DualSculpting the Abdomen Using CoolSculpting
Phase: NA
Conditions: Body Fat Disorder
Sponsor: Zeltiq Aesthetics

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Protocol Summary 
 
 
 
 
 
Study Title:    
 
Dualsculpting The Abdomen Using Cryolipolysis 
 
Protocol Number: 
 
ZA16-004 
 
Study Device:   
 
Zeltiq CoolSculpting System with Vacuum Applicator 
 
Sponsor:   
 
 
Zeltiq Aesthetics 
 
  
 
 
4410 Rosewood Dr. 
 
  
 
 
Pleasanton, CA 94588 
 
Date:   
 
 
05 June 2020 
 
Date of IRB Approval: 
06 October 2016 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1. Introduction 
1.1 Background 
ZELTIQ Aesthetics has developed and commercialized a technology to non-invasively reduce 
subcutaneous fat. The ZELTIQ technology, termed CoolSculpting and generically referred to 
as cryolipolysis, enables a non-invasive alternative for subcutaneous fat reduction through 
cellular apoptosis. The CoolSculpting System, which is FDA-cleared for use in the United 
States for an indication of fat layer reduction in the submental area, thighs, flanks, abdomen, 
bra fat, and banana roll, has been clinically proven to reduce fat bulges, allowing patients to 
achieve noticeable and measurable aesthetic results without the pain, expense, downtime, and 
risks associated with existing invasive and minimally-invasive procedures.  
 
The purpose of this study is to evaluate the safety and efficacy of the ZELTIQ CoolSculpting 
System using vacuum applicators for non-invasive subcutaneous fat reduction in the abdomen. 
Slightly different size vacuum applicators will be used in this study.  
1.2 Device Description 
The study treatments will be performed using the ZELTIQ CoolSculpting System. The 
ZELTIQ CoolSculpting System is comprised of a control unit which houses the system 
controller and power source, and a detachable vacuum applicator used to apply the cooling to 
the treatment site.  
 
This study will evaluate the safety and efficacy of the vacuum applicators to treat the abdomen. 
The subjects will receive 4-6 cooling cycles during each of two treatment visits  The treatment 
cooling cycle on the abdomen  will be up to (REDACTED) minutes in duration with a 
temperature of  (REDACTED)°C. At the investigator’s discretion, an additional cooling cycle 
may be delivered to cover the treatment area..  
1.3 Regulatory Status 
The ZELTIQ CoolSculpting System has been cleared in the United States for use as an 
aesthetic treatment to affect the appearance of the flanks (DEN090002), the abdomen 
(K120023), the thighs (K133212) the submental area (K151179), and bra fat, back fat, and 
banana roll (K160259). Additionally, the System has been cleared for flexible treatment 
parameter ranges (K142491).  
 
The ZELTIQ CoolSculpting System can also provide localized thermal therapy (hot or cold) to 
minimize pain for post-traumatic and/or post-surgical pain and to temporarily relieve minor 
aches and pains and muscle spasms. The optional massage function can also be used for 
temporary:  
 
· Relief of minor muscle aches, pain, and spasm 
· Improvement in local circulation 
 

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This study will investigate the use of the FDA cleared ZELTIQ CoolSculpting System and 
(REDACTED) applicators for DualSculpting the abdomen. 
 
2. Study Protocol 
2.1 Design 
 
Prospective, non-randomized interventional cohort 
 
2.2 Study Duration  
 
Enrollment and follow-up is expected to take up to six (6) months for each subject. 
 
2.3 Physician Participants 
 
Study investigators must be practicing medical physicians with experience in the use of the 
Zeltiq System.   
 
2.4 Site Requirements  
 
Study investigators must have at least one study coordinator with experience in conducting 
 
aesthetic research and with sufficient time to conduct the study. 
 
2.5 Subject Recruitment  
Subjects who seek reduction of fat in the abdomen and who the investigator has assesses to be 
eligible for multiple CoolSculpting treatments will be recruited from the general population.  
 
2.6 Sample Size  
 
A maximum of twenty (20) subjects will be treated at up to 2 investigational sites. 
 
2.7  Patient Eligibility  
 
To be eligible to participate, subjects must meet all of the inclusion criteria and none of the 
 
exclusion criteria listed in Table 1. 
 
 
Table 1. Eligibility criteria.  
 
Inclusion Criteria 
a) Male or female subjects > 22 years of age and < 65 years of age.  
b) Subject who has been assessed to be eligible to receive multiple DualSculpting 
treatments on the abdomen using the (REDACTED) and/or (REDACTED) applicator. 
c) No weight change exceeding 5% in the preceding month.  
d) Subject agrees to maintain his/her weight (i.e., within 5% of total body weight) by 
not making any major changes in their diet or exercise routine during the course of the 

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study.  
e) Subject has read and signed the study written informed consent form.  
 
Exclusion Criteria  
a) Subject has had a surgical procedure(s) in the area of intended treatment. 
b) Subject has had an invasive fat reduction procedure (e.g., liposuction, mesotherapy) 
in the area of intended treatment.  
c) Subject has had a non-invasive fat reduction and/or body contouring procedure in the 
area of intended treatment within the past 12 months. 
d) Subject needs to administer, or has a known history of subcutaneous injections into 
the area of intended treatment (e.g., heparin, insulin) within the past month.  
e) Subject has a known history of cryoglobulinemia, cold urticaria, cold agglutinin 
disease or paroxysmal cold hemoglobinuria.  
f) Subject has a known history of Raynaud’s disease, or any known condition with a 
response to cold exposure that limits blood flow to the skin.  
g) Subject has a history of bleeding disorder or is taking any medication that in the 
investigator’s opinion may increase the subject’s risk of bruising.  
h) Subject is taking or has taken diet pills or supplements within the past month.  
i) Subject has any dermatological conditions, such as moderate to excessive skin laxity, 
or scars in the location of the treatment sites that may interfere with the treatment or 
evaluation (stretch marks is not an exclusion).  
j) Subject has an active implanted device such as a pacemaker, defibrillator, or drug 
delivery system or any other metal containing implant.  
k) Subject is pregnant or intending to become pregnant during the study period  
l) Subject is lactating or has been lactating in the past 6 months.  
m) Subject has a history of hernia in the areas to be treated.  
n) Subject is unable or unwilling to comply with the study requirements.  
o) Subject is currently enrolled in a clinical study of any other unapproved 
investigational drug or device.  
p) Any other condition or laboratory value that would, in the professional opinion of 
the investigator, potentially affect the subject’s response or the integrity of the data or 
would pose an unacceptable risk to the subject.  
2.8  Informed Consent  
 
 
 
Study candidates shall receive an explanation of the study objectives, possible risks and 
benefits of the study, and be given adequate time to read the information included in the 
informed consent document. Candidates will be given an opportunity to ask questions about 
any of the information contained in the informed consent. Candidates must verbally 
acknowledge understanding of the informed consent, and sign the consent form accordingly. 
This form must have prior approval of the Institutional Review Board (IRB) or Ethics 
Committee (EC). 

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2.9  Study Procedures 
2.9.1 Screening 
Subjects will undergo screening to determine eligibility for study participation.  Screening 
procedures include the collection of demographic information medical history and 
examination, concomitant medications, and pre-treatment imaging of the intended 
treatment area.  All female subjects of childbearing potential will be asked to take a 
pregnancy test (urine) prior to being treated. If the subject is pregnant, she will be excluded 
from participation.  
2.9.2 Treatment  
 
Treatment will be performed in accordance with Zeltiq Aesthetic’s Instructions for Use for 
the CoolSculpting System and vacuum applicator.  Cooling will be delivered to the 
abdomen using two (2) applicators simultaneously. Treatment parameters such as cooling 
temperature and duration of cooling will be preset by Zeltiq Aesthetics. 
2.9.3 Follow-up Schedule 
 
Follow-up will occur at 1, 6 and 12 weeks post-treatment with the CoolSculpting System.  
Post-treatment images will be collected at all in-office follow-up visits. 
 
3. 
Study Endpoints 
 
The primary endpoints of the study will be defined as follows:  
 
• 
Safety endpoint: measurement of device- or procedure-related adverse events  
• 
Efficacy endpoint: Correct identification of pre-treatment vs. 12-week post-final 
treatment   images by two out of three blinded independent reviewers. Success will be 
defined as at least 70% correct identification of the pre-treatment images.  
 
The secondary endpoint of the study is defined as subject satisfaction as assessed by 
questionnaire administered at 12-weeks post-treatment. 
 
3.1 Statistical Analysis Plan 
3.1.1 Statistical Methods: Overall Plan  
 
Data will be summarized based on the nature of the data. Dichotomous (e.g., gender, 
independent photographic review) and ordinal (e.g., Fitzpatrick Skin type) data will be 
tabulated by category. The mean, standard error, maximum and minimum will be tabulated for 
continuous data (e.g., age,). The significance level will be two-sided 0.05 for all statistical tests. 
 
3.1.2 Endpoint Analysis 

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3.1.2.1    Primary Safety Endpoint 
The primary safety endpoint is measurement of all device- or procedure-related adverse 
events. All adverse events reported during and following the treatment will be included 
in the safety analysis. 
3.1.2.2   Primary Efficacy Analysis 
The primary efficacy endpoint is the correct identification of pre- vs 12-week post-
treatment images. Since weight change will affect the image, the analysis will be based on 
the evaluation of the PP population, (i.e. treated subjects followed for 12 weeks who did 
not became pregnant, and with weight change of no more than 5% at the 12-week visit). 
Success will be defined as at least 70% correct identification of the pre-treatment images. 
3.1.2.3 Secondary Endpoint Analysis 
The secondary endpoint of the study is subject satisfaction as assessed by questionnaire 
administered at 12-weeks post treatment.  The number and percentage of subjects will 
be summarized for each possible point grade of the satisfaction questionnaire at 12-
weeks post-treatment.  The percentage of subjects with moderately or very satisfied will 
be provided, and the corresponding exact 95% confidence interval (per binomial 
distribution) will be calculated. The percentage and the exact 95% confidence interval of 
unsatisfied response (very, moderately, or mildly) will also be calculated. 
4.  Adverse Events 
 
Adverse events (AE) will be assessed continuously throughout the study. An adverse event is 
defined as any untoward medical occurrence in a subject, regardless of whether the event is 
related to the device. 
 
 
 
Adverse Device Effect (ADE)  
 
Any sign, symptom, or disease in a study subject that occurs during the course of a 
 
clinical trial that is determined by the investigator to have a causal relationship or 
 
possible causal relationship with the device under investigation.  
 
 
Serious Adverse Event (SAE)  
Any untoward medical occurrence in a subject, regardless of whether the event is 
related to the device that:  
a. results in death;  
b. results in a life threatening illness or injury;  
c. results in a permanent impairment of a body structure or body function;  
d. requires in-patient hospitalization or prolongation of existing hospitalization  
e. results in medical or surgical intervention to prevent impairment to body structure or 
function;  
f. results in fetal distress, fetal death, or a congenital abnormality/birth defect.  
 
 
Unanticipated Adverse Device Effect (UADE)  
Any serious adverse effect on health and 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 

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plan or application, or any other unanticipated serious problem associated with a device 
that relates to the rights, safety, or welfare of subjects. 
 
The Sponsor is responsible for the ongoing safety evaluation of the product(s). The Sponsor shall 
be responsible for adjudication of all reported adverse events to determine whether the event is 
reportable under federal regulations (i.e., 21 CFR 812.150[b][1]). The Sponsor will promptly 
notify all participating investigators and regulatory authorities, as appropriate, of findings that 
could affect adversely the safety of subjects, impact the conduct of the trial or alter the IRB’s 
approval opinion to continue the trial. 
5.  Study Conduct 
5.1  Confidentiality 
 All information and data concerning study subjects will be considered confidential, and 
handled in compliance with all applicable regulations including the requirements of the Health 
Information Protection Act (HIPAA) of 2004.  
 
Only authorized site staff, the study Sponsor or the Sponsor’s designee and IRB will have 
access to these confidential files and case report forms. A unique identification code will be 
assigned to each subject participating in this trial. All data used in the analysis, reporting and 
publication of this clinical trial will be maintained without identifiable reference to the subject. 
Any data that may be published in abstracts, scientific journals, or presented at medical 
meetings will reference a unique subject code and will not reveal the subject’s identity. 
5.2 Ethics and Good Clinical Practice 
 
The Investigator will ensure that this study is conducted in full conformance with the 
principles of the “Declaration of Helsinki” (as amended in Tokyo, Venice, Hong Kong, 
Somerset-West and Edinburgh).  
Additionally, all Investigators and staff must follow the ICH Guidelines for Good Clinical 
Practice and the applicable Code of Federal Regulations  (21 CFR 50, 56 and 812). 
5.3 Institutional Review Board 
The Investigator will submit this protocol and any related documents to be provided to the 
subject (such as subject informed consent form) to an IRB with jurisdiction for his/her site. 
Approval from the IRB must be obtained before starting the Study, and should be 
documented in a dated letter to the Investigator, clearly identifying the trial, the documents 
reviewed and the date of approval.  A list of members participating in the meeting must be 
provided. 
Modifications made to the protocol after receipt of the IRB approval must also be 
submitted as amendments by the Investigator to the IRB. 
Since this study will be conducted as a non-significant risk trial, the IRB must also grant its 
concurrence with non-significant risk status before the study can begin at that site.