A Single-center, Prospective, Non-randomized, Open-label Clinical Study to Evaluate the Performance of the truSculpt Radiofrequency Device for Non-invasive Fat Reduction in Abdominal Tissue in Subjects Who Are Scheduled for Abdominoplasty
Phase: NA
Conditions: Body Fat
Sponsor: Cutera Inc.

Cutera, Inc. 
Protocol # C-17-TS13 
“Clinical Study to Evaluate the Performance the TruSculpt Radiofrequency Device for Lipolysis of Abdominal Fat” 
 
Confidential and Proprietary 
                                            Page 1 of 26                                                       Version 2.0,06JUL 2017 
 
 
 
TITLE PAGE 
 
 
 
 
Protocol Number: 
C-17-TS13 
Protocol Title: 
Clinical Study to Evaluate the Performance the truSculpt 
Radiofrequency Device for Lipolysis of Abdominal Fat 
 
Sponsor: 
 
Cutera, Inc. 
3240 Bayshore Boulevard 
Brisbane, CA 94005 
 
 
 
 
 
Principal Investigator: 
 
Stephen Ronan, MD 
 
 
 
 
Version, Date: 
Version 2, Dated July 6, 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-TS13 
“Clinical Study to Evaluate the Performance the TruSculpt Radiofrequency Device for Lipolysis of Abdominal Fat” 
 
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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 
Efficacy endpoints .................................................................................................................... 7 
4.1.2 
Safety Endpoint ........................................................................................................................ 7 
4.2 
Study Duration ................................................................................................................................. 8 
4.3 
Study Assessments .......................................................................................................................... 8 
4.3.1 
Safety Assessments .................................................................................................................. 8 
4.4 
Study Discontinuation ..................................................................................................................... 8 
4.5 
Investigator Selection ...................................................................................................................... 8 
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 
5.3 
Subject Discontinuation Criteria.................................................................................................... 10 
6 
STUDY PROCEDURES ............................................................................................................................ 10 
6.1 
Screening and Enrollment Visit Procedures .................................................................................. 10 
6.2 
RF Treatment Visit ......................................................................................................................... 10 
6.3 
Biopsy Collection Visit ................................................................................................................... 11 
7 
ADVERSE DEVICE EFFECTS .................................................................................................................... 12 
7.1 
Definitions ..................................................................................................................................... 12 
7.1.1 
Adverse Device Effect (ADE) .................................................................................................. 12 
7.1.2 
Serious Adverse Device Effect (SADE) .................................................................................... 12 
7.1.3 
Anticipated Serious Adverse Device Effect (ASADE) .............................................................. 12 
7.1.4 
Unanticipated Serious Adverse Device Effect (USADE/UADE) .............................................. 12 
7.2 
Recording Adverse Device Effects ................................................................................................. 14 
7.3 
Follow-up of Subjects after ADEs .................................................................................................. 14 
8 
POTENTIAL RISKS / BENEFITS ............................................................................................................... 14 
8.1 
Potential Risks ............................................................................................................................... 14 
8.2 
Potential Benefits .......................................................................................................................... 15 

Cutera, Inc. 
Protocol # C-17-TS13 
“Clinical Study to Evaluate the Performance the TruSculpt Radiofrequency Device for Lipolysis of Abdominal Fat” 
 
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8.3 
Risk Management .......................................................................................................................... 15 
9 
DATA ANALYSIS PLAN ........................................................................................................................... 16 
9.1 
Sample Size .................................................................................................................................... 16 
9.2 
Analysis Sets .................................................................................................................................. 16 
9.3 
Analysis of Efficacy Endpoints ....................................................................................................... 16 
9.3.1 
Primary Endpoint Analysis ..................................................................................................... 16 
9.4 
Safety Analyses .............................................................................................................................. 16 
10 SUBJECT PAYMENT ............................................................................................................................... 16 
11 STUDY MANAGEMENT AND ADMINISTRATIVE PROCEDURES ............................................................. 16 
11.1 
Training and Monitoring ............................................................................................................ 16 
11.2 
Informed Consent ...................................................................................................................... 17 
11.3 
Protocol Compliance .................................................................................................................. 17 
11.3.1 
Protocol Amendments ............................................................................................................... 17 
11.3.2 
Protocol Deviations .................................................................................................................... 17 
11.4 
Study Personnel ......................................................................................................................... 18 
11.5 
Disclosure of Financial Interest .................................................................................................. 18 
11.6 
Data Collection, Record Keeping and Storage ........................................................................... 18 
11.7 
Subject Confidentiality ............................................................................................................... 19 
11.8 
Publication Policy ....................................................................................................................... 20 
REFERENCES ............................................................................................................................................. 21 
Appendix 1: Study Schedule ......................................................................................................................... 23 
Appendix 2: Pain Rating Scale .................................................................................................................... 24 
Appendix 3: Fitzpatrick Skin Type Classification .......................................................................................... 25 
Appendix 4:  Before and After Treatment Instructions ............................................................................... 26 
 
 
 

Cutera, Inc. 
Protocol # C-17-TS13 
“Clinical Study to Evaluate the Performance the TruSculpt Radiofrequency Device for Lipolysis of Abdominal Fat” 
 
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Protocol Summary 
 
Title 
Clinical Study to Evaluate the Performance the truSculpt 
Radiofrequency Device for Lipolysis of Abdominal Fat 
Objective 
 
To evaluate the truSculpt Radiofrequency Device for non-
invasive fat reduction in abdominal tissue 
Study Design 
A single-center, prospective, non-randomized, open-label 
study 
Enrollment 
Approximately 14 subjects 
Primary Endpoint 
Histological evaluation of tissue for selective fat necrosis, with 
sparing of the dermis and epidermis, following truSculpt 
treatment vs. untreated contralateral control 
Safety Endpoint 
Incidence and severity of adverse device effects during the 
study period, including subject pain level during RF treatment 
Subject Population 
Female and male subjects, age 24 to 60 years, Fitzpatrick skin 
type I-VI 
Planned Schedule 
First subject enrolled:  June 2017 
Last subject last visit:  June 2018 
 
 
 
 
 

Cutera, Inc. 
Protocol # C-17-TS13 
“Clinical Study to Evaluate the Performance the TruSculpt Radiofrequency Device for Lipolysis of Abdominal Fat” 
 
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1 
PURPOSE 
The purpose of this investigation is to evaluate the performance of the truSculpt Radiofrequency Device 
for non-invasive lipolysis of abdominal fat.  
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].   
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 

Cutera, Inc. 
Protocol # C-17-TS13 
“Clinical Study to Evaluate the Performance the TruSculpt Radiofrequency Device for Lipolysis of Abdominal Fat” 
 
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4.2 
Study Duration 
Subjects enrolled in this trial will be asked to participate for up to 3 months and will complete 3 visits:  1 
screening visit, 1 RF treatment visit, and 1 follow-up visit (biopsy collection visit) on the day of their 
planned abdominoplasty surgery.  
4.3 
Study Assessments 
4.3.1 
Safety Assessments 
4.3.1.1 Incidence and Severity of Adverse Events:   
Following the first RF treatment, adverse device effects (ADEs) will be assessed post-treatment and at 
each subsequent subject 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. 
4.3.1.2 Treatment-related Discomfort 
Subjects will be asked to rate the average amount of discomfort experienced during RF treatment using 
the Pain Rating Scale found in Appendix 3. 
4.4 
Study Discontinuation 
The study sponsor has the right to terminate this study at any time.  Reasons for terminating the study 
may include, but are not limited to, unsatisfactory subject enrollment or the incidence or severity of 
adverse events in this study, or other studies with the study device, indicates a potential health hazard to 
subjects. 
4.5 
Investigator Selection 
Investigators will be invited to participate in the study based on their medical specialty, experience 
conducting clinical research studies and experience in the use of energy based devices for aesthetic 
indications. The site’s access to potential study subjects and ability to cooperate with study 
requirements will also be considered.  
5 
STUDY POPULATION 
5.1 
Study Subject Recruitment and Selection 
Approximately 14 male or female subjects, ages 24 to 60, Fitzpatrick Skin Type I-VI, who are scheduled 
for abdominoplasty, and will undergo one RF treatment on tissue to be removed during their 
abdominoplasty, will be studied. Subjects will be recruited to participate from those patients who 
present themselves to the site requesting abdominoplasty surgery, or from those patients who respond 
to advertisement. Only subjects who meet all Inclusion and Exclusion Criteria and 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.  

Cutera, Inc. 
Protocol # C-17-TS13 
“Clinical Study to Evaluate the Performance the TruSculpt Radiofrequency Device for Lipolysis of Abdominal Fat” 
 
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5.1.1 
Inclusion Criteria 
To be included in the study, subjects must meet all of the following Inclusion Criteria: 
 
1.  
Male or Female, 24 to 60 years of age (inclusive) 
2.  
Fitzpatrick Skin Type I – VI (Appendix 3) 
3.  
Has visible fat bulges or skin laxity in the abdominal region 
4.  
Scheduled to undergo surgery (abdominoplasty). 
5.  
Non-smoking for at least 6 months and willing to refrain from smoking for the duration 
of the study. 
6.  
Subject must agree to not undergo any other procedure(s) in the abdominal region 
during the study period. 
7.  
Subject must be able to read, understand and sign the Informed Consent Form. 
8.  
Subject must adhere to the follow-up schedule and study instructions. 
9.  
Subject must adhere to the same diet/ exercise/medication regimen for the entire 
course of the study. 
10.  
Willing to provide histology samples during the surgery from the intended to be 
harvested areas. 
11.  
Post-menopausal or 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, 
and no plans to become pregnant. 
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 in the target area during the 
study period. 
2.  
Any type of prior cosmetic treatment to the target area within 12 months of study 
participation e.g., radiofrequency, cryolysis or light-based treatments. 
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 surgical clips, plates and screws, 
intrauterine device (IUD), artificial heart valves or artificial joints. 
6.  
Significant concurrent illness, such as diabetes mellitus, cardiovascular disease, 
peripheral vascular disease or pertinent neurological disorders. 
7.  
Diagnosed or documented immune system disorders. 
8.  
History of any disease or condition that could impair wound healing. 
9.  
History of diseases stimulated by heat, such as recurrent herpes zoster in the treatment 
area, unless treatment is conducted following a prophylactic regimen. 
10.  
History of keloid formation, hypertrophic scarring or abnormal/delayed wound healing 
in the treatment area. 
11.  
Infection, dermatitis, rash or other skin abnormality in the target area. 
12.  
Currently undergoing systemic chemotherapy or radiation treatment for cancer, or 

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Protocol # C-17-TS13 
“Clinical Study to Evaluate the Performance the TruSculpt Radiofrequency Device for Lipolysis of Abdominal Fat” 
 
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history of treatment in the target area within 3 months of study participation. 
13.  
Pregnant or currently breastfeeding. 
14.  
As per the Investigator’s discretion, any physical or mental condition which might make 
it unsafe for the subject to participate in this study. 
5.2 
Subject Numbering  
Each enrolled subject will be assigned a subject ID number, comprised of the sequential number 
assigned for each subject treated and the subject initials. The subject initials will be comprised of the 
first letter of the first and last name.  
5.3 
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.  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, or the study 
is stopped. In addition, subjects may be discontinued from the study if s/he develops any of the 
exclusion criteria during the study period. A subject will be considered lost to follow-up only after three 
unsuccessful, documented attempts to contact the subject have been made.   
 
6 
STUDY PROCEDURES 
A summary of all required study procedures and assessments can be found in Appendix 1. 
6.1 
Screening and Enrollment Visit Procedures 
The following screening procedures will be performed: 
 
1. Informed Consent process. 
2. Review of subject medical history. 
3. Assessment of treatment area. 
4. Assessment of concomitant medications. 
5. Assign subject to a subgroup. 
6.2 
RF Treatment Visit 
 
The following procedures will be performed at the RF Treatment Visit: 
 
1. If needed, cleanse subject’s treatment area with a mild cleanser to remove any cosmetics, 
perfume or lotions and then dry the area. 
2. Prior to performing RF treatment, the Investigator should confirm the subject continues to 
meet the study eligibility criteria, including asking about any changes in medical history 
and/or concomitant medications or significant increase or decrease in subject weight. 
3. Using a surgical marker, mark the subject’s abdomen as it will be marked on the day of the 
subsequent planned abdominoplasty procedure. 

Cutera, Inc. 
Protocol # C-17-TS13 
“Clinical Study to Evaluate the Performance the TruSculpt Radiofrequency Device for Lipolysis of Abdominal Fat” 
 
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c. Each biopsy sample will be immediately placed in the prepared fixative vials, making sure 
the samples are fully submerged in the solution. The vials will be labeled with the subject 
ID number, subject initials and biopsy date. The vials will be randomly numbered, and the 
numbers of the vials containing the biopsy from the RF treated and control skin will be 
recorded in the patient chart. The histologist will remain blinded to the nature of each 
biopsy sample (treatment or control).  
7 FADVERSE DEVICE EFFECTS 
7.1 
Definitions 
7.1.1 
Adverse Device Effect (ADE) 
An adverse device effect (ADE) is defined as any untoward medical occurrence, unintended disease or 
injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, device users or 
other persons, related to the investigational medical device. ADEs may be previously identified in 
nature, incidence, severity or outcome in the study protocol, informed consent document, device 
operator manual, other risk analysis documentation or regulatory application. 
7.1.2 
Serious Adverse Device Effect (SADE) 
A serious adverse device effect (SADE) is any adverse device effect, related to the use of an 
investigational device or clinical study device, that: 
 
• led to a death; 
• led to a serious deterioration in the health of the subject that:  
• resulted in a life-threatening illness or injury; 
• resulted in a permanent impairment of a body structure or body function; 
• required in-patient hospitalization or prolongation of existing hospitalization; 
• resulted in medical or surgical intervention to prevent permanent impairment to a body 
structure or a body function 
• led to fetal distress, fetal death or a congenital abnormality or birth defect. 
7.1.3 
Anticipated Serious Adverse Device Effect (ASADE) 
An anticipated serious adverse device effect (ASADE) is any SADE on health or safety or any life-
threatening problem or death caused by, or associated with the device, if that effect, problem, or death 
was previously identified in nature, severity, or degree of incidence in the investigational plan, informed 
consent, operator manual, other risk analysis documentation or regulatory application; or any other 
serious problem associated with a device that relates to the rights, safety, or welfare of subjects.  
7.1.4 
Unanticipated Serious Adverse Device Effect (USADE/UADE) 
An unanticipated serious adverse device effect (USADE) is any SADE on health or safety or any life-
threatening problem or death caused by, or associated with the device, if that effect, problem, or death 
was not previously identified in nature, severity, or degree of incidence in the investigational plan, 
informed consent, operator manual, other risk analysis documentation, or regulatory application; or any 
other unanticipated serious problem associated with a device that relates to the rights, safety, or 
welfare of subjects.  
 

Cutera, Inc. 
Protocol # C-17-TS13 
“Clinical Study to Evaluate the Performance the TruSculpt Radiofrequency Device for Lipolysis of Abdominal Fat” 
 
 
 
 
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In subjects, the ADEs/SADEs include the effects related to the investigational medical device (clinical study 
device), the comparator or the procedures involved. For device users or other persons (other clinical staff 
in the treatment room) ADE/SADE is restricted to the effects related to investigational medical devices. 
ADEs/SADEs may include the effects (1) resulting from insufficient or inadequate instructions for use, 
deployment, installation, or operation, or any malfunction of the investigational medical device; or (2) 
resulting from user error or from intentional misuse of the investigational medical device. 
 
Figure 1. Flowchart for classification of adverse device effects [19]  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Adverse Event Occurrence             
(i.e., Untoward Medical Occurrence)  
Is it device, 
comparator or 
procedure 
related? 
yes 
Adverse Device Event (ADE) 
- Reported on Visit CRF  
- Examples: erythema, edema, bruise, 1st and 2nd 
degree burn 
no 
Anticipated Serious Adverse Device Effect 
(ASADE) 
- Reported on Cutera SADE Form 
- Reported on ADE CRF 
- Examples: 3rd degree burn, eye damage from 
laser 
Serious Adverse Device 
Effect (SADE) 
Unanticipated Serious Adverse Device Effect 
(USADE/UADE) 
- Reported on Cutera SADE Form 
- Reported on ADE CRF 
- Examples: seizure, event leading to death 
yes 
no 
yes 
Is it 
anticipated? 
Does it meet 
seriousness 
criteria? 
yes 

Cutera, Inc. 
Protocol # C-17-TS13 
“Clinical Study to Evaluate the Performance the TruSculpt Radiofrequency Device for Lipolysis of Abdominal Fat” 
 
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Crusting/Scabbing 
Mild to Severe 
3-14 days 
Rare 
Edema (Swelling) 
Mild to 
Moderate 
< 72 hours 
Very Common 
Erythema (Redness)  
Mild to 
Moderate 
< 24 hours 
Very Common 
Hyperpigmentation 
Mild to Severe 
> 1 month 
Rare 
Hypopigmentation 
Mild to Severe 
> 1 month 
Very Rare 
Infection 
Mild to Severe 
2-14 days 
Rare 
Palpable nodules 
Mild to 
Moderate 
> 1 month 
Common 
Oozing 
Mild to Severe 
2-14 days 
Very Rare 
Pain (Discomfort) 
Mild to Severe 
During 
procedure 
Very Common 
Purpura (Bruising) 
Mild to 
Moderate 
7-21 days 
Common 
Scarring 
Mild to Severe 
> 1 month 
Rare 
Textural Changes 
Mild to Severe 
> 1 month 
Rare 
Partial, over treatment, and/or no 
treatment with the study device(s) due to 
equipment problem (device malfunction) 
Mild to Severe 
 
Rare 
Improper treatment (partial, over-
treatment, and/or no treatment) with the 
study device(s) due to user error 
Mild to Severe 
 
Rare 
Unintended injury to subject, user or 
others due to user error (e.g., 
unintentional treatment to non-target 
location) 
Mild to Severe 
 
Rare 
 
8.2 
Potential Benefits 
The subjects may or may not benefit from the treatment. Potential benefits include improved 
appearance of the treated abdominal and flank region and circumferential reduction in the treated 
abdominal and flank region. There is no guarantee of success.  
8.3 
Risk Management 
The Investigator chosen for this study will have extensive and safe experience with the use of RF systems 
in dermatology applications. This is the most critical element in managing subject risk. In addition, the 
Investigators will be trained on the use of the Cutera RF device and any investigational handpieces. 

Cutera, Inc. 
Protocol # C-17-TS13 
“Clinical Study to Evaluate the Performance the TruSculpt Radiofrequency Device for Lipolysis of Abdominal Fat” 
 
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9 
DATA ANALYSIS PLAN  
9.1 
Sample Size 
The planned sample size of up to approximately 14 subjects was determined based on clinical 
judgement to provide sufficient information to evaluate the performance of RF treatment for lipolysis of 
abdominal fat. 
9.2 
Analysis Sets 
The efficacy analysis set will include all enrolled subjects who complete the RF treatment session using 
the study device. 
 
The safety analysis set will include all subjects enrolled in the study who start the RF treatment session 
using the study device. 
 
Missing data will not be imputed for efficacy or safety endpoints. 
9.3 
Analysis of Efficacy Endpoints 
9.3.1 
Primary Endpoint Analysis 
Formal hypothesis testing and statistical analysis are not planned for this study. The primary efficacy 
endpoint data will be summarized descriptively for the control and treatment areas.  
9.4 
Safety Analyses 
Device-related and procedure-related adverse effects (AEs) and subjects who prematurely terminate 
from the study due to an adverse device effect, including the treatment-related pain ratings, 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. Subject pain ratings during treatment will also be summarized descriptively. 
10 SUBJECT PAYMENT 
 
 
11 STUDY MANAGEMENT AND ADMINISTRATIVE PROCEDURES  
11.1 Training and Monitoring 
The investigators and site research staff will be trained on the study procedures. Sponsor 
representative(s) may be present at the site during the treatments to ensure that all procedures and 
documentation are in place.  
 
Investigator will allow sponsor representatives to periodically review the study documentation.  
Monitoring of the site will occur at regular intervals to evaluate the progress of the study, verify the 
accuracy and completeness of CRFs against subject source documentation, assure that all protocol 
requirements, applicable FDA regulations and the investigator’s obligations are being fulfilled and 
resolve any inconsistencies in the study records. 

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Protocol # C-17-TS13 
“Clinical Study to Evaluate the Performance the TruSculpt Radiofrequency Device for Lipolysis of Abdominal Fat” 
 
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11.2 Informed Consent 
The investigator is responsible for ensuring that written informed consent, using an Institutional Review 
Board (IRB) approved informed consent document, is obtained from each subject before the 
performance of any protocol procedures, including administration of the study device. The informed 
consent document must comply with all essential elements as defined in 21 CFR 50.25 “Elements of 
Informed Consent” and must contain a statement that consent is freely given, the study involves 
research, the subject is aware of the risks and benefits of entering the study, and that the subject is free 
to withdraw from the study at any time.  An evaluation of each candidate will be conducted by the 
investigator. Upon determining a subject’s eligibility status, the subject will be offered the opportunity 
to participate in the study.  
 
The investigator or the investigator’s designee will inform all subjects regarding the purpose of the study 
and expected duration, as well as the potential risks and benefits that may result from participation. The 
subjects shall be informed by the investigator or investigator’s designee that they are free to refuse 
participation in this clinical study. If they elect to participate, it will be made clear that they may 
withdraw from the study at any time without prejudicing further care.  
 
The subjects will also be informed of alternative methods of treatment should they not wish to 
participate in the study.  
 
The subjects will be given the opportunity to discuss the procedure, risks, benefits, alternative therapies, 
and the study requirements with the investigator and have any and all questions answered to the 
subjects’ satisfaction. A signed and dated informed consent form must be obtained from the subject by 
the Investigator or the Investigator’s designee prior to a subject’s involvement in the study.  
 
The acquisition of informed consent will be documented in the subject’s medical records, as required by 
21 CFR 812.140. A copy of the consent form will be given to the subject. The original consent forms will 
be kept in the CRF binder by the investigator and will be subject to review by Cutera or a representative 
of Cutera, and by appropriate regulatory bodies.  
11.3 Protocol Compliance 
The principal investigator must comply with all terms of the protocol. 
11.3.1 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. 
11.3.2  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, use of out of range treatment parameters and incomplete or 

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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. 
11.4 Study Personnel 
Prior to the start of the study, the investigator must supply the sponsor with a list of the names and 
curricula vitae that describe the professional backgrounds of the clinically responsible study 
investigators (principal, sub-investigators), research nurses, and other possible participants (e.g. medical 
doctor, nurse, etc.). 
11.5 Disclosure of Financial Interest 
Each investigator [principal and sub-investigator(s)] is required to disclose sufficient accurate financial 
information to the sponsor, to allow sponsor to submit complete and accurate certification or disclosure 
statements. 
11.6 Data Collection, Record Keeping and Storage 
The principal investigator is responsible for assuring that all study records including case report forms 
(CRFs), informed consent forms, device accountability records, source documents (e.g., medical records, 
histology reports etc.) and other study records are complete, accurate and recorded in a timely manner.  
 
CRFs should not be the only record of a patient’s participation in the study and will be used for 
transcribing data from source documents which are the point of first entry of data collected for each 
subject (with the exception of documents listed under B). The investigator or research staff at the site 
will ensure that: 
 
A. 
Source documentation thoroughly and adequately documents:  
 
1. That patient is participating in a clinical study and has been properly informed and consented 
prior to participation in the study,  
2. Medical history,  
3. Concomitant medications,  
4. Patient’s condition upon entering and during the course of the study, 
5. Any adverse event(s) that might have occurred (in addition to the Visit CRFs and/or Adverse 
Device Effect CRF and/or Cutera SADE form completed),  
6. Results of any diagnostic tests/histology conducted during the study. 
 
B. 
The following data will be recorded directly onto CRFs: 
 
7. Patient meets study inclusion and exclusion criteria, 
8. A record of the treatment parameters, including the date of each RF treatment and any other 
adjunct therapy, a drawing of the patients abdomen showing the treatment location, and the 
vial numbers containing control and treatment biopsies, 
9. Any protocol deviations, 
10. Subject Questionnaire(s), 
11. Study related improvement assessments by the investigator or investigator’s designee,  

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12. Treatment-related pain ratings. 
 
C. 
The following documents will be maintained in the study records: 
 
13. The Investigator or the research staff will check signed informed consent for accuracy and will 
always keep the original copy of the signed informed consent in the CRF binder.  
14. All correspondence with an Institutional Review Board (IRB), the sponsor, or FDA including 
required reports will also be retained in the study records.  
15. Records of receipt, use or disposition of the investigational device. 
 
All data entries on the CRFs will be recorded completely, promptly, and legibly using blue or black 
indelible ink pen and accuracy will be ensured. The corrections on CRFs will be made only by the 
investigator or the documented investigator’s designee. To make a correction to an entry, the data will 
be crossed through with a single line (the original entry should be visible) and then will be initialed and 
dated by the person making the correction.  
 
The study records will be maintained in a secure location throughout the duration of the study.  Upon 
study completion or termination, records will be kept at a secure location until at least 2 years after the 
last approval of a marketing application and until there are no pending or contemplated marketing 
applications or at least 2 years have elapsed since the formal discontinuation of clinical development of 
the investigational product.  
11.7 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:   
 
The subjects will be informed by the investigator or the investigator’s designee that their medical 
records will be kept as confidential as possible but may be subject to review by: (1) Cutera, or its 
representative; (2) reviewing IRB; and/or (3) by appropriate regulatory bodies (e.g. the US Food and 
Drug Administration (FDA), Department of Health and Human Services (DHHS) agencies).  
 
Only pieces of personal information required for purposes of the study will be collected. The personal 
information will be collected and used to ensure subject eligibility for study participation, to conduct the 
study and to assess the results of the study as required and permitted by law. Subjects have the right to 
see and copy any of the information gathered about them and request changes if the information is not 
correct, until it is no longer kept by the investigator. Permission to use or disclose personal information, 
except for that has been collected and relied on may be cancelled by the subject by written notice. If the 
subject is withdrawn from the study, the information collected to that time may still be used to preserve 
the scientific integrity of the study. There is no expiration date to this authorization.  
 
Subjects’ identities will be kept confidential. Subjects will be assigned a unique study code that will not 
reveal the subjects’ identity, and this code will be used on all study documents. To protect subject 
identity with regards to the photographs taken of the treatment areas, care will be taken to cover areas 
of photographs to protect identity. Techniques such as covering of eyes on full face photographs, 

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“Clinical Study to Evaluate the Performance the TruSculpt Radiofrequency Device for Lipolysis of Abdominal Fat” 
 
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cropping off portions of the face in close-up photos will be used to obscure identifying characteristics in 
photographs. The results of research, including photographs, may be published in scientific journals, 
presented at medical meetings, and used in training and marketing materials but subject identities will 
not be disclosed.  
11.8 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.  
 
The International Committee of Medical Journal Editors (ICMJE) member journals have adopted a trials 
registration policy as a condition for publication. This policy 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. It is the responsibility of the sponsor to register this trial in ClinicalTrials.gov. Any clinical trial 
starting enrollment after September 27, 2007 must be registered either on or before the onset of 
patient enrollment. 
 
 
 
 

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REFERENCES 
1. Ross EV, Yashar SS, Naseef GS, Barnette DJ, Skrobal M, Grevelink J, Anderson RR. A pilot study of 
in vivo immediate tissue contraction with CO2 skin laser resurfacing in a live farm pig. Dermatol 
Surg. 1999 Nov;25(11):851-6. PubMed PMID: 10594596. 
 
2. Kulick M. Evaluation of the combination of radio frequency, infrared energy and mechanical 
rollers with suction to improve skin surface irregularities (cellulite) in a limited treatment area. J 
Cosmet Laser Ther. 2006 Dec;8(4):185-90. PubMed PMID: 19839171. 
 
3. Alexiades-Armenakas M, Dover JS, Arndt KA. Unipolar radiofrequency treatment to improve the 
appearance of cellulite. J Cosmet Laser Ther. 2008 Sep;10(3):148-53. PubMed PMID: 18788033. 
 
4. Sadick N. Tissue tightening technologies: fact or fiction. Aesthet Surg J. 2008 Mar-Apr;28(2):180-
8. Review. PubMed PMID: 19083525. 
 
5. Sukal SA, Geronemus RG. Thermage: the nonablative radiofrequency for rejuvenation. Clin 
Dermatol. 2008 Nov-Dec;26(6):602-7. PubMed PMID: 18940540. 
 
6. Elsaie ML. Cutaneous remodeling and photorejuvenation using radiofrequency devices. Indian J 
Dermatol. 2009 Jul;54(3):201-5. PubMed PMID: 20161847; PubMed Central PMCID: 
PMC2810682. 
 
7. Emilia del Pino M, Rosado RH, Azuela A, Graciela Guzmán M, Argüelles D, Rodríguez C, Rosado 
GM. Effect of controlled volumetric tissue heating with radiofrequency on cellulite and the 
subcutaneous tissue of the buttocks and thighs. J Drugs Dermatol. 2006 Sep;5(8):714-22. 
PubMed PMID: 16989185. 
 
8. Goldberg DJ, Fazeli A, Berlin AL. Clinical, laboratory, and MRI analysis of cellulite treatment with a 
unipolar radiofrequency device. Dermatol Surg. 2008 Feb;34(2):204-9; discussion 209. Epub 2007 
Dec 17. PubMed PMID: 18093200. 
 
9. Nootheti PK, Magpantay A, Yosowitz G, Calderon S, Goldman MP. A single center, randomized, 
comparative, prospective clinical study to determine the efficacy of the VelaSmooth system 
versus the Triactive system for the treatment of cellulite. Lasers Surg Med. 2006 Dec;38(10):908-
12. PubMed PMID: 17163477. 
 
10. Montesi G, Calvieri S, Balzani A, Gold MH. Bipolar radiofrequency in the treatment of 
dermatologic imperfections: clinicopathological and immunohistochemical aspects. J Drugs 
Dermatol. 2007 Sep;6(9):890-6. PubMed PMID: 17941360. 
 
11. Elman M, Vider I, Harth Y, Gottfried V, Shemer A. Non-invasive therapy of wrinkles and lax skin 
using a novel multisource phase-controlled radio frequency system. J Cosmet Laser Ther. 2010 
Apr;12(2):81-6. PubMed PMID: 20331345. 
 

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12. Sadick N, Magro C. A study evaluating the safety and efficacy of the VelaSmooth system in the 
treatment of cellulite. J Cosmet Laser Ther. 2007 Mar;9(1):15-20. PubMed PMID: 17506136. 
 
13. Brightman L, Weiss E, Chapas AM, Karen J, Hale E, Bernstein L, Geronemus RG. Improvement in 
arm and post-partum abdominal and flank subcutaneous fat deposits and skin laxity using a 
bipolar radiofrequency, infrared, vacuum and mechanical massage device. Lasers Surg Med. 2009 
Dec;41(10):791-8. PubMed PMID: 20014259. 
 
14. Sadick NS, Mulholland RS. A prospective clinical study to evaluate the efficacy and safety of 
cellulite treatment using the combination of optical and RF energies for subcutaneous tissue 
heating. J Cosmet Laser Ther. 2004 Dec;6(4):187-90. PubMed PMID: 16020202 
 
15. Alster TS, Lupton JR. Nonablative cutaneous remodeling using radiofrequency devices. Clin 
Dermatol. 2007 Sep-Oct;25(5):487-91. Review. PubMed PMID: 17870527. 
 
16. Zelickson BD, Kist D, Bernstein E, Brown DB, Ksenzenko S, Burns J, Kilmer S, Mehregan D, Pope K. 
Histological and ultrastructural evaluation of the effects of a radiofrequency-based nonablative 
dermal remodeling device: a pilot study. Arch  Dermatol. 2004 Feb;140(2):204-9. PubMed PMID: 
14967794. 
 
17. Lack EB, Rachel JD, D'Andrea L, Corres J. Relationship of energy settings and impedance in 
different anatomic areas using a radiofrequency device. Dermatol Surg. 2005 Dec;31(12):1668-
70. PubMed PMID: 16336885. 
 
18. Sadick NS. Combination radiofrequency and light energies: electro-optical synergy technology in 
esthetic medicine. Dermatol Surg. 2005 Sep;31(9 Pt 2):1211-7; discussion 1217. PubMed PMID: 
16176773. 
 
19. Clinical investigation of medical devices for human subjects — Good clinical practice. ISO, 2011. 
14155. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix 1: Study Schedule 
 
 

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Appendix 2: Pain Rating Scale 
 
Subjects will be instructed to rate the pain associated with RF treatment by indicating a number that 
best represents the overall average pain experienced using the following scale: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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“Clinical Study to Evaluate the Performance the TruSculpt Radiofrequency Device for Lipolysis of Abdominal Fat” 
 
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Appendix 3: Fitzpatrick Skin Type Classification 
 
 
 
 
 
 
 
 
 
 

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Appendix 4:  Before and After Treatment Instructions 
 
Before Treatment Instructions: 
 
 The day before and the day of your truSculpt treatment, drink plenty of water to ensure you are 
well hydrated. The truSculpt treatment works best when patients have had plenty of fluids prior 
to treatment.    
 
 
After Treatment Care Instructions: 
 
 Redness is expected and should resolve within a few hours. 
 
 Mild swelling may occur and should go away within 72 hours.  
 
 Tenderness of the treatment area may persist up to 1 week. 
 
 Avoid hot showers or baths and avoid scrubbing the treated area when bathing. 
 
 Please call your study doctor if you experience any of the following in your treatment area: 
 
o 
Blistering 
o 
Bleeding 
o 
Burn 
o 
Crusting or scabbing 
o 
Pain or Tenderness, Redness or Swelling that lasts more than 72 hours 
o 
Nodules or lumps 
 
 Do not pop or un-roof blisters if they occur.   
 
 If you need to take any over-the-counter medications for discomfort after the RF treatment, 
take non-aspirin pain medications, such as Tylenol or Advil.