................................................ 19 
8.4.3 
Unanticipated Problem Reporting ........................................................................ 20 
8.4.4 
Reporting of Pregnancy ....................................................................................... 20 
8.5 
Study Halting Rules................................................................................................................ 20 
8.6 
Safety Oversight..................................................................................................................... 20 
9 
CLINICAL MONITORING ................................................................................................................ 21 
10 
STATISTICAL CONSIDERATIONS ................................................................................................ 21 
10.1 
Statistical and Analytical Plans .............................................................................................. 21 
10.2 Statistical Hypotheses ..................................................................................................................... 21 
10.3 
Analysis Datasets .................................................................................................................. 22 
10.4 
Description of Statistical Methods .......................................................................................... 22 
10.4.1 
General Approach ................................................................................................ 22 
10.4.2 
Analysis of the primary endpoints ........................................................................ 23 
10.4.3 
Analysis of the secondary endpoints ................................................................... 23 
10.4.5 
Safety analysis ..................................................................................................... 24 
10.4.6 
Adherence and Retention Analyses..................................................................... 25 
10.4.7 
Baseline Descriptive Statistics ............................................................................. 25 
10.4.8 
Planned Interim Analyses .................................................................................... 25 
10.4.10 
Multiple Comparison/Multiplicity ........................................................................... 25 
10.4.11 
Tabulation of Individual Response Data .............................................................. 25 
10.4.12 
Exploratory Analyses ........................................................................................... 25 
10.5 
Sample Size ........................................................................................................................... 25 
10.6 
Measures to Minimize Bias .................................................................................................... 26 
10.6.1 
Enrollment/ Randomization/ Masking Procedures ............................................... 26 
10.6.2 
Evaluation of Success of Blinding ........................................................................ 26 
10.6.3 
Breaking the Study Blind/Participant Code .......................................................... 27 
11 
SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS ............................... 27 
12 
QUALITY ASSURANCE AND QUALITY CONTROL ...................................................................... 27 
13 
ETHICS/PROTECTION OF HUMAN SUBJECTS ........................................................................... 28 
13.1 
Ethical Standard ..................................................................................................................... 28 
13.2 
Institutional Review Board ..................................................................................................... 28 
13.3 
Informed Consent Process .................................................................................................... 28 

iv 
 
13.3.1 
Consent/assent and Other Informational Documents Provided to Participants ... 28 
13.3.2 
Consent Procedures and Documentation ............................................................ 28 
13.4 
Participant and data Confidentiality ....................................................................................... 29 
13.4.1 
Research Use of Stored Human SAMPLES, SPECIMENS or Data .................... 29 
14 
DATA HANDLING AND RECORD KEEPING ................................................................................. 29 
14.1 
Data Collection and Management Responsibilities ............................................................... 29 
14.2 
Study Records Retention ....................................................................................................... 30 
14.3 
Protocol Deviations ................................................................................................................ 30 
14.4 
Publication and Data Sharing Policy ...................................................................................... 30 
15 
STUDY ADMINISTRATION ............................................................................................................. 31 
15.1 
Study Leadership ................................................................................................................... 31 
16 
CONFLICT OF INTEREST POLICY ................................................................................................ 31 
17 
LITERATURE REFERENCES ......................................................................................................... 31 
APPENDIX .................................................................................................................................................. 32 

Diode Laser for Non-invasive Fat Reduction of the Abdomen 
Protocol #CS1317 
Version 1.0 
19 September 2018 
 
LIST OF ABBREVIATIONS 
 
 
AE 
Adverse Event 
Analysis of Covariance 
Body Mass Index 
Code of Federal Regulations 
Case Report Form 
Continuous Wave 
Food and Drug Administration 
Good Clinical Practice 
Graphical User Interface 
International Conference on Harmonisation 
International Conference on Harmonisation Guidance for Industry, Good Clinical 
Practice: Consolidated Guidance 
International Committee of Medical Journal Editors 
Institutional Review Board 
International Organization for Standardization Good Clinical Practices for Clinical 
Medical Dictionary for Regulatory Activities 
Principal Investigator 
Quality Control 
Serious Adverse Event 
Statistical Analysis Plan 
Subcutaneous 
Simple Lifestyle Indicator Questionnaire 
Ultrasound 
Unanticipated Problem 
ANCOVA 
BMI 
CFR 
CRF 
CW 
FDA 
GCP 
GUI 
ICH 
ICH E6 
ICMJE 
IRB 
ISO 14155:2011 
MedDRA 
PI 
QC 
SAE 
SAP 
SC 
SLIQ 
US 
UP 

Diode Laser for Non-invasive Fat Reduction of the Abdomen 
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STATEMENT OF COMPLIANCE 
 
The trial will be carried out in accordance with Good Clinical Practice (GCP) as required by the following: 
• 
United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR Part 
46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812) or equivalent local 
regulatory regulations or guidelines 
• 
ICH E6 
• 
ISO 14155:2011 
 
All key personnel (all individuals responsible for the design and conduct of this trial) have 
completed Human Subjects Protection Training. 
 
 
I agree to ensure that all staff members involved in the conduct of this study are informed about their 
obligations in meeting the above commitments. 
 
 
Principal Investigator:   
 
Print/Type Name 
 
 
Signed: 
Signature Date:   
 

Diode Laser for Non-invasive Fat Reduction of the Abdomen 
Protocol #CS1317 
Version 1.0 
19 September 2018 
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TITLE 
Clinical Evaluation of the Safety and Efficacy of a 1060nm Diode Laser for Non- 
Invasive Fat Reduction of the Abdomen 
SUMMARY 
Open-label, baseline-controlled, evaluator-blind multi-center study evaluating a 
1060 nm diode laser for non-invasive fat reduction of the abdomen. The study 
will enroll up to 50 subjects requesting non-invasive lipolysis of the abdomen. 
Each subject will receive a single study treatment. Subjects will be followed at 
six weeks and twelve weeks post-treatment. Twelve week outcomes will be 
compared to baseline. 
OBJECTIVE 
The objective of this clinical study is to assess the safety and efficacy of using a 
1060 nm diode laser for non-invasive fat reduction of the abdomen. 
ENDPOINT 
Primary endpoints 
• 
Photographic evaluation by independent, blinded reviewers with 
correct identification of pre-treatment baseline images when compared 
to post-treatment images taken at twelve weeks 
Secondary endpoints 
• 
To determine the change in thickness of the adipose layer as measured 
by ultrasound (US) at twelve weeks post-treatment as compared to 
baseline 
• 
To determine the change in abdominal circumference at twelve weeks 
post-treatment as compared to baseline 
• 
To assess subject satisfaction with treatment at twelve weeks using the 
5-Point Likert Subject Satisfaction Scale 
Safety 
• 
Subject’s assessment of discomfort and pain post-treatment as 
measured by the Wong-Baker Faces Pain rating scale 
• 
Subjects experiencing a treatment-related adverse event (AE) 
POPULATION 
The study will enroll up to 50 male and female subjects, 18 to 60 years of age 
who are seeking fat reduction of the abdomen. 
PHASE 
Pre-Market 
NUMBER OF SITES 
Up to 5 sites 
DESCRIPTION OF 
DEVICE 
The investigational device (Venus Bliss™) is a non-invasive medical aesthetic 
device designed for body contouring. The device is comprised of a console, four 
1060 nm diode laser applicators (60 mm x 60 mm). A belt is included to allow 
the operator to secure the laser applicators on the lipolysis treatment area, 
allowing hands free operation. 
STUDY DURATION 
Twelve months 
PARTICIPANT 
DURATION 
Three months 
PROTOCOL SUMMARY 

Diode Laser for Non-invasive Fat Reduction of the Abdomen 
Protocol #CS1317 
Version 1.0 
19 September 2018 
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Screening 
Obtain informed consent 
Physical exam, demographics, medical history, concomitant medication 
Screen potential subjects by inclusion and exclusion enrollment criteria 
 
Visit 1 
Day 0 
Weight, urine pregnancy test 
AEs, concomitant medication, lifestyle questionnaire, abdominal circumference 
Baseline photographs for blinded evaluation 
Baseline ultrasound for subcutaneous fat assessment 
Administer study treatment 
Visual pain scale, immediate response 
 
Visit 2 
Week 6 
Weight 
AEs, concomitant medication, abdominal circumference 
Photographs for blinded evaluation 
Ultrasound for subcutaneous fat assessment 
 
Visit 3 
Month 3 
Final Assessments 
Weight 
AEs, concomitant medication 
Lifestyle questionnaire, subject satisfaction, subject treatment evaluation 
Abdominal circumference 
Photographs for blinded evaluation 
Ultrasound for subcutaneous fat assessment 
SCHEMATIC OF STUDY DESIGN 

Diode Laser for Non-invasive Fat Reduction of the Abdomen 
Protocol #CS1317 
Version 1.0 
19 September 2018 
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Paul Cardarelli 
Senior Director, Product Marketing and Clinical Affairs 
Address: Venus Concept Ltd. 
255 Consumers Rd., Suite 110 
Toronto, Ontario M2J 1R4 
Canada 
Telephone 888-907-0115 
E-mail: pcardarelli@venusconcept.com 
 
 
 
There are multiple, non-invasive fat reduction procedures currently available for non-surgical body- 
contouring. Technologies include cryolipolysis, radiofrequency, high frequency focused ultrasound, and 
photobiomodulation. All modalities deliver some form of energy that creates changes in the adipocytes. 
Studies show that these therapies are safe and effective. 
 
Many non-invasive laser technologies have been studied with the efficacy of laser therapy purported to 
be related to the wavelength and the energy delivered. Initial lasers studied include the neodymium- 
doped yttrium aluminum garnet (Nd:YAG) laser delivering 1064nm and 1320nm wavelengths. Diode 
lasers were introduced delivering energy at 980nm, 924nm, 975nm and 920nm wavelengths. The quest 
for the most effective laser diode wavelength for lipolysis with the least adverse effect continues, most 
recently with the 1060nm wavelength. 
 
The 1060nm laser diode leads to the injury of the adipocytes through direct heating of the tissue. The 
energy delivered creates movement within the molecules of the exposed tissue, which then generates 
heat. A controlled temperature of 42-47 °C must be maintained at the site of adipocytes. At this 
temperature, the cell membranes of the adipocytes lose their structural integrity leading to cell death. 
Upon cell injury and death, the body naturally eliminates the contents of the adipocytes with results at 6 
weeks but optimally at 12 weeks. The 1060nm wavelength has a particular affinity for adipocytes with 
low absorption within the dermis. In addition, melanin is minimally targeted so the device can be used 
in all skin types. (Schilling L et al) 
 
This study will investigate whether a single treatment with a 1060nm laser delivered by the Venus Bliss™ 
investigational device is safe and efficacious for the reduction of abdominal fat. In addition, the study 
will investigate whether the effects of this single treatment are maintained at six months post-therapy. 
 
 
The use of 1060nm laser diode technology has been shown in clinical studies to be safe and effective for 
lipolysis. The objective of this clinical study is to evaluate the safety and efficacy of the use of the Venus 
Bliss™ investigational medical device for non-invasive fat reduction of the abdomen. 
1 
KEY ROLES 
2 
INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE 
2.1 
BACKGROUND INFORMATION 
2.2 
RATIONALE 

Diode Laser for Non-invasive Fat Reduction of the Abdomen 
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The use of the Venus Bliss™ has been determined to present non-significant risk in accordance with 21 
CFR 812.3 for the intended use in this study, because the device is not: 
 
• 
Intended as an implant; 
• 
purported or represented to be for use supporting or sustaining human life; 
• 
for use of substantial importance in diagnosing, curing, mitigating, or treating disease, or 
otherwise preventing impairment of human health; or 
• 
Otherwise presenting a potential for serious risk to the health, safety, or welfare of a subject. 
Furthermore, the use of the non-invasive 1060nm laser diode technology for lipolysis has been reported 
without incidents or significant complications by Bass LS et al, 2018; Decorato, JW et al, 2017 and Katz B 
et al, 2018. 
 
This study will be conducted in compliance with the protocol and according to Good Clinical Practice 
(GCP) standards. 
 
 
 
Expected adverse events of the laser treatment procedure include transient tenderness, erythema, 
edema, and/or induration in the treated area lasting from one to three weeks after the treatment. In 
addition, other adverse events may include and include localized firmness, ecchymosis, skin burn, 
hyperpigmentation, hypopigmentation, blister and changes in skin laxity. Rarely, skin contour 
irregularities, dimpling, asymmetry (uneven appearance due to uneven anatomy or uneven treatment of 
the area), necrosis (tissue death), hardness and nodules occur. Protective laser eyewear will be worn by 
the subject and operator providing the procedure. 
 
The device has a contact tissue cooling system in place during the procedure to minimize thermal 
discomfort and prevent damage to the treatment area. Expected adverse events related to the contact 
cooling include tingling, itching, decreased sensation, numbness, erythema and tenderness. 
 
The boundaries of the treatment area will be marked with a semi-permanent tattoo ink using a 
microblade. The ink markings should dissipate within one year. Microblade marking may be associated 
with tenderness. 
 
There are minimal risks associated with the use of ultrasound. The use of the ultrasound may cause 
redness of the skin. Skin rashes rarely occur with the use of ultrasound gel. 
 
Risks will be mitigated by conducting this protocol with an investigator experienced in the therapeutic 
area of the clinical investigation. The investigator will be trained by the sponsor on the use of the 
device. The device design incorporates safety mechanisms which minimize risks. Patients will also be 
rigorously screened prior to their enrollment and rigorously followed over the course of the study. 
 
 
If the subject agrees to participate in this study, he/she will be contributing to the understanding of the 
safety and efficacy of the use of this investigational device for abdominal fat reduction. This 
2.3 
POTENTIAL RISKS AND BENEFITS 
2.3.1 KNOWN POTENTIAL RISKS 
2.3.2 KNOWN POTENTIAL BENEFITS 

Diode Laser for Non-invasive Fat Reduction of the Abdomen 
Protocol #CS1317 
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understanding may lead to optimization of the treatment with this device. In addition, the subject may 
benefit from reduction in unwanted adipocytes. 
 
 
The objective of this clinical study is to assess the safety and efficacy of using a 1060 nm diode laser for 
non-invasive fat reduction of the abdomen. 
 
Primary objectives 
• 
To determine proportion of independent, blinded reviewers who correctly identify pre- 
treatment baseline images and images taken at twelve weeks post-treatment 
Secondary objectives 
• 
To determine the change in thickness of the adipose layer as measured by ultrasound at twelve 
weeks post-treatment as compared to baseline 
• 
To determine the change in abdominal circumference at twelve weeks post-treatment as 
compared to baseline 
• 
To assess subject satisfaction with treatment at twelve weeks using the 5-Point Likert Subject 
Satisfaction Scale 
Safety 
• 
Subject’s assessment of discomfort and pain post-treatment as measured by the Wong-Baker 
Faces Pain rating scale. 
• 
Subjects experiencing a treatment-related adverse event (AE). 
 
 
 
This is an open-label, baseline-controlled, evaluator-blind multi-center study evaluating one treatment 
with a 1060 nm diode laser for non-invasive fat reduction of the abdomen. 
 
• 
Photographic evaluation by independent, blinded reviewers with correct identification of pre- 
treatment baseline images when compared to post-treatment images taken at twelve weeks 
 
• 
To determine the change in thickness of the adipose layer as measured by ultrasound at twelve 
weeks post-treatment as compared to baseline 
• 
To determine the change in abdominal circumference at twelve weeks post-treatment as 
compared to baseline 
• 
To assess subject satisfaction with treatment at twelve weeks using the 5-Point Likert Subject 
Satisfaction Scale 
 
Safety Endpoints: 
• 
Report subject’s assessment of discomfort and pain as measured by the Wong-Baker Faces Pain 
rating scale. 
• 
Report subjects experiencing a treatment-related adverse event (AE). 
3 
OBJECTIVES AND PURPOSE 
4 
STUDY DESIGN AND ENDPOINTS 
4.1 
DESCRIPTION OF THE STUDY DESIGN 
4.2.1 PRIMARY ENDPOINTS 
4.2.2 SECONDARY ENDPOINTS 

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1. Able to read, understand and voluntarily provide written informed consent . 
2. Healthy male or female,  ≥ 18 years of age seeking treatment for unwanted fat in the abdomen. 
3. BMI score is less than 30. 
4. Agree to not making any major changes in their diet or lifestyle during the course of the study. 
5. Able and willing to comply with the treatment/follow-up schedule and requirements. 
6. Women of child-bearing age are required to be using a reliable method of birth control at least 3 
months prior to study enrollment and for the duration of the study, and have a negative Urine 
Pregnancy test at baseline. 
 
1. Pregnant in the last 3 months, intending to become pregnant, postpartum or nursing in the last 
6 months. 
2. Any previous liposuction/lipo-sculpture or any type of surgical procedure in the treatment area 
in the past 12 months. 
3. History of immunosuppression/immune deficiency disorders (including AIDS and HIV infection) 
or use of immunosuppressive medications, 6 months prior to and during the course of the study. 
4. History of hyperlipidemia, diabetes mellitus, hepatitis, blood coagulopathy or excessive 
bleeding. 
5. Use of antiplatelet medications (81 mg acetylsalicylic acid daily permitted), anticoagulants, 
thrombolytics or anti-inflammatory medications within 2 weeks of treatment. 
6. 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. 
7. Having a permanent implant in the treatment area such as metal plates or an injected chemical 
substance such as silicone or parenteral gold therapy (gold sodium thiomalate). 
8. Use of medications, herbs, food supplements, and vitamins known to induce photosensitivity to 
light exposure at the wavelength used or history of photosensitivity disorder. 
9. Suffering from significant skin conditions in the treatment area or inflammatory skin conditions 
including but not limited to open lacerations, abrasions, herpes sores, cold sores, active 
infections. 
10. Tattoos in the treatment area. 
11. Poor skin quality (severe laxity). 
12. Abdominal wall, muscular abnormality or hernia on physical examination. 
13. Unstable weight within the last 6 months (± 3% weight change in the prior six months). 
14. Use of retinoids such as oral isotretinoin (Accutane™) within the past six months or during 
course of the study. 
15. Participation in another clinical study involving the same anatomical areas within the last 6 
months. 
16. History of keloid or hypertrophic scar formation or poor wound healing in the treatment area. 
17. As per the investigator’s discretion, any physical or mental condition which may make it unsafe 
for the subject to participate. 
5 
STUDY ENROLLMENT AND WITHDRAWAL 
5.1 
PARTICIPANT INCLUSION CRITERIA 
5.2 
PARTICIPANT EXCLUSION CRITERIA 

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18. Unable or unlikely to refrain from sun exposure, artificial tanning, including the use of tanning 
booths, prior to (six weeks) and during the course of the evaluation. 
 
 
Up to 50 subjects will be enrolled at up to 5 sites. It is anticipated that it will take up to twelve months 
to complete the study. Subjects requesting non-invasive lipolysis of the abdomen will be recruited 
primarily from the investigator’s clinic. Any advertising campaigns and materials will be reviewed and 
approved by an institutional review board (IRB) before implementation. Due to the duration of the 
study, subjects will be contacted by the investigative site on a regular basis in order to enhance 
retention. 
 
 
 
Subjects are free to withdraw from participation in the study without prejudice at any time upon 
request. In the event that a subject drops out of the study or is withdrawn from the study, the End of 
Study/Early Discontinuation CRF form should be completed. On the withdrawal page, the Investigator 
should record the date of the withdrawal and the reason for withdrawal. 
 
Reasonable effort should be made to contact any subject lost to follow up during the course of the study 
in order to complete assessments and retrieve any outstanding data. The records of subjects who 
terminate prior to completing the study will be retained and the reason for termination will be 
documented. 
 
An investigator may terminate participation in the study if: 
 
• 
Any clinical adverse event (AE), laboratory abnormality, or other medical condition or situation 
occurs such that continued participation in the study would not be in the best interest of the 
subject. 
• 
The subject meets an exclusion criterion (either newly developed or not previously recognized) 
that precludes further study participation. 
 
 
Every effort will be made to continue follow-up of withdrawn or terminated subjects or subjects who 
discontinue the intervention but remain in the study for follow-up, especially for safety and efficacy 
study endpoints. Every effort will be made to conduct a final visit and undertake protocol-specified 
safety follow-up procedures to capture AEs, serious adverse events (SAEs), and unanticipated problems 
(UPs). 
 
 
The sponsor may suspend or prematurely terminate this study at an individual investigation site or the 
entire study for significant and documented reasons. 
5.3 
STRATEGIES FOR RECRUITMENT AND  RETENTION 
5.4 
PARTICIPANT WITHDRAWAL OR TERMINATION 
5.4.1 REASONS FOR WITHDRAWAL OR TERMINATION 
5.4.2 HANDLING OF PARTICIPANT WITHDRAWALS OR TERMINATION 
5.5 
PREMATURE TERMINATION OR SUSPENSION OF STUDY 

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A principal investigator (PI), IRB, or regulatory authority may suspend or prematurely terminate 
participation in the study at the investigation site for which they are responsible. 
 
If suspicion of an unacceptable risk to subjects arises during the study, or when so instructed by the IRB 
or regulatory authorities, the sponsor shall suspend the clinical investigation while the risk is assessed. 
The sponsor shall terminate the study if an unacceptable risk is confirmed. 
 
The sponsor shall consider terminating or suspending the participation of the investigation site or 
investigator in the study if monitoring or auditing identifies serious or repeated deviations on the part of 
an investigator. 
 
If suspension or premature termination occurs, the terminating party shall justify its decision in writing 
and promptly inform the other parties with whom they are in direct communication. The principal 
investigator and sponsor shall keep each other informed of any communication received from either the 
EC/IRB or the regulatory authority. 
 
If, for any reason, the sponsor suspends or prematurely terminates the study at the investigation site, the 
sponsor shall inform the responsible regulatory authority as appropriate and ensure that the EC/IRB is 
notified, either by the principal investigator or by the sponsor. If the suspension or premature termination 
was in the interest of safety, the sponsor shall inform all other principal investigators. 
 
If suspension or premature termination occurs, 
a) the sponsor shall remain responsible for providing resources to fulfil the obligations from the 
protocol and existing agreements for following up the subjects enrolled in the study, and 
b) the principal investigator or authorized designee shall promptly inform the enrolled subjects at 
the investigation site, if appropriate 
 
In case of early termination, final study activities according to the protocol, including the follow-up visits 
and procedures to assess the safety and efficacy of the device will be conducted, regardless of the 
sponsor's interest in the study. Follow-up activities will be conducted so that device deficiencies can be 
identified, and appropriate safety measures can be implemented. 
 
At the completion or termination of the study, the Investigator will return all remaining clinical supplies 
to Sponsor along with a copy of the device supply and inventory records. 
 
Circumstances that may warrant termination or suspension include, but are not limited to: 
• 
Determination of unexpected, significant, or unacceptable risk to participants (examples of 
findings that might trigger a safety review are the number of SAEs overall, the number of 
occurrences of a particular type of SAE, severe AEs/reactions, or increased frequency of events – 
refer to section 8.5 STUDY HALTING RULES). 
• 
Demonstration of performance that would warrant stopping 
• 
Insufficient compliance to protocol requirements 
• 
Data that are not sufficiently complete and/or evaluable 
• 
Determination of futility 
Study may resume once concerns about safety, protocol compliance, data quality and the like as the 
case may be are addressed and satisfy the sponsor, IRB and/or regulatory authorities. 

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The Venus Bliss™ investigational device will be shipped to the investigative site directly from the 
sponsor. Training on the use of the device will be provided by the sponsor. The investigative site will 
not perform any treatments until all regulatory and IRB approvals are in place and the site has received 
training for both devices and the study. 
 
 
The Venus BLISS™ investigational device is a 1060nm diode laser system intended for non-invasive 
lipolysis of the abdomen in individuals with a Body Mass Index (BMI) of less than 30. The device consists 
of a console, four laser applicators and a belt that secures the laser applicators in place securely to the 
subject’s selected treatment area. Each applicator includes contact tissue cooling and has an active area 
of 60mm x 60mm. 
 
The clinician is able to control the settings from the graphical user interface (GUI) display on the main 
console. The available settings for this applicator is: 
 
• 
Optical power up to 1.4 W/cm2 at 1060nm 
Treatment time is 25 minutes. 
 
The device and applicators will be shipped to the site by the sponsor. Traceability shall be achieved 
during and after the clinical investigation by assignment of serial numbers to device and applicators and 
accounting for the device and applicators returned to the sponsor by each site. 
 
The device will be labeled as an investigational device and will require protocol and device training from 
the sponsor. 
 
 
 
 
The following procedures and evaluations will be done as part of the study: 
Demographics 
Medical / surgical history 
6 
STUDY DEVICE 
6.1 
STUDY DEVICE AND CONTROL DESCRIPTION 
6.1.1 ACQUISITION 
6.1.2 DEVICE SPECIFIC CONSIDERATIONS 
6.2 
STUDY DEVICE ACCOUNTABILITY PROCEDURES 
7 
STUDY PROCEDURES AND SCHEDULE 
7.1 
STUDY PROCEDURES/EVALUATIONS 
7.1.1 STUDY SPECIFIC PROCEDURES 

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Physical examination (as per site’s standard of care) 
Assessment of eligibility 
Urine pregnancy test for women of child bearing potential (visit 1 only) 
Treatment area marking 
Abdominal circumference measurements 
Photographs (visit 1, visit 2 and visit 3) 
Ultrasound subcutaneous fat (visit 1, visit 2 and visit3) 
Administration of a questionnaires/scales for patient-reported outcomes (visit 1 and visit 3 only) 
Adverse event recording 
Concomitant medications 
 
 
 
For women of child-bearing potential, urine pregnancy test to be performed according to local site 
standards within 24 hours of study intervention. Results must be available prior to administration of the 
treatment. 
 
 
 
Screening Visit 
 
If the subject meets the preliminary study criteria the study doctor, and/or his/her designee, will obtain 
an informed consent from the subject, clearly indicating his/her understanding of the requirements and 
possible risks involved with study participation and other applicable treatment options. Subjects will 
receive a unique identifying number that will be composed of a two-digit site number and a three digit 
subject number in sequence. This unique identifier will be used throughout the entire study and will be 
entered in the subject's case report form (CRF) and for each treatment. 
 
During screening visit, the study investigator, and/or his/her designee, will assess the subject for eligibility 
to participate in the clinical study using the inclusion/exclusion criteria. A urine sample for the pregnancy 
test will be obtained for female subjects of child-bearing potential. During screening, the study doctor will 
review the subject's medical/surgical history and examine the target treatment areas to ensure they meet 
the study criteria. 
 
Subjects will be instructed to avoid sun exposure of the target treatment areas for at least six weeks before 
treatment and to use broad spectrum sunscreen of no less than 30 SPF daily, replenishing it as often as 
needed throughout the course of the study and for six weeks after the treatment. In addition, tanning is 
to be strictly avoided. Subjects should not receive any treatment with a laser or other devices in the study 
treatment area throughout the course of this study and follow-up examinations. 
 
The investigator will ask women of child-bearing potential for the date of their last period. The 
investigator shall inquire about the form of contraceptive they use to confirm they meet the inclusion 
criteria. 
7.2 
LABORATORY PROCEDURES/EVALUATIONS 
7.2.1 CLINICAL LABORATORY EVALUATIONS 
7.3 
STUDY SCHEDULE 
7.3.1 SCREENING 

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The subject will complete screening and the treatment will be scheduled. Treatment may be performed on the 
day the subject was enrolled if the results of the urine pregnancy test are available (and negative) and the subject 
has avoided sun exposure of the target treatment area for at least six weeks. 
 
 
Enrollment/Baseline/Treatment Visit (Visit 1 – Day 0) 
Pre-Treatment 
The investigator will confirm that the subject continues to meet the inclusion and none of the exclusion 
criteria. Adverse events, weight and any changes to concomitant medications will be recorded. The 
subject will complete the modified Simple Lifestyle Indicator Questionnaire (SLIQ). 
 
The location and size of the treatment area will be left to the principal investigator’s judgement based 
on his/her assessment of individual subject requirements for treatment. The defined abdominal 
treatment area will be marked with a semi-permanent pigment using a treatment template as per the 
sponsor’s instructions. Photographs of the marked treatment area followed by ultrasound 
measurements of the marked treatment area will be made as per the instructions supplied by the 
sponsor. Measurement of the abdominal circumference will be made with the sponsor supplied tape 
measure using the marked boundaries as a guide for replication. 
 
Treatment 
Protective eye goggles will be worn by both the patient and site staff performing the treatment for the 
duration of the treatment session. 
 
Based on the mild nature of treatment, anesthesia is not required. The treatment procedure should 
include positioning of the patient in a manner that enables access to the target treatment anatomical 
site. 
 
The belt will be positioned on the subject as per the marked treatment template. Laser applicators will 
be secured in place by the belt with the areas treated for up to 25 minutes. The laser energy will be 
delivered to the area while cooling is administered to the skin surface to increase subject comfort. 
Treatment will continue until the total treatment area has been treated. The subject will receive one 
treatment session only. 
 
The assessment of discomfort/pain during the treatment procedure will be assessed using the Wong- 
Baker Faces Pain rating scale with treatment parameters adjusted according to patient’s comfort level. 
 
Post Treatment 
 
Assessment 
 
The investigator will examine the treated areas and report immediate response (pain during treatment, 
hemorrhage, burn, erythema, edema, purpura) using a 5 point scale: 1=none; 2=trace; 3=moderate; 
4=marked; 5=severe. 
 
The assessment of discomfort/pain based on the subject’s completion of the 10 cm viusla pain scale 
should also be documented immediately after treatment. 
7.3.2 ENROLLMENT/BASELINE 

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The normal response to this treatment is transient tenderness, edema and/or induration in the treated 
area which should resolve within one to two weeks. If any other side effects occur or persist for longer 
than expected, they must be recorded in the adverse event (AE) section of the case report form (CRF). 
 
For post-treatment cooling and/or discomfort, cold packs can be applied to treatment area if needed 
with acetaminophen at recommended doses used to alleviate pain as needed. 
 
During the day following treatment, care should be taken to prevent any mechanical or thermal damage 
to the treated sites: avoid hot baths, massage, contact sports, swimming, etc. The treated areas should 
be kept clean to avoid contamination or infection. The subject should be reminded to not make any 
major changes in their diet or lifestyle during the course of the study. 
 
Subjects will be discharged from the clinic and will be scheduled to return for the six week assessment. 
 
 
Visit 2, Week 6 (± 3 days) 
 
Subjects will return to the clinic six weeks after the treatment. Adverse events, weight and any changes 
to concomitant medications will be recorded. 
 
Measurement of the abdominal circumference will be made with the sponsor supplied tape measure 
using the marked boundaries as a guide for replication. 
 
Photographs of the marked treatment area followed by ultrasound measurements of the marked 
treatment area will be made as per the instructions supplied by the sponsor. 
 
Subjects will be discharged from the clinic and will be scheduled to return for the Twelve week (Final) 
assessment. 
 
 
Visit 3, Week 12 (± 7 days) 
Subjects may return to the clinic twelve weeks after the treatment. Adverse events, weight and any 
changes to concomitant medications will be recorded. 
 
Subjects will be asked to complete the lifestyle, 5-point Likert subject satisfaction and treatment 
evaluation questionnaires. Measurement of the abdominal circumference will be made with the 
sponsor supplied tape measure using the marked boundaries as a guide for replication. 
 
Photographs of the marked treatment area followed by ultrasound measurements of the marked 
treatment area will be made as per the instructions supplied by the sponsor. 
 
The End of Study form will be completed and subjects will be discharged from the clinic and terminated 
from the study. 
 
The PI will record all reportable events with start dates occurring any time after informed consent is 
obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. 
7.3.3 FOLLOW-UP 1 
7.3.4 FINAL STUDY VISIT 

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Subjects who terminate the study early for whatever reason, will be asked to provide a reason for their 
early termination.  Adverse events and the reason for early termination will be recorded. 
 
 
If an unscheduled visit occurs, the reason for the unscheduled visit will be documented. If the 
unscheduled visit is the result of an adverse event, the event will be recorded on the adverse event CRF. 
 
 
Procedures 
Screening 
(-6 weeks) 
Enrollment/Treatment 
(Visit 1, Day 0) 
Follow-up 1 
Visit 2, Week 6 (±3 days) 
Follow-up 2 
(Visit 3, Week 12 (±7 days) 
Informed consent 
X 
Inclusion/exclusion criteria 
X 
X 
Demographics 
X 
Medical history 
X 
Physical exam 
X 
Weight 
X 
X 
X 
Urine pregnancy testa 
X 
Lifestyle Indicator Questionnaire 
X 
X 
Abdominal circumference 
X 
X 
X 
Photographs 
X 
X 
X 
Ultrasound subcutaneous fat 
X 
X 
X 
Administer Treatment 
X 
Discomfort/Pain Visual Pain Scale 
X 
PI immediate response 
X 
Blinded reviewers GAIS 
X 
X 
Subject satisfaction questionnaire 
X 
Treatment evaluation questionnaire 
Concomitant medication 
X 
X 
X 
X 
Adverse event evaluation 
X 
X 
X 
 
 
 
N/A 
7.3.5 EARLY TERMINATION VISIT 
7.3.6 UNSCHEDULED VISIT 
7.3.6 SCHEDULE OF EVENTS TABLE 
7.4 
JUSTIFICATION FOR SENSITIVE PROCEDURES 

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All concomitant prescription medications taken during study participation will be recorded on the case 
report forms (CRFs). For this protocol, a prescription medication is defined as a medication that can be 
prescribed only by a properly authorized/licensed clinician. Other medications to be reported in the CRF 
are concomitant over-the-counter medications and non-prescription medications. 
 
 
The use of immunosuppressive medications, antiplatelet medications, thrombolytics, anti-inflammatory 
medicatons and anticoagulant medications is to be avoided. Herbal supplements, perfumes, cosmetics 
and/or medications that may affect sensitivity to light are prohibited. The use of Accutane™ 
(Isotretinoin) within the past six months is also strictly prohibited. 
 
 
None. 
 
 
In the event that the subject experiences pain, the principal investigator may prescribe any analgesic 
deemed appropriate to the level of pain. If a subject experiences any first, second or third degree burn 
or pain beyond narcotics, then the following procedure will be implemented: 
Immediate triage and treatment of the patient shall be determined by the treating physician and based 
upon severity and type of burn identified. 
 
The event will be reported to the study Director within 24 hours of occurrence. If the event meets the 
criteria of a SAE, then it must be reported on the SAE form. 
 
A copy of the patient chart and treatment parameters are to be forwarded to the study Director within 
24 hours. 
 
The study Director will be responsible for issuing a written report to the company and the IRB Chairman 
no later than 7 days from the incident. 
 
Long term follow up and care shall continue at the discretion of the treating physician. 
 
All patients experiencing a complication of the device will be followed a minimum of 2 years following 
the initial injury. Longer care and observation will be at the discretion of the treating physician. 
 
All minor complications such as appearance or altered sensation, except for pain, can be reported within 
30 days of patient complaint. Both chart and treatment parameters are to be provided to the study 
Director and shared with the company and IRB chairman. 
7.5 
CONCOMITANT MEDICATIONS, TREATMENTS, AND PROCEDURES 
7.6 
PROHIBITED MEDICATIONS, TREATMENTS, AND PROCEDURES 
7.7 
PROPHYLACTIC MEDICATIONS, TREATMENTS, AND PROCEDURES 
7.8 
RESCUE MEDICATIONS, TREATMENTS, AND PROCEDURES 

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In addition to spontaneous reports of adverse events, subjects will complete a 10 cm discomfort/pain 
visual pain scale and the principal investigator will examine the treated area and report immediate 
response. 
 
 
Adverse event means any untoward medical occurrence associated with the use of an intervention in 
humans, whether or not considered intervention-related (21 CFR 312.32 (a)). 
 
 
NOTE: The term serious is not synonymous with severity, which may be used to describe the intensity of 
an event experienced by the subject). An AE that does not meet any of the below criteria will be 
classified as non-serious. 
 
A serious AE is any event that: 
• 
Results in, or contributes to a death; 
• 
Is immediately life threatening (injury or illness); 
• 
Results in hospitalization, or prolongs an existing hospitalization; 
• 
Results in permanent impairment of body structure or function, or in persistent or significant 
disability/incapacity; 
• 
Results in an injury that requires medical intervention to prevent permanent impairment of 
body structure or function; 
• 
Is a device malfunction or deterioration in the characteristics and/or performance of the device 
that results in death or serious deterioration in health; 
• 
Is a device malfunction or deterioration in the characteristics and/or performance of the device 
that, if it were to occur again, could result in death or serious deterioration in health; 
• 
Results in a congenital anomaly or birth defect. 
• 
Is any medically significant injury, event or experience that requires medical/surgical 
intervention to prevent one of the outcomes listed above; 
• 
Results in end organ toxicity, including hematological, renal, cardiovascular, hepatic, 
gastrointestinal, and central nervous system events; 
 
 
This definition includes an unanticipated adverse device effect, any serious adverse effect on health or 
safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, 
problem, or death was not previously identified in nature, severity, or degree of incidence in the 
investigational plan or application (including a supplementary plan or application), or any other 
unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of 
subjects (21 CFR 812.3(s)). 
8 
ASSESSMENT OF SAFETY 
8.1 
SPECIFICATION OF SAFETY PARAMETERS 
8.1.1 DEFINITION OF ADVERSE EVENTS (AE) 
8.1.2 DEFINITION OF SERIOUS ADVERSE EVENTS (SAE) 
8.1.3 DEFINITION OF UNANTICIPATED PROBLEMS (UP) 

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For AEs not included in the protocol defined grading system, the following guidelines will be used to 
describe severity. 
 
• 
Mild – Events require minimal or no treatment and do not interfere with the participant’s daily 
activities. 
• 
Moderate – Events result in a low level of inconvenience or concern with the therapeutic 
measures. Moderate events may cause some interference with functioning. 
• 
Severe – Events interrupt a participant’s usual daily activity and may require systemic drug 
therapy or other treatment. Severe events are usually potentially life-threatening or 
incapacitating. 
 
 
The clinician’s assessment of an AE's relationship to the study agent is part of the documentation 
process, but it is not a factor in determining what is or is not reported in the study. If there is any doubt 
as to whether a clinical observation is an AE, the event should be reported. All AEs must have their 
relationship to study agent assessed. In a clinical trial, the study product must always be suspect. To 
help assess, the following guidelines are used. 
 
• 
Related – The AE is known to occur with the study agent, there is a reasonable possibility that 
the study agent caused the AE, or there is a temporal relationship between the study agent and 
event. Reasonable possibility means that there is evidence to suggest a causal relationship 
between the study agent and the AE. 
• 
Not Related – There is not a reasonable possibility that the administration of the study agent 
caused the event, there is no temporal relationship between the study agent and event onset, 
or an alternate etiology has been established. 
 
 
Expected adverse reactions are AEs that are common and known to occur for the study agent being 
studied. Expected adverse events of the treatment include transient tenderness, erythema, edema, 
and/or induration in the treated area lasting from one to three weeks after the treatment. 
The device has a contact tissue cooling system in place during the procedure to minimize thermal 
discomfort and prevent damage to the treatment area. Expected adverse events related to the contact 
cooling include tingling, itching, decreased sensation, numbness, erythema and tenderness. 
 
An AE or suspected adverse reaction is considered "unexpected" if it is not known to occur for the study 
treatment being studied and at the specificity or severity that has been observed. 
 
 
The occurrence of an AE or SAE may come to the attention of study personnel during study visits and 
interviews of a study participant presenting for medical care, or upon review by a study monitor. All AEs 
8.2 
CLASSIFICATION OF AN ADVERSE EVENT 
8.2.1 SEVERITY OF EVENT 
8.2.2 RELATIONSHIP TO STUDY AGENT 
8.2.3 EXPECTEDNESS 
8.3 
TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP 

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including local and systemic reactions not meeting the criteria for SAEs will be captured on the 
appropriate CRF. Information to be collected includes event description, time of onset, clinician’s 
assessment of severity, relationship to study product (assessed only by those with the training and 
authority to make a diagnosis), and time of resolution/stabilization of the event. All AEs occurring while 
on study must be documented appropriately regardless of relationship. All AEs will be followed to 
adequate resolution. 
 
Any medical condition that is present at the time that the participant is screened will be considered as 
baseline and not reported as an AE. However, if the study participant’s condition deteriorates at any 
time during the study, it will be recorded as an AE. UPs will be recorded in the data collection system 
throughout the study. 
 
Changes in the severity of an AE will be documented to allow an assessment of the duration of the event 
at each level of severity to be performed. AEs characterized as intermittent require documentation of 
onset and duration of each episode. 
 
The PI will record all reportable events with start dates occurring any time after informed consent is 
obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. At 
each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events 
will be followed for outcome information until resolution or stabilization. 
 
 
 
All AEs will be recorded on the appropriate CRF and will include information about the start and stop 
dates, severity and relatedness. There should be an attempt to report a “diagnosis” rather than the 
individual signs, symptoms and abnormal laboratory values associated with the diagnosis. However, a 
diagnosis should be reported only if, in the Investigator’s judgment, it is relatively certain (i.e., definite 
or possible). Otherwise individual signs, symptoms and abnormal laboratory values should be reported 
as distinct adverse events. 
 
 
All serious AE, whether or not deemed expected or device related, must be reported to the sponsor’s 
clinical research department immediately or within 24 hours by telephone (see contact details below). 
 
Name: Andrea Biro, Clinical Research Manager 
Phone: 888-907-0115 ext. 132 
Email: abiro@venusconcept.com 
Address: 255 Consumers Road, #110, Toronto, Ontario, Canada, M2J 1R4 
 
A written report prepared by the Principal Investigator must follow within seven working days to the 
clinical monitor and should include a full description of the event and sequence. 
 
The study investigator shall complete a Serious Adverse Event / Serious Adverse Device Effect Form and 
submit to the study sponsor and to the reviewing IRB as soon as possible, but in no event later than 10 
working days after the investigator first learns of the effect. The study sponsor contact information is 
provided in Section 1, Key Roles. The study sponsor is responsible for conducting an evaluation of an 
8.4 
REPORTING PROCEDURES 
8.4.1 ADVERSE EVENT REPORTING 
8.4.2 SERIOUS ADVERSE EVENT REPORTING 

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unanticipated adverse device effect and shall report the results of such evaluation to Health Canada, the 
FDA or local regulatory agency and to all reviewing IRBs and participating investigators within 10 
working days after the sponsor first receives notice of the effect. Thereafter the sponsor shall submit 
such additional reports concerning the effect as Health Canada, the FDA or local regulatory agency 
requests. 
 
 
Incidents or events that meet the criteria for UPs require the creation and completion of an UP report 
form. It is the site investigator’s responsibility to report UPs to their IRB and to the study sponsor. The 
UP report will include the following information: 
 
Protocol identifying information: protocol title and number, PI’s name, and the IRB project number; 
 
• 
A detailed description of the event, incident, experience, or outcome; 
• 
An explanation of the basis for determining that the event, incident, experience, or outcome 
represents an UP; 
• 
A description of any changes to the protocol or other corrective actions that have been taken or 
are proposed in response to the UP. 
 
An investigator shall submit to the sponsor and to the reviewing IRB a report of any unanticipated 
adverse device effect occurring during an investigation as soon as possible, but in no event later than 10 
working days after the investigator first learns of the effect (21 CFR 812.150(a)(1)), A sponsor who 
conducts an evaluation of an unanticipated adverse device effect under 812.46(b) shall report the 
results of such evaluation to Health Canada, the FDA or local regulatory agency and to all reviewing IRB's 
and participating investigators within 10 working days after the sponsor first receives notice of the 
effect. Thereafter the sponsor shall submit such additional reports concerning the effect as FDA (21 CFR 
812.150(b)(1)) or local regulatory agency requests. 
 
 
If a subject becomes pregnant during the course of the study, the subject will be terminated from the 
study. The pregnancy will be immediately reported to the sponsor on the Notification of Subject or 
Partner Pregnancy form and to the IRB using the same reporting timelines as a SAE. The investigator will 
follow the pregnancy until completion and will report the outcome of the pregnancy to the sponsor on 
the Notification of Subject or Partner Pregnancy Outcome form and the IRB within 10 business days. 
 
 
The study may be halted at any time by the sponsor, the IRB, Health Canada, the FDA or local regulatory 
agencies due to safety concerns. Examples of findings that might trigger a safety review are the number 
of SAEs overall, the number of occurrences of a particular type of SAE, severe AEs/reactions, or 
increased frequency of events. If the study is halted, the sponsor will immediately notify all 
investigational sites, the IRB(s), Health Canada, the FDA or local regulatory agencies. 
 
 
Independent oversight is an important component to ensure human subjects' protection. Safety 
oversight will be under the direction of the sponsor and a medical monitor. 
8.4.3 UNANTICIPATED PROBLEM REPORTING 
8.4.4 REPORTING OF PREGNANCY 
8.5 
STUDY HALTING RULES 
8.6 
SAFETY OVERSIGHT 

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Clinical site monitoring is conducted to ensure that the rights and well-being of human subjects are 
protected, that the reported trial data are accurate, complete, and verifiable, and that the conduct of 
the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with 
applicable regulatory requirement(s). 
 
• 
Monitoring for this study will be performed by the sponsor or designate. 
• 
On-site monitoring will occur within 10 weeks of first enrolled subject and will occur at a 
frequency described in the Monitoring Plan. 
• 
Variables to be monitored will be described in the Monitoring Plan. 
• 
The Study Director or designate will be provided copies of monitoring reports within 15 business 
days of visit. 
 
 
 
The Statistical and Analytical Plans (SAP) may be revised during the study to accommodate Clinical Trial 
Protocol Amendments and to make changes to adapt to unexpected issues in study execution and data 
that affect planned analyses. If revised, a formal SAP will be completed and issued prior to database 
lock and unblinding of the study data. 
 
 
The null and alternative hypotheses for the study’s primary, key secondary and safety endpoints are; 
 
• 
Primary Efficacy Endpoints: Statistical hypothesis will not be applied in the analysis of the study’s 
primary endpoint 
 
• 
Secondary Efficacy Endpoint(s): 
o Null Hypothesis (Ho: µd = µpost – µbaseline = 0) – There is no change in thickness of the adipose 
layer as measured by ultrasound (US) at twelve weeks post-treatment as compared to 
baseline. 
 
Alternative Hypothesis (Ha: µd = µpost – µbaseline ≠ 0) – There is a change in thickness of the 
adipose layer as measured by ultrasound (US) at twelve weeks post-treatment as 
compared to baseline. The efficacy endpoint to treatment will be defined by reduction in 
abdominal fat determined by decrease in thickness of the adipose layer as measured by 
ultrasound (US) at twelve weeks post-treatment as compared to baseline. 
 
o Null Hypothesis (Ho: µd = µpost – µbaseline = 0) – There is no change in abdominal 
circumference at twelve weeks post-treatment as compared to baseline. 
 
Alternative Hypothesis (Ha: µd = µpost – µbaseline ≠ 0) – There is a change in abdominal 
circumference at twelve weeks post-treatment as compared to baseline. The change will 
9 
CLINICAL MONITORING 
10 
STATISTICAL CONSIDERATIONS 
10.1 
STATISTICAL AND ANALYTICAL PLANS 
10.2 STATISTICAL HYPOTHESES 

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be defined by reduction in abdominal circumference at twelve weeks post-treatment as 
compared to baseline. 
 
o Null Hypothesis (Ho: µd = µpost – µpre = 0) – There is no satisfaction with the treatment at 
twelve weeks using the 5-Point Likert Subject Satisfaction Scale as assessed by the 
subjects. 
 
Alternative Hypothesis (Ha: µd = µpost – µpre ≠ 0) – There is satisfaction with the treatment 
at twelve weeks using the 5-Point Likert Subject Satisfaction Scale as assessed by the 
subjects. 
 
• 
Safety Endpoint: Statistical hypothesis will not be used in the analysis of the study’s safety 
endpoint. 
 
 
The Intention-to-Treat Analysis Dataset will be used; efficacy and safety analyses will be carried out on all 
subjects who underwent Venus Bliss™ treatment. 
 
 
 
This is an open-label, baseline-controlled, evaluator-blind multi-center study evaluating one treatment 
with a 1060 nm diode laser for non-invasive fat reduction of the abdomen. 
 
All summary tables for quantitative parameters will display mean, standard deviation, median, range 
(minimum and maximum), percentages as well as number of missing data (if relevant). All summary 
tables for qualitative parameters will display counts, percentages and number of missing data if 
relevant. Baseline data are defined as the last photograph and measurement performed before the first 
treatment on Visit 1. 
 
All statistical tests will be two-sided, where applicable. The level of statistical significance for 
effectiveness analyses is 5% (α = 0.05) for all tests of differences. Where appropriate, t-test and/or two- 
proportion z-test will be used to compare outcome at twelve weeks post-treatment as compared to 
baseline. This test will enable us to accept or reject the null hypotheses. Rejection of null hypotheses will 
establish that: 
 
• 
The two-sided 95% confidence interval for the difference between the means excludes zero. 
• 
The two means are statistically significantly different at the 5% level (P < 0.05) two-sided. 
Upon rejection of null hypotheses, further statistical test tools such as Confidence Interval, and/or One- 
way ANOVA and/or descriptive statistical tools may be used to determine the performance of the 
treatment. 
10.3 
ANALYSIS DATASETS 
10.4 
DESCRIPTION OF STATISTICAL METHODS 
10.4.1 GENERAL APPROACH 

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In order to accommodate imbalances of some baseline of scores or measurements, covariate adjustment 
analysis may be performed in SAP to estimate adjusted treatment effects for the primary endpoint 
analysis. 
 
The assumption for the statistical test is that variables are normally distributed within study group and 
the variation of scores or measurements at twelve weeks post-treatment as compared to baseline is not 
reliably different. 
 
The safety analysis will be done by analyzing spontaneous reports of adverse events (AE), subjects’ 
completed 10 cm discomfort/pain visual pain scale and immediate response reports by the principal 
investigator from his/her observation/examination of the treated area. Appropriate Medical Dictionary 
for Regulatory Activities (MedDRA) code will be used to describe all spontaneously reported or other study 
related adverse events. 
 
 
The following will be consider for the analysis primary endpoints: 
The results of each Blinded Reviewer’s evaluation of photographs taken at three and six moth compared 
to baseline will be analyzed and the results will be reported as a % of the correctly identified post 
treatment photographs chosen per Blinded Reviewer. An average of the % of the correctly identified post 
treatment photographs chosen by Blinded Reviewer will be calculated and used to determine 
 
Bar, pie charts or graphs indicating percentages of the correctly identified post treatment photographs 
chosen by Blinded Reviewer may also be used to analyse efficacy. 
 
The efficacy endpoint to treatment will be defined by an average of the 80% of the correctly identified 
post treatment photographs chosen by Blinded Reviewer This will be used to determine if the study meets 
the primary endpoint expectation. 
 
The % of the correctly identified post treatment photographs chosen by Blinded Reviewer of all subjects 
who received at least one treatment of Venus Bliss™ and for whom at least one valid post-baseline 
assessment were obtained will be analysed for these primary endpoints. Mutiple imputation method or 
modelling of available data may be used for missing data as appropriate. 
 
 
For the analysis of changes in change in thickness of the adipose layer, abdominal circumference and 
subjects’ assessment of satisfaction with the treatment secondary endpoints the following analysis will be 
considered: 
 
Summary tables of changes in thickness of the adipose layer measured by ultrasound (US), abdominal 
circumference, and subjects’ assessment of satisfaction at twelve weeks post-treatment as compared to 
baseline will be displayed as mean difference, standard deviation and standard error. 
 
Bar charts, pie chart, graphs or any other descriptive statistical displays indicating scores, percentages 
and/or proportions of changes in thickness of the adipose layer measured by ultrasound (US), abdominal 
circumference, and subjects’ assessment of satisfaction at twelve weeks post-treatment as compared to 
baseline will be used where applicable to analyse efficacy. 
10.4.2 ANALYSIS OF THE PRIMARY ENDPOINTS 
10.4.3 ANALYSIS OF THE SECONDARY ENDPOINTS 

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All statistical tests that will be two-sided. The level of statistical significance for effectiveness analyses is 
5% (α = 0.05) for all tests of differences. Where appropriate, two-proportion z-test will be used to compare 
the differences between of changes in thickness of the adipose layer measured by ultrasound (US), 
abdominal circumference, and subjects’ assessment of satisfaction at twelve weeks post-treatment as 
compared to baseline. Analysis of Covariance (ANCOVA) may also be used where appropriate. 
Change in thickness of the adipose layer measured by ultrasound (US), abdominal circumference, and 
subjects’ assessment of satisfaction assessments at twelve weeks post-treatment as compared to baseline 
of all subjects who received at least one treatment of Venus Bliss™ and for whom at least one valid post- 
baseline assessment were obtained will be analysed for these secondary endpoints. Mutiple imputation 
method or modelling of available data may be used for missing data as appropriate. 
 
 
The safety analysis will be done by analyzing spontaneous reports of adverse events (AE), subjects’ 
completed 10 cm discomfort/pain visual pain scale and a response questionnaire as well as analysis of 
immediate response reports by the principal investigator from his/her observation/examination of the 
treated area. Appropriate Medical Dictionary for Regulatory Activities (MedDRA) code will be used to 
describe all spontaneously reported or other study related adverse events. 
 
Summaries of spontaneously reported or other study related adverse events will be presented as: 
 
o Number (%) of subjects with any AE, 
o Number (%) of subjects with any serious adverse events (SAE), 
o Number (%) of subjects permanently withdrawn from treatment due to AE 
Summaries of analysis of immediate response reports by the principal investigator examination will be 
displayed on a bar or pie chart as; 
 
o the overall frequency of subjects with each event (pain during treatment, hemorrhage, burn, 
erythema, edema, purpura) 
o Frequency of subjects with specific severity/intensity for each event using a 5 points scale: 
1=none; 2=trace; 3=moderate; 4=marked; 5=severe 
o The overall percentage or proportion of subject observed with marked or severe intensity of any 
event will be calculated and compared to those with none, trace or moderate severity/intensity 
with the aid of a bar or pie chart. 
 
The following will be considered for the analysis of 10 cm discomfort/pain visual pain scale scores safety 
data: 
 
A summary table of the 10 cm discomfort/pain visual pain scale scores post treatment will be displayed 
as mean difference, standard deviation and standard error. The 10 cm discomfort/pain visual pain scale is 
a 11-level (0 to 10) ordinal scale tool for assessing pain. 
 
The overall percentage or proportion of subject that recorded marked or severe post treatment 
discomfort/pain visual pain scale scores may be calculated and compared to those with none, trace, low 
or moderate discomfort/pain using a bar or pie chart. 
10.4.5 SAFETY ANALYSIS 

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Adherence to the protocol will be assessed by calculating the number or (%) subjects’ data for each 
endpoint assessment that is not provided in subjects Case Report Forms. This will be further analyzed as 
per frequency of each endpoint data that is not available due to loss to follow-up, discontinuation of the 
intervention or any other reason. 
 
 
Subjects baseline measurements and scores of all applicable endpoints will be compared using 
descriptive statistics such as mean score, standard deviation, standard error, range and graphical 
presentations. 
 
 
No interim analysis is planned. 
 
 
There will be no interim analysis during this study. However, this study may be temporarily suspended or 
prematurely terminated if there is sufficient reasonable cause as per section 5.5 and 8.5. 
 
 
There will be no interim analysis during this study. However, this study may be temporarily suspended 
or prematurely terminated if there is sufficient reasonable cause as per section 5.5 and 8.5. 
 
 
Not applicable. Primary or secondary endpoints may be analyzed based on age, sex, race/ethnicity or 
other demographic characteristic(s). 
 
 
Not applicable. 
 
 
Individual participant data will be listed by measure and time point as appendix to the study report. 
 
 
Not applicable. 
 
 
The change in thickness of the adipose layer as measured by ultrasound (US) at twelve weeks post- 
treatment as compared to baseline secondary endpoint outcome measures was used to calculate the 
study sample size. 
10.4.6 ADHERENCE AND RETENTION ANALYSES 
10.4.7 BASELINE DESCRIPTIVE STATISTICS 
10.4.8 PLANNED INTERIM ANALYSES 
10.4.8.1 
SAFETY REVIEW 
10.4.8.2 
EFFICACY REVIEW 
10.4.9    ADDITIONAL SUB-GROUP ANALYSES 
10.4.10 
MULTIPLE COMPARISON/ MULTIPLICITY 
10.4.11 
TABULATION OF INDIVIDUAL RESPONSE DATA 
10.4.12 
EXPLORATORY ANALYSES 
10.5 
SAMPLE SIZE 

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Sample size calculation using secondary endpoint outcome measure; 
 
• 
Null and alternate hypotheses: 
Null Hypothesis (Ho: µd = µpost – µbaseline = 0) – There is no change in thickness of the adipose 
layer as measured by ultrasound (US) at twelve weeks post-treatment as compared to 
baseline. 
 
Alternative Hypothesis (Ha: µd = µpost – µbaseline ≠ 0) – There is a change in thickness of the 
adipose layer as measured by ultrasound (US) at twelve weeks post-treatment as 
compared to baseline. The efficacy endpoint to treatment will be defined by reduction in 
abdominal fat determined by decrease in thickness of the adipose layer as measured by 
ultrasound (US) at twelve weeks post-treatment as compared to baseline. 
Expected reduction in abdominal fat of 2.65 + 1.41 obtained from a similar study (,Bass LS 
et al) will be used to determine the sample size. 
• 
In view of the nature of this study in regard to number of visits, we make provision for 10% study 
drop out, withdrawal or loss to follow-up. 
• 
2- Tailed Sample Size calculation formula for two Samples was used in the table below: 
 
(1-β), Desired Power 
0.8 
α, Level of Significance 
0.05 
μd, expected reduction in abdominal fat measured from 
baseline to 3 month post treatment visit under Ha 
2.65 
σ, Standard Deviation (obtained from a study) 
1.41 
Z1-α/2 
1.96 
Z1-β, (for 80%) 
0.84 
Estimated Sample Size 
40 
Estimated Sample Size of each equal group + 10% drop out 
44 
Conclusion: The estimated sample size for the study and the additional 10% provision for drop out (44 
subjects) obtained from the secondary endpoint outcome measure calculation is required for this study. 
However, to ensure statistical significance, up to 50 subjects will be enrolled. 
 
 
At screening, once a subject has signed the informed consent, and inclusion/exclusion criteria has been 
met, a subject number will be assigned. Subjects will receive a unique identifying number that will be 
composed of a two-digit site number and a three digit subject number in sequence. This unique 
identifier will be used throughout the entire study and will be entered in the subject's case report form 
(CRF) and for each treatment. Subjects are not randomized; this is an open-label, baseline-controlled, 
evaluator-blind multi-center study. 
 
 
This is an open-label, baseline-controlled, evaluator-blind multi-center study; only the independent 
reviewers will be blinded. 
10.6 
MEASURES TO MINIMIZE BIAS 
10.6.1 ENROLLMENT/ RANDOMIZATION/ MASKING PROCEDURES 
10.6.2 EVALUATION OF SUCCESS OF BLINDING 

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Not applicable. 
 
 
Each participating site will maintain appropriate medical and research records for this trial, in 
compliance with ICH E6, ISO 14155:2011, HIPAA and regulatory and institutional requirements for the 
protection of confidentiality of participants. Each site will permit authorized representatives of the 
study sponsor and regulatory agencies to examine (and when permitted by applicable law, to copy) 
clinical records for the purposes of quality assurance reviews, audits, and evaluation of the study safety, 
progress, and data validity. 
 
Source data are all information, original records of clinical findings, observations, or other activities in a 
clinical trial necessary for the reconstruction and evaluation of the trial. Examples of these original 
documents and data records include, but are not limited to, hospital records, clinical and office charts, 
laboratory notes, memoranda, participants' memory aids or evaluation checklists, pharmacy dispensing 
records, recorded audio tapes of counseling sessions, recorded data from automated instruments, 
copies or transcriptions certified after verification as being accurate and complete, microfiches, 
photographic negatives, microfilm or magnetic media, x-rays, and participant files and records kept at 
the pharmacy, at the laboratories, and medico-technical departments involved in the clinical trial. 
 
It is acceptable to use CRFs as source documents. The subject self-reported modified Simple Lifestyle 
Indicator Questionnaire, 5-point Likert Subject satisfaction Scale, treatment evaluation and visual pain 
scale data for this study will be collected on the CRF. The immediate response as assessed by the 
principal investigator will be collected on the CRF with the remainder of the data collected from other 
sources. It is not acceptable for the CRF to be the only record of a subject’s participation in the study. 
This is to ensure that anyone who would access the patient medical record has adequate knowledge 
that the patient is participating in a clinical trial. 
 
 
Prior to any independent use of the Venus Bliss™ investigational device, study personnel will receive 
proper training from the sponsor. Site personnel will be trained on the use of the device prior to study 
initiation at the site. Additional training requirements will be discussed during study initiation and will 
include site responsibilities, and study documentation. In addition, the sponsor will provide protocol 
specific training for the site. The site will document which individual has been assigned to a specific task 
and will ensure that appropriate training has occurred for that task. 
 
Regular monitoring and an independent audit, if conducted, must be performed according to ICH-GCP 
and ISO 14155:2011. See also Section 9, Clinical Monitoring. 
 
Quality control (QC) procedures will be implemented beginning with the data entry system and data QC 
checks that will be run on the database will be generated. Any missing data or data anomalies will be 
communicated to the site(s) for clarification/resolution. 
 
Monitors will verify that the clinical trial is conducted and data are generated, documented (recorded), 
and reported in compliance with the protocol, GCP, and the applicable regulatory requirements. 
10.6.3 BREAKING THE STUDY BLIND/PARTICIPANT CODE 
11 
SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS 
12 
QUALITY ASSURANCE AND QUALITY CONTROL 

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The investigational site will provide direct access to all trial related sites, source data/documents, and 
reports for the purpose of monitoring and auditing by the sponsor, and inspection by local and 
regulatory authorities. 
 
 
 
The investigator will ensure that this study is conducted in full conformity with Regulations for the 
Protection of Human Subjects of Research codified in 45 CFR Part 46, 21 CFR Part 50, 21 CFR Part 56, 
and/or the ICH E6, the Declaration of Helsinki, Council for International Organizations of Medical Science 
(CIOMS), ISO 14155:2011, International Ethical Guidelines for Biomedical Research Involving Human 
Subjects (2002), or another country’s ethical policy statement, whichever provides the most protection 
to human subjects. 
 
 
The protocol, informed consent form(s), recruitment materials, and all participant materials will be 
submitted to the IRB for review and approval. Approval of both the protocol and the consent form must 
be obtained before any participant is enrolled. Any amendment to the protocol will require review and 
approval by the IRB before the changes are implemented to the study. All changes to the consent form 
will be IRB approved; a determination will be made regarding whether previously consented participants 
need to be re-consented. 
 
 
 
Informed consent is required for all subjects in a study. In obtaining and documenting informed 
consent, the investigator should comply with applicable regulatory requirements and should adhere to 
45 CFR Part 46, 21 CFR Part 50, 21 CFR Part 56, or equivalent local regulatory regulations or guidelines 
and/or ICH GCP. Prior to the beginning of a trial, the investigator should have the IRB's written approval 
for the protocol and the written informed consent forms(s) and any other written information to be 
provided to the participants. Consent forms describing in detail the study agent, study procedures, and 
risks are given to the participant and written documentation of informed consent is required prior to 
starting intervention/administering study product. 
 
 
Informed consent is a process that is initiated prior to the individual’s agreeing to participate in the 
study and continues throughout the individual’s study participation. Extensive discussion of risks and 
possible benefits of participation will be provided to the participants and their families. Consent forms 
will be IRB-approved and the participant will be asked to read and review the document. The 
investigator will explain the research study to the participant and answer any questions that may arise. 
All participants will receive a verbal explanation in terms suited to their comprehension of the purposes, 
procedures, and potential risks of the study and of their rights as research participants. Participants will 
13 
ETHICS/PROTECTION OF HUMAN SUBJECTS 
13.1 
ETHICAL STANDARD 
13.2 
INSTITUTIONAL REVIEW BOARD 
13.3 
INFORMED CONSENT PROCESS 
13.3.1 CONSENT/ASSENT AND OTHER INFORMATIONAL DOCUMENTS PROVIDED TO 
PARTICIPANTS 
13.3.2 CONSENT PROCEDURES AND DOCUMENTATION 

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have the opportunity to carefully review the written consent form and ask questions prior to signing. 
The participants should have the opportunity to discuss the study with their surrogates or think about it 
prior to agreeing to participate. The participant will sign the informed consent document prior to any 
procedures being done specifically for the study. The participants may withdraw consent at any time 
throughout the course of the trial. A copy of the informed consent document will be given to the 
participants for their records. The rights and welfare of the participants will be protected by 
emphasizing to them that the quality of their medical care will not be adversely affected if they decline 
to participate in this study. 
 
 
Participant confidentiality is strictly held in trust by the participating investigators, their staff, and the 
sponsor(s) and their agents. This confidentiality is extended to cover testing of biological samples and 
genetic tests in addition to the clinical information relating to participants. Therefore, the study 
protocol, documentation, data, and all other information generated will be held in strict confidence. No 
information concerning the study or the data will be released to any unauthorized third party without 
prior written approval of the sponsor. 
 
The study monitor, other authorized representatives of the sponsor, representatives of the IRB or device 
company supplying study product may inspect all documents and records required to be maintained by 
the investigator, including but not limited to, medical records (office, clinic, or hospital) and pharmacy 
records for the participants in this study. The clinical study site will permit access to such records. 
 
The study participant’s contact information will be securely stored at each clinical site for internal use 
during the study. At the end of the study, all records will continue to be kept in a secure location for as 
long a period as dictated by the sponsor, local IRB and any other regulations. 
 
Study participant research data, which is for purposes of statistical analysis and scientific reporting, will 
be transmitted to and stored at the sponsor’s office. This will not include the participant’s contact or 
identifying information. Rather, individual participants and their research data will be identified by a 
unique study identification number. The study data entry and study management systems used by 
clinical sites and by sponsor’s research staff will be secured and password protected. At the end of the 
study, all study databases will be de-identified and archived by the sponsor. 
 
 
The investigator will store all data according to the local regulatory standards. 
 
 
 
Data collection is the responsibility of the clinical trial staff at the site under the supervision of the site 
PI. The investigator is responsible for ensuring the accuracy, completeness, legibility, and timeliness of 
the data reported. 
 
All source documents should be completed in a neat, legible manner to ensure accurate interpretation 
of data. Black ink is required to ensure clarity of reproduced copies. When making changes or 
13.4 
PARTICIPANT AND DATA CONFIDENTIALITY 
13.4.1 RESEARCH USE OF STORED HUMAN SAMPLES, SPECIMENS OR DATA 
14 
DATA HANDLING AND RECORD KEEPING 
14.1 
DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES 

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corrections, cross out the original entry with a single line, and initial and date the change. DO NOT 
ERASE, OVERWRITE, OR USE CORRECTION FLUID OR TAPE ON THE ORIGINAL. 
 
Copies of the paper CRF will be provided for use as source documents and maintained for recording data 
for each participant enrolled in the study. Data reported in the CRF derived from source documents 
should be consistent with the source documents or the discrepancies should be explained and captured 
in a progress note and maintained in the participant’s official study record. Self-reported subject data 
recorded on the non-carbon copy CRF page is permitted. The original form will be collected by the 
sponsor and the copy will remain at the site. 
 
Clinical data (including AEs, concomitant medications, and expected adverse reactions data) and clinical 
laboratory data from paper CRFs will be collected by the study sponsor and will be entered directly onto 
paper CRFs from the source documents. 
 
 
Study documents, including copies of the paper CRFs, signed informed consent forms, photographs, 
laboratory results, medical records, data clarification forms and regulatory documents, should be 
retained for a minimum of 2 years after the last approval of a marketing application in an 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 
product. These documents should be retained for a longer period, however, if required by local 
regulations. No records will be destroyed without the written consent of the sponsor, if applicable. It is 
the responsibility of the sponsor to inform the investigator when these documents no longer need to be 
retained. 
 
 
A protocol deviation is any noncompliance with the clinical trial protocol or GCP requirements. The 
noncompliance may be either on the part of the participant, the investigator, or the study site staff. As a 
result of deviations, corrective actions are to be developed by the site and implemented promptly. 
These practices are consistent with ISO 14155:2011 and ICH E6: 
• 
4.5 Compliance with Protocol, sections 4.5.1, 4.5.2, and 4.5.3 
• 
5.1 Quality Assurance and Quality Control, section 5.1.1 
• 
5.20 Noncompliance, sections 5.20.1, and 5.20.2. 
It is the responsibility of the site to use continuous vigilance to identify and report deviations within 10 
working days of identification of the protocol deviation, or within 10 working days of the scheduled 
protocol-required activity. All deviations must be addressed in study source documents. Protocol 
deviations must be sent to the local IRB per their guidelines. The site PI/study staff is responsible for 
knowing and adhering to their IRB requirements. 
 
 
The International Committee of Medical Journal Editors (ICMJE) member journals have adopted a 
clinical trials registration policy as a condition for publication. The ICMJE defines a clinical trial as any 
research project that prospectively assigns human subjects to intervention or concurrent comparison or 
14.2 
STUDY RECORDS RETENTION 
14.3 
PROTOCOL DEVIATIONS 
14.4 
PUBLICATION AND DATA SHARING POLICY 

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control groups to study the cause-and-effect relationship between a medical intervention and a health 
outcome. Medical interventions include drugs, surgical procedures, devices, behavioral treatments, 
process-of-care changes, and the like. Health outcomes include any biomedical or health-related 
measures obtained in patients or participants and adverse events. The ICMJE policy, and the Section 
801 of the Food and Drug Administration Amendments Act of 2007, requires that all clinical trials be 
registered in a public trials registry such as ClinicalTrials.gov, which is sponsored by the National Library 
of Medicine. Other biomedical journals are considering adopting similar policies. The ICMJE does not 
review specific studies to determine whether registration is necessary; instead, the committee 
recommends that researchers who have questions about the need to register err on the side of 
registration or consult the editorial office of the journal in which they wish to publish. 
 
The sponsor or designated principal investigator will register and report results of certain "applicable 
clinical trials": 
 
• 
Trials of Devices: Controlled trials with health outcomes of a product subject to Health Canada 
or FDA regulation (other than small feasibility studies) and pediatric post market surveillance 
studies. 
 
 
 
The study will be administered by the sponsor. 
 
 
The independence of this study from any actual or perceived influence, such as by the device industry, is 
critical. Therefore, any actual conflict of interest of persons who have a role in the design, conduct, 
analysis, publication, or any aspect of this trial will be disclosed and managed. Furthermore, persons 
who have a perceived conflict of interest will be required to have such conflicts managed in a way that is 
appropriate to their participation in the trial. The sponsor will ensure that all study group members 
disclose all conflicts of interest and will establish a mechanism for the management of all reported 
dualities of interest. 
 
 
Alizadeh Z, Halabchi F, Mazaheri R, et al. Review of the Mechanisms and Effects of Noninvasive Body 
Contouring Devices on Cellulite and Subcutaneous Fat. Int J Endorcrinol Metab. 2016 Oct; 14(4): 
e36727. 
 
Auh SL, Iyengar S, Weil A, Bolotin D et al. Quantification of Noninvasive Fat Reduction: A Systematic 
Review. Laser in Surg Med.  2018 50: 96-110. 
 
Bass LS, Doherty ST. Safety and Efficacy of a noninvasive 1060nm Diode Laser for Fat Reduction of the 
Abdomen. J Drugs Dermatol. 2018 17(1): 106-112 
 
Chilukuri S, Mueller G. “Hands Free” Noninvasive Body contouring Devices: Review of Effectiveness and 
Patient Satisfaction. J Drugs Dermatol. 2016 15(11): 1402-1406. 
15 
STUDY ADMINISTRATION 
15.1 
STUDY LEADERSHIP 
16 
CONFLICT OF INTEREST POLICY 
17 
LITERATURE REFERENCES 

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Decorato JW, Chen B, Sierra R. Subcutaneous Adipose Tissue Response to a Non-Invasive Hyperthermic 
Treatment using a 1060nm Laser. Lasers in Surg Med. 2017 49(5): 480-489. 
 
Godwin M, Pike A, Bethune C et al. Concurrent and Convergent Validity of the Simple Lifestyle Indicator 
Questionnaire. ISRN Family Medicine Volume 2013, Article ID 529645, 6 pages. 
 
Katz B, Doherty S. Safety and Efficacy of a Noninvasive 1060nm Diode Laser for Fat Reduction of the 
Flanks. Dermatol Surg. 2018 44(3): 388-396. 
 
McBean JC, Katz BE. Laser Lipolysis: An Update. J Clin Aesthetic Derm. 2011 4(7): 25-34. 
 
Schilling L, Saedi N, Weiss R. 1060 nm Diode Hyperthermic Laser Lipolysis: The Latest in Non-Invasive 
Body Contouring. J Drugs Dermatol. 2017 Jan 1;16(1):48-52. 
 
 
Version 
Date 
Significant Revisions 
 
APPENDIX