Magnetic Muscle Stimulation of Abdominal Muscle
Phase: NA
Conditions: Muscle Weakness
Sponsor: Zeltiq Aesthetics



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Part Number: CS-304247 
Revision: 02 
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Title: Magnetic Muscle Stimulation of Abdominal Muscle 
 
ZELTIQ P/N: CS-304247-02 
Protocol Number: ZA19-001 
(DC00025 Rev D) 
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Summary of Changes to Protocol from Previous Version  
ZELTIQ Part 
Number 
Protocol Version 
Date 
CS-304247 
01 
11 October 2019 
02 
15 April 2020 
Affected Section (s)  Summary of revisions made 
Rationale 
N/A 
Initial release. 
 
 
 

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Title: Magnetic Muscle Stimulation of Abdominal Muscle 
 
ZELTIQ P/N: CS-304247-02 
Protocol Number: ZA19-001 
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INVESTIGATOR SIGNATURE PAGE 
 
For protocol number ZA19-001 
 
 
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 Institutional Review 
Board (IRB) or 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 
 
 
______________________         ______________________         _______ 
Investigator printed name                        Signature  
 
Date 
 
 
 
 
 
RETURN PAGE TO SPONSOR 
 
 

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Title: Magnetic Muscle Stimulation of Abdominal Muscle
ZELTIQ P/N: CS-304247-02
Protocol Number: ZA19-001
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Table of Contents
1.
Protocol Summary......................................................................................................... 7
2.
Introduction .................................................................................................................. 8
Background .......................................................................................................................8
Regulatory Status...............................................................................................................9
Prior Clinical Studies.........................................................................................................9
3.
Device Description....................................................................................................... 10
4.
Study Objectives.......................................................................................................... 10
5.
Investigational Plan..................................................................................................... 10
Study Design ....................................................................................................................10
Investigator Qualifications...............................................................................................11
Study Population..............................................................................................................11
5.3.1.
Target Patient Population....................................................................................................11
5.3.2.
Subject Eligibility ...............................................................................................................11
5.3.3.
Vulnerable Populations.......................................................................................................12
6.
Study Conduct and Procedures................................................................................... 13
Recruitment.....................................................................................................................13
Informed Consent ............................................................................................................13
Screening Procedures.......................................................................................................13
6.3.1.
Enrollment...........................................................................................................................14
6.3.2.
Photo Visit; Required, day -60 to 0.....................................................................................14
Treatment Procedures......................................................................................................15
6.4.1.
Treatment Visit #1;  Required; Day 0 for Cohorts 1, 2 and 3.............................................15
6.4.2.
Treatment Visits 2, 3 and 4; Required for Cohorts 1, 2 and 3 ............................................16
6.4.3.
Treatment Visits 5 and 6; Required for Cohorts 2 and 3 only ............................................18
6.4.4.
Treatment Visits 7 and 8; Required for Cohort 3 only........................................................19
Follow-up Procedures ......................................................................................................20
6.5.1.
1-Month Post-Treatment Visit; Required (Day 30 +/- 7 days post treatment)....................20
6.5.2.
Two-Month Post-Treatment Follow-up; Required (Day 60 +/- 7 days post-treatment).....21
6.5.3.
Three-Month Post-Treatment Follow-up; Required (Day 90 +/- 14 days post-treatment) . 21
Assessments .....................................................................................................................25
6.6.1.
Subject Global Aesthetic Improvement Scale (SGAIS) .....................................................25
6.6.2.
Body Satisfaction Scale Questionnaire – Abdomen ...........................................................25
6.6.3.
Photography........................................................................................................................25

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Title: Magnetic Muscle Stimulation of Abdominal Muscle
ZELTIQ P/N: CS-304247-02
Protocol Number: ZA19-001
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6.6.11.
Safety Assessments.............................................................................................................27
7.
Statistical Methodology and Analyses ......................................................................... 27
Primary Endpoints...........................................................................................................27
Statistical Methods: Overall Plan.....................................................................................28
Analysis Cohorts..............................................................................................................28
7.3.1.
Safety Cohort ......................................................................................................................28
7.3.2.
Effectiveness Cohorts .........................................................................................................28
7.3.3.
Endpoint Analysis...............................................................................................................29
7.3.4.
Missing Data Handling .......................................................................................................29
7.3.5.
Data Pooling........................................................................................................................29
7.3.6.
Sample Size Justification ....................................................................................................29
8.
Adverse Events............................................................................................................ 30
Adverse Device Effect (ADE) ...........................................................................................30
8.1.1.
Serious Adverse Device Effect (SADE) .............................................................................31
8.1.2.
Unanticipated Serious Adverse Device Effect (USADE)...................................................31
8.1.3.
Serious Adverse Event (SAE).............................................................................................31
8.1.4.
Time Period and Frequency for Collecting AE and SAE Information ...............................32
8.1.5.
Method of Detecting AEs and SAEs...................................................................................32
8.1.6.
Follow-up of AEs and SAEs...............................................................................................32
8.1.7.
Reportable of Serious Adverse Events (SAEs)...................................................................33
8.1.8.
Assessment of Severity.......................................................................................................33
8.1.9.
Assessment of Relatedness ................................................................................................. 34
8.1.10.
Serious Adverse Event Reporting Procedures ....................................................................36
8.1.11.
Pregnancy............................................................................................................................37
9.
Device Tracking .......................................................................................................... 37
Device Packaging and Labeling........................................................................................37
10.
Device Deficiencies and Malfunctions ...................................................................... 38
11.
Ethical and Regulatory Considerations ................................................................... 38

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Title: Magnetic Muscle Stimulation of Abdominal Muscle
ZELTIQ P/N: CS-304247-02
Protocol Number: ZA19-001
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Compliance with Good Clinical Practice ......................................................................38
Institutional Review Board (IRB) and Informed Consent.............................................38
Protocol Adherence ......................................................................................................39
Protocol Amendments ..................................................................................................39
12.
Study Management and Quality Control ................................................................. 40
Study Data Collection...................................................................................................40
Data Management ........................................................................................................40
12.2.1.
Data Receipt and Data Entry...............................................................................................40
Confidentiality..............................................................................................................40
Quality Assurance Audits.............................................................................................41
Investigator Responsibilities.........................................................................................41
12.5.1.
General Responsibilities .....................................................................................................41
12.5.2.
Investigator Records ...........................................................................................................42
12.5.3.
Investigator Reports............................................................................................................43
Sponsor Responsibilities...............................................................................................43
12.6.1.
General Responsibilities: ....................................................................................................43
12.6.2.
Site Monitoring ...................................................................................................................44
12.6.3.
Final Report ........................................................................................................................46
12.6.4.
Trial Registration ................................................................................................................46
13.
Data Ownership ....................................................................................................... 46
14.
Publication Policy .................................................................................................... 47
15.
Risk/Benefit Analysis ............................................................................................... 47
Benefits.........................................................................................................................47
Risks.............................................................................................................................47
15.2.3.
Adverse Effects...................................................................................................................47
16.
Selected References.................................................................................................. 49

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Title: Magnetic Muscle Stimulation of Abdominal Muscle 
 
ZELTIQ P/N: CS-304247-02 
Protocol Number: ZA19-001 
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Inc.  Disclosure to unauthorized individuals or dissemination, publication or copying is prohibited without prior written consent 
of ZELTIQ. 
 
 
1. Protocol Summary 
Title 
Magnetic Muscle Stimulation of Abdominal Muscle 
Design 
Prospective, open-label interventional study 
Objective/Purpose 
Evaluate the safety and efficacy of magnetic muscle stimulation (MMS) of 
abdominal muscle. 
Enrollment 
Up to 60 subjects 
Clinical Sites 
Up to 4 investigational sites 
Participant/ 
Subject population 
 
Healthy adult men and women aged 22 – 65 who desire abdominal toning. 
Treatment 
 
 
 
 
 
 
 
Primary Endpoint(s) 
Safety endpoint:   
The frequency of device and procedure-related adverse events (AEs), 
including device-related serious adverse events (SADEs), will be 
summarized. 
 
Efficacy endpoint: 
Change in subject perception of body shape as measured using the Body 
Satisfaction Scale (BSS) at the one-month post-final-treatment follow-up 
visit. 
Sponsor 
ZELTIQ Aesthetics, Inc., An Allergan Affiliate  
4410 Rosewood Dr. 
Pleasanton, CA 94588 

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Title: Magnetic Muscle Stimulation of Abdominal Muscle
ZELTIQ P/N: CS-304247-02
Protocol Number: ZA19-001
(DC00025 Rev D)
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2. Introduction 
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. 
In response to physician feedback, ZELTIQ Aesthetics has explored other non-invasive 
aesthetic treatment technologies and modalities to enhance and/or improve the contouring 
effects of the CoolSculpting treatment.  
One treatment of interest is the use of magnetic muscle stimulation (MMS) as an adjunct to 
CoolSculpting treatment and/or as a standalone procedure.  Electrical muscle stimulation, 
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. [1] 

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Title: Magnetic Muscle Stimulation of Abdominal Muscle
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NEMS 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. [2] High intensity magnetic muscle stimulation devices (MMS) can elicit stronger, 
more effective muscle contractions believed to increase muscle strength and endurance. 
MMS 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. [3]  
Regulatory Status
The MMS devices that will be used in the proposed evaluation,
are non-significant risk 
devices that are FDA-cleared for the indications of improvement in abdominal tone, 
strengthening of abdominal muscles and development of firmer abdomen.   
Prior Clinical Studies
   

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6. Study Conduct and Procedures
Recruitment
Potential study subjects will be recruited from clinics of participating investigators as well as 
through local advertising.  Any study-related advertisements will be approved by the 
governing IRB/EC prior to use.   
Informed Consent 
Subjects will be recruited from the Investigator’s clinical practice and via IRB/EC approved 
advertising.  Once the patient’s potential eligibility has been determined, the Investigator or 
designee trained to the protocol will explain the nature and scope of the study, risks and 
benefits of participation, answer questions for the subject, and invite the subject to 
participate.  The study will be explained in lay terms.  If the patient agrees to participate, the 
IRB/EC-approved informed consent will be signed and dated by the patient and the 
Investigator or designee.  A copy of the signed and dated informed consent will be provided 
to the study subject.  
Screening Procedures
After the informed consent is signed, participants will be screened for eligibility.  Each 
participant will be interviewed to determine that all selection criteria are met.  The 
Investigator or designee shall complete a medical history and examine the participant to 
confirm eligibility for the study. The following activities will be performed at the screening 
visit:
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.
As applicable, document previous CoolSculpting treatments, including treatment 
area(s), number of treatment cycles (if known), and when the treatments occurred.  
5.
Document medication use, Fitzpatrick Skin Type, and ethnicity. 
6.
Schedule pre-treatment photo visit (to be completed within 60 days prior to 
treatment).
7.
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.  

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of ZELTIQ. 
 
 
 
 
   
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
   
 
  
  
  
  
 
 
 
 
  
 
 

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of ZELTIQ. 
 
 
 
  
 
 
 
  
  
 
 
 
 
  
  
 
 

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Title: Magnetic Muscle Stimulation of Abdominal Muscle 
 
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Title: Magnetic Muscle Stimulation of Abdominal Muscle 
 
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publication or copying is prohibited without prior written consent of ZELTIQ. 
 
 

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7. Statistical Methodology and Analyses 
Primary Endpoints 
The primary endpoints of the study are defined as follows:  

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•
Safety Endpoint: The frequency of device and procedure-related adverse 
events (AEs), including device-related serious adverse events (SADEs), will 
be summarized.  
•
Efficacy Endpoint: Change in subject perception of body shape as measured 
using the Body Satisfaction Scale (BSS) at the one-month post-final-treatment 
follow-up visit. 
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, fat thickness). The significance level will be 
two-sided 0.05 for all statistical tests. 
Analysis Cohorts
7.3.1.
Safety Cohort  
This cohort will consist of all the treated participants with safety evaluation 
after the treatment.  This cohort should be identical to the As Treated (AT) 
cohort.  The safety data analyses will be performed based on the Safety 
Cohort. 
7.3.2.
Effectiveness Cohorts
Two groups of subjects will be identified for the analysis of effectiveness 
endpoints:  Per Protocol Cohort and the As Treated Cohort.  All analyses of 
effectiveness will be performed on each cohort of subjects.  However, study 
success will be based on the Per Protocol Cohort of subjects. 
Per-protocol Cohort (PP):
The Per-protocol Population will consist of all the treated subjects followed 
through to the final post-treatment visit and with weight change of no more 
than five percent at the time the final post-treatment visit images are taken. 
Since a weight change of more than 5 percent will affect the images, the 
primary efficacy analysis will be performed based on this study population. 
Subjects who do not complete the treatment or had an interruption in the 
treatment will not be included in the primary and secondary efficacy analyses 
As-Treated Cohort (AT):

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This cohort consists of all treated participants regardless of whether they 
become pregnant or undergo weight change during the study.   
 
7.3.3. 
Endpoint Analysis 
Primary Safety Endpoint  
The primary safety endpoint will be the frequency of device and procedure-
related adverse events (AEs), including device-related serious adverse events 
(SADEs).  The number and percentage of subjects experiencing each AE will 
be descriptively summarized. Adverse events and SAEs will be presented as 
summary tables showing the frequency and type of events.  
 
Primary Efficacy Endpoint  
The primary efficacy endpoint of the study will measure subject perception 
about body shape, assessed using the Body Satisfaction Questionnaire at the 
1-Month follow-up visit. The scale measures body image using a set of ten 
dichotomous items used to describe aspects of shape and appearance. The 
items are rated on a five-point semantic differential scale. Mean scores will 
be tabulated. Differences and percentage change from baseline at the 1-
Month follow-up visit will be determined. 
7.3.4. 
Missing Data Handling  
In general, no imputation for missing data will be made. Data will be 
analyzed “as-is” where subjects with missing data not being included in the 
analysis. 
7.3.5. 
Data Pooling  
Data are assumed to be poolable across sites due to: 1) use of the same study 
protocol, 2) equivalent training of all sites in the study protocol and use of 
the investigational device, 3) use of the same CRF at each site, and 4) use of 
Independent Evaluator(s).  
 
 
 
 

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8. Adverse Events
Adverse events (AE) will be collected and assessed continuously throughout 
the study. An AE is defined in accordance with ISO 14155 as any untoward 
medical occurrence, unintended disease or injury, or untoward clinical signs 
(including abnormal laboratory findings) in study participants, users, or other 
persons temporally associated with the use of study treatment, whether or not 
considered related to the study treatment.
Disease signs and symptoms that existed prior to the study treatment are not 
considered AEs unless the condition recurs after the patient has recovered 
from the pre-existing condition or the condition worsens in intensity or 
frequency during the study.
Adverse events will be monitored throughout the study beginning with signing 
of informed consent. At each post-baseline visit, the investigator will begin 
querying for AEs by asking each patient a general, non-directed question such 
as “Have you had any changes to your condition since your last visit?” 
Previous AEs and changes in therapy/concomitant medications are to be 
updated. Directed questioning and examination will then be done as 
appropriate. All AEs and clinically significant abnormal laboratory findings 
will be documented on the appropriate CRF.
Adverse events will be reported by the participant (or, when appropriate, by a 
caregiver, surrogate, or the participant's legally authorized representative). The 
investigator and any designees are responsible for detecting, collecting and
recording events that meet the definition of an AE or SAE and remain 
responsible for following up AEs that are serious, considered related to the 
study treatment or study procedures, or that caused the participant to 
discontinue the study until the event has resolved or until 30 days after the 
completion of the study. 
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 

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investigation. This definition includes any AE s resulting from insufficient or 
inadequate instructions for use, deployment, implantation, installation, or 
operation, or any malfunction of the investigational medical device as well as 
any event resulting from use error (per ISO 62366) or from intentional 
misuse of the investigational medical device. 
8.1.1. 
Serious Adverse Device Effect (SADE) 
A serious adverse device effect (SADE) is defined in 
accordance with ISO 14155 as “an adverse device effect that 
has resulted in any of the consequences characteristic of a 
serious adverse event.” 
8.1.2. 
Unanticipated Serious Adverse Device Effect (USADE) 
An unanticipated serious adverse device effect (USADE) is 
defined in accordance with ISO 14155 as “any serious adverse 
device effect which by its nature, incidence, severity, or 
outcome has not been identified in the current version of the 
risk analysis report.” The investigator is to consult the IFU for 
anticipated risks or anticipated AEs. 
8.1.3. 
Serious Adverse Event (SAE) 
An SAE is defined in accordance with ISO 14155 as an AE that: 
1. Led to death 
2. Led to serious deterioration in the health of the 
patient, that either resulted in: 
a. a life-threatening illness or injury, or 
b. a permanent impairment of a body structure or a body function, or 
c. inpatient or prolonged hospitalization, or 
d. medical or surgical intervention to prevent life-
threatening illness or injury or permanent impairment 
to a body structure or a body function, or 
e. led to fetal distress, fetal death or a congenital 
abnormality or birth defect 
NOTE: Planned hospitalization for a pre-existing condition, 
or a procedure required by the protocol, without serious 
deterioration in health, is not considered an SAE. 

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Protocol Number: ZA19-001 
(DC00025 Rev D) 
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Inc.  Disclosure to unauthorized individuals or dissemination, publication or copying is prohibited without prior written consent 
of ZELTIQ. 
 
 
8.1.4. 
Time Period and Frequency for Collecting AE and SAE Information 
All AEs and SAEs from the signing of the Informed Consent Form (ICF) 
until the last 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 as an AE on the 
appropriate CRF. 
All SAEs will be recorded and submitted to the Sponsor or designee within 
24 hours of learning about the event using the SAE form. All non-serious 
AEs related to the devices used in the study, as well as Device Complaints, 
will be submitted to the Sponsor within 7 working days. The investigator will 
submit any updates on these events to the Sponsor within 24 hours of it being 
available. 
Investigators are not obligated to actively seek AE or SAE in former study 
participants. However, if the investigator learns of any SAE, including a 
death, at any time after a participant has completed the final visit of the 
study, and he/she considers the event to be reasonably related to the study 
treatment or study participation, the investigator must promptly report the 
event to the Sponsor. 
8.1.5. 
Method of Detecting AEs and SAEs 
Care will be taken not to introduce bias when detecting AEs and/or SAEs. 
Open-ended and non-leading verbal questioning of the participant is the 
preferred method to inquire about possible AEs. 
8.1.6. 
Follow-up of AEs and SAEs 
After the initial AE/SAE report, the investigator is required to proactively 
follow each participant at subsequent visits/contacts. All SAEs will be 
followed until resolution, stabilization, the event is otherwise explained, the 
participant is lost to follow-up or until 30 days after completion of the study. 
The investigator is obligated to perform or arrange for the conduct of 
supplemental measurements and/or evaluations as medically indicated or as 
requested by the Sponsor to elucidate the nature and/or causality of the AE or 
SAE as fully as possible. This may include additional laboratory tests or 
investigations, histopathological examinations, or consultation with other 
health care professionals. 
New or updated information will be recorded in the originally 
completed CRF. 

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The investigator will submit any updated SAE data to the 
Sponsor within 24 hours of receipt of the information. 
8.1.7. 
Reportable of Serious Adverse Events (SAEs) 
Serious adverse events (SAEs and SADEs) as well as unanticipated adverse 
device effects (UADEs) must be reported within 24 hours of knowledge of 
the event to the Sponsor. 
All adverse events observed by the investigator or reported by the subject 
will be recorded on the appropriate CRF, irrespective of the relationship to 
the investigational device used in the study. Medically significant adverse 
events will be followed until resolved or considered stable. For each event, 
the investigator will record a description, dates of onset and resolution, 
severity, and relationship to the investigational device. The investigator may 
be required to provide follow-up information as-needed to fulfill 
requirements for regulatory reporting. 
Any adverse event that results in withdrawal from the study must be reported 
to the Sponsor after the decision to withdraw the subject is made. 
Any death occurring during the study must be reported to the Sponsor within 
24 hours.  
If an event is classified as an SADE or a UADE, the Sponsor will determine 
if there is an unreasonable risk to the patients within the study.  In the event a 
UADE is reported during this study, it will be reported to the IRB and to the 
regulatory agencies as appropriate according to the relevant standard 
operating procedures and law of the country where the trial is performed.   
8.1.8. 
Assessment of Severity 
Severity of adverse events will be determined using the following 
scale: 
• 
Mild: Event that is easily tolerated and may require only 
minimal treatment or therapeutic intervention. The event does 
not generally interfere with usual activities of daily living. 
• 
Moderate: Events that interfere with usual activities of daily 
living, causing discomfort but poses no significant or 
permanent risk of harm to the research participant. It is 
usually alleviated with additional specific therapeutic 
intervention. 
• 
Severe: Event that is incapacitating, with inability to work 

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and do the usual activities of daily living, or significantly 
affects clinical status. This may require intensive therapeutic 
intervention. 
8.1.9. 
Assessment of Relatedness 
• 
The investigator is obligated to assess the relationship between 
study treatment and each occurrence of each AE/SAE. 
• 
A reasonable possibility of a relationship conveys that there 
are facts, evidence, and/or arguments to suggest a causal 
relationship, rather than a relationship cannot be ruled out. 
• 
The investigator will use clinical judgment to determine the relatedness. 
• 
Alternative causes, such as underlying disease(s), concomitant 
therapy, and other risk factors, as well as the temporal 
relationship of the event to study treatment administration will 
be considered and investigated. 
• 
The investigator will also consult the investigator’s brochure 
and/or product information, for marketed products, in his/her 
assessment. 
• 
For each AE/SAE, the investigator must document in the 
medical notes that he/she has reviewed the AE/SAE and has 
provided an assessment of relatedness. 
• 
For each AE/SAE, there are 4 levels of relatedness, as follows: 
• 
Not related 
• 
Possible 
• 
Probable 
• 
Definite relationship 
There may be situations in which an SAE has occurred and the investigator 
has minimal information to include in the initial report to the Sponsor. 
However, it is very important that the investigator always make an 
assessment of relatedness for every event before the initial transmission of 
the SAE data to the Sponsor. 
• 
The investigator may change his/her opinion of relatedness in 

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light of follow-up information and send an SAE follow-up 
report with the updated relatedness assessment. 
• 
The relatedness assessment is one of the criteria used when 
determining regulatory reporting requirements. 
 
The investigator will determine the relationship of each adverse event to the 
study device using the question: "Is there a reasonable possibility that the 
event may be related to treatment with the device? Answer 'yes' or 'no' for 
each adverse event." 
The guideline below should be used to consider relatedness: 
For a “not related” assessment, the adverse event: 
• 
May be judged to be due to extraneous causes such 
as disease or environment or toxic factors 
• 
May be judged to be due to the subject's clinical state or 
other therapy being administered 
• 
Is not biologically plausible 
• 
Does not reappear or worsen when the investigational 
device is re-administered 
• 
Does not follow a temporal sequence from treatment with 
the investigational device,  
For an assessment of relatedness (including, probable and 
possible assessments) there is a reasonable possibility that the 
event may have been caused by the investigational device, the 
adverse event: 
• 
Follows a temporal sequence from treatment with the 
device.   
• 
Is a known response to the device based on clinical or 
nonclinical data 
• 
Could not be explained by the known characteristics of the 
subject's clinical state, environmental or toxic factors, or other 
therapy administered 
• 
Disappears or decreases upon cessation of the use 
of the device.   

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• 
Reappears or worsens when the device is re-
administered.  
8.1.10. 
Serious Adverse Event Reporting Procedures 
All serious adverse events must be reported to the Sponsor within 24 hours of 
discovery or notification of the event and according to IEC/IRB requirements 
and the institution at which the study is conducted, if applicable. Serious 
adverse event information and any follow-up information will be recorded on 
a Serious Adverse Event Form and transmitted to the Sponsor using the 
contact information provided by the Sponsor. Note that for each device used 
in this study, a separate SAE form and contact information will be used.  The 
Sponsor is responsible for evaluating and reporting any serious adverse event 
and unexpected serious adverse reactions in accordance with all applicable 
laws and standards.  
Serious Adverse Event Reporting 
Serious adverse events (SAEs) and unanticipated adverse device effects 
(UADEs) must be recorded and reported to the Sponsor or designee within 
24 hours of knowledge of the event by the clinical study site to  the following 
contact: 
 
Clinical Trial Management 
Fax: 
 
Email: 
 
 
Any additional information regarding the serious adverse event should be 
submitted to the sponsor in a follow-up form within 24 hours of awareness.  
The Sponsor is responsible for regulatory reporting and 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.  
Safety Monitoring Considerations 

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If an adverse event occurs that in the judgment of the investigator represents a 
potential risk for new subjects, the investigator will contact the Sponsor within 
1 working day after becoming aware of the event. 
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/EC, as required. 
8.1.11.
Pregnancy
•
Details of all pregnancies in female participants will be 
collected after the start of study treatment through the 
duration of the pregnancy. 
•
If a pregnancy is reported, the investigator should inform 
the Sponsor within 24 hours of learning of the pregnancy. 
•
If a female of childbearing potential becomes pregnant 
during the study, the investigator should notify the 
participant’s physician that the participant may have been 
treated with the investigational device and exit the participant 
from the study. 
•
Abnormal pregnancy outcomes (e.g., spontaneous abortion, 
fetal death, stillbirth, congenital anomalies, ectopic 
pregnancy) are considered SAEs. 
9. Device Tracking
The Sponsor will send the Investigator investigational devices. The Investigator must house 
study devices in an appropriate, secure location.   
The Sponsor will track sending and receiving of devices to/from the Investigator. The 
Investigator must track receipt and final disposition of the devices, and maintain accurate 
records of the use of the device on each study subject.   
In addition, for IDE studies, the Investigator must maintain records of receipt, use and 
disposition of all devices on a device accountability log which will be monitored by the 
Sponsor and a copy collected at the end of the study. An accurate record of the date the 
device was used on each subject must be available for inspection at any time. 
Device Packaging and Labeling 
Clinical study devices will be packaged and labeled according to the country’s regulatory 
requirements.  

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The study device or its immediate package, will be labeled per the requirements of 
21CFR 812.5(a).  
10. Device Deficiencies and Malfunctions
A device deficiency is defined in accordance with ISO 14155 as “inadequacy of a medical 
device 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 investigator will notify the Sponsor. Device deficiencies 
shall be documented throughout the study and appropriately managed and reported to 
regulatory authorities and IRBs as required by national regulations.  
11.
Ethical and Regulatory Considerations 
Compliance with Good Clinical Practice
This study will be conducted in compliance with the principles of the Declaration of 
Helsinki, with the current Good Clinical Practice (GCP) guidelines and with other 
applicable regulations. The Investigator and all study staff will conduct the study in 
compliance with this protocol. Voluntary informed consent will be given by every subject 
prior to the initiation of any study-related procedures. The rights, safety and well-being of 
the study subjects are the most important considerations and prevail over the interests of 
science and society. All personnel involved in the conduct of this study must be qualified 
by education, training and experience to perform their assigned responsibilities. 
Institutional Review Board (IRB) and Informed Consent 
Before study initiation, the Investigator must have written and dated approval from the 
IRB/EC for the protocol, consent form, subject recruitment materials/process (e.g., 
advertisements), and any other written information to be provided to subjects. The 
Investigator should also provide the IRB/EC with a copy of the product labeling, 
information to be provided to subjects and any updates. The Investigator will submit 
documentation of the IRB/EC approval to the Sponsor. Copies of all correspondence with 
the IRB/EC regarding this study must be sent to the Sponsor.
The IRB/EC-approved consent form must include all elements required by FDA, state, 
and local regulations, and may include appropriate additional elements. 
The Investigator/designee will explain the study to each potential subject and the subject 
must indicate voluntary consent by signing and dating the approved informed consent 
form. The Investigator must provide the subject with a copy of the consent form in a 

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language the subject understands. The Investigator will maintain documentation that 
informed consent was obtained prior to the initiation of any study-specific procedures.
Withdrawal of IRB/EC approval of the Investigator’s part in the investigation must be 
reported to the Sponsor within 5 working days.
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, 
protocol deviation, as defined below. 
Protocol Violation 
Non-adherence to the protocol that may result in significant additional risk to the 
participant (e.g., enrollment of a participant 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 and the IRB within 5 working days if they occur. 
Protocol Deviation 
Non-adherence to study procedures which does not result in additional risk to the 
participant (e.g., participant missed visit).  Protocol deviations are not required to be 
reported to the IRB; however, they must be recorded and addressed 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. 
Protocol Waivers 
Waivers, exceptions or any intentional deviation from the approved protocol are not 
permitted in the study. 
Protocol Amendments
Amendments to the study protocol can be made only by the study Sponsor. A revised 
protocol can be put into place only after governing IRB/EC approval.  All administrative 
letters must be submitted to the IRB/EC for their information. 
New or altered consent forms required by the IRB due to a protocol change must be used 
for any subsequent subject enrollment and when the IRB requires, signed by subjects 
currently enrolled in the study. 

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12. Study Management and Quality Control  
Study Data Collection  
Zeltiq will supply Case Report Forms (CRFs) to all participating sites for this study.  
A CRF is required and will be completed for each included subject. The Investigator has 
ultimate responsibility for the collection and reporting of all data entered on the CRFs 
and any other data collection forms (source documents) and ensuring that they are 
accurate, authentic/original, attributable, complete, consistent, legible, timely 
(contemporaneous), enduring and available when required. The CRFs must be signed by 
the Investigator to attest that the data contained therein are true. 
  
Data Management 
Data management activities will be performed in accordance with internal Zeltiq SOPs
for handling data in non-significant risk studies conducted under abbreviated IDE 
requirements.
12.2.1.
Data Receipt and Data Entry 
The monitor will collect clinical study related documents including Case Report 
Forms (CRFs), Data Clarification Forms (DCFs), and any other clinical 
documents from clinical sites and transmit the documents to the Sponsor as 
appropriate.   
Confidentiality
All information and data concerning study participants 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. 

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The investigator is responsible for ensuring the confidentiality of subjects throughout the 
trial.  A unique identification code will be assigned to each subject participating in this 
trial.  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.  
Only authorized site staff, the study Sponsor or the Sponsor’s designee, IRB/EC or 
regulatory authorities 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 participant. Any data that may be published in abstracts, 
scientific journals, or presented at medical meetings will reference a unique participant
code and will not reveal the participant’s identity.
Quality Assurance Audits
Sponsor representatives or designees may conduct site quality assurance (QA) audits 
during the study.  The Investigator must agree to provide the auditor with direct access 
to all relevant documents and discuss any findings with the auditor. 
In the event of an inspection by the FDA or other regulatory authorities, the Investigator 
must give the inspector direct access to relevant documents and to discuss any findings 
with the inspector. The Investigator must notify Zeltiq in the event of a FDA site audit. 
Investigator Responsibilities
12.5.1. General Responsibilities 
Investigators are responsible for ensuring the investigation is conducted 
according to all signed agreements, the Protocol, and applicable FDA 
regulations.  The investigator must protect the rights, safety, privacy and 
welfare of the participants 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 applicable regulations, including but not limited to:
IRB approval: The investigator may not begin the study until the FDA and 
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 participant in accordance with 21 CFR 
Part 50 and that the study is not commenced until FDA and IRB approvals 
have been obtained.   
Financial Disclosure:  Investigators shall provide financial disclosure 
according to federal regulations.  

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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.  
12.5.2. 
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, a 
monitor, or the FDA 
• 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 device 
• Informed Consent documentation for all enrolled participants 
• Records of each participant'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 participant upon entering and during the course 
of the investigation and any relevant medical history and results of 
any diagnostic tests 
• Record of each participant’s exposure to the device, including the 
date and time of use 
• Protocol 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.   

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These records must be available and suitable for inspection at any time by 
Sponsor representatives (monitor), the reviewing IRB, or FDA. 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 study staff have adequate 
time and resources to devote to the study, including study enrollment, 
participant evaluations, study documentation and site monitoring. 
12.5.3.
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 protocol shall be reported to the Sponsor and the 
IRB
•
Failure to obtain informed consent prior to use of a device in a
participant 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.  
Sponsor Responsibilities  
12.6.1.
General Responsibilities:
As the Sponsor, ZELTIQ Aesthetics assumes overall responsibility for the 
conduct of the study including assurance that the study satisfies applicable 
regulatory requirements. ZELTIQ Aesthetics assumes all responsibilities per 
applicable regulations, and shall: 
IRB approval:  Ensure IRB approval for the investigation. No IDE 
application is necessary for this study. 

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Investigators:  Select investigators qualified by training and experience, and 
providing them with the information they need to conduct the study properly.  
Obtain a signed Investigator Agreement from each participating investigator. 
Study sites will be evaluated to ensure that they have an adequate participant 
base and can provide sufficient staff and documentation support to conduct 
the study properly. 
Monitoring:  Select monitors qualified by training and experience and 
ensure proper monitoring of the study. 
Data Management and analysis:  Ensure data collection, verification, 
analysis, records storage, etc. Sponsor will assist with presentation(s) and/or 
publication(s). 
Essential Document Records:  Maintain all Essential Documents pertaining 
to the study per ISO 14155:2011. 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. 
Study Training: To ensure uniform data collection and protocol compliance, 
Sponsor personnel will provide an educational session to study site personnel 
which will cover the Protocol, techniques for the identification of eligible 
participants, data collection and form completion, and the device directions 
for use.  The investigator and study staff will be trained on the study device 
and protocol, applicable regulations and requirements, and expectations of 
the study, enrollment expectations, participant selection, informed consent, 
required clinical data and record keeping, etc.   
Device Use: Representatives of the Sponsor will train investigators in use of 
the study device. 
12.6.2. 
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 protocol and 
applicable regulations, any specific recommendations made by the site’s IRB 
and the signed Investigator Agreement.   

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The extent and nature of monitoring of this study will, at a minimum, consist 
of source document verification for data related to subject informed consent, 
eligibility, safety, and study endpoints. 
Monitoring Visits 
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.  
The frequency of monitoring for this study is determined by the relatively 
short duration of the study, nature of the study (aesthetic study in healthy 
volunteers), minimal complexity of the data to be monitored and the study 
site’s research experience. In addition, the endpoint of this clinical study 
involves data captured at the 1-Month follow-up visit. Therefore a 
monitoring visit will occur after the 1-Month follow-up visits are completed 
at each site.  At least one additional monitoring visit will occur at each site 
prior to, or in conjunction with, study closeout.  
During monitoring visits, the monitor will review participant records and 
other supporting documents 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 protocol is being followed, and only eligible participants are 
being enrolled into the study 
• Deviations to the Protocol 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 
• Participants failing to complete the clinical study and the reason 
for failure are recorded 
• Missed follow-up visits are noted in the study documentation 

ZELTIQ Aesthetics – Confidential and Proprietary 
Part Number: CS-304247 
Revision: 02 
Page 47 of 49 
Title: Magnetic Muscle Stimulation of Abdominal Muscle 
 
ZELTIQ P/N: CS-304247-02 
Protocol Number: ZA19-001 
(DC00025 Rev D) 
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. 
 
 

ZELTIQ Aesthetics – Confidential and Proprietary 
Part Number: CS-304247 
Revision: 02 
Page 48 of 49 
Title: Magnetic Muscle Stimulation of Abdominal Muscle 
 
ZELTIQ P/N: CS-304247-02 
Protocol Number: ZA19-001 
(DC00025 Rev D) 
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.