This is an Exploratory Multi-center, Pilot Study to Evaluate the Safety, Efficacy and Ergonomics of Cutera truSculpt Device. Subjects May Receive up to Three Treatments and Will be Followed at 12 Weeks Post the First and Final Treatment.
Phase: NA
Conditions: Bulging, Body Fat
Sponsor: Cutera Inc.

Cutera, Inc. 
Protocol # C-17-TS16 
“Multi-Center Pilot Study of truSculpt Device” 
 
Confidential and Proprietary 
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                                                       Version 1.0, 28 JUL 2017 
 
 
 
TITLE PAGE 
 
 
 
 
Protocol Number: 
C-17-TS16 
Protocol Title: 
Multi-Center Pilot Study of truSculpt Device 
Sponsor: 
 
Cutera, Inc. 
3240 Bayshore Boulevard 
Brisbane, CA 94005 
Telephone: 415-657-5500 
Fax: 415-715-3518 
Contact: Michaela Bell 
Email: mbell@cutera.com 
 
 
Version, Date: 
Version 1, Dated July 28, 2017 
 
 
 
 
 
 
Statement of Compliance  
The study will be conducted in accordance with the design and specific provisions of this IRB approved protocol, in 
accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent 
with Good Clinical Practice (GCP) and the applicable regulatory requirement(s).  
 
 
 
 
NOTE:  The confidential information in the following document is provided to you as an Investigator, potential Investigator, or 
consultant for review by you, your staff, and applicable Institutional Review Board. By accepting this document, you agree that 
the information contained herein will not be disclosed to others, without written authorization from Cutera, Inc. except to the 
extent necessary to obtain informed consent from those persons to whom the device will be administered. 
 
 

Cutera, Inc. 
Protocol # C-17-TS16 
“Multi-Center Pilot Study of truSculpt Device” 
 
Confidential and Proprietary 
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                                                       Version 1.0, 28 JUL 2017 
Protocol Signature Page – Principal Investigator 
 
 
PROTOCOL C-17-TS16 
 
 
Study Title:   Multi-Center Pilot Study of truSculpt Device 
 
 
Protocol Version 1.0, Dated July 28, 2017 
 
I have received and read the protocol dated July 28, 2017 and agree to adhere to the requirements. I am 
aware that my adherence to the above protocol is mandatory and that any changes in the protocol or 
informed consent form must first be approved by Cutera, Inc. and the Institutional Review Board, except 
those changes necessary to eliminate apparent immediate hazards to subjects.  I will provide copies of 
this protocol and all pertinent information to the study personnel under my supervision. I will discuss this 
material with them and ensure they are fully informed regarding their role in the study. I will ensure that 
the study is conducted in compliance with the protocol, Good Clinical Practice (GCP), and all applicable 
regulatory requirements, and with the reviewing Institutional Review Board (IRB) requirements. I agree 
to commence this study only after documented IRB approval is obtained. 
 
 
 
 
Principal 
Investigator 
 
 
 
 
 
 
Signature 
 
Date 
 
 
 
 
 
 
 
 
 
Printed Name 
 
 
 
 
 
 
 
 
 

Cutera, Inc. 
Protocol # C-17-TS16 
“Multi-Center Pilot Study of truSculpt Device” 
 
Confidential and Proprietary 
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Table of Contents 
Protocol Summary 
5 
1 
PURPOSE 
6 
2 
BACKGROUND INFORMATION 
6 
3 
STUDY OBJECTIVES 
7 
4 
STUDY DESIGN 
7 
4.1.1 
Safety Endpoint 
7 
4.1.2  
Exploratory Endpoints                                                                                                                          7 
4.2 
Study Duration 
7 
     4.3    Study Assessments 
4.3.1 
Safety Assessments 
8 
4.3.2 
Exploratory Assessments 
8 
     4.4 Study Discontinuation 
     4.5   Investigator Selection 
5 
STUDY POPULATION 
8 
5.1 
Study Subject Recruitment and Selection 
8 
5.1.1 
Inclusion Criteria 
9 
5.1.2 
Exclusion Criteria 
9 
5.2 
Subject Numbering 
10 
5.2.1 Subject Discontinuation Criteria 
6 
STUDY PROCEDURES 
10 
6.1 
Screening and Enrollment Visit Procedures 
10 
6.2 
Pre-Treatment Procedures and Treatment Visits 
11 
    6.3      Follow-up Visit 
7 
ADVERSE EVENTS AND ADVERSE DEVICE EVENTS 
12 
7.1 
Definitions 
12 
7.1.1 
Adverse Event (AE) 
12 
7.1.2 
Serious Adverse Event (SAE) 
12 
7.1.3 
Anticipated Serious Adverse Device Effect (ASADE) 
12 
7.1.4 
Unanticipated Serious Adverse Device Effect (USADE) 
12 
7.2 
Recording AEs/ADEs and SAEs/SADEs 
14 
7.3   Follow-up of Subjects after AEs 
14 
8 
POTENTIAL RISKS / BENEFITS 
14 
8.1 
Potential Risks 
14 

Cutera, Inc. 
Protocol # C-17-TS16 
“Multi-Center Pilot Study of truSculpt Device” 
 
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8.2 
Potential Benefits 
15 
9 
DATA ANALYSIS PLAN 
16 
9.1 
Sample Size 
16 
9.2 
Analysis Sets 
16 
9.3 
Analysis of Exploratory/Efficacy Endpoints 
16 
9.4 
Safety Analysis 
16 
10 STUDY MANAGEMENT AND ADMINISTRATIVE PROCEDURES 
16 
10.1 
Training and Monitoring 
16 
10.2 
Informed Consent 
16 
10.3 
Protocol Compliance 
17 
10.3.1 
Protocol Amendments 
17 
10.3.2 
Protocol Deviations 
17 
10.4 
Data Collection, Record Keeping and Storage 
17 
10.5 
Subject Confidentiality 
18 
10.6 
Publication Policy 
18 
REFERENCES 
19 
Appendix 1: Study Schedule 
21 
Appendix 2: Pain Rating Scale                                                                                                                                   22 
Appendix 3: Before and After Treatment Instructions                                                                                         23 
Appendix 4: Subject Questionnaire                                                                                                                         24 
Appendix 5: Global Aesthetic Improvement Scale (GAIS)                                                                                    26 
Appendix 6: Investigator Evaluation                                                                                                                        27  
 
 
 

Cutera, Inc. 
Protocol # C-17-TS16 
“Multi-Center Pilot Study of truSculpt Device” 
 
Confidential and Proprietary 
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                                                       Version 1.0, 28 JUL 2017 
Protocol Summary 
 
Title 
Multi-Center Pilot Study of truSculpt Device  
Objective 
 
An exploratory pilot study to evaluate the safety, efficacy and 
ergonomics of Cutera truSculpt device 
Study Design 
Multi-center, exploratory pilot study  
Enrollment 
Approximately 40 subjects at three sites within the US 
Safety Endpoint 
Incidence and severity of adverse device events. 
Exploratory Endpoints 
 
 
. 
GAIS at 12 weeks post first and final treatment from Baseline. 
 
 
 
 
  
Subject Population 
Female and male subjects between the ages of 18-65  
Planned Schedule 
First subject enrolled:  August 2017 
Last subject last visit:  May 2018 
 
 
 
 
 

Cutera, Inc. 
Protocol # C-17-TS16 
“Multi-Center Pilot Study of truSculpt Device” 
 
Confidential and Proprietary 
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                                                       Version 1.0, 28 JUL 2017 
1 
PURPOSE 
The purpose of this pilot study is to evaluate the truSculpt device.  
2 
 BACKGROUND INFORMATION 
Unwanted excess fat pockets/bulges have been among the top concerns expressed by patients in the 
aesthetic field.  Although surgical interventions produce the most definitive results with body contouring, 
these invasive methods require significant recovery time and come with inherent risks.   
 
As a non-invasive option, laser, intense pulsed light (IPL), RF, or a combination of these technologies have 
been developed to reduce cellulite and body circumference with minimal recovery time and risks [1]. The 
tightening effect of the thermal energy generated by these devices has been used for reduction in cellulite 
and body circumference in areas including but not limited to arms, abdomen, thigh, back and flanks [2-
14].  Although lasers and IPLs can target the deep dermal layers, the thermal effects of these devices are 
limited due to light scattering and energy absorption by water in the dermis. 
 
RF, which is the most studied device in the non-ablative category, uses electrical current rather than light 
energy.  Unlike light energy, radio waves can penetrate deeper depending on the frequency of operation. 
RF can be used with all Fitzpatrick skin types without jeopardizing epidermal integrity [15].   
 
Magnitude of thermal energy generated is dependent on the resistance (impedance) of the target tissue.  
When RF energy is conducted electrically to tissue, heat is produced as the tissue’s inherent resistance 
(impedance) converts the electrical current to thermal energy [(J) = I x R x T where I = current, R = tissue 
impedance, and T = time of application)].  Subcutaneous fat which is a high impedance tissue generates 
greater heat and accounts for the deeper thermal effects of RF devices [15-18].   
 
RF may be delivered in three different ways: 1) Monopolar when energy is applied as current between a 
single electrode tip and a grounding plate.  2) Bipolar when energy is applied between two points on the 
tip of a probe.  3) Unipolar when energy is delivered as the emission of electromagnetic radiation (EMR) 
rather than current and no grounding pad is necessary. This could be achieved by capacitive, inductive or 
resonant electrical coupling with the tissue. 
 
 
 
 
 
 
 
  
 
 
 
 

Cutera, Inc. 
Protocol # C-17-TS16 
“Multi-Center Pilot Study of truSculpt Device” 
 
Confidential and Proprietary 
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4.3 Study Assessments 
4.3.1 
Exploratory Assessments 
 
 
  
Investigators will complete an assessment of the device along with the Global Aesthetic Improvement of 
the subjects from baseline vs. 12 weeks post first and last treatment.   
  
   
 
   
  
   
4.3.2 
Safety Assessments 
Following the first treatment, adverse events (AEs) will be assessed post-treatment and at each 
subsequent visit using the following scale: 
1= mild: requires minimal or no treatment and does not interfere with the subject’s daily activities. 
2= moderate: may cause some interference with functioning.  
3= severe: interrupts subject’s usual daily activity and may require treatment. 
Treatment-related Discomfort: 
After each treatment, subjects will be asked to rate the average amount of discomfort experienced 
during treatment and immediately after treatment using the Pain Rating Scale (VAS Scale) Appendix 2. 
4.4 Study Discontinuation 
Cutera, Inc. (the sponsor) has the right to terminate this study at any time.  Reasons for terminating the 
study may include, but are not limited to, the following: incidence or severity of adverse events in this or 
other studies indicates a potential health hazard to subjects; subject enrollment is unsatisfactory; number 
of protocol deviations is unacceptable; data recording is inaccurate or incomplete; or questionable study 
site compliance with ICH-E6, Good Clinical Practice. 
4.5 
Investigator Selection 
The Investigator(s) will be invited to participate in the study based on his or her medical specialty, 
experience conducting clinical research studies and experience in the use of RF devices for aesthetic 
indications. Access to potential study subjects and the Investigator’s sincere interest in this study along 
with expressed willingness to cooperate with the study process and requirements are also considered. 
5 
STUDY POPULATION 
5.1 Study Subject Recruitment and Selection 
Approximately 40 male or female subjects, ages 18 to 65, who desire treatment with truSculpt. Subjects 
will be recruited to participate from the local population. Subjects may also be recruited from the 

Cutera, Inc. 
Protocol # C-17-TS16 
“Multi-Center Pilot Study of truSculpt Device” 
 
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Investigator’s existing patient database or from patients who present themselves to the study site 
requesting treatment. Only subjects who meet all eligibility criteria and who provide written informed 
consent will be enrolled into the study. 
 
Each subject will be evaluated by the Investigator to assess his/her suitability for entry into the study 
according to the following inclusion and exclusion criteria.  
5.1.1 Inclusion Criteria 
To be included in the study, subjects must meet all of the following Inclusion Criteria: 
 
1.  
Subject must be able to read, understand and sign the Informed Consent Form. 
2.  
Female or Male, 18 to 65 years of age (inclusive). 
3.  
Subject has visible fat bulges in the area to be treated. 
4.  
Non-smoking for at least 6 months and willing to refrain from smoking for the duration 
of the study. 
5.  
Subject must agree to not undergo any other procedure(s) in the treatment region 
during the study period. 
6.  
Subject must adhere to the follow-up schedule and study instructions. 
7.  
Subject must adhere to the same diet and/or exercise routine throughout the study, 
and agree to maintain the same weight throughout the study. 
8.  
Willing to have digital photographs taken of the treatment area and agree to use of 
photographs for presentation, (educational and/or marketing), publications, and any 
additional marketing purposes. 
9.  
For female subjects: not pregnant or lactating and is either post-menopausal, surgically 
sterilized, or using a medically acceptable form of birth control at least 3 months prior 
to enrollment and during the entire course of the study. 
5.1.2 Exclusion Criteria 
Subjects will be excluded from the study if they meet any of the following Exclusion Criteria: 
1.  
Participation in a clinical trial of another device or drug within 3 months of study 
participation, or during the study period. 
2.  
Any type of prior cosmetic treatment to the target area within 6 months of study 
participation. 
3.  
Any prior invasive cosmetic surgery to the target area, such as liposuction. 
4.  
Has a pacemaker, internal defibrillator, implantable cardioverter-defibrillator, nerve 
stimulator implant, cochlear implant or any other electronically, magnetically or 
mechanically activated implant. 
5.  
Has metal implant(s) within the body, such as artificial heart valves. 
6.  
Significant uncontrolled concurrent illness that in the opinion of the Investigator would 
make the subject unsuitable for inclusion. 
7.  
History of any disease or condition that could impair wound healing. 
8.  
History of keloid formation, hypertrophic scarring or abnormal/delayed wound healing. 
9.  
Skin abnormality in the treatment area that in the opinion of the Investigator would 

Cutera, Inc. 
Protocol # C-17-TS16 
“Multi-Center Pilot Study of truSculpt Device” 
 
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make the subject unsuitable for inclusion. 
10.  
Currently undergoing systemic chemotherapy or radiation treatment for cancer, or 
history of treatment in the target area within 3 months of study participation. 
11.  
As per the Investigator’s discretion, any physical or mental condition which might make 
it unsafe for the subject to participate in this study or a condition that would 
compromise the subject’s ability to comply with the study requirements. 
 
5.2 
Subject Numbering  
If a subject completes the Informed Consent Form, meets the study eligibility criteria and is willing to 
participate, the subject will be assigned a study subject identification number. This number is comprised 
of a site number (which is provided by the sponsor) and a sequential subject number and the subject 
initials (first and last names). 
5.2.1 
Subject Discontinuation Criteria 
If possible, every subject should remain in the study until completion of the required follow-up period. 
However, participation in this study is completely voluntary and a subject can choose to withdraw from 
the study at any time.  Decision to withdraw will not affect or prejudice the subject’s continued medical 
care in any way. In those instances, the investigator will attempt to obtain a final clinical assessment and 
an adverse device effect evaluation for the subject prior to this withdrawal. A subject will be considered 
lost to follow-up only after three unsuccessful, documented attempts to contact the subject have been 
made.   
 
In addition, a subject can be discontinued for any of the following reasons: the Principal Investigator 
decides that continuing in the study would not be in the subject’s best interest, a subject is 
noncompliant with the protocol, a subject has a serious reaction to the treatment, a subject develops 
any of the exclusion criteria during the study period or the study is stopped by the study sponsor. 
 
6 
STUDY PROCEDURES 
 
 
 
 
 
 
 
   
 
 
  
  
 

Cutera, Inc. 
Protocol # C-17-TS16 
“Multi-Center Pilot Study of truSculpt Device” 
 
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7 
ADVERSE EVENTS AND ADVERSE DEVICE EVENTS 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
  
 
 
 
 

Cutera, Inc. 
Protocol # C-17-TS16 
“Multi-Center Pilot Study of truSculpt Device” 
 
 
 
 

Cutera, Inc. 
Protocol # C-17-TS16 
“Multi-Center Pilot Study of truSculpt Device” 
 
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8.2 
Potential Benefits 
The subjects may or may not benefit from the treatment with the study device. Potential benefit is 
improved appearance of treated area. There is no guarantee of success.  

Cutera, Inc. 
Protocol # C-17-TS16 
“Multi-Center Pilot Study of truSculpt Device” 
 
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9 
DATA ANALYSIS PLAN  
9.1 
Sample Size 
This is an exploratory pilot study and 40 subjects has been deemed appropriate for evaluation of the 
device.   
9.2 
Analysis Sets 
The analysis sets will include all enrolled subjects who complete treatment. 
9.3 
Analysis of Efficacy/Exploratory Endpoints 
Formal hypothesis testing and statistical analysis are not planned for this study.  
9.4 
Safety Analyses 
Device-related and procedure-related adverse effects (AEs) will be tabulated and analyzed. For a given AE 
term, counting will be done by subject, not by event, i.e. for a subject reporting the same AE more than 
once, the event will be counted only once, at the most severe and longest duration. The number and 
percentage of subjects experiencing each AE Term will be descriptively summarized. 
10 STUDY MANAGEMENT AND ADMINISTRATIVE PROCEDURES  
 
 
 
  
 
  
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 

Cutera, Inc. 
Protocol # C-17-TS16 
“Multi-Center Pilot Study of truSculpt Device” 
 
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10.3 Protocol Compliance 
The principal investigator must comply with all terms of the protocol. 
10.3.1 Protocol Amendments 
Neither the principal investigator nor the sponsor will modify or alter this protocol without first obtaining 
the concurrence of the other party (with the exception of amendments which involves mitigating a 
medical emergency or immediate health risk to the subject). The party initiating an amendment must 
confirm it clearly in writing and it must be signed and dated by the sponsor and the principal investigator. 
IRB approval must be obtained before implementation of an amendment. 
10.3.2  Protocol Deviations 
All protocol deviations must be clearly described on the case report form (i.e., Cutera Protocol Deviation 
Form). Deviations from the protocol may include but are not limited to subject’s failure to attend 
scheduled visit during a visit window, and incomplete or incorrect study procedures. Any medical 
emergency or immediate health risk to the subject which results in a protocol deviation and must be 
reported to the sponsor within 5 working days 
 
Significant protocol deviations must be reported to IRB according to their policies. 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
  

Cutera, Inc. 
Protocol # C-17-TS16 
“Multi-Center Pilot Study of truSculpt Device” 
 
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10.5 Subject Confidentiality 
This study preserves the confidentiality of all subjects under the Health Insurance Portability and 
Accountability Act of 1996 (HIPAA) Privacy Rule. The following safeguards will be in place to protect the 
privacy of the individuals who are the subjects of the health information to be used in the research and 
the confidentiality of that information:   
 
 
 
 
  
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
not be disclosed.  
10.6 Publication Policy 
The investigator shall have the right to publish the results of the study. Unless mutually agreed upon in 
writing, prior to submission for publication of any manuscript, poster, presentation, abstract or other 
written or oral material describing the results of the study, the investigator shall allow sponsor to review 
manuscript, poster presentation, abstract or other written or oral material which describes the results of 
the study for the purpose only of determining if any patentable information is disclosed. At the sponsor’s 
request, the investigator shall withhold any publication or presentation to permit sponsor to seek patent 
protection and to remove any confidential information from all publications.  
 
 
 
 

Cutera, Inc. 
Protocol # C-17-TS16 
“Multi-Center Pilot Study of truSculpt Device” 
 
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Cutera, Inc. 
Protocol # C-17-TS16 
“Multi-Center Pilot Study of truSculpt Device” 
 
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Cutera, Inc. 
Protocol # C-17-TS16 
“Multi-Center Pilot Study of truSculpt Device” 
 
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Cutera, Inc. 
Protocol # C-17-TS16 
“Multi-Center Pilot Study of truSculpt Device” 
 
Confidential and Proprietary 
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