A Feasibility Study to Evaluate Electromagnetic Muscle Stimulation and CoolSculpting for Abdominal Contouring
Phase: NA
Conditions: Body Fat Disorder
Sponsor: Zeltiq Aesthetics

Information Cover Page 
 
 
 
Zeltiq Aesthetics Protocol ZA18-003 
 
A Feasibility Study to Evaluate Electromagnetic Muscle Stimulation and 
CoolSculpting for Abdominal Contouring 
 
Clinicaltrials.gov Identifier:  NCT03738891 
 
 
Protocol Date:  22 February 2019 
 
 
Protocol Redaction Date:  1 November 2021 
 
 
Version 1.0 IRB Approval Date:  22 October 2018 
Version 2.0 IRB Approval Date: 11 March 2019 
 
 

ZELTIQ Aesthetics – Confidential and Proprietary 
 
Part Number: 
Revision: 02 
Page 1 of 40 
Title: A Feasibility Study to Evaluate Electromagnetic Muscle Stimulation and CoolSculpting 
for Abdominal Contouring 
Note: Check with Document Control for current revisions of all referenced documents. 
 
ZELTIQ P/N: 
Protocol Number: ZA18-003 
 
This document and the contents hereof are considered proprietary and confidential information of ZELTIQ Aesthetics, 
Inc.  Disclosure to unauthorized individuals or dissemination, publication or copying is prohibited without prior written consent of 
ZELTIQ. 
A FEASIBILITY STUDY TO EVALUATE ELECTROMAGNETIC MUSCLE 
STIMULATION AND COOLSCULPTING FOR ABDOMINAL CONTOURING  
Investigational Plan 
Sponsor 
ZELTIQ Aesthetics, an Allergan affiliate 
4410 Rosewood Dr. 
Pleasanton, CA 94588 
Protocol Number: 
ZA18-003 
Protocol Version: 
2.0 
February 22, 2019 
Investigators:  
Eric P. Bachelor, MD 
4410 Rosewood Dr. 
Pleasanton, CA 94588 
 
Sue Ellen Cox, MD 
Aesthetic Solutions, P.A. 
5821 Farrington Rd, Suite 101 
Chapel Hill, NC 27517 
 
Suzanne Kilmer, MD  
Laser and Skin Surgery of Northern California  
3835 J Street  
Sacramento, CA 95816 
 
Grant Stevens, MD 
Marina Plastic Surgery 
4644 Lincoln Blvd. Suite 552 
Marina Del Rey, CA  90292 
 
Brian Zelickson, MD 
Zel Skin & Laser Specialist 
4100 West 50th Street 
Edina, MN  55424 
Sponsor Contact: 
 
Lori Brandt 
Director, Clinical Trial Management 

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Part Number: 
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Title: A Feasibility Study to Evaluate Electromagnetic Muscle Stimulation and CoolSculpting for 
Abdominal Contouring 
 
ZELTIQ P/N: 
Protocol Number: ZA18-003 
 
This document and the contents hereof are considered proprietary and confidential information of ZELTIQ Aesthetics, 
Inc.  Disclosure to unauthorized individuals or dissemination, publication or copying is prohibited without prior written consent of 
ZELTIQ. 
Summary of Changes to Protocol from Previous Version 
ZELTIQ Part Number 
Protocol Version 
Date 
  
Version 01 
October 3, 2018 
Version 02 
February 22, 2019 
Affected Section (s)  
Summary of Revisions Made 
Rationale 
Protocol Summary  
Corrected typographical error for the number of 
clinical sites from six to five.  
Administrative change 
1.2, 1.3 
EMS devices description was corrected.  
Other minor formatting changes 
EMS devices are nonsignificant risk 
devices, and FDA clearance is not 
required for their use in the study. 
1.2 
EMS treatment will be conducted prior to or 
post CoolSculpting 
Reflects the study design for Cohort 4. 
2.7(g) 
A new inclusion criterion has been added to 
specify criteria for eligibility specifically for the 
new Cohort 4.  
Cohort 4 will consist exclusively of 
Cohort 3 participants who have 
completed CoolSculpting treatment.   
Table 2 
Modified format and removed specific 
requirement for enrollment by Cohort 
Sponsor will decide number of 
participants for each Cohort 
2.12.1(e)  
2.12.2(e) 
Modified procedure to allow up to two 
applicators.  
It is common in current commercial 
treatment practice to use 2 applicators 
2.12.2(i) 
Revised description of pain score from average 
to maximum pain score 
Changed to improve participant’s 
comprehension of assessment. 
2.12.1, 2.12.2, 2.12.4 
Added use of a support arm with EMS device 
Support arm may be supplied with 
EMS device and is an optional tool for 
the clinician 
2.12.4 
Added Cohort 4 
Assess effects of EMS post- 
CoolSculpting 
2.12.5 
Corrected reference to photographs to 2.14 
Administrative correction 
 
  
 
2.18 
Added description of the requirement for 
documentation of device deficiencies 
 
Updated description of investigator reporting 
time lines for adverse event reporting.  
This is a requirement in accordance 
with ISO 14155 
 
Reporting time line consistent with 
company procedure.   
6.2 
Hernia was added to the list of risks 
This potential adverse event was 
inadvertently not listed in Version 1. It 
is not a new risk, it is a recognized and 
documented rare side effect.  
6.2 
The description of the Adverse Effect, 
Discomfort During the Procedure was corrected.  
The description provided in the 
protocol was for post-procedure 
discomfort. The amended description 
is for intra-procedure discomfort.  

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Title: A Feasibility Study to Evaluate Electromagnetic Muscle Stimulation and CoolSculpting for 
Abdominal Contouring 
 
ZELTIQ P/N: 
Protocol Number: ZA18-003 
 
This document and the contents hereof are considered proprietary and confidential information of ZELTIQ Aesthetics, 
Inc.  Disclosure to unauthorized individuals or dissemination, publication or copying is prohibited without prior written consent of 
ZELTIQ. 
 
 
INVESTIGATOR SIGNATURE PAGE 
 
For protocol number ZA18-003 
 
 
I agree to: 
 
• Implement and conduct this study diligently and in strict compliance with this 
protocol, GCP, and all applicable laws and regulations. 
 
• Maintain all information supplied by the Sponsor, ZELTIQ Aesthetics, an Allergan affiliate, in 
confidence and, when this information is submitted to an Ethics Committee (EC), or another group, 
it will be submitted with a designation that the material is confidential. 
 
I have read this protocol in its entirety and I agree to all aspects. 
 
 
 
________________________ 
_______________________ 
_______________ 
Investigator printed name 
Signature 
Date 
 
 
 
 
_________________________ 
_______________________ 
_______________ 
Co- Investigator printed name 
Signature 
Date 
 
 
 
RETURN PAGE TO SPONSOR 
 
 
 

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Part Number: 
Revision: 02 
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Title: A Feasibility Study to Evaluate Electromagnetic Muscle Stimulation and CoolSculpting for 
Abdominal Contouring 
 
ZELTIQ P/N: 
Protocol Number: ZA18-003 
 
This document and the contents hereof are considered proprietary and confidential information of ZELTIQ Aesthetics, 
Inc.  Disclosure to unauthorized individuals or dissemination, publication or copying is prohibited without prior written consent of 
ZELTIQ. 
 
Table of Contents 
 
1. 
Introduction .............................................................................................................. 7 
1.1 
Background .................................................................................................................... 7 
1.2 
Device Descriptions ....................................................................................................... 8 
1.3 
Regulatory Status ......................................................................................................... 11 
2. 
Study Protocol ....................................................................................................... 12 
2.1 
Design ........................................................................................................................... 12 
2.2 
Study Duration .............................................................................................................. 12 
2.3 
Physician Participants ................................................................................................. 12 
2.4 
Site Requirements ........................................................................................................ 12 
2.5 
Subject Recruitment ..................................................................................................... 12 
2.6 
Sample Size .................................................................................................................. 12 
2.7 
Subject Eligibility .......................................................................................................... 12 
2.8 
Informed Consent ......................................................................................................... 14 
2.9 
Screening Procedures .................................................................................................. 14 
Screening Visit; Required; Day -60 to Day 0 ............................................................................................ 14 
2.10 
Enrollment ..................................................................................................................... 16 
2.11  
Photo Visit; Required, day -30 to 0 .............................................................................. 16 
2.12  
Study Treatment ........................................................................................................... 16 
Treatment Visit 1; Required; Day 0 .......................................................................................................... 16 
2.12.1 
COHORT 1 .............................................................................................................................. 16 
2.12.2 
COHORT 2 .............................................................................................................................. 17 
2.12.3 
COHORT 3 .............................................................................................................................. 19 
2.12.4 
COHORT 4 .............................................................................................................................. 20 
2.12.5 
Additional EMS Treatment Visits; Required ............................................................................ 20 
2.13 
Follow-up Procedures .................................................................................................. 21 
2.13.1 Two-Week Post-Final Treatment Follow-Up; Day 14 ± 3 days ..................................................... 21 
2.13.2 Four-Week Post-Final Treatment Follow-Up; 4 Weeks ± 1 week; ................................................ 22 
2.13.3 Twelve-week Post Final Treatment Follow-Up Visit; 12 Weeks ± 2 weeks .................................. 22 
2.13.4 Optional Follow-Up Evaluations (up to 4 within study period) ....................................................... 22 
2.14 
Assessments ................................................................................................................ 24 
2.14.1 Global Aesthetic Improvement Scale (GAIS-Independent) ........................................................... 24 
2.14.2 Global Aesthetic Improvement Scale (GAIS-Subject) ................................................................... 24 
2.14.3 Photography .................................................................................................................................. 24 

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Title: A Feasibility Study to Evaluate Electromagnetic Muscle Stimulation and CoolSculpting for 
Abdominal Contouring 
 
ZELTIQ P/N: 
Protocol Number: ZA18-003 
 
This document and the contents hereof are considered proprietary and confidential information of ZELTIQ Aesthetics, 
Inc.  Disclosure to unauthorized individuals or dissemination, publication or copying is prohibited without prior written consent of 
ZELTIQ. 
2.14.4 Circumference Measurements ...................................................................................................... 25 
2.15 
Endpoints ...................................................................................................................... 25 
2.15.1 Primary Endpoints ......................................................................................................................... 25 
2.15.2 Secondary Endpoints .................................................................................................................... 25 
2.15.3 Exploratory Assessments: ............................................................................................................. 25 
2.16 
Statistical Analysis Plan .............................................................................................. 26 
2.16.1 Statistical Methods: Overall Plan .................................................................................................. 26 
2.16.2 Analysis Population ....................................................................................................................... 26 
2.16.3 Endpoint Analysis .......................................................................................................................... 26 
Primary Endpoints: ............................................................................................................................................... 26 
Secondary Endpoints: ........................................................................................................................................... 27 
2.17 
Protocol Adherence ...................................................................................................... 27 
2.18 
Adverse Events ............................................................................................................. 28 
3. 
Study Management and Quality Control.............................................................. 30 
3.1 
Study Data Collection ................................................................................................... 30 
3.2 
Confidentiality ............................................................................................................... 30 
3.3 
Investigator Responsibilities ....................................................................................... 31 
General Responsibilities ........................................................................................................................... 31 
Investigator Records................................................................................................................................. 32 
Investigator Reports ................................................................................................................................. 33 
3.4 
Sponsor Responsibilities ............................................................................................. 33 
General Responsibilities: .......................................................................................................................... 33 
Training ..................................................................................................................................................... 34 
Site Monitoring .......................................................................................................................................... 34 
Final Report .............................................................................................................................................. 36 
4. 
Data Ownership ..................................................................................................... 36 
5. 
Publication Policy .................................................................................................. 36 
6. 
Risk/Benefit Analysis ............................................................................................ 36 
6.1 
Benefits ......................................................................................................................... 36 
6.2 
Risks .............................................................................................................................. 37 
7. 
Selected References ............................................................................................. 40 

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Part Number: 
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Title: A Feasibility Study to Evaluate Electromagnetic Muscle Stimulation and CoolSculpting for 
Abdominal Contouring 
 
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Protocol Number: ZA18-003 
 
This document and the contents hereof are considered proprietary and confidential information of ZELTIQ Aesthetics, 
Inc.  Disclosure to unauthorized individuals or dissemination, publication or copying is prohibited without prior written consent of 
ZELTIQ. 
Protocol Summary 
Title 
A Feasibility Study to Evaluate Electromagnetic Muscle 
Stimulation and CoolSculpting for Abdominal Contouring 
 
Design 
 
Prospective, multi-center, non-randomized, feasibility study 
Purpose 
 
 
 
Enrollment 
 
Clinical site(s) 
Up to sixty (60) subjects 
 
Up to five (5) investigational sites 
 
Subject Population 
Healthy adult men and women aged 22 – 65 who desire 
abdominal subcutaneous fat reduction and abdominal toning. 
 
Primary  
Endpoints 
 
 
 
 
 
 
Secondary  
Endpoints 
 
 
 
 
 
 
 
 
Efficacy endpoint:  Comparison of pre-treatment- and 12-week 
post-final treatment photographs to assess visible changes in the 
abdomen.  
 
Safety endpoint:  Incidence of unanticipated adverse device 
effects (UADE).  It is expected there will be zero UADEs.  
 
 
The secondary endpoints in the study are: 
 
1. Reduction in abdominal circumference as measured by 3-
Dimensional imaging. 
 
2. Subject- graded Global Aesthetic Improvement Scale at 
12-week post-final treatment follow-up. 
 
Sponsor 
ZELTIQ Aesthetics, an Allergan affiliate  
4410 Rosewood Dr. 
Pleasanton, CA 94588 
 

ZELTIQ Aesthetics – Confidential and Proprietary 
 
Part Number: 
Revision: 02 
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Title: A Feasibility Study to Evaluate Electromagnetic Muscle Stimulation and CoolSculpting for 
Abdominal Contouring 
 
ZELTIQ P/N: 
Protocol Number: ZA18-003 
 
This document and the contents hereof are considered proprietary and confidential information of ZELTIQ Aesthetics, 
Inc.  Disclosure to unauthorized individuals or dissemination, publication or copying is prohibited without prior written consent of 
ZELTIQ. 
1. Introduction 
1.1 
Background 
Fat reduction and body contouring procedures, which include invasive, minimally-invasive, 
and non-invasive procedures, have become increasingly popular aesthetic procedures. 
Patients who are obese and do not have specific fat bulges but require significant fat 
reduction to achieve aesthetic results are candidates for invasive and minimally-invasive 
procedures, such as liposuction and laser-assisted liposuction. Although effective at reducing 
fat, these invasive and minimally-invasive procedures involve significant patient discomfort, 
expense, downtime, and the risks typically associated with surgical procedures. As a result, 
patients who do not require significant fat reduction to achieve meaningful aesthetic results 
typically seek non-invasive fat reduction and body contouring procedures to avoid the pain, 
expense, downtime, and surgical risks associated with invasive and minimally-invasive 
procedures. 
ZELTIQ Aesthetics has developed and commercialized a technology for cold-assisted 
lipolysis.  The ZELTIQ CoolSculpting technology is based on the sensitivity of fat cells to 
cold injury in order to selectively eliminate subcutaneous fat tissue without affecting the skin 
or other surrounding tissues. The technology, cryolipolysis, enables a non-invasive 
alternative for subcutaneous fat reduction through cellular apoptosis. The ZELTIQ 
CoolSculpting System is cleared for use in the United States for the indication of cold-
assisted lipolysis of various body areas, including the abdomen, flanks, thighs, submental and 
submandibular areas, back fat, bra fat, and banana roll. It 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.    
Clinical studies of the CoolSculpting System used on the abdomen have demonstrated the 
treatment to be safe and effective for the reduction of subcutaneous fat.  Subjects in a recent 
study rated their satisfaction with the CoolSculpting procedure at 73% and 89% indicated 
they would recommend the procedure. [1]   
While the CoolSculpting procedure is successful in reducing subcutaneous fat in the 
abdomen, ZELTIQ Aesthetics is exploring the concept of combining other non-invasive 
aesthetic treatment modalities to enhance and/or improve the contouring effects of 
CoolSculpting.   

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Title: A Feasibility Study to Evaluate Electromagnetic Muscle Stimulation and CoolSculpting for 
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Protocol Number: ZA18-003 
 
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  Electromagnetic muscle stimulation (EMS), also known 
as neuromuscular electrical stimulation (NMES) is the elicitation of muscle contraction using 
electric impulses. The impulses mimic the action potential that comes from the central 
nervous system, causing the muscles to contract. [2]  
EMS devices are frequently used in physical therapy or rehabilitation settings to strengthen 
and tone muscles damaged by illness or disease but they may also be used for other purposes. 
[3] High intensity EMS devices can elicit stronger, more effective muscle contractions 
believed to increase muscle strength and endurance.  EMS has received an increasing amount 
of attention in the last few years from fitness enthusiasts as various manufacturers promote 
the technology for muscle strengthening, firming and improvement in muscle tone 
specifically in the abdomen, buttocks and thighs. [4]  
  
1.2 
Device Descriptions 
EMS Devices 
Electromagnetic (EMS) devices that may be used in this evaluation produce electromagnetic 
muscle stimulation by a non-contact magnetic field in tissue. Each device under 
consideration for use in this study has the same indications for use and similar technological 
characteristics and principles of operation.  Figure 1 below depicts a representative EMS 
device. 
 
 
Figure 1.  Representative EMS Device 

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Title: A Feasibility Study to Evaluate Electromagnetic Muscle Stimulation and CoolSculpting for 
Abdominal Contouring 
 
ZELTIQ P/N: 
Protocol Number: ZA18-003 
 
This document and the contents hereof are considered proprietary and confidential information of ZELTIQ Aesthetics, 
Inc.  Disclosure to unauthorized individuals or dissemination, publication or copying is prohibited without prior written consent of 
ZELTIQ. 
 
 
All EMS devices considered for use in the proposed evaluation have the following 
indications: 
• Improvement of abdominal tone, strengthening of the abdominal muscles, 
development of firmer abdomen.  
 
EMS devices utilized in this study will be operated in accordance with the manufacturer’s 
Instructions for Use.   
 
CoolSculpting System 
 
Both the control unit and the applicators are cleared by the FDA and are 
commercially available.  
 
Safety features are built into the device to avoid any unexpected excursions in temperature. 
The device will automatically shut down if the thermal exposure at the skin interface exceeds 
specified criteria.  

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Title: A Feasibility Study to Evaluate Electromagnetic Muscle Stimulation and CoolSculpting for 
Abdominal Contouring 
 
ZELTIQ P/N: 
Protocol Number: ZA18-003 
 
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Inc.  Disclosure to unauthorized individuals or dissemination, publication or copying is prohibited without prior written consent of 
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Figure 2:  ZELTIQ CoolSculpting System control unit. 
 
 
 

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Title: A Feasibility Study to Evaluate Electromagnetic Muscle Stimulation and CoolSculpting for 
Abdominal Contouring 
ZELTIQ P/N: 
Protocol Number: ZA18-003
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Inc.  Disclosure to unauthorized individuals or dissemination, publication or copying is prohibited without prior written consent of
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The materials used for patient-contacting surfaces are all common materials with a history of 
use in medical and/or skin-contact consumer applications or have been tested for 
biocompatibility. 
1.3 
Regulatory Status 
The EMS devices that may be used in the proposed evaluation are non-significant risk 
devices. 
Other devices under consideration 
for use in this study may not be FDA cleared, and will have similar technological 
characteristics and principles of operation, and have passed all performance and safety 
testing.
The ZELTIQ CoolSculpting System received market clearance on August 24, 2010 for “use 
as a non-invasive dermatological aesthetic treatment to affect the appearance of flanks” 
(DEN090002). On May 9, 2012, the ZELTIQ System received market clearance for 
treatment of the abdomen (K120023); on April 9, 2014 the System received market clearance 
for treatment of the thighs (K133212); and on September 24, 2015 the System received 
market clearance for treatment of the submental area (K151179). Subsequently, the System 
received clearance for bra fat, back fat and banana roll (K160259), upper arms (K162050), 
the submandibular area (K181740), and can affect the appearance of lax tissue after 
submental treatment (K172144). 
The device was also previously cleared for cooling as a method to minimize localized pain 
and thermal injury during laser and dermatological treatments under: K060407 (initial 
clearance), K063715 (clearance for warming and massage), K072152 (clearance for flat and 
belt applicators), K080118 (clearance for vacuum applicator), and K090094 (clearance for 
commercial device).

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Title: A Feasibility Study to Evaluate Electromagnetic Muscle Stimulation and CoolSculpting for 
Abdominal Contouring 
 
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Protocol Number: ZA18-003 
 
This document and the contents hereof are considered proprietary and confidential information of ZELTIQ Aesthetics, 
Inc.  Disclosure to unauthorized individuals or dissemination, publication or copying is prohibited without prior written consent of 
ZELTIQ. 
2. Study Protocol 
2.1 
Design 
Prospective, multi-center, non-randomized, feasibility study 
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 
CoolSculpting System and EMS devices.   
2.4 
Site Requirements 
Site Investigators must have at least one study coordinator with experience in conducting 
aesthetic research and with sufficient time to perform study activities. 
2.5 
Subject Recruitment 
Patients who seek reduction of fat layer in the abdomen, and/or who wish to have adjunctive 
treatment for abdominal firming and toning will be recruited for this study.  
2.6 
Sample Size 
A maximum of sixty (60) subjects will be included in the study. 
2.7 
Subject 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 and female subjects > 22 years of age and ≤65 years of age. 
b) Subject has not had weight change exceeding 5% of body weight in the preceding 
month. 
c) Subject agrees to maintain her weight (i.e., within 5%) by not making any major 
changes in diet or exercise routine during the course of the study.  

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Title: A Feasibility Study to Evaluate Electromagnetic Muscle Stimulation and CoolSculpting for 
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Protocol Number: ZA18-003 
 
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d) Subject agrees to refrain from any new abdominal training exercises during the course 
of the study. 
e) BMI ≤ 30 kg/m2 as determined at screening. 
f) Abdominal skin fold thickness 2.0 to 5.0 cm, as measured by caliper below umbilicus. 
g) Cohort 4 only:  Subject participated in protocol ZA18-003 in Cohort 3, and received 
the CoolSculpting treatment no more than 6 months prior.   
h) Subject has read and signed a 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, body contouring and/or skin tightening 
procedure in the area of intended treatment within the past 12 months. 
d) Subject has numbness, tingling or other altered sensation in the treatment area. 
e) 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. 
f) Subject has not had an intrauterine contraceptive device inserted or removed within the 
past month. 
g) Subject has a known history of cryoglobulinemia, cold urticaria, cold agglutinin 
disease, or paroxysmal cold hemoglobinuria  
h) 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. 
i) 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. 
j) Subject has known sensitivity or allergy to isopropyl alcohol and propylene glycol, or 
latex. 
k) Subject is taking or has taken diet pills or supplements within the past month. 
l) 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). 
m) Subject has a metal implant or active implanted device such as a pacemaker, 
defibrillator, or drug delivery system. 
n) Subject has been involved in any type of abdominal muscle training program within 
the previous 6 months. 
o) Subject has pulmonary insufficiency. 
p) Subject has a cardiac disorder. 

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q) Subject has a malignant tumor. 
r) Subject has been diagnosed with epilepsy. 
s) Subject currently has a fever. 
t) Subject is pregnant or intending to become pregnant during the study period (in the 
next 9 months). 
u) Subject is lactating or has been lactating in the past 6 months. 
v) Subject is unable or unwilling to comply with the study requirements. 
w) Subject is currently enrolled in a clinical study of any other investigational drug or 
device. 
x) 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).  
2.9 
Screening Procedures 
Once informed consent is obtained, interested subjects will undergo screening.  
Screening Visit; Required; Day -60 to Day 0 
After the informed consent is signed, subjects will be screened for eligibility.  
Each subject will be evaluated to determine that all selection criteria are met.  
The Investigator or designee shall complete a brief medical history and examine 
the subject to confirm eligibility for the study. 
1. Obtain height and weight. 
2. Calculate BMI  
3. Assess for any medical conditions that would lead to exclusion of a subject 
from the study. 
4. Document potential candidate’s medication use (including over-the-counter 
medications, vitamins, and herbs), Fitzpatrick Skin Type, and ethnicity as 

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Title: A Feasibility Study to Evaluate Electromagnetic Muscle Stimulation and CoolSculpting for 
Abdominal Contouring 
 
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well as any skin irregularities (e.g. moles, birth marks, scars, stretch marks, 
discoloration) at the intended treatment area. 
5. 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.  
 
Female subjects of childbearing potential will be advised to avoid becoming 
pregnant during the course of the study by using a medically accepted form of 
contraception if they are sexually active. If the subject becomes pregnant during 
the course of the study, she will not be treated subsequently with the study 
device or be required to have follow-up photographs taken or any other efficacy 
assessment performed. 
All subjects will be asked to maintain their weight by not making any major 
changes to their diet or exercise regimen during the course of the study.  Subjects 
who do not maintain their weight within 5% will still continue in the study.  
However, if the weight change is more than 5% after the final treatment, the 
subjects’ data will be excluded from the per protocol data analysis. All subjects 
will be asked to avoid sun tanning during the course of the study.  
After completion of the screening procedures and confirmation of eligibility, 
subjects will be assigned to one of four treatment groups described in Table 2 
below.    
 
Table 2. Treatment Cohorts 
Cohort 1 
Cohort 2 
Cohort 3 
Cohort 4 
EMS only  
(4 sessions) 
EMS  
(4 sessions) 
followed by 
CoolSculpting  
(3-6 cycles) 
CoolSculpting only 
 (3-6 cycles) 
CoolSculpting  
(3-6 cycles)  
followed by  
EMS  
(4 sessions) 
 
 
Subjects that do not meet all eligibility criteria will be excluded from further 
participation in the study. 

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2.10 Enrollment 
Study candidates who sign the informed consent form, meet eligibility criteria, and 
undergo initiation of study treatment are considered enrolled.  Study treatment 
initiation is defined as the initiation of treatment with a study device after the 
placement of the applicator on the intended treatment area on the scheduled treatment 
day. 
2.11  Photo Visit; Required, day -30 to 0 
All subjects will have their photos taken within 30 days prior to study treatment.  
a) Obtain weight. 
b) Obtain baseline 3-Dimensional photographs of the abdomen using Vectra or 
similar imaging system.   
c) Obtain baseline photographs of the treatment area using standardized setup 
and settings.  
 
2.12  Study Treatment 
Treatment Visit 1; Required; Day 0 
Treatment instructions for the four (4) interventional cohorts are described 
below: 
2.12.1 COHORT 1 
For subjects assigned to receive EMS as a stand-alone intervention (Cohort 1), 
preparation activities are described in steps 2.12.1 a) through k): 
 
a) Review inclusion and exclusion criteria. 
b) Repeat pregnancy test for female subjects of childbearing potential (urine).  
Exclude subject from participation if the results are positive. 
c) If the subjects meet all of the inclusion criteria and none of the exclusion 
criteria, then proceed with the study treatment. 
d) Obtain weight prior to first EMS treatment. 
e) Apply EMS device per manufacturer’s Instructions for Use, and place one or 
two applicators in the center of treatment area. 
f) Support the EMS device with treatment arm, pillows or straps as needed. 

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g) Initiate treatment using recommended program for abdominal toning and 
firming supplied by manufacturer. 
h) Record the highest % energy utilized for the EMS treatment.  
i) At the conclusion of the EMS treatment, the site(s) will be examined for any 
epidermal, dermal, or subcutaneous findings (e.g., blanching, erythema, 
bruising, swelling); alterations in sensation (e.g., numbness, tingling). 
j) 
 
k) Three (3) additional EMS treatment visits will be scheduled wherein the 
intervention will be repeated for a total of 4 treatment sessions to occur 
within a two-week period. Treatment Visits 2, 3 and 4 will be performed as 
specified in Section 2.12.1 a) through j). 
 
2.12.2 COHORT 2 
For subjects assigned to receive EMS treatments prior to CoolSculpting (Cohort 
2), follow steps in Section 2.12.2 a) through k): 
a) Review inclusion and exclusion criteria.  
b) Repeat pregnancy test for female subjects of childbearing potential (urine).  
Exclude subject from participation if the results are positive. 
c) If the subjects meet all of the inclusion criteria and none of the exclusion 
criteria, then proceed with the study treatment. 
d) Obtain weight prior to first EMS treatment. 
e) Apply EMS device per manufacturer’s Instructions for Use, and place one or 
two applicators in the center of the treatment area. 
f) Support the EMS device with treatment arm, pillows or straps as needed. 
g) Initiate treatment using recommended program for abdominal toning and 
firming supplied by manufacturer. 
h) Record the highest % energy utilized for the EMS treatment. 
i) At the conclusion of the EMS treatment, the site(s) will be examined for any 
epidermal, dermal, or subcutaneous findings (e.g., blanching, erythema, 
bruising, swelling); alterations in sensation (e.g., numbness, tingling). 
j) 

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k) Three (3) additional EMS treatment visits will be scheduled wherein the 
intervention will be repeated for a total of 4 treatment sessions to occur 
within a two-week period.  Treatment Visits 2, 3 and 4 will be performed as 
specified in Section 2.12.2 a) through j). 
l) At the conclusion of the 4th EMS treatment or within 7 days, the subject will 
receive multiple CoolSculpting cycles per the Investigator’s discretion. 
Cooling cycles may be applied to the upper or lower abdomen or in both 
areas. CoolSculpting treatments will be performed using a minimum of 3 
cycles and will not exceed 6 cycles. Per Investigator discretion, 
CoolSculpting cycles may be performed simultaneously (dual-sculpting 
method). 
 
i. 
Obtain subject’s weight.  
 
 
 
 
 
  
 
  
 
 
 
 
 
 
 
x. 
Immediately post treatment, the treatment site will be examined for 
any epidermal, dermal or subcutaneous findings (e.g., blanching, 
erythema, bruising, swelling), and alterations in sensation (e.g., 
numbness, tingling). 
xi. 
 
 
 
 
 
 
xii. 

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2.12.3 COHORT 3 
For subjects assigned to Cohort 3, all CoolSculpting cycles will be completed in 
a single visit. 
a) Review inclusion and exclusion criteria.  
b) Repeat pregnancy test for female subjects of childbearing potential (urine).  
Exclude subject from participation if the results are positive. 
c) If the subjects meet all of the inclusion criteria and none of the exclusion 
criteria, then proceed with the study treatment. 
d) Obtain weight. 
e) Use template to mark the treatment areas on the abdomen.  
f) Apply a new gasket onto applicator, then, attach the contour. 
 
 
 
 
 
n) Immediately post treatment, the treatment site will be examined for any 
epidermal, dermal or subcutaneous findings (e.g., blanching, erythema, 
bruising, swelling), and alterations in sensation (e.g., numbness, tingling).  
o) 
 
 
 
 

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The need for post-treatment care is not expected for this study.  Subjects will be 
encouraged to call the study site if they experience any unusual effects (e.g., 
severe discomfort, severe and/or prolonged erythema, bruising, swelling; 
blistering, etc.), which may be related to the study. 
2.12.4 COHORT 4 
For subjects assigned to Cohort 4, all CoolSculpting cycles will be completed in 
a single visit as part of prior participation in Cohort 3 of this protocol.  For these 
subjects assigned to receive EMS treatments, follow steps in Section 2.12.4 a) 
through k):   
 
a) Review inclusion and exclusion criteria. 
b) Repeat pregnancy test for female subjects of childbearing potential (urine).  
Exclude subject from participation if the results are positive. 
c) If the subjects meet all of the inclusion criteria and none of the exclusion 
criteria, then proceed with the study treatment. 
d) Obtain weight prior to first EMS treatment. 
e) Apply EMS device per manufacturer’s Instructions for Use, and place one or 
two applicators in the center of the treatment area.   
f) Support the EMS device with treatment arm, pillows or straps as needed. 
g) Initiate treatment using recommended program for abdominal toning and 
firming supplied by manufacturer. 
h) Record the highest % energy utilized for the EMS treatment.  
i) At the conclusion of the EMS treatment, the site(s) will be examined for any 
epidermal, dermal, or subcutaneous findings (e.g., blanching, erythema, 
bruising, swelling); alterations in sensation (e.g., numbness, tingling). 
  
k) Three (3) additional EMS treatment visits will be scheduled wherein the 
intervention will be repeated for a total of 4 treatment sessions to occur 
within a two-week period.  Treatment Visits 2, 3 and 4 will be performed as 
specified in Section 2.12.4 a) through j).  
2.12.5 Additional EMS Treatment Visits; Required 
EMS Treatment Visit 2 (Cohorts 1, 2 and 4); Required; during Week 1 following 
first EMS treatment 
a) Review and verify the subject continues to meet all eligibility criteria.  

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b) Repeat pregnancy test for female subjects of childbearing potential (urine). 
Exclude subject from participation if the results are positive. 
c) Perform EMS treatment as described in Section 2.12.1 a) through j). 
 
EMS Treatment Visit 3 (Cohorts 1, 2 and 4); Required; during Week 2 following 
first EMS treatment 
a) Review and verify the subject continues to meet all eligibility criteria.  
b) Repeat pregnancy test for female subjects of childbearing potential (urine). 
Exclude subject from participation if the results are positive. 
c) Perform EMS treatment as described in Section 2.12.1 a) through j). 
 
EMS Treatment Visit 4 (Cohorts 1, 2 and 4); Required; during Week 2 following 
first EMS treatment 
a) Review and verify the subject continues to meet all eligibility criteria.  
b) Repeat pregnancy test for female subjects of childbearing potential (urine). 
Exclude subject from participation if the results are positive. 
c) Perform EMS treatment as described in Section 2.12.1 a) through j). 
d) Obtain 3-Dimensional photographs of the abdomen using Vectra or similar 
imaging system.  
e) Obtain photographs of the treatment area using standardized setup and 
settings (Optional). See Section 2.14 for details. 
2.13 Follow-up Procedures 
Subjects who receive study treatment with the study devices will be required to 
complete all follow-up visits and assessments (2-Week, 4-Week and 12-Week).  
2.13.1 Two-Week Post-Final Treatment Follow-Up; Day 14 ± 3 days 
Clinical site staff will contact (via phone call or email) subjects two weeks after 
the CoolSculpting treatment and the final EMS treatment for assessment of the 
treatment area, pain score, and adverse events. If there are any observations 
reported, the study site should obtain a resolution date of the symptoms. If there 
is evidence that an adverse event may have occurred, the subject, at the 
discretion of the Investigator, may be asked to come in for an optional visit for 
appropriate evaluation. 

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2.13.2 Four-Week Post-Final Treatment Follow-Up; 4 Weeks ± 1 week; 
The following evaluations will be performed at the 4-week post-treatment 
follow-up visit: 
i. 
Obtain weight. 
ii. 
Clinical assessment of the treatment area for any epidermal, dermal, 
and subcutaneous findings (e.g., erythema, bruising, swelling, 
pigment changes) as well as alterations in sensation (e.g., numbness, 
tingling).   
iii. 
Assessment of any adverse events. 
iv. 
Obtain 3-Dimensional photographs of the abdomen using Vectra or 
similar imaging system. 
v. 
Obtain photographs of the treatment area using standardized setup 
and settings, optional. See Section 2.14 for details. 
2.13.3 Twelve-week Post Final Treatment Follow-Up Visit; 12 Weeks ± 2 weeks 
The following evaluations will be performed at the 12-week post final treatment 
follow-up visit: 
i.   Obtain weight. 
ii. 
Clinical assessment of the treatment area for any epidermal, dermal, 
and subcutaneous findings (e.g., erythema, bruising, swelling, 
pigment changes) as well as alterations in sensation (e.g., numbness, 
tingling).   
iii. 
Assessment of any adverse events. 
iv. 
Obtain 3-Dimensional photographs of the abdomen using Vectra or 
similar imaging system.  
v. 
Obtain photographs of the treatment area using standardized setup 
and settings. See Section 2.14 for details. 
vi. 
Subject to complete Global Aesthetic Improvement Scale. 
2.13.4 Optional Follow-Up Evaluations (up to 4 within study period) 
The full evaluation is not required at optional follow-up visits; the extent of the 
assessment will be at the discretion of the Investigator. 
Table 3 summarizes the study schedule and events at each visit. 

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ZELTIQ P/N: 
Protocol Number: ZA18-003 
 
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Table 3.  Schedule of Visits 
 
Screening 
(< 1hr) 
Photo Visit 
(<1hr) 
 EMS  
Treatment #1 
(<2hrs) 
EMS 
Treatment #2 
(<2hrs) 
 EMS 
Treatment #3 
(<2hrs) 
EMS 
Treatment #4 
(<2hrs) 
CoolSculpting 
Treatment 
(<4hrs) 
2-Wk Post Tx 
Phone 
Follow-Up 
(<30 min) 
4-Wk Post-Tx 
Follow-Up 
(< 1 hr) 
12-Wk Post-
Tx Follow-Up 
(< 1 hr) 
Optional 
Follow-
Up***** 
Time Frame 
Day 
-60 to 0 
Day  
-30 to 1 
Day 
0 
Week 1 
 
Week 2 
Week 2 
Day 0- 
Day 10 ±3 
days 
Week 2-3**** 
(4 ± 1 weeks) 
(12 ± 2 weeks) 
Open 
Informed Consent*** 
X 
 
 
 
 
 
 
 
 
 
 
Eligibility Criteria 
X 
 
X 
X 
X 
X 
X 
 
 
 
 
Medical History 
X 
 
 
 
 
 
 
 
 
 
 
Tx Site Assessment 
X 
 
X 
X 
X 
X 
X 
 
X 
X 
 
Height 
X 
 
 
 
 
 
 
 
 
 
 
Weight 
X 
X 
X 
 
 
 
X 
 
X 
X 
 
BMI 
X 
 
 
 
 
 
 
 
 
 
 
3D Photography  
 
X 
 
 
 
X 
 
 
X 
X 
 
Standardized 
Photography 
 
X 
 
 
 
X# 
 
 
X# 
X 
 
CoolSculpting 
 
 
 
 
 
 
X** 
 
 
 
 
EMS  
 
 
X* 
X* 
X* 
X* 
 
 
 
 
 
Pain Assessment 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
AE Assessment 
 
 
X 
X 
X 
X 
 
X 
X 
X 
 
Subject GAIS 
 
 
 
 
 
 
 
 
 
X 
 
*         EMS treatment visits 1, 2, 3, 4 apply to Cohorts 1, 2 and 4 only.  
**       Cohort 2 after EMS and Cohort 3.  
***     Informed Consent to be signed by subject prior to the collection of any data or initiation of any study procedures.  
****   2-week F/U timing is dependent on cohort assignment.  
***** Investigator discretion as to timing and extent of follow-up assessment for optional visits.  
#         Optional

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2.14 Assessments 
Study-related assessments are described below. 
2.14.1 Global Aesthetic Improvement Scale (GAIS-Independent) 
Independent physician(s) experienced in body contouring treatment will be asked to 
rate the improvement observed in the subject’s treated area between 12-week post 
final treatment images and baseline images, using the Global Aesthetic Improvement 
Scale: 
• 3 = Very much improved 
• 2 = Much improved 
• 1= Improved 
• 0 = No change 
• -1 = Worse 
• -2 = Much worse 
• -3 = Very much worse 
 
2.14.2 Global Aesthetic Improvement Scale (GAIS-Subject) 
At 12-weeks post-final treatment, subjects will be asked to rate the improvement 
observed in the treated area using the Global Aesthetic Improvement Scale:  
• 3 = Very much improved 
• 2 = Much improved 
• 1 = Improved 
• 0 = No change 
• -1 = Worse 
• -2 = Much worse 
• -3 = Very much worse 
 
2.14.3 Photography  
Three-Dimensional (3-D) photography will be used in this evaluation. 3-D photography 
may be performed using a commercially available photography system, such as the 
Canfield VECTRA or similar device.  
In addition, standardized photos of the treatment areas will be obtained at pre-
treatment and 12-week visits, using standardized setup, lighting, and camera settings 

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to ensure consistency. All standard photographs will be captured at fixed angles and 
posture. Using a series of pre-determined markings on the floor, the photographer 
will position the camera at the pre-determined reference points to ensure that the 
reproduction ratio and focal distance are maintained throughout the image series 
during the study.  Subjects will use a Foot Positioning Guide (FPG) for each body 
angle.  During follow-up visits, the photographer will re-align subjects on the FPG 
by referencing baseline images.  The photos will be used in the Independent GAIS 
evaluation 
2.14.4 Circumference Measurements 
Subjects will undergo 3-D imaging. The imaging will be used to calculate abdomen 
circumference using the 3-D imaging manufacturer’s software tools. 
2.15 Endpoints 
 
2.15.1 Primary Endpoints 
The primary endpoints of the study will be defined as follows: 
• Efficacy endpoint:  Comparison of pre-treatment and 12-week post-final treatment 
photographs to assess visible changes in the abdomen.  
 
• Safety endpoint:  Incidence of unanticipated adverse device effects (UADE).  It is 
expected there will be zero UADEs.  
2.15.2 Secondary Endpoints 
The secondary endpoints in the study are: 
• Reduction in abdominal circumference as measured by 3-Dimensional imaging. 
• Subject Global Aesthetic Improvement Scale at 12-weeks post-final follow-up 
visit. 
2.15.3 Exploratory Assessments: 
Additional analyses, which may be performed, include: 
 
 

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2.16 Statistical Analysis Plan 
2.16.1 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 deviation, 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. 
2.16.2 Analysis Population 
Analysis Populations are defined as following: 
 
Per-protocol Population (PP): 
The Per-protocol Population will consist of all treated subjects followed for 12 
weeks and with weight change of no more than five percent (5%) of total body 
weight at the time the 12-week images are taken compared to the weight taken at the 
photo visit.  Since significant weight change will affect the images, the primary 
efficacy analysis will be performed based on this study population. Subjects who do 
not complete treatment will not be included in the efficacy analyses. 
 
As-Treated Population (AT): 
This population consists of all treated subjects regardless of weight change etc.   
 
2.16.3 Endpoint Analysis 
Primary Endpoints: 
The primary efficacy endpoint will be evaluated by a comparison of pre-treatment 
and 12-week post-final treatment photographs to assess visible changes in the 
abdomen. Independent physician(s) experienced in body contouring treatment will 
be asked to rate the improvement observed in the subject’s treated area between 
12-week post final treatment images and baseline images, using the Global 
Aesthetic Improvement Scale. 
The primary safety endpoint is the incidence of Unanticipated Adverse Device 
Effects (UADE).  The number and percentage of subjects experiencing each AE 
Term will be descriptively summarized. 

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Secondary Endpoints:  
Circumference 
Circumference measurements obtained using 3-D imaging pre-treatment and at 
the 12-week post-final visit will be analyzed using the imaging manufacturer’s 
software tools.   
Global Aesthetic Improvement Scale 
At 12-weeks post-final treatment, the subject will be asked to rate the 
improvement observed in the treated area using the Global Aesthetic 
Improvement Scale.  The questionnaire is scored on a 7-point scale with 3 = Very 
much improved, 2 = Much improved, 1 = Improved, 0 = No change, -1 = Worse, -
2 = Much worse, and -3 = Very much worse. 
 
The number and percentage of subjects will be summarized for each possible 
point grade of the survey at 12 weeks.  The percentage of subjects who noted 
some improvement will be tabulated, and the corresponding exact 95% 
confidence interval (per binomial distribution) will be calculated. 
2.17 Protocol Adherence 
The study Investigators are responsible for performing the study in compliance with the protocol.   
Non-adherence to the protocol is to be classified as a protocol violation or protocol deviation as 
defined below. 
Protocol Violation 
Non-adherence to the protocol that may result in significant additional risk to the subject (e.g., 
enrollment of a subject who does not meet the study criteria).  Or, non-adherence to Good 
Clinical Practices (GCP) that may impact patient safety (e.g., failure to obtain proper consent 
prior to performing study procedures).  Violations should be reported to the study Sponsor within 
5 working days and reported to the IRB per IRB guidelines. 
Protocol Deviation 
Non-adherence to study procedures which does not result in additional risk to the subject (e.g., 
subject missed visit).  Protocol deviations are not required to be reported to the IRB; however, 
they must be recorded on the study case report forms and may be reported and reviewed in 
conjunction with the progress report as part of the annual review process. 

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2.18 Adverse Events 
Adverse events (AEs) will be assessed continuously throughout the study. An adverse event is 
defined as any untoward medical occurrence in a participant, regardless of whether the event is 
related to the device.  
All AEs and device deficiencies will be recorded on the corresponding CRF for the subject.  
Adverse Device Effect (AE) 
Any sign, symptom, or disease in a study participant 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. 
Device Deficiencies 
A device deficiency is defined in accordance with ISO 14155 as inadequacy of a medical device 
including issues with respect to its identity, quality, durability, reliability, safety, or performance. 
Device deficiencies include malfunctions, use errors, and inadequate labeling. 
If a device deficiency occurs, the investigational site will document the event using the CRF. 
Device deficiencies will be documented throughout the study and appropriately managed and 
reported to regulatory authorities and IRBs as required by Federal regulations. 
Serious Adverse Event (SAE) 
Any untoward medical occurrence in a participant, regardless of whether the event is related to 
the device that: 
a. results in death; 
b. results in a life-threatening illness or injury; 
The term life threatening in the definition of serious refers to an event in which the 
participant was at risk of death at the time of the event. It does not refer to an event, which 
hypothetically might have caused death, if it were more severe. 
c. results in a permanent impairment of a body structure or body function;  
o Impairment of body function means a substantial disruption of a person’s ability to 
conduct normal life functions. 
o This definition is not intended to include experiences of relatively minor medical 
significance such as uncomplicated headache, nausea, vomiting, diarrhea, influenza, 
and accidental trauma (e.g., sprained ankle) which may interfere with or prevent 
everyday life functions but do not constitute a substantial impairment. 
 

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d. requires in-patient hospitalization or prolongation of existing hospitalization; 
o In general, hospitalization signifies that the participant has been detained (usually 
involving at least an overnight stay) at the hospital or emergency ward for 
observation and/or treatment that would not have been appropriate in the physician’s 
office or outpatient setting. Complications that occur during hospitalization are AEs. 
If a complication prolongs hospitalization or fulfills any other serious criteria, the 
event is serious. When in doubt as to whether hospitalization occurred or was 
necessary, the AE should be considered serious. Hospitalization for elective treatment 
of a pre-existing condition that did not worsen from baseline is not considered an AE. 
 
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. 
 
Time Period and Frequency for Collecting AE and SAE Information 
All AEs and SAEs from the signing of the ICF until the follow-up visit will be collected 
at the time points specified in the schedule of activities, and as observed or reported 
spontaneously by study participants.  
 
Medical occurrences that begin after signing of informed consent and before administration of 
study treatment will be recorded on the Medical History/Current Medical Conditions section of 
the CRF not the AE section. 
 
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 plan or application, or any other 
unanticipated serious problem associated with a device that relates to the rights, safety, or 
welfare of participants.  
The Investigator shall be responsible for determination of the causal relationship of all adverse 
events to the device and/or procedure.  The Principal Investigator is responsible for monitoring 
the safety of the participants enrolled.   
Reportable Incidents 

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Part Number: 
Revision: 02 
Page 30 of 40 
Title: A Feasibility Study to Evaluate Electromagnetic Muscle Stimulation and CoolSculpting for 
Abdominal Contouring 
 
ZELTIQ P/N: 
Protocol Number: ZA18-003 
 
This document and the contents hereof are considered proprietary and confidential information of ZELTIQ Aesthetics, Inc.  Disclosure to 
unauthorized individuals or dissemination, publication or copying is prohibited without prior written consent of ZELTIQ. 
Serious adverse events (SAEs) and unanticipated adverse device effects (UADEs) must be 
recorded and reported to the manufacturer of the study device and to the Sponsor or designee 
within 24 hours of knowledge of the event.  
Sponsor Contact: 
Lori Brandt 
Director, Clinical Trial Management 
ZELTIQ Aesthetics, an Allergan affiliate  
4410 Rosewood Dr. 
Pleasanton, CA 94588 
 
 
A full reporting of the event shall be provided within 10 working days of the event.  The Sponsor 
is then responsible for notifying the IRB, as required. 
Other adverse events, deemed by the investigator to be non-serious, should be provided to the 
Sponsor as soon as possible and not later than 1 week after knowledge of the event. This will be 
forwarded to the Product Surveillance team within 24 hours of receipt by the Sponsor Contact.  
Additional information obtained by the Clinical Site regarding any adverse event, both serious 
and non-serious, will be reported to the Sponsor within 24 hours of awareness.  
 
3. Study Management and Quality Control  
3.1 
Study Data Collection   
Standardized Case Report Forms (CRFs) will be provided to all participating sites.  Data will be 
reviewed by the study monitor and data management to identify inconsistent or missing data 
and to ensure compliance with the study protocol.  
3.2 
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 Insurance 
Portability and Accountability Act (HIPAA) of 1996. 

ZELTIQ Aesthetics – Confidential and Proprietary 
 
Part Number:
Revision: 02 
Page 31 of 40 
Title: A Feasibility Study to Evaluate Electromagnetic Muscle Stimulation and CoolSculpting for 
Abdominal Contouring 
 
ZELTIQ P/N: 
Protocol Number: ZA18-003 
 
This document and the contents hereof are considered proprietary and confidential information of ZELTIQ Aesthetics, Inc.  Disclosure to 
unauthorized individuals or dissemination, publication or copying is prohibited without prior written consent of ZELTIQ. 
Only authorized site staff, the study Sponsor or the Sponsor’s designee, IRB and FDA will have 
access to these confidential files. 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. 
3.3 
Investigator Responsibilities 
General Responsibilities  
Investigators are responsible for ensuring the investigation is conducted according to 
all signed agreements, the Investigational Plan, and applicable FDA regulations.  
The Investigator must protect the rights, safety, privacy and welfare of the subjects 
under the Investigator’s care. Investigators will assume overall responsibility and 
accountability for study site staff and for the clinical data obtained during the study.  
The Investigator assumes all responsibilities per 21 CFR 812 and other applicable 
regulations, including but not limited to: 
IRB approval: The Investigator may not begin the study until the governing 
institutional review board (IRB) provide written approval of the study protocol and 
consent form.  The Investigator is also responsible for fulfilling any conditions of 
approval imposed by the IRB. 
Informed Consent: The Investigator must ensure that informed consent is obtained 
from each prospective study subject in accordance with 21 CFR Part 50 and that the 
study is not commenced until IRB approvals have been obtained.   
Device Accountability:  The Investigator is responsible for controlling all 
investigational device(s) stored at their site, including supervision of device use, 
disposal of the device or returning the device as instructed by the Sponsor. (21 CFR 
812.110 & 812.140 (2))  
Financial Disclosure:  Investigators shall provide financial disclosure according to 
federal regulations (21 CFR 54).  
Study Coordinator:  To assure proper execution of the study protocol, each 
Investigator must identify a study coordinator for the site who will work with and 
under the authority of the Investigator to assure that study requirements are fulfilled 
as appropriate.  

ZELTIQ Aesthetics – Confidential and Proprietary 
 
Part Number: 
Revision: 02 
Page 32 of 40 
Title: A Feasibility Study to Evaluate Electromagnetic Muscle Stimulation and CoolSculpting for 
Abdominal Contouring 
 
ZELTIQ P/N: 
Protocol Number: ZA18-003 
 
This document and the contents hereof are considered proprietary and confidential information of ZELTIQ Aesthetics, Inc.  Disclosure to 
unauthorized individuals or dissemination, publication or copying is prohibited without prior written consent of ZELTIQ. 
Investigator Records   
The Investigator and study staff must maintain accurate, complete, and current 
records relating to the conduct of the investigation.  Records must be retained for a 
period of two years following (1) the date the investigation was completed or 
terminated, or (2) the records are no longer required to support a regulatory 
submission or completion of a product development protocol, whichever is longer.  
Participating Investigators shall maintain the following:  
• All correspondence with the Sponsor, another Investigator, the IRB, or a 
monitor 
• Records of all persons authorized to conduct the study (e.g. Delegation of 
Duties/Signature Authorization, CV) 
• Records of receipt, use or disposition of the devices 
• Informed Consent documentation for all enrolled subjects 
• Records of each subject's case history, including study-required Case Report 
Forms and source documentation (e.g. physician notes, lab reports, study 
worksheets, clinic charts) 
• All relevant observations of adverse device effects 
• Records of any protocol deviations 
• The condition of each subject upon entering and during the course of the 
investigation and any relevant medical history and results of any diagnostic 
tests 
• Record of each subject’s exposure to the devices, including the date and time 
of use 
• Investigational plan with all amendments 
• Current IRB approved informed consent and all previously approved 
versions 
• Signed Investigator agreement 
• Investigators will be responsible for the accurate and timely completion of 
CRFs during the trial.   
These records must be available and suitable for inspection at any time by Sponsor 
representatives (monitor) or the reviewing IRB. The Investigator will supply access 
to study-related medical records, original laboratory data, and other records and data 
as they relate to the trial.  The Investigator will ensure that both he/she and his/her 

ZELTIQ Aesthetics – Confidential and Proprietary 
 
Part Number: 
Revision: 02 
Page 33 of 40 
Title: A Feasibility Study to Evaluate Electromagnetic Muscle Stimulation and CoolSculpting for 
Abdominal Contouring 
 
ZELTIQ P/N: 
Protocol Number: ZA18-003 
 
This document and the contents hereof are considered proprietary and confidential information of ZELTIQ Aesthetics, Inc.  Disclosure to 
unauthorized individuals or dissemination, publication or copying is prohibited without prior written consent of ZELTIQ. 
study staff have adequate time and resources to devote to the study, including study 
enrollment, subject evaluations, study documentation and site monitoring. 
Investigator Reports   
The Investigator is responsible for preparation and submission of the following 
reports: 
• Report of any unanticipated adverse device effects shall be submitted to the 
Sponsor within 24 hours and no later than 10 working days after the 
Investigator first learns of the effect. 
• Withdrawal of IRB approval of the Investigator’s part in the investigation 
shall be reported to the Sponsor within 5 working days 
• Progress reports on the investigation to the Sponsor, the monitor, and the 
reviewing IRB annually. Alternatively, the Sponsor may prepare the report.  
• Deviations from the investigational plan shall be reported to the Sponsor and 
the IRB. 
• Failure to obtain informed consent prior to use of a device in a subject shall 
be reported to the Sponsor and IRB within 5 working days after the use 
occurs. 
• A final report shall be submitted to the Sponsor and IRB within 3 months 
after termination or completion of the investigation, or the Investigator’s part 
of the investigation.  
3.4 
Sponsor Responsibilities  
General Responsibilities: 
As the Sponsor, ZELTIQ Aesthetics assumes overall responsibility for the conduct 
of the study. ZELTIQ Aesthetics assumes all responsibilities per 21 CFR 812 and 
other applicable regulations, and shall: 
IRB approval: Ensure IRB approval for the investigation before shipping the device 
to any Investigator.  
Investigators:  Select Investigators qualified by training and experience, and 
providing them with the information they need to conduct the investigation properly 
(21 CFR 812.43). Obtain a signed Investigator Agreement (21 CFR 812.43(c)) from 
each participating Investigator. Study sites will be evaluated to ensure that they have 
an adequate patient base and can provide sufficient staff and documentation support 
to conduct the study properly. 

ZELTIQ Aesthetics – Confidential and Proprietary 
 
Part Number: 
Revision: 02 
Page 34 of 40 
Title: A Feasibility Study to Evaluate Electromagnetic Muscle Stimulation and CoolSculpting for 
Abdominal Contouring 
 
ZELTIQ P/N: 
Protocol Number: ZA18-003 
 
This document and the contents hereof are considered proprietary and confidential information of ZELTIQ Aesthetics, Inc.  Disclosure to 
unauthorized individuals or dissemination, publication or copying is prohibited without prior written consent of ZELTIQ. 
Monitoring:  Select monitors qualified by training and experience to monitoring the 
study (21 CFR 812.43), and ensure proper monitoring of the investigation. (21 CFR 
812.46) 
Investigational devices:  Provide devices only to qualified Investigators (21 CFR 
812.43). No study site may receive shipment of study devices until the following 
documents are received by the Sponsor: 
• Signed Investigator’s Letter of Agreement 
• Signed Clinical Site Agreement 
• Investigator current curriculum vitae  
Data Management and analysis:  Ensure data collection, verification, analysis, 
records storage, etc. Sponsor will assist with presentation(s) and/or publication(s). 
Training  
Study Training: To ensure uniform data collection and protocol compliance, 
Sponsor personnel will provide an educational session to study site personnel as 
needed, which will cover the Investigational Plan, techniques for the identification of 
eligible subjects, data collection and form completion, and the device directions for 
use.  The Investigator and study staff will be trained on the study devices and 
protocol, applicable regulations and requirements, and expectations of the study, 
enrollment expectations, subject selection, informed consent, required clinical data 
and record keeping, etc.   
Investigational Device Use: Representatives of the Sponsor will train Investigators 
in use of the study device prior to study initiation.  Sponsor representatives may be 
present at study procedures. 
Site Monitoring  
The Sponsor will ensure that qualified clinical monitors are available to monitor and 
oversee the conduct of the trial and that monitoring is performed in accordance with 
the Sponsor’s approved procedures or third-party procedures approved by the 
Sponsor.  
The clinical monitors will evaluate compliance with the investigational plan, FDA 
regulations, any specific recommendations made by the site’s IRB and the signed 
Investigator Agreement.   
Monitoring Visits 

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Part Number: 
Revision: 02 
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Title: A Feasibility Study to Evaluate Electromagnetic Muscle Stimulation and CoolSculpting for 
Abdominal Contouring 
 
ZELTIQ P/N: 
Protocol Number: ZA18-003 
 
This document and the contents hereof are considered proprietary and confidential information of ZELTIQ Aesthetics, Inc.  Disclosure to 
unauthorized individuals or dissemination, publication or copying is prohibited without prior written consent of ZELTIQ. 
On-site monitoring visits will assess the progress of the clinical study and identify 
any concerns that result from device performance or review of the Investigator’s 
study records, study management documents, and informed consent documents.   
Monitoring will ensure continued protocol compliance, accurate data reporting, and 
adequate accounting of shipments of study devices. Monitoring visits will occur at 
minimum once before study close-out. 
During monitoring visits, the monitor will compare subject records and other 
supporting documents with reports at the site to determine that; 
• The facilities used by the investigation continue to be acceptable for the 
purposes of the clinical study 
• Informed consent was properly obtained and documented for all enrolled 
study participants 
• The Investigational Plan is being followed, and only eligible subjects are 
being enrolled into the study 
• Deviations to the Investigational Plan have been reported to ZELTIQ and 
the IRB, as appropriate 
• Adverse events are promptly being reported 
• Device accountability is being maintained 
• Information recorded in the case report forms and study reports are 
accurate, complete, legible and consistent with source documentation.  
• Subjects failing to complete the clinical study and the reason for failure 
are recorded. 
• Missed follow-up visits are noted in the study documentation 
Clinical monitors will provide feedback to the site regarding protocol or study 
compliance. 
Study Site Closeout   
At the close of the study at an investigational site, the monitor will ensure that all 
case report forms have been monitored and retrieved and that the Investigator’s files 
are accurate and complete. The monitor will ensure that all investigational devices 
and study supplies are accounted for, and provide for appropriate disposition of any 
remaining supplies. The monitor will review record retention requirements with the 

ZELTIQ Aesthetics – Confidential and Proprietary 
 
Part Number: 
Revision: 02 
Page 36 of 40 
Title: A Feasibility Study to Evaluate Electromagnetic Muscle Stimulation and CoolSculpting for 
Abdominal Contouring 
 
ZELTIQ P/N: 
Protocol Number: ZA18-003 
 
This document and the contents hereof are considered proprietary and confidential information of ZELTIQ Aesthetics, Inc.  Disclosure to 
unauthorized individuals or dissemination, publication or copying is prohibited without prior written consent of ZELTIQ. 
Investigator and any remaining Investigator obligations are reviewed and ensure that 
all applicable requirements are met for the study.  The monitor will prepare a report 
of the site closeout visit.  
Final Report  
A final report will be prepared at the conclusion of the trial. Copies of the final 
report will be provided to each Investigator and to the respective IRB. 
4. Data Ownership 
ZELTIQ Aesthetics, the study Sponsor, retains ownership of all data generated in this study, and 
controls the use of the data for purposes of regulatory submissions to the US and/or other 
governments. Investigator(s) and institution(s) (which shall include their employees, agents, and 
representatives) may not issue or disseminate any press release or statement, nor initiate any 
communication of information regarding this study (written or oral) to the communications 
media or third parties without the prior written consent of the Sponsor.  
5. Publication Policy 
Participating Investigators and/or Institutions may publish information or data collected or 
produced as a result of participation in appropriate scientific conference or journals or other 
professional publications subject to written permission from the Sponsor, provided that drafts of 
the material are provided to the Sponsor for purposes of review and comment at least sixty (60) 
days prior to the first submission for publication or public release.  Investigators may not publish 
information regarding site-specific data until a multicenter study report has been published.  
6. Risk/Benefit Analysis 
The Sponsor has undertaken a comprehensive risk-benefit analysis. 
6.1 
Benefits 
Abdominal muscle toning and contouring in the treatment area is anticipated to provide an 
aesthetic benefit and this non-invasive device accomplishes the desired effect without anesthesia 
and with minimal recovery time.  Furthermore, the results of this study will help in the 
development of the optimal aesthetic procedure for fat removal with cryolipolysis followed by 
EMS.  Considering the number of body contouring surgical procedures performed for the 
removal of fat each year (1.3 million procedures worldwide, according to the 2011 International 
Society of Aesthetic Plastic Surgeons Biennial Global Survey), the use of such a non-invasive 

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Part Number: 
Revision: 02 
Page 37 of 40 
Title: A Feasibility Study to Evaluate Electromagnetic Muscle Stimulation and CoolSculpting for 
Abdominal Contouring 
 
ZELTIQ P/N: 
Protocol Number: ZA18-003 
 
This document and the contents hereof are considered proprietary and confidential information of ZELTIQ Aesthetics, Inc.  Disclosure to 
unauthorized individuals or dissemination, publication or copying is prohibited without prior written consent of ZELTIQ. 
procedure has the potential to significantly reduce the incidence of complications and post-
surgical limitations associated with those procedures. 
6.2 
Risks 
Although this study presents minimal risks to the subject, there is always the potential for some 
risk when a medical procedure is performed.  
Anticipated Device Effects from CoolSculpting procedure: 
These are known effects of the ZELTIQ Procedure, previously noted in prior studies as transient 
and/or temporary effects related to the treatment. Anticipated effects of the device which will not 
be considered adverse events include:  
• inflammation of the subcutaneous fat layer, which is a desired effect of the procedure; 
• sensations of coldness, stinging, burning, pinching, or pressure associated with placement of 
the applicator and the initiation of the cold treatment; 
• known skin effects (e.g., blanching; erythema, bruising, purpura, petechiae, swelling, 
discomfort, tenderness, or soreness at the treatment site, all mild to moderate in nature) 
which are temporary effects that resolve spontaneously shortly after the procedure; 
• transient, localized sensory changes (e.g., numbness, tingling) resolving within 12 weeks of 
the procedure; 
 
Anticipated Device Effects of EMS: 
• muscular pain in the treatment area 
• temporary muscle spasm 
• temporary joint or tendon pain 
• local erythema and/or skin redness 
• skin irritation and burns under the electrodes may cause possible allergic 
skin reaction to tape or gel 
 
Adverse Effects 
 
The following summarizes the potential adverse effects in this study: 
 
 

ZELTIQ Aesthetics – Confidential and Proprietary 
 
Part Number: 
Revision: 02 
Page 38 of 40 
Title: A Feasibility Study to Evaluate Electromagnetic Muscle Stimulation and CoolSculpting for 
Abdominal Contouring 
 
ZELTIQ P/N: 
Protocol Number: ZA18-003 
 
This document and the contents hereof are considered proprietary and confidential information of ZELTIQ Aesthetics, Inc.  Disclosure to 
unauthorized individuals or dissemination, publication or copying is prohibited without prior written consent of ZELTIQ. 
Potential Adverse Effect 
Description 
Severe Bruising 
The appearance of bruising (purple discoloration); purpura 
(purple colored spots or patches); or petechiae (pin point red 
dots) that is rated as severe by the Investigator;  
Prolonged Bruising 
Bruising lasting longer than 1 month 
Severe Erythema 
The appearance of erythema (redness) that is rated as severe 
by the Investigator  
Prolonged Erythema 
Erythema lasting longer than 2 weeks. 
Severe Swelling 
The appearance of swelling (edema) that is rated as severe by 
the Investigator  
Prolonged Swelling 
Swelling lasting longer than 1 month. 
First Degree Burn 
 
A first degree burn is superficial and causes local 
inflammation of the skin. The inflammation is characterized 
by pain, redness, and mild swelling. The skin may be very 
tender to touch. 
Second Degree Burn 
Second degree burns are deeper and in addition to the pain, 
redness and inflammation, there is also blistering of the skin.  
Third Degree Burn 
Third degree burns are deeper still, involving all layers of the 
skin.  Because the nerves and blood vessels are damaged, 
third degree burns appear white, leathery and tend to be 
relatively painless. 
Cold-Induced Panniculitis 
Severe inflammation which requires medical or surgical 
intervention. 
Skin Pigmentary Changes 
The appearance of hyperpigmentation or hypopigmentation in 
the treatment area. 
Infection 
Infection at the treatment site, diagnosed by a Physician and 
requiring medical intervention. 
Discomfort During Procedure 
Discomfort during the procedure that is intolerable to the 
subject and results in an interruption or discontinuation of the 
procedure.   
Discomfort Post Procedure 
Significant discomfort, pain, cramping, tenderness, soreness, 
muscle spasm following the procedure which results in 
medical intervention (physician visit and/or prescription pain 
reliever) 
Prolonged Sensory Alteration Post 
Procedure 
Sensory changes (numbness, tingling, burning sensation) that 
are prolonged (i.e., lasting longer than 12 weeks). 
Sensory Alteration Requiring 
Medical Intervention 
Sensory changes (pain, burning, stinging, hypersensitivity) 
with a severity warranting medical intervention. 
Vasovagal Symptoms 
The occurrence of symptoms of anxiety, lightheadedness, 
dizziness, nausea, sweating, near syncope, or syncope 
(fainting). 

ZELTIQ Aesthetics – Confidential and Proprietary 
 
Part Number: 
Revision: 02 
Page 39 of 40 
Title: A Feasibility Study to Evaluate Electromagnetic Muscle Stimulation and CoolSculpting for 
Abdominal Contouring 
 
ZELTIQ P/N: 
Protocol Number: ZA18-003 
 
This document and the contents hereof are considered proprietary and confidential information of ZELTIQ Aesthetics, Inc.  Disclosure to 
unauthorized individuals or dissemination, publication or copying is prohibited without prior written consent of ZELTIQ. 
Potential Adverse Effect 
Description 
Gastrointestinal Symptoms 
Nausea, bloating, or diarrhea temporally related to the 
procedure (within the first few hours after the procedure) 
Contour Irregularity 
Significant indentation or contour irregularity in the treatment 
area that would require surgical intervention. 
Skin surface irregularities 
Significant indentation or rippling which develops 1 month 
after treatment that would require medical intervention. 
Allergic/Irritant Contact Dermatitis 
Itchy rashes and skin peeling that may result from prolonged 
exposure to gel or gelpad, foam borders or applicator pressure 
Subcutaneous Induration 
Hardness within the treatment area, either as generalized 
firmness or discrete nodules. 
Hernia 
Creation or exacerbation of hernia. Hernia is defined as a 
protrusion of an organ or the fascia of an organ through the 
wall of the cavity that normally contains it.  
Paradoxical Hyperplasia 
Visibly enlarged tissue volume within the treatment area 
which may develop 2-5 months after treatment. Surgical 
intervention may be required. 
Other 
Any other untoward medical event determined by the 
Investigator to be an adverse event, regardless of the 
relationship to the device or treatment. 
 
 
 

ZELTIQ Aesthetics – Confidential and Proprietary 
 
Part Number: 
Revision: 02 
Page 40 of 40 
Title: A Feasibility Study to Evaluate Electromagnetic Muscle Stimulation and CoolSculpting for 
Abdominal Contouring 
 
ZELTIQ P/N: 
Protocol Number: ZA18-003 
 
This document and the contents hereof are considered proprietary and confidential information of ZELTIQ Aesthetics, Inc.  Disclosure to 
unauthorized individuals or dissemination, publication or copying is prohibited without prior written consent of ZELTIQ. 
7. Selected References 
 
1. Krueger, N., Mai, S. V., Luebberding, S., & Sadick, N. S. (2014). Cryolipolysis for noninvasive 
body contouring: clinical efficacy and patient satisfaction. Clinical, cosmetic and investigational 
dermatology, 7, 201. 
 
2. Maffiuletti NA, Minetto MA, Farina D, Bottinelli R. Electrical stimulation for neuromuscular 
testing and training: state-of-the art and unresolved issues. Eur J Appl Physiol. 2011 
Oct;111(10):2391-7. 
 
3. Leon-Salas WD, Rizk H, Mo C, et al. A Dual Mode Pulsed Electro-Magnetic Cell Stimulator 
Produces Acceleration of Myogenic Differentiation. Recent patents on biotechnology. 
2013;7(1):71-81. 
 
4. Jacob CI, Paskova K. Safety and efficacy of a novel high‐intensity focused electromagnetic 
technology device for noninvasive abdominal body shaping. J Cosmet Dermatol. 2018;00:1-5.