Multi-Center Pilot Study of Cutera truSculpt Device
Phase: NA
Conditions: Treatment for Cellulite on the Stomach and Flanks
Sponsor: Cutera Inc.

Cutera, Inc. 
Protocol # C-18-TS18 
“Multi-Center Pilot Study of Cutera truSculpt Device” 
 
Confidential and Proprietary 
                                            Page 1 of 27
 
                                                       Version 1.0, 26APR2018 
 
 
 
TITLE PAGE 
 
 
 
 
Protocol Number: 
C-18-TS18 
Protocol Title: 
Multi-Center Pilot Study of Cutera truSculpt Device 
Sponsor: 
 
Cutera, Inc. 
3240 Bayshore Boulevard 
Brisbane, CA 94005 
Telephone: 408-207-6659 
Contact: Minda Seal 
Email: mseal@cutera.com 
 
 
Version, Date: 
Version 1, Dated April 26, 2018 
 
 
 
 
 
 
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-18-TS18 
“Multi-Center Pilot Study of Cutera truSculpt Device” 
 
Confidential and Proprietary 
                                            Page 2 of 27
 
                                                       Version 1.0, 26APR2018 
Protocol Signature Page – Principal Investigator 
 
 
PROTOCOL C-18-TS18 
 
 
Study Title:   Multi-Center Pilot Study of truSculpt Device 
 
 
Protocol Version 1.0, Dated April 26, 2018 
 
I have received and read the protocol dated April 26, 2018 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-18-TS18 
“Multi-Center Pilot Study of Cutera truSculpt Device” 
 
Confidential and Proprietary 
                                            Page 3 of 27
 
                                                       Version 1.0, 26APR2018 
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 
8 
     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 
9 
5.1 
Study Subject Recruitment and Selection 
9 
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-18-TS18 
“Multi-Center Pilot Study of Cutera truSculpt Device” 
 
Confidential and Proprietary 
                                            Page 4 of 27
 
                                                       Version 1.0, 26APR2018 
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-18-TS18 
“Multi-Center Pilot Study of Cutera truSculpt Device” 
 
Confidential and Proprietary 
                                            Page 9 of 27
 
                                                       Version 1.0, 26APR2018 
5 
STUDY POPULATION 
5.1 Study Subject Recruitment and Selection 
Approximately 60 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 
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 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 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 1 month 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. 

Cutera, Inc. 
Protocol # C-18-TS18 
“Multi-Center Pilot Study of Cutera truSculpt Device” 
 
Confidential and Proprietary 
                                            Page 10 of 27
 
                                                       Version 1.0, 26APR2018 
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 
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.  
Allergy or sensitivity to Tegaderm.   
12.  
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-18-TS18 
“Multi-Center Pilot Study of Cutera truSculpt Device” 
 
Confidential and Proprietary 
                                            Page 21 of 27
 
                                                       Version 1.0, 26APR2018 

Cutera, Inc. 
Protocol # C-18-TS18 
“Multi-Center Pilot Study of Cutera truSculpt Device” 
 
Confidential and Proprietary 
                                            Page 22 of 27
 
                                                       Version 1.0, 26APR2018 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Cutera, Inc. 
Protocol # C-18-TS18 
“Multi-Center Pilot Study of Cutera truSculpt Device” 
 
Confidential and Proprietary 
                                            Page 24 of 27
 
                                                       Version 1.0, 26APR2018 

Cutera, Inc. 
Protocol # C-18-TS18 
“Multi-Center Pilot Study of Cutera truSculpt Device” 
 
Confidential and Proprietary 
                                            Page 25 of 27
 
                                                       Version 1.0, 26APR2018 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Cutera, Inc. 
Protocol # C-18-TS18 
“Multi-Center Pilot Study of Cutera truSculpt Device” 
 
Confidential and Proprietary 
                                            Page 26 of 27
 
                                                       Version 1.0, 26APR2018 
Appendix 5 
 
Week 12-Investigator Global Aesthetic Improvement Scale (GAIS): Compared to Baseline Photos 
 
 
0 
No Change 
+1 
Mild Improvement 
+2 
Moderate Improvement 
+3 
Significant Improvement 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Cutera, Inc. 
Protocol # C-18-TS18 
“Multi-Center Pilot Study of Cutera truSculpt Device” 
 
Confidential and Proprietary 
                                            Page 27 of 27
 
                                                       Version 1.0, 26APR2018