Electromagnetic Muscle Stimulation for Abdominal and Gluteal Muscle Toning
Phase: NA
Conditions: Non-Therapeutic Body Modification
Sponsor: Zeltiq Aesthetics

Information Cover Page 
 
 
 
Zeltiq Aesthetics Protocol ZA19-002 
 
Electromagnetic Muscle Stimulation for Abdominal and Gluteal Toning 
 
 
Clinicaltrials.gov Identifier:  NCT03983304 
 
 
Protocol Date:  1 May, 2019 
 
Protocol Redaction Date:  21 October, 2021 
 
 
IRB Approval Date:  10 May 2019 
 

ZELTIQ Aesthetics – Confidential and Proprietary 
 
Part Number: 
Revision: 01 
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Title: Electromagnetic Muscle Stimulation for Abdominal and Gluteal Muscle Toning 
Note: Check with Document Control for current revisions of all referenced documents. 
 
ZELTIQ P/N: 
Protocol Number: ZA19-002 
 
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. 
ELECTROMAGNETIC MUSCLE STIMULATION FOR ABDOMINAL AND 
GLUTEAL MUSCLE TONING 
Investigational Plan 
Sponsor 
ZELTIQ Aesthetics, an Allergan affiliate 
4410 Rosewood Dr. 
Pleasanton, CA 94588 
 
Protocol Number: 
 
ZA19-002 
 
Protocol Version: 
 
1.0 
May 1, 2019 
 
 
Sponsor Contact: 
 
Lori Brandt 
Director, Clinical Trial Management 
 
 
 
 
 
 
 
 
 
 
 
 

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Title: Electromagnetic Muscle Stimulation for Abdominal and Gluteal Muscle Toning 
 
ZELTIQ P/N: 
Protocol Number: ZA19-002 
 
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 ZA19-002 
 
 
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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Title: Electromagnetic Muscle Stimulation for Abdominal and Gluteal Muscle Toning 
 
ZELTIQ P/N: 
Protocol Number: ZA19-002 
 
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 .............................................................................................................. 6 
1.1 
Background ....................................................................................................................... 6 
1.2 
Device Descriptions .......................................................................................................... 7 
1.3 
Regulatory Status .............................................................................................................. 8 
2. 
Study Protocol ......................................................................................................... 9 
2.1 
Design ................................................................................................................................ 9 
2.2 
Study Duration ................................................................................................................... 9 
2.3 
Physician Participants ...................................................................................................... 9 
2.4 
Site Requirements ............................................................................................................. 9 
2.5 
Subject Recruitment ......................................................................................................... 9 
2.6 
Sample Size ....................................................................................................................... 9 
2.7 
Subject Eligibility .............................................................................................................. 9 
2.8 
Informed Consent ............................................................................................................ 11 
2.9 
Screening Procedures .................................................................................................... 11 
Screening Visit; Required; Day -60 to Day 0 ............................................................................................ 11 
2.10 
Enrollment ........................................................................................................................ 12 
2.11  
Photo Visit; Required, day -30 to 0 ................................................................................ 12 
2.12 
Study Treatment .............................................................................................................. 12 
Treatment Visit 1 ...................................................................................................................................... 12 
Treatment Visits 2 and 3 ........................................................................................................................... 13 
Treatment Visit 4 ...................................................................................................................................... 14 
2.13 
Follow-up Procedures ..................................................................................................... 15 
2.13.1Four-Week Post-Final Treatment Visit; 4 Weeks ± 1 week; ........................................................... 15 
2.13.2 Twelve-Week Post Final Treatment Visit; 12 Weeks ± 2 weeks ................................................... 15 
2.13.3 Optional Follow-Up Evaluations (up to 4 within study period) ....................................................... 15 
2.14 
Assessments ................................................................................................................... 17 
2.14.1 Global Aesthetic Improvement Scale (GAIS-Subject) ................................................................... 17 
2.14.2 Body Satisfaction Questionnaire – Abdomen ................................................................................ 17 
2.14.3 Body Satisfaction Questionnaire – Buttocks ................................................................................. 17 
2.14.4 Photography .................................................................................................................................. 17 
2.14.5 
 ...................................................................................................... 18 
2.14.6 
............................................................................................................ 18 
2.14.7 Photograph Review ....................................................................................................................... 18 

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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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2.15 
Endpoints ......................................................................................................................... 18 
2.15.1 Primary Endpoints ......................................................................................................................... 18 
2.15.2 Secondary Endpoints .................................................................................................................... 19 
2.16 
Statistical Analysis Plan ................................................................................................. 19 
2.16.1 Statistical Methods: Overall Plan ................................................................................................... 19 
2.16.2 Analysis Population ....................................................................................................................... 19 
2.16.3 Endpoint Analysis .......................................................................................................................... 19 
Primary Endpoints: ............................................................................................................................................... 19 
Secondary Endpoint: ............................................................................................................................................ 20 
2.17 
Protocol Adherence ........................................................................................................ 20 
2.18 
Adverse Events ............................................................................................................... 20 
3. 
Study Management and Quality Control.............................................................. 23 
3.1 
Study Data Collection ..................................................................................................... 23 
3.2 
Confidentiality ................................................................................................................. 23 
3.3 
Investigator Responsibilities ......................................................................................... 24 
General Responsibilities ........................................................................................................................... 24 
Investigator Records ................................................................................................................................. 24 
Investigator Reports ................................................................................................................................. 25 
3.4 
Sponsor Responsibilities ............................................................................................... 26 
General Responsibilities: .......................................................................................................................... 26 
Training                      ................................................................................................................................ 27 
Site Monitoring .......................................................................................................................................... 27 
Final Report .............................................................................................................................................. 28 
4. 
Data Ownership ..................................................................................................... 28 
5. 
Publication Policy .................................................................................................. 29 
6. 
Risk/Benefit Analysis ............................................................................................ 29 
6.1 
Benefits ............................................................................................................................ 29 
6.2 
Risks ................................................................................................................................. 29 
7. 
Selected References ............................................................................................. 31 

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Title: Electromagnetic Muscle Stimulation for Abdominal and Gluteal Muscle Toning 
 
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Inc.  Disclosure to unauthorized individuals or dissemination, publication or copying is prohibited without prior written consent of 
ZELTIQ. 
Protocol Summary 
Title 
Electromagnetic Muscle Stimulation for Abdominal and Gluteal 
Muscle Toning 
 
Design 
 
Prospective, multi-center, non-randomized, interventional 
Purpose 
 
 
Evaluate the use of Electromagnetic Muscle Stimulation for 
body contouring  
Enrollment 
 
Clinical site(s) 
Up to 200 subjects 
 
Up to 20 investigational sites 
 
Subject Population 
Healthy adult men and women aged 22 – 65 who desire 
abdominal and/or gluteal muscle toning. 
 
Primary  
Endpoints 
 
 
 
 
 
 
 
Secondary  
Endpoint 
 
 
 
Efficacy endpoint:   
Measurement of subject feeling about body shape, assessed 
using the Body Satisfaction Scale at the 4-Week follow-up visit. 
 
 
Safety endpoint:   
The frequency of device-related adverse events (AEs) including 
device-related serious adverse events (SAEs) will be 
summarized. 
 
Secondary endpoint: 
Subject-graded improvement in the treated area using the Subject 
Global Aesthetic Scale (SGAIS) at the 4-Week follow-up visit. 
 
 
Sponsor 
ZELTIQ Aesthetics, an Allergan affiliate  
4410 Rosewood Dr. 
Pleasanton, CA 94588 
 
 
 

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Title: Electromagnetic Muscle Stimulation for Abdominal and Gluteal Muscle Toning 
 
ZELTIQ P/N: 
Protocol Number: ZA19-002 
 
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.    
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.   
One treatment of interest is the use of electromagnetic muscle stimulation (EMS) 
  Electromagnetic muscle stimulation (EMS), also known 
as neuromuscular electrical stimulation (NMES) is the elicitation of muscle contraction using 

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Title: Electromagnetic Muscle Stimulation for Abdominal and Gluteal Muscle Toning 
 
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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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electric impulses. The impulses mimic the action potential that comes from the central 
nervous system, causing the muscles to contract. [1]  
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. 
[2] 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. [3]  
 
 
 
 
 
 
 
 
 
 
 
   
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. 
 

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Inc.  Disclosure to unauthorized individuals or dissemination, publication or copying is prohibited without prior written consent of 
ZELTIQ. 
 
Figure 1.  Representative EMS Device 
 
This study will evaluate the feasibility of EMS treatments for improvement in abdominal and 
buttock contouring. 
  One or more EMS 
devices may be used in this evaluation. 
The 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.  
• Strengthening, toning and firming of buttocks 
 
EMS devices utilized in this study will be operated in accordance with the manufacturer’s 
Instructions for Use.   
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. 

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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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2. Study Protocol 
2.1 
Design 
Prospective, multi-center, non-randomized, interventional study 
2.2 
Study Duration  
Enrollment and follow-up are expected to take up to four (4) months for each subject. 
2.3 
Physician Participants 
Study Investigators must be practicing medical physicians with experience in the use of the 
CoolSculpting System.   
2.4 
Site Requirements 
Site Investigators should 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 abdominal and/or gluteal muscle firming and toning will be recruited for 
this study.  
2.6 
Sample Size 
A maximum of 200 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 or female ≥ 22 years 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 body weight within 5% during the study by not making any 
changes in diet or exercise routine.  
d) Subject has a BMI ≤ 30 as determined at screening.  

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e) Subject agrees to have photographs taken of the treatment area(s) during the scheduled 
time periods.  
f) Subject agrees to refrain from any new abdominal and/or gluteal muscle training 
exercises of the treatment area during the course of the study. 
g) Subject agrees to avoid sun tanning during the course of the study. 
h) Subject has read and signed the study written informed consent form.    
Exclusion Criteria 
a) Subject has had a recent surgical procedure(s) in the area of intended treatment and 
muscle contractions may disrupt the healing process. 
b) Subject has had an invasive fat reduction procedure (e.g., liposuction, mesotherapy) in 
the area of intended treatment. 
c) 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. 
d) Subject has not had an intrauterine contraceptive device inserted or removed within the 
past month. 
e) Subject has a bleeding disorder 
f) Subject is taking or has taken diet pills or supplements within the past month. 
g) Subject has a metal implant or active implanted device such as a cardiac pacemaker, 
cochlear implant, intrathecal pump, hearing aids, defibrillator, or drug delivery system.  
h) Subject agrees not to change muscle exercise routine in the treatment area (abdominal 
and/or gluteal) while participating in the study 
i) Subject has pulmonary insufficiency. 
j) Subject has a cardiac disorder. 
k) Subject has a malignant tumor. 
l) Subject has been diagnosed with a seizure disorder such as epilepsy. 
m) Subject currently has a fever. 
n) Subject is diagnosed with Grave’s disease. 
o) Subject is pregnant or intending to become pregnant during the study period (in the 
next 9 months). 
p) Subject is lactating or has been lactating in the past 6 months. 
q) Subject is unable or unwilling to comply with the study requirements. 
r) Subject is currently enrolled in a clinical study of any other investigational drug or 
device. 
s) 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. 
 
 

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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 to determine if all 
eligibility 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. 
 
 
 
5. Document medication use, Fitzpatrick Skin Type, and ethnicity. 
6. 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 study by using a medically accepted form of contraception if 
they are sexually active. If the subject becomes pregnant during 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 study.  Subjects who do not 
maintain their weight within 5% will 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.  

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Subjects that do not meet all eligibility criteria will be excluded from further 
participation in the study. 
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 first study treatment.  
a) Obtain weight. 
b) 
 
 
   
c) Obtain baseline 2-Dimensional photographs of the treatment area using 
standardized setup and settings.  
 
2.12 Study Treatment 
  
The 
abdomen and/or buttocks may be treated.  
 
 
  
Treatment Visit 1 
Prior to EMS Treatment 
a) Review and confirm subject meets all of the inclusion criteria and none of the 
exclusion criteria, then proceed with the study treatment. 

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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) Obtain weight (Note: weight measurement is only required prior to first EMS 
treatment). 
d) Subject completes Body Satisfaction Scale for abdomen and or Body 
Satisfaction Scale for buttocks as appropriate. Note: Completion of these 
scales is required prior to first EMS treatment). 
 
EMS Treatment Steps 
e) Apply EMS device per manufacturer’s Instructions for Use.  
f) Support the EMS device with pillows or straps as needed. 
g) Initiate treatment using recommended program for toning and firming the 
targeted treatment area supplied by manufacturer. 
h) Record the highest percent (%) energy utilized for the EMS treatment.  
 
 
 
Treatment Visits 2 and 3 
The required study activities are the same for both Treatment Visits 2 and 3:  
Prior to EMS Treatment 
a) Review and confirm subject meets all of the inclusion criteria and none of the 
exclusion criteria. 
b) Repeat pregnancy test for female subjects of childbearing potential (urine).  
Exclude subject from participation if the results are positive. 
EMS Treatment Steps 
c) Apply EMS device per manufacturer’s Instructions for Use.  
d) Support the EMS device with pillows or straps as needed. 
e) Initiate treatment using recommended program for toning and firming the 
targeted treatment area supplied by manufacturer. 
f) Record the highest percent (%) energy utilized for the EMS treatment.  

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g) 
 
 
 
 
Treatment Visit 4  
Prior to EMS Treatment 
a) Review and confirm subject meets all of the inclusion criteria and none of the 
exclusion criteria, then proceed with the study treatment. 
b) Repeat pregnancy test for female subjects of childbearing potential (urine).  
Exclude subject from participation if the results are positive. 
EMS Treatment Steps 
c) Apply EMS device per manufacturer’s Instructions for Use.  
d) Support the EMS device with pillows or straps as needed. 
e) Initiate treatment using recommended program for toning and firming the 
targeted treatment area supplied by manufacturer. 
f) Record the highest percent (%) energy utilized for the EMS treatment.  
g) 
 
 
Post-EMS Treatment # 4 
h) Subject completes Body Satisfaction Scale(s) (for abdomen and/or buttocks, 
as appropriate) 
i) 
   
j) Optional - Obtain 2-Dimensional photographs of the treatment area using 
standardized setup and settings.  
 
The need for post-treatment care is not expected following the EMS treatments 
performed in this study.  Subjects will be encouraged to call the study site if they 
experience any unusual effects (e.g., severe discomfort etc.), which may be related to 
the study. 
 
 

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2.13 Follow-up Procedures 
Subjects who receive study treatment are required to complete all follow-up visits 
and assessments (4-Week and 12-Week).  
 
2.13.1Four-Week Post-Final Treatment Visit; 4 Weeks ± 1 week; 
The following activities will be performed at the 4-week visit: 
a) Obtain weight. 
b) Assess for adverse events. 
d) Obtain standard 2D imaging of treatment areas  
e) Subject Completes SGAIS questionnaire 
f) Subject completes Body Satisfaction Scale for abdomen and/or Body 
Satisfaction Scale for buttocks as appropriate. 
 
 
2.13.2 Twelve-Week Post Final Treatment Visit; 12 Weeks ± 2 weeks 
The following activities will be performed at the 12-Week visit: 
a) Obtain weight. 
b) Assess for adverse events. 
 
d) Optional - Obtain standard 2D imaging of treatment areas  
e) Subject Completes SGAIS questionnaire 
f) Subject completes Body Satisfaction Scale for abdomen and/or Body 
Satisfaction Scale for buttocks as appropriate. 
 
 
2.13.3 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 2 summarizes the study schedule and events at each visit. 

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Table 2.  Schedule of Visits 
 
Screening 
(< 1hr) 
Photo 
Visit 
(<1hr) 
EMS  
Treatment #1 
(<4hrs) 
EMS  
Treatment #2 
(<4hrs) 
 EMS  
Treatment #3 
(<4hrs) 
EMS  
Treatment #4 
(<4hrs) 
4-Wk  
Follow-Up 
(< 1 hr) 
12-Wk  
Follow-Up 
(< 1 hr) 
Optional 
Follow-
Up** 
Time Frame 
Day 
-60 to 0 
Day 
-30 to 1 
Week 1 
(Day0) 
Week 1 
Week 2 
Week 2 
Week 4 
(± 1 weeks) 
Week 12 
(± 2 weeks) 
Open 
Informed Consent* 
X 
 
 
 
 
 
 
 
 
Eligibility Criteria 
X 
 
X 
X 
X 
X 
 
 
 
Medical History 
X 
 
 
 
 
 
 
 
 
Height & BMI 
X 
 
 
 
 
 
 
 
 
Weight 
X 
X 
X 
 
 
 
X 
X 
 
3D Photos and/or tape 
measurements 
 
X 
 
 
 
X# 
X 
X# 
 
2D Photos 
 
X 
 
 
 
X# 
X 
X# 
 
EMS  
 
 
X 
X 
X 
X 
 
 
 
 
 
X 
X 
X 
X 
X 
X 
 
AE Assessment 
 
 
X 
X 
X 
X 
X 
X 
 
BSQ*** per body area 
 
 
X 
 
 
X 
X 
X 
 
 
 
 
 
 
 
X 
X 
 
Subject GAIS 
 
 
 
 
 
 
X 
X 
 
 
*     Informed Consent to be signed by subject prior to the collection of any data or initiation of any study procedures.  
**   Investigator discretion as to timing and extent of follow-up assessment for optional visits.  
*** BSQ (Body Satisfaction Questionnaire) 
#     Optional 

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Note: Check with Document Control for current revisions of all referenced documents. 
 
ZELTIQ P/N: 
Protocol Number: ZA19-002 
 
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unauthorized individuals or dissemination, publication or copying is prohibited without prior written consent of ZELTIQ. 
2.14 Assessments 
Study-related assessments are described below. 
2.14.1 Global Aesthetic Improvement Scale (GAIS-Subject) 
At 4-Weeks post-final treatment, subjects will be asked to rate the improvement 
observed in the treated area(s) 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 Body Satisfaction Questionnaire – Abdomen 
At 4-Weeks post-final treatment, the subjects’ feeling about the shape and 
appearance of their abdomen will be assessed using the Body Satisfaction 
Questionnaire. 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.  
2.14.3 Body Satisfaction Questionnaire – Buttocks 
At 4-Weeks post-final treatment, the subjects’ feeling about the appearance of their 
buttocks will be assessed using the Body Satisfaction Questionnaire. 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.   
 
2.14.4 Photography  
Three-Dimensional (3-D) photography will be used in this evaluation and may be 
performed using a commercially available photography system, such as the Quantificare 
LifeViz Body or similar device.  
In addition, standardized photos of the treatment areas will be obtained at pre-
treatment and 4-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.  A subject Foot Positioning Guide (FPG) will be used to 
standardize images of each body angle.  During follow-up visits, the photographer 
will re-align subjects on the FPG by referencing baseline images.   
 
 
  
  
2.14.7 Photograph Review 
Independent physician(s) experienced in body contouring treatment may review study 
photographs to evaluate the outcome of treatment.  
 
2.15 Endpoints 
  
2.15.1 Primary Endpoints 
The primary endpoints of the study will be defined as follows: 
• Efficacy endpoint:  Measurement of subject feeling about body shape, assessed 
using the Body Satisfaction Questionnaire at the 4-Week follow-up visit.  
 
• Safety endpoint:  The frequency of device-related adverse events (AEs) including 
device-related serious adverse events (SAEs) will be summarized. 
.  

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2.15.2 Secondary Endpoints 
• Subject-graded improvement in the treated area using the Subject Global Aesthetic 
Scale (SGAIS) at the 4-Week follow-up visit. 
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 4 Weeks 
and with weight change of no more than five percent (5%) of total body weight at the 
time the 4-Week images are taken compared to the weight taken at the first treatment 
visit.  Since significant weight change may affect the effectiveness of the treatment, 
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 secondary endpoint of the study will measure subject feeling about body 
shape, assessed using the Body Satisfaction Questionnaire at the 4-Week 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 4-week follow-up visit will be determined.  
 

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The primary safety endpoint will be the frequency of device-related adverse 
events (AEs) including device-related serious adverse events (SAEs).  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.  
 
Secondary Endpoint:  
The secondary efficacy endpoint will be the subject rating of improvement of the 
treatment area based on the SGAIS score 4 weeks after the fourth (final) EMS 
treatment. Subjects who have reported ‘Very much improved,’ ‘Much Improved,’ 
and ‘Improved’ will be categorized as ‘Improved.’ The counts and percentage of 
subjects who noted improvement will be summarized and the 95% confidence 
interval 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. 
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.  

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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. 
 
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 

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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 
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: 

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ZELTIQ P/N: 
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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. 
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. 

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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.   
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.  
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 

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• 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 
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 

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• 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. 
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  

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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 
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 

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• 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 
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 

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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 
Muscle toning and contouring in the treatment area is anticipated to provide an aesthetic benefit 
and the EMS device is a non-invasive device that accomplishes the desired effect without 
anesthesia and with minimal-to-no recovery time.    
 
 
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 
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. Per manufacturers’ user manuals, side effects of 
EMS treatment includes muscular pain, temporary muscle spasm, temporary joint or tendon pain, 
and local erythema.  Scientific literature regarding use of EMS devices for aesthetic purposes to 
tone and strengthen abdominal and gluteal muscle describe mild muscle soreness, minor 
discomfort during treatment[4-8]. 
Anticipated Device Effects of EMS: 

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• muscular pain in the treatment area 
• temporary muscle spasm 
• temporary joint or tendon pain 
• local erythema and/or skin redness 
• muscular contraction adjacent to the treatment area during treatment 
 
Adverse Effects 
 
The following summarizes the potential adverse effects in this study:   
 
Potential Adverse Effect 
Description 
Severe Erythema 
The appearance of erythema (redness) that is rated as severe 
by the Investigator  
Prolonged Erythema 
Erythema lasting longer than 2 weeks. 
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 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) 
Sensory Alteration Outside 
Treatment Area 
Sensory or motor nerve alteration that does not resolve within 
twenty minutes following applicator removal. 
Nerve injury 
Injury to the motor nerves that innervate the legs. 
Vasovagal Symptoms 
The occurrence of symptoms of anxiety, lightheadedness, 
dizziness, nausea, sweating, near syncope, or syncope 
(fainting). 
Gynecological symptoms 
Menstrual cycle irregularity 
Allergic/Irritant Contact Dermatitis 
Itchy rashes and skin peeling that may result exposure to 
wrap/bonnet material or applicator pressure 
Hernia 
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.  
Other 
Any other untoward medical event determined by the 
Investigator to be an adverse event, regardless of the 
relationship to the device or treatment. 
 
 
 

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unauthorized individuals or dissemination, publication or copying is prohibited without prior written consent of ZELTIQ. 
 
7. Selected References 
 
1. 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. 
 
2. 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. 
 
3. 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. 
 
4. Katz B, Bard R, Goldfarb R, Shilow A, Kenolova E. Ultrasound Assessment of Subcutaneous 
Abdominal Fat Thickness after treatments with a high-intensity focused electromagnetic field 
device:  A multicenter study.  Dermatol Surg 2019;00: 1-7 
 
5. Kinney BM, Lozanova P. High Intensity Focused Electromagnetic Therapy Evaluated by 
Magnetic Resonance Imaging: Safety and Efficacy Study of a Dual Tissue Effect Based Non-
Invasive Abdominal Body Shaping. Lasers Surg Med. 2019 Jan;51(1):40-46 
 
6. American Society for Laser Medicine and Surgery abstract, 2019. Kinney BM, Kent DE. Long-
term Follow-up on Patients with HIFEM-Induced Abdominal Tissue Changes: MRI and CT 
Assisted Quantification of Muscle Growth and Fat Reduction.  
 
7. American Society for Laser Medicine and Surgery abstract, 2019. Katz BE, Bard RL, Goldfarb 
RM, Shiloh A. Ultrasonography Evaluation of Changes in Subcutaneous Abdominal Fat 
Thickness Following HIFEM Treatments: Results of 6-Month Follow-up.  
 
8. American Society for Laser Medicine and Surgery late-breaking abstract, 2019. Palm M, 
Lozanova P.  MRI Evaluation of Changes in Gluteal Muscles Following Treatments with the 
High-Intensity Focused Electromagnetic (HIFEM) Technology.