CoolSculpting® Elite: Multi-Country Study to Evaluate Patient Satisfaction for Non-Invasive Fat Reduction in Abdomen, Flanks, Upper Arms, Inner Thighs, Outer Thighs and Submental Area
Phase: PHASE4
Conditions: Non-invasive Fat Reduction
Sponsor: Allergan

CONFIDENTIAL  
Protocol MED-MA-PLS-0647 
CoolSculpting® Elite 
GRD-CLN-T-01-01 v5.0
1 
Title Page 
Protocol Title: 
CoolSculpting® Elite: Multi-Country Study to Evaluate Patient Satisfaction for Non-Invasive Fat 
Reduction in Abdomen, Flanks, Upper Arms, Inner Thighs, Outer Thighs and Submental Area 
 
Protocol Number:  
MED-MA-PLS-0647 
Investigational Product: 
CoolSculpting® Elite 
Study Phase:  
Post-marketing 
Sponsor Name and Legal Registered Address: 
Allergan Aesthetics, an AbbVie Company 
Allergan Ltd. 
2525 Dupont Drive 
Marlow International 
Irvine, CA 92612 
Parkway, Marlow, Buckinghamshire SL7 1YL 
USA  
United Kingdom 
Manufacturer: 
ZELTIQ Aesthetics, Inc. 
4410 Rosewood Drive 
Pleasanton, CA 94588 
USA 
Allergan Device Medical Safety Physician Contact Information: 
 
Allergan plc 
95 Corporate Drive 
Bridgewater, NJ 08807, USA 
Tel (office):
 
Email: 
 
SAE Reporting Email: 
For US and All other countries outside EU: LC-Medical_Safety@Allergan.com 
For EU: DL-LC-Global_Safety_Reporting@Allergan.com 
Sponsor Signatory: 
 
Director, Medical Affairs 
U.S. Body Contouring 
Allergan Aesthetics, an AbbVie Company 
Refer to the Protocol Approval Signature section of this protocol for electronic signature and 
date of approval. 
 
 
  
Date: 23 Feb 2021
NCT04897867

CONFIDENTIAL  
Protocol MED-MA-PLS-0647 
CoolSculpting® Elite 
GRD-CLN-T-01-01 v5.0 
2 
Table of Contents 
Title Page ........................................................................................................................................1 
Table of Contents ...........................................................................................................................2 
List of Tables ..................................................................................................................................5 
List of Figures .................................................................................................................................5 
Protocol Approval Signature ........................................................................................................6 
1. 
Protocol Summary ..........................................................................................................7 
1.1. 
Synopsis ............................................................................................................................7 
1.2. 
Schema ............................................................................................................................10 
2. 
Introduction ...................................................................................................................15 
2.1. 
Study Rationale ...............................................................................................................15 
2.2. 
Background .....................................................................................................................15 
2.3. 
Benefits and Risks ..........................................................................................................17 
2.3.1. 
Benefits ...........................................................................................................................17 
2.3.2. 
Risks ................................................................................................................................18 
3. 
Objectives and Measures..............................................................................................21 
4. 
Study Design ..................................................................................................................22 
4.1. 
Overall Design ................................................................................................................22 
4.2. 
Scientific Rationale for Study Design ............................................................................24 
4.3. 
Justification for Dose ......................................................................................................24 
4.4. 
End of Study Definition ..................................................................................................24 
5. 
Study Population ...........................................................................................................25 
5.1. 
Inclusion Criteria ............................................................................................................25 
5.2. 
Exclusion Criteria ...........................................................................................................25 
5.3. 
Lifestyle Considerations .................................................................................................27 
5.4. 
Screen Failures ................................................................................................................27 
6. 
Study Intervention ........................................................................................................28 
6.1. 
Study Intervention Administered (CoolSculpting Elite System) ....................................28 
6.1.1. 
Identity of the CoolSculpting Elite System ....................................................................28 
6.1.2. 
Control Unit ....................................................................................................................29 
6.1.3. 
Applicators ......................................................................................................................30 
6.2. 
Additional Study Intervention Supplies ..........................................................................30 
6.3. 
Randomization and Blinding ..........................................................................................31 
6.4. 
Study Intervention Compliance ......................................................................................31 
6.5. 
Concomitant Therapy .....................................................................................................32 
6.5.1. 
Prohibited Therapy..........................................................................................................32 
6.6. 
Dose Modification ..........................................................................................................32 
6.7. 
Intervention after the End of the Study ...........................................................................33 
7. 
Discontinuation of Study Intervention and Participant 
Discontinuation/Withdrawal........................................................................................34 
7.1. 
Discontinuation of Study Intervention ............................................................................34 
 
 
  

CONFIDENTIAL  
Protocol MED-MA-PLS-0647 
CoolSculpting® Elite 
GRD-CLN-T-01-01 v5.0 
3 
7.2. 
Participant Discontinuation/Withdrawal from the Study ................................................34 
7.3. 
Lost to Follow-up............................................................................................................35 
8. 
Study Assessments and Procedures.............................................................................36 
8.1. 
Effectiveness Assessments .............................................................................................36 
8.1.1. 
Patient-reported Outcomes ..............................................................................................36 
8.1.2. 
Photography ....................................................................................................................37 
8.1.3. 
Other Assessments ..........................................................................................................37 
8.2. 
Safety Assessments .........................................................................................................38 
8.2.1. 
Pain Assessment Score ...................................................................................................38 
8.2.2. 
Treatment Site Assessment .............................................................................................38 
8.2.3. 
Other Laboratory Assessments .......................................................................................38 
8.2.4. 
Suicidal Ideation and Behavior Risk Monitoring ...........................................................38 
8.3. 
Adverse Events and Serious Adverse Events .................................................................38 
8.3.1. 
Time Period and Frequency for Collecting AE and SAE 
Information .....................................................................................................................39 
8.3.2. 
Method of Detecting AEs and SAEs ..............................................................................39 
8.3.3. 
Follow-up of All AEs and SAEs .....................................................................................39 
8.3.4. 
Regulatory Reporting Requirements for SAEs ...............................................................39 
8.3.5. 
Pregnancy ........................................................................................................................40 
8.3.6. 
Protocol-specific AEs .....................................................................................................40 
8.3.7. 
Adverse Events of Special Interest .................................................................................40 
8.3.8. 
Medical Device Deficiencies ..........................................................................................40 
8.4. 
Treatment of Overdose ...................................................................................................42 
8.5. 
Pharmacokinetics ............................................................................................................42 
8.6. 
Pharmacodynamics .........................................................................................................42 
8.7. 
Genetics ..........................................................................................................................42 
8.8. 
Biomarkers ......................................................................................................................42 
8.9. 
Immunogenicity Assessments.........................................................................................42 
8.10. 
Health Economics ...........................................................................................................42 
9. 
Statistical Considerations .............................................................................................43 
9.1. 
Statistical Hypotheses .....................................................................................................43 
9.2. 
Sample Size Determination ............................................................................................43 
9.3. 
Populations for Analyses ................................................................................................44 
9.4. 
Statistical Analyses .........................................................................................................44 
9.4.1. 
General Considerations ...................................................................................................44 
9.4.2. 
Primary Effectiveness Endpoint .....................................................................................45 
9.4.3. 
Secondary Effectiveness Endpoints ................................................................................45 
9.4.4. 
Exploratory Effectiveness Endpoints ..............................................................................45 
9.4.5. 
Safety Analyses ...............................................................................................................46 
9.4.6. 
Subgroup Analyses .........................................................................................................47 
9.5. 
Interim Analyses .............................................................................................................47 
9.6. 
Data Monitoring Committee ...........................................................................................47 
10. 
Supporting Documentation and Operational Considerations ..................................48 
10.1. 
Appendix 1: Regulatory, Ethical, and Study Oversight 
Considerations ................................................................................................................49 
 
 
  

CONFIDENTIAL  
Protocol MED-MA-PLS-0647 
CoolSculpting® Elite 
GRD-CLN-T-01-01 v5.0 
4 
10.1.1. Regulatory and Ethical Considerations ...........................................................................49 
10.1.2. Financial Disclosure........................................................................................................49 
10.1.3. Informed Consent Process ..............................................................................................50 
10.1.4. Data Protection................................................................................................................50 
10.1.5. Dissemination of Clinical Study Data.............................................................................51 
10.1.6. Data Quality Assurance ..................................................................................................51 
10.1.7. Source Documents ..........................................................................................................52 
10.1.8. Study and Site Start and Closure ....................................................................................52 
10.1.9. Publication Policy ...........................................................................................................53 
10.1.10. Compliance with Protocol...............................................................................................53 
10.2. 
Appendix 2: Abbreviations .............................................................................................54 
10.3. 
Appendix 3: Standard Discontinuation Criteria..............................................................55 
10.4. 
Appendix 4: Contraceptive Guidance and Collection of 
Pregnancy Information ...................................................................................................57 
10.4.1. Definitions.......................................................................................................................57 
10.4.2. Contraception Guidance..................................................................................................57 
10.4.3. Pregnancy Testing ...........................................................................................................59 
10.5. 
Appendix 5: AEs, ADEs, SAEs, SADEs, and Device 
Deficiencies: Definitions and Procedures for Recording, 
Evaluating, Follow-up, and Reporting in Medical Device Studies ................................60 
10.5.1. Definition of AE and ADE .............................................................................................60 
10.5.2. Definition of SAE, SADE, and USADE/UADE ............................................................61 
10.5.3. Definition of Device Deficiency .....................................................................................62 
10.5.4. Recording and Follow-Up of AE and/or SAE and Device 
Deficiencies.....................................................................................................................62 
10.5.5. Reporting of SAEs ..........................................................................................................65 
10.5.6. Reporting of SADEs .......................................................................................................66 
10.6. 
 
 ......................................................................................................................67 
10.7. 
 ............................................................................................................................68 
10.8. 
 ...................................................................................................................69 
10.9. 
 
 ....................................................................................................................70 
10.10. 
 
.....................................................................................................................71 
10.11. 
 
................................................................................................................72 
10.12. 
 
 ...........................................................................................................................73 
10.13. 
 
 .............................................................................................................................75 
10.14. 
 .................................77 
10.15. 
...............................................................................................78 
10.16. 
Appendix 16: Investigator Signature Page .....................................................................83 
 
 
  

CONFIDENTIAL  
Protocol MED-MA-PLS-0647 
CoolSculpting® Elite 
GRD-CLN-T-01-01 v5.0 
5 
10.17. 
References .......................................................................................................................84 
 
List of Tables 
Table 1-1 
Schedule of Activities ........................................................................................... 11 
Table 2-1 
Guidance for Anticipated Device Effects ............................................................. 19 
Table 2-2 
Reported Adverse Events ...................................................................................... 20 
Table 6-1 
Guidance for Number of Treatment Sessions and Treatment Cycles Per Body 
Area ....................................................................................................................... 33 
Table 8-1 
Investigator guidance for thermal events and pop offs ......................................... 41 
Table 10-1 
Highly Effective and Acceptable Contraceptive Methods .................................... 58 
 
List of Figures 
Figure 1-1 
Study Schema........................................................................................................ 10 
Figure 6-1 
CoolSculpting Elite Control Unit.......................................................................... 29 
 
 
 
  

CONFIDENTIAL  
Protocol MED-MA-PLS-0647 
CoolSculpting® Elite 
GRD-CLN-T-01-01 v5.0 
7 
1. 
Protocol Summary 
1.1. 
Synopsis 
Protocol Title: CoolSculpting® Elite: Multi-Country Study to Evaluate Patient Satisfaction for Non-
Invasive Fat Reduction in Abdomen, Flanks, Upper Arms, Inner Thighs, Outer Thighs and Submental 
Area 
 
Short Title:  CoolSculpting Elite for Non-Invasive Fat Reduction  
Rationale: The purpose of this trial is to further evaluate the safety, effectiveness, and patient 
satisfaction with the redesigned dual applicator CoolSculpting Elite System when cryolipolysis 
treatments are applied simultaneously or sequentially for non-invasive subcutaneous fat 
reduction of the abdomen and flanks, upper arms, submental area, inner thighs, and/or outer 
thighs. In addition, patient reported outcome (PRO) instruments were developed to better assess 
overall patient satisfaction.  
Objectives and Measures 
Objectives 
Measures 
To evaluate participant satisfaction and 
effectiveness of the CoolSculpting Elite 
System using CoolSculpting Elite 
applicators for non-invasive subcutaneous 
fat reduction of the abdomen and flanks, 
upper arms, inner thighs, outer thighs and 
submental area 
 
Cryolipolysis Satisfaction Questionnaire (CSQ)-
Midsection (abdomen and flanks) 
 
CSQ-Overall (if additional body area(s) beyond 
abdomen and flanks are treated) 
 
CSQ for individual additional body areas treated 
(upper arms, inner thighs, outer thighs, submental 
area) 
 
Cryolipolysis General Procedure Questionnaire 
(CGPQ) 
 
Cryolipolysis Psychosocial Impact Questionnaire 
(CPIQ) 
 
Participant Evaluation of Noticeable Improvement 
 
Photography and independent photography review 
(IPR) 
 
3D (three-dimensional) imaging of change in volume 
of fat 
To evaluate safety of the CoolSculpting 
Elite System using CoolSculpting Elite 
applicators for non-invasive subcutaneous 
fat reduction of the abdomen and flanks, 
upper arms, inner thighs, outer thighs and 
submental area 
 
Adverse events (AEs) and adverse device effects 
(ADEs); serious adverse events (SAEs), serious 
adverse device effects (SADEs) 
 
Unanticipated AEs or SAEs (previously unknown to 
the device) 
 
Pain assessment 
 

CONFIDENTIAL  
Protocol MED-MA-PLS-0647 
CoolSculpting® Elite 
GRD-CLN-T-01-01 v5.0 
8 
Overall Design 
Disclosure Statement: This is a multicenter, multi-country, prospective, open-label, 
nonrandomized, interventional cohort, medical device post-marketing study evaluating the use of 
CoolSculpting Elite and CoolSculpting Elite applicators for noninvasive subcutaneous fat 
reduction of the abdomen, flanks, upper arms, inner thighs, outer thighs, and submental area in 
healthy volunteers. 
Number of Participants: Approximately 110 participants will be enrolled and approximately 96 
participants are expected to complete the primary endpoint assessment based on an anticipated 
attrition rate of 12% or less.  
The effectiveness measures are the CSQ for midsection (abdomen and flanks) and other treated 
body areas, the CGPQ, the CPIQ, Participant Evaluation of Noticeable Improvement, 
photography with IPR, and 3D Imaging.  
The primary effectiveness endpoint is the proportion of participants who report being “satisfied” 
or “very satisfied” on item 1 for the CSQ-Midsection, measured at Week 12 (Visit 8) for 
participants who receive 1 treatment session, or at Week 20 (Visit 9) for participants who receive 
2 treatment sessions. 
Intervention Groups and Duration: All participants will be assigned a participant number 
sequentially based on the order in which the participant is screened into the study. This 
participant number will serve as the participant identification number on all study documents. 
Participants are eligible to receive up to two treatment sessions separated 8 weeks apart for the 
body areas eligible for treatment. Assessments will be completed 12 weeks after the final 
treatment session. 
 If a participant receives only one treatment session for specific body area(s), the 
participant will return at Visit 8 for the 12-week post-treatment session 1 follow-up 
assessment and study exit.  
 If a participant receives two treatment sessions for specific body area(s), the participant 
will return at Visit 9 for the 12-week post-treatment session 2 follow-up assessment and 
study exit. 
 If a participant receives only one treatment session to a specific body area and two 
treatment sessions to another specific body area, the participant will return for both 
12-week follow-up visits: Visit 8 for the 12-week post-treatment session 1 assessment of 
the body area that received only one treatment session and Visit 9 for the 12-week post 
treatment session 2 assessment of the body area receiving two treatment sessions; Visit 9 
will also be the study exit visit for this participant. 
Participant body areas selected for treatment during the study must be treated during the first 
treatment visit (Visit 2) and no new body areas may be treated at Visit 6. Participants planning to 
receive only one treatment session to a specific body area must have this treatment in Visit 2 
during the first treatment session. Per investigator discretion, body areas identified for treatment 
may be treated simultaneously or sequentially. If sequential or simultaneous treatment is 
performed, there will be no difference in other treatment activities. Skin preparation, pain 
assessment, treatment site assessment, and post-massage, etc. will be identical in either case. 
 
 
  

CONFIDENTIAL  
Protocol MED-MA-PLS-0647 
CoolSculpting® Elite 
GRD-CLN-T-01-01 v5.0 
9 
The study duration is up to approximately 20 weeks and consists of up to 7 scheduled study 
visits and 2 phone follow-ups per participant:  
 Visit 1 (screening, Days -7 to 1) 
 Visit 2 (treatment session #1, Day 1 + 3 days) 
Note: Treatment plan may be completed within a 7-day window from the day when the 
initial treatment is administered for this visit. The entire treatment session #1 plan for all 
the body areas selected for treatment must be completed within these 7 days. 
 Visit 3 (1-week phone follow-up from last treatment day for participants who received 
treatment session #1 on any body area)  
Note: If any of the following local effects of erythema, bruising, swelling, and/or sensory 
alteration are reported during Visit 3, additional phone follow-up (or in-person visit if 
aligned to planned study visit) will be scheduled in accordance with the time criteria 
outlined in Table 2-1 for potential AE categorization. 
 Visit 4 (4-week follow-up after treatment session #1, Day 28 + 10 days) 
 Visit 5 (8-week follow-up after treatment session #1, Day 56 + 14 days) 
 Visit 6 (treatment session #2 [optional], Day 56 + 14 days, can be completed on the same 
day as Visit 5) 
Note: Only body area(s) that were treated at Visit 2 and that require a second treatment 
session are to be treated at Visit 6. The treatment plan for specific body area(s) may be 
completed within a 7-day window from when the initial treatment is administered for this 
visit. The entire treatment session #2 plan for the body area(s) selected for a second 
treatment must be completed within these 7 days.  
 Visit 7 (1-week phone follow-up from last treatment day for participants who received 
treatment session #2 on any body area) 
Note: If any of the following local effects of erythema, bruising, swelling, and/or sensory 
alteration are reported during this Visit, additional phone follow-up (or in-person visit if 
aligned to planned study visit) will be scheduled in accordance with the time criteria 
outlined in Table 2-1 for potential AE categorization. 
 Visit 8 (12-week follow-up/exit for participants with any body area that underwent 
only treatment session 1 at Visit 2, Day 84 + 14 days). If the participant receives only one 
treatment session to all body areas, this visit is also the study exit visit.  
Note: If the participant receives only one treatment session to a specific body area and 
two treatment sessions to another specific body area, the body area that received only one 
treatment session will be assessed at this visit. The participant will return at Visit 9 for 
assessment of body area that received two treatment sessions and study exit.  
 Visit 9 (20-week follow-up/exit, corresponding to 12-week follow up for participants with 
any body area that underwent treatment session 2 at Visit 6, Day 140 + 14 days). If the 
participant receives two treatment sessions to any or all treated body areas, this visit is 
also the study exit visit. 
 
 
  

CONFIDENTIAL  
Protocol MED-MA-PLS-0647 
CoolSculpting® Elite 
GRD-CLN-T-01-01 v5.0 
10 
During the course of the study, should it ever become necessary to remain isolated at home or to 
shelter-in-place per local, regional, or state pandemic-related orders, the sponsor will engage 
with study site staff in efforts to ensure the safety of participants, maintain protocol compliance, 
and minimize risks to the integrity of the study while trying to best manage participant continuity 
of care. This may include alternative methods for assessments (eg, phone contacts or virtual site 
visits) in agreement with the sponsor. In all cases, these alternative measures must be allowed by 
local regulations and permitted by the Independent Review Board (IRB)/Independent Ethics 
Committee (IEC). Investigators should notify the sponsor if any urgent safety measures are taken 
to protect the participants against any immediate hazard. 
1.2. 
Schema 
The study schema is presented in Figure 1-1. 
Figure 1-1 
Study Schema 
 
 
The SoA is presented in Table 1-1.Study procedures are recommended to be done in sequence as 
listed in the below schedule.
  
 
 
 
 
  
 
 
  
  
 
    
 
 
 
 
 
 
  
 
 
 
 
  
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
  
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
  
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
  
 
 
 
 
 

CONFIDENTIAL  
Protocol MED-MA-PLS-0647 
CoolSculpting® Elite 
GRD-CLN-T-01-01 v5.0 
11 
Table 1-1 
Schedule of Activities 
Evaluations
Visit 1 
Screening
Visit 2 
Treatment 
Session #1
Visit 3 
1-week Phone 
Follow-up 1a,b
Visit 4 
4-week 
Follow-up
Visit 5 
8-week 
Follow-up
Visit 6 
Treatment 
Session #2
Visit 7 
1-week Phone 
Follow-up2a,b
Visit 8 
12-week 
Follow-up/Exit 
for participants 
who received only 
1 treatment 
session3
Visit 9 
20-week 
(12-week 
Follow-up/ Exit 
for participants 
who received 
2 treatment 
sessions)3 
Notes
Visit Window 
Day -7 
to 1
Day 1 + 3 
 
Day 28 + 10 
Day 56 + 14 
Day 56 + 14 
 
Day 84 + 14 
Day 140 + 14 
 
Visit Notes 
Mandatory 
for all 
treatment 
areas 
Mandatory 
for all 
treatment 
areas 
Mandatory 
for all 
treatment 
areas 
Mandatory 
for all 
treatment 
areas 
Mandatory 
for all 
treatment 
areas.  
Mandatory, 
by treatment 
area, if two 
treatment 
sessions. May 
occur same 
day as Visit 5.
Mandatory, 
by treatment 
area, if two 
treatment 
sessions 
Mandatory, by 
treatment area, if 
only one treatment 
session 
Mandatory, by 
treatment area, if 
two treatment 
sessions 
See Section 7.2 
for detail on 
information to be 
captured in Visit 
in case of study 
discontinuation  
Informed 
Consent
X 
 
 
 
 
 
 
 
 
 
Inclusion/ 
Exclusion
X 
X 
 
X 
X 
X 
 
X 
X 
See Sections 5.1 
and 5.2
Demographics
X
Medical/ 
Surgical 
History
X 
 
 
 
 
 
 
 
 
 
Concomitant 
Medications 
and procedures 
X 
X 
X 
X 
X 
X 
X 
X 
X 
See 
Section 6.5.1. At 
Visits 2 and 6, 
repeat if 
participant is 
treated over 
multiple days 
with > 24 hours 
between 
treatments.
Review 
Contraceptive 
Guidance
X 
X 
X 
X 
X 
X 
X 
X 
X 
See Section 10.4, 
for WOCBP 
  
 

CONFIDENTIAL  
Protocol MED-MA-PLS-0647 
CoolSculpting® Elite 
GRD-CLN-T-01-01 v5.0 
12 
Evaluations
Visit 1 
Screening
Visit 2 
Treatment 
Session #1
Visit 3 
1-week Phone 
Follow-up 1a,b
Visit 4 
4-week 
Follow-up
Visit 5 
8-week 
Follow-up
Visit 6 
Treatment 
Session #2
Visit 7 
1-week Phone 
Follow-up2a,b
Visit 8 
12-week 
Follow-up/Exit 
for participants 
who received only 
1 treatment 
session3
Visit 9 
20-week 
(12-week 
Follow-up/ Exit 
for participants 
who received 
2 treatment 
sessions)3 
Notes
Urine 
Pregnancy Test 
X 
X 
 
 
 
X 
 
 
 
See 
Section 8.2.3, 
conduct before 
cryo-lipolysis 
treatments at 
Visits 2 and 6. At 
Visits 2 and 6, 
repeat if 
participant is 
treated over 
multiple days 
with > 24 hours 
between 
treatments.
Treatment site 
assessment  
 
X  
 
X 
X 
X  
 
X 
X 
Conduct after 
cryo-lipolysis 
treatments and 
prior to massage 
at Visits 2 and 6.
Height
X
Weight 
X 
X 
 
X 
X 
 
 
X 
X 
Conduct before 
cryo-lipolysis 
treatments at 
Visits 2 and 6.
2D/3D 
Photography4 
X 
X 
 
X 
X 
 
 
X 
X 
See 
Section 8.1.2, 
conduct before 
cryo-lipolysis 
treatment at 
Visits 2 and 6
Cryolipolysis 
Treatment
 
X 
 
 
 
X 
 
 
 
See Section 6 
Pain 
Assessment
 
X 
X 
X 
X 
X 
X 
X 
X 
See Section 8.2.1 
  
 

CONFIDENTIAL  
Protocol MED-MA-PLS-0647 
CoolSculpting® Elite 
GRD-CLN-T-01-01 v5.0 
13 
Evaluations
Visit 1 
Screening
Visit 2 
Treatment 
Session #1
Visit 3 
1-week Phone 
Follow-up 1a,b
Visit 4 
4-week 
Follow-up
Visit 5 
8-week 
Follow-up
Visit 6 
Treatment 
Session #2
Visit 7 
1-week Phone 
Follow-up2a,b
Visit 8 
12-week 
Follow-up/Exit 
for participants 
who received only 
1 treatment 
session3
Visit 9 
20-week 
(12-week 
Follow-up/ Exit 
for participants 
who received 
2 treatment 
sessions)3 
Notes
AE, SAE, 
ADE, SADE 
X 
X 
X 
X 
X 
X 
X 
X 
X 
At Visits 2 and 6, 
repeat if 
participant is 
treated over 
multiple days 
with > 24 hours 
between 
treatments.
Device 
Complaint 
Query 
 
X 
X 
X 
X 
X 
X 
X 
X 
At Visits 2 and 6, 
repeat if 
participant is 
treated over 
multiple days 
with > 24 hours 
between 
treatments.
CSQ [6 
versions]5 
 
 
 
 
X 
 
 
X 
X 
See Section 10.6-
10.11
CGPQ6 
 
 
 
 
 
 
 
X 
X 
See 
Section 10.12
CPIQ7 
 
X 
 
 
X 
 
 
X 
X 
See 
Section 10.13 
Complete before 
cryolipolysis 
treatment at 
Visit 2.
Participant 
Evaluation of 
Noticeable 
Improvement
 
 
 
 
X 
 
 
 
 
 
See 
Section 10.15 
 
 
 
 
 
 
 
 
X 
X 
 
 
 
 
 
 
 
  
 

CONFIDENTIAL  
Protocol MED-MA-PLS-0647 
CoolSculpting® Elite 
GRD-CLN-T-01-01 v5.0 
14 
1a 
Phone follow-up should be scheduled 7 days from last treatment visit day in instance where participant received treatment session #1 over multiple days. 
1b 
If, during this phone follow-up, any of the following local effects of erythema, bruising, swelling, and/or sensory alteration are reported related to treatment 
session #1, additional phone follow-up (or in-person visit if aligned to planned study visit) will be scheduled in accordance with the time criteria outlined in 
Table 2-1 for potential AE categorization. 
2a  
Phone follow-up should be scheduled 7 days from last treatment visit day in instance where participant received treatment session #2 over multiple days.  
2b  If, during this phone follow-up, any of the following local effects of erythema, bruising, swelling, and/or sensory alteration are reported related to treatment 
session #2, additional phone follow-up (or in-person visit if aligned to planned study visit) will be scheduled in accordance with the time criteria outlined in 
Table 2-1 for potential AE categorization. 
3  
If a participant receives only one treatment session for specific body area(s), the participant will return at Visit 8 for the 12-week post-treatment session #1 
follow up assessment and study exit. If a participant receives two treatment sessions to any or all treated body areas, participant will return at Visit 9 for 
12-week post-treatment session #2 follow-up and study exit. If a participant receives only one treatment session to one specific body area and two treatment 
sessions to another specific body area, the participant will return for Visit 8 for 12-week follow-up for the body area that received only one treatment session 
and Visit 9 for 12-week follow-up of body area that received two treatment sessions. The exit for this participant is Visit 9.  
4  
For select study sites with 3D camera system, 3D images will also be taken at this time.  
5  
CSQ-Overall is to be administered only if patient received treatment to midsection (abdomen and flank) plus at least one additional specific body area. The 
CSQ-Overall should be completed at visit where at least 12-weeks have passed since the final treatment session for all the treated body areas. For example, if 
the participant receives only one treatment session for one specific body area but two treatment sessions for another specific body area, the CSQ-Overall 
should be administered at Visit 9 where all the treated areas will have undergone at least a 12-week post treatment period.  
6  
The CGPQ should be completed at visit where at least 12-weeks have passed since the final treatment session for all the treated body areas. For example, if 
the participant receives only one treatment session for one specific body area but two treatment sessions for another specific body area, the CGPQ should be 
administered at Visit 9 where all the treated areas will have undergone at least a 12-week post treatment period. 
7  
The 12-week post final treatment CPIQ should be completed at visit where at least 12-weeks have passed since the final treatment session for all the treated 
body areas. For example, if the participant receives only one treatment session for one specific body area but two treatment sessions for another specific 
body area, the CPIQ should be administered at Visit 9 where all the treated areas will have undergone at least a 12-week post treatment period. 
 
Should it ever become necessary to remain isolated at home or to shelter-in-place per local, regional, or state orders, study visits may 
be impacted. This may include changes such as phone or virtual visits, visits at alternative locations, or changes in the visit frequency 
and timing of study procedures, among others. Additional details are provided throughout Section 8. Every effort should be made to 
ensure the safety of participants and site staff, while maintaining the integrity of the study. If visits cannot be conducted onsite due to 
travel restrictions or other pandemic or natural disaster-related reasons, follow the modifications provided throughout Section 8. 

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2. 
Introduction 
The sponsor is investigating non-invasive subcutaneous fat reduction of the midsection 
(abdomen and flanks), upper arms, inner thighs, outer thighs, and submental area utilizing the 
CoolSculpting® Elite System with CoolSculpting® Elite applicators. 
2.1. 
Study Rationale 
The CoolSculpting device and applicators have been redesigned and updated (now known as 
CoolSculpting Elite) and therefore warrant further clinical investigation. While the technological 
characteristics and operating principals associated with the treatment remain unchanged from the 
predicate CoolSculpting device, the system has been enhanced to support the simultaneous use of 
two applicators, improving overall treatment efficiency. This innovation is reflective of 
physician feedback that suggests patients would prefer to have multiple treatment cycles 
performed at once rather than serial treatments in order to reduce the overall time of procedure 
and office visits. In addition, there is minimal data evaluating CoolSculpting treatment across 
multiple body areas that also captures patient satisfaction and treatment experience. This 
approach is reflective of real-world experience, where patients may be assessed for treatment on 
multiple body regions depending on areas of interest for noninvasive fat reduction. This study 
will collect meaningful data for the use of the CoolSculpting Elite system and CoolSculpting 
Elite applicators. 
 
. The 
purpose of the study described here is thus to further evaluate the safety, effectiveness, and 
patient satisfaction with the CoolSculpting Elite System in a more robust population and at both 
US and International sites. With the CoolSculpting Elite system, treatment applicators can be 
applied simultaneously while undergoing non-invasive subcutaneous fat reduction of the 
abdomen and flanks, upper arms, submental area, inner thighs, and/or outer thighs. The full 
applicator range will be utilized as applicable and per country clearances. In addition, patient 
reported outcome (PRO) instruments were developed and modified following additional 
qualitative research to better assess overall patient satisfaction comprising multiple body areas 
for treatment. This will be a global study to better inform CoolSculpting providers and patients 
worldwide about expected outcomes with the updated system and applicators, and to support a 
more patient-centric consultation and tailored treatment approach when multiple body areas are 
considered for treatment. 
2.2. 
Background 
CoolSculpting is a noninvasive, clinically proven fat-reduction treatment that selectively targets 
adipocytes using a patented cooling technology. The CoolSculpting mechanism of action is 
based on cryolipolysis, which works by cooling the subcutaneous tissue and preferentially targets 
adipocytes, leading to controlled elimination of adipocytes (Manstein 2008, Zelickson 2009). 
Adipose tissue appears more preferentially sensitive to cold injury than skin and other tissues 
(eg, skin, muscle, and nerve) and the crystallization of cytoplasmic lipids in adipocytes occurs at 
temperatures well above the freezing point of water (Epstein 1970, Beacham 1980, 
Manstein 2008). 
 
 
  

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In the United States, the CoolSculpting system first received FDA clearance in 2010 for 
noninvasive fat reduction in the flank followed by clearance for the abdomen in 2012 
(Bernstein 2014). Further approvals were gained for visible fat bulges in the submental and 
submandibular area, thigh, along with bra fat, back fat, underneath the buttocks (also known as 
“banana roll”), and upper arm. 
The CoolSculpting System was first CE marked for fat layer reduction in 2009. The clearance 
was for general fat layer reduction, without a specified treatment area. Up to now, the 
CoolSculpting system has gained clearance/approval in more than 70 countries. 
The latest iteration of the CoolSculpting System (CoolSculpting® Elite) initially received US 
FDA clearance on 21 Jan 2020 (510k clearance) and was first CE marked in Europe in 
November 2020. 
Several enhancements to the predicate CoolSculpting device were made to develop 
CoolSculpting Elite and accommodate simultaneous applicator use. For the vacuum applicators, 
the applicator cup was updated to provide a single assembled unit incorporating the contour, thus 
eliminating the need for the gasket. Consequently, the geltrap on some applicators was 
repositioned to the top of the applicator, and the latches and contour interface were removed 
from the applicator housing. The applicator umbilical is lighter and more flexible. Changes were 
also made to the predicate’s system control unit, vacuum, and chiller subsystems, hardware, and 
software to allow 1 or 2 treatments to be performed simultaneously. Simultaneous CoolSculpting 
Elite treatment consists of using Applicator A and Applicator B simultaneously. The applicator 
heating and cooling technology and method remain unchanged, utilizing the same thermoelectric 
coolers to achieve heating and cooling. The temperature feedback control mechanism remains 
the same and the device monitoring is through software monitoring.  
The applicators are designed to treat most body areas, and there are 7 total body applicators that 
operate with the system (Curve 80, Curve 120, Curve 150, Curve 240, Flat 125, Flat 165, and 
Surface 150). The applicator consists of the applicator connector, the applicator umbilical, and 
the applicator head. All applicators except the Curve 80 and Surface 150 provide the ability to 
disconnect the handpiece from the umbilical. 
While the CoolSculpting procedure is successful in reducing subcutaneous fat in various 
anatomical areas, patients often desire treatment in multiple body areas and typically more than 
one treatment session may be necessary to achieve desired results. Retrospective chart reviews 
indicate patients most commonly seek treatment for the abdomen and/or flanks and there is 
demand to treat other body areas beyond the midsection. In addition, physician feedback 
suggested that patients would prefer to have multiple CoolSculpting cycles performed at once in 
a single office visit to reduce the overall time of the procedures. 
 
 
The present study would expand the eligible body areas that can be treated to be reflective of 
real-world treatment consultations. In addition, capabilities of the device to allow for 
simultaneous use of applicators would allow for treatment of multiple body areas in the same or 
reduced treatment time. 
A previous global (ex-US) study by Braun et al evaluated PROs via the CSQ, CGPQ, and 
CPIQ-Midsection (CPIQ-M) (Study CMO-MA-PLS-0602). These were created de novo to 
address treatment satisfaction with the abdomen only, flank only, or abdomen and flank together. 
 
 
  

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The study demonstrated high levels of patient satisfaction after CoolSculpting treatment for the 
abdomen and/or flanks with up to 24 cycles that could be delivered over two treatment sessions 
(the primary endpoint being 89.6% of participants rating their satisfaction with the fat reduction 
procedure as “Satisfied” or “Very Satisfied” on the CSQ Item 1). Patients also reported 
significant improvement in psychosocial impact after CoolSculpting treatment as measured by 
the CPIQ-M as well as measures derived from the CGPQ (which were exploratory endpoints). 
The findings demonstrated that patients benefited from tailored and optimized treatment plans to 
achieve their aesthetic goals in the abdomen and flank areas. 
Given that the present study will also allow treatment of the inner thighs, outer thighs, submental 
area, and/or upper arms, the available PRO instruments required modification and qualitative 
patient research for the additional body areas. It was also important to further develop and refine 
a generalizable questionnaire considering that all of the above body areas could be included in 
the treatment plan. Hybrid concept elicitation/cognitive debriefing interviews were conducted 
with 12 participants to confirm the concepts and test the clarity and understanding of the 
following PRO measures: Cryolipolysis General Procedure Questionnaire – (CGPQ), 
Cryolipolysis Psychosocial Impact Questionnaire (CPIQ), CSQ-Overall, CSQ - Midsection, 
CSQ - Upper Arms, CSQ - Inner Thighs, CSQ - Outer Thighs, and CSQ - Fat under Chin.  
In addition, this study will evaluate effectiveness by correct identification of baseline vs post-
treatment images of the treated body area(s) by at least two out of three blinded, independent 
physician reviewers. This is consistent with prior CoolSculpting studies where independent 
photographic review was used for the correct identification of pre- vs final post-treatment visit 
images as a marker of visible improvement. Three-dimensional images will also be obtained at 
select study sites that have access to 3D imaging system to assess volumetric measurements. 
A participant question will be administered (Participant Evaluation of Noticeable Improvement) 
to assess whether participant starts to observe noticeable improvement at 4 weeks post-treatment 
#1 with CoolSculpting Elite on the treated body areas. 
 
.  
Although there are numerous clinical studies that have been conducted with the prior 
CoolSculpting system, there have been a limited number of patients who have been studied with 
the CoolSculpting Elite device and applicators globally with treatment plans facilitating 
simultaneous applicator use and multiple body areas. There is a need to evaluate effectiveness, 
safety, and patient-centric outcomes related to the CoolSculpting Elite procedure as well as to 
generate data with the updated applicators across body areas. 
2.3. 
Benefits and Risks 
2.3.1. 
Benefits 
Non-invasive subcutaneous fat reduction in the treatment area is anticipated to provide an 
aesthetic benefit and the use of this non-invasive system will eliminate the need for an invasive 
procedure that requires anesthesia or recovery time. Non-surgical fat reduction is one of the most 
frequent noninvasive cosmetic procedures and these procedures have become increasingly 
popular due to their convenience and accessibility. 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 
 
 
  

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with invasive and minimally invasive procedures such as liposuction and laser-assisted 
liposuction. Over the last decade, the safety and effectiveness of cryolipolysis with 
CoolSculpting system for subcutaneous fat reduction has been well-established. In addition, 
patient satisfaction with cryolipolysis reported in the literature is consistently high. 
Advancements with the CoolSculpting Elite system in particular allow for dual applicator use 
that can shorten the overall time in clinic to complete treatment plan and provide for the 
opportunity to treat body areas simultaneously. 
2.3.2. 
Risks 
Although this study presents minimal risks to the participant, there is the potential for some risk 
when any cryolipolysis procedure is performed. The risks of using a CoolSculpting device can 
occur during and after the treatment and usually resolve within a few days. During the treatment, 
sensations of intense cold, numbness, tingling, cramping, pulling and mild pinching are expected 
due to the vacuum and cold temperatures to which the treatment area is subjected. Immediately 
after the treatment, it is common to see redness, firmness, bruising, swelling, as well as to have 
sensations of tingling, itchiness, numbness and pain on the treatment area. A sensation of 
fullness at the back of the throat may happen after a submental treatment. 
Less commonly, the following side effects have been noted to occur after treatment, as outlined 
in the User’s Manual: Paradoxical adipose hyperplasia that may require surgical intervention, 
late onset pain with typical onset several days after a treatment and resolution within several 
weeks, freeze burn that typically resolves without sequalae with proper care, hyperpigmentation 
and the additional events described in  
Table 2-2. 
The benefits of noninvasive fat reduction with CoolSculpting Elite treatment outweigh the risks. 
Considering a pandemic or natural disaster, the benefit and risk to participants in this study has 
also been evaluated. Based on the limited information to date, no additional risk to study 
participants has been identified with the use of CoolSculpting Elite. 
Anticipated Device Effects (Local effects of the treatment) 
There are known effects of the CoolSculpting procedure, previously recorded in prior studies as 
transient and/or temporary effects related to the cold application and/or vacuum pressure inherent 
in the treatment. Anticipated effects of treatment with the CoolSculpting device include:  
 Inflammation of the subcutaneous fat layer, which is a desired effect of the procedure 
 Sensations of coldness, stinging, burning, pinching, or pressure associated with placement 
of the applicator and the initiation of the cold treatment 
 Known skin effects (eg, blanching, erythema, bruising, purpura, petechiae, swelling, 
discomfort, tenderness, or soreness at the treatment site, all mild to moderate in nature), 
which are temporary effects that resolve spontaneously shortly after the procedure 
 Localized sensory changes (eg, numbness, tingling) at the treatment area spontaneously 
resolving without medical intervention within 12 weeks of the procedure 
 
 
  

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Anticipated device effects should not be reported as adverse events (AEs) unless the criteria 
below are met (Table 2-1). 
When Anticipated Device Effects May Be Considered as Potential Adverse Events 
If an anticipated device effect is considered severe, prolonged, results in treatment interruption or 
discontinuation and/or requires medical intervention as outlined below, then the event will need 
to be evaluated as a potential AE.  
In addition to the anticipated device effects that meet the criteria of reporting as an AE, other 
reported AEs with CoolSculpting treatment are presented in Table 2-2. 
Table 2-1 
Guidance for Anticipated Device Effects 
Anticipated Device Effect 
Criteria for AE 
Reporting 
Description for AE criteria 
Bruising 
Severe or prolonged 
Severe: Bruising (purple discoloration); purpura 
(purple-colored spots or patches); or petechiae (pin 
point red dots) that causes disruption to the 
participant’s daily activities as assessed by the study 
investigator. 
Prolonged: Bruising lasting longer than 1 month.
Erythema 
Severe or prolonged 
Severe: Erythema (redness) that causes disruption to 
the participant’s daily activities as assessed by the 
study investigator. 
Prolonged: Erythema lasting longer than 2 weeks.
Swelling 
Severe or prolonged 
Severe: The appearance of swelling (edema) that 
causes disruption to the participant’s daily activities 
as assessed by the study investigator. 
Prolonged: Swelling lasting more than 1 month.
Discomfort during procedure 
Interruption/ 
discontinuation of 
treatment, or requiring 
medical intervention
Discomfort reported during the procedure that is 
intolerable to the participant and results in an 
interruption or discontinuation of the procedure. 
Discomfort post procedure 
Requiring medical 
intervention 
Significant discomfort, pain, cramping, tenderness, 
soreness, or muscle spasm following the procedure 
which results in medical intervention (unplanned 
physician visit and/or prescription pain reliever).
Sensory Alteration 
Severe or prolonged 
Severe: Sensory changes (pain, burning, stinging, 
hypersensitivity) with a severity warranting medical 
intervention or causing disruption to the 
participant’s daily activities as assessed by the study 
investigator 
Prolonged: Sensory changes (numbness, tingling, 
burning sensation) that are prolonged (ie, lasting 
longer than 12 weeks).
 

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Table 2-2 
Reported Adverse Events  
Adverse Events 
Description 
First-degree burn 
Skin damage from burns may be due to hot or cold. A first-degree burn is 
superficial and causes local inflammation of the skin. The inflammation is 
characterized by pain, redness, and mild swelling. The skin may be very tender 
to touch.
Second-degree burn 
Second-degree burns are deeper and, in addition to the pain, redness, and 
inflammation, there is also blistering of the skin.
Third-degree burn 
Third-degree burns are deeper still, involving all layers of the skin. Because the 
nerves and blood vessels are damaged, third-degree burns appear white, 
leathery, and tend to be relatively painless.
Severe pain 
Patients may experience pain of varying severity, which more commonly can be 
described as mild to moderate, and in rare instances, can be severe.
Cold-induced panniculitis
Severe inflammation which requires medical or surgical intervention.
Skin pigment changes 
The appearance of hyperpigmentation or hypopigmentation in the treatment 
area.
Infection 
Infection at the treatment site, diagnosed by a physician and requiring medical 
intervention.
Vasovagal symptoms 
The occurrence of symptoms of anxiety, light-headedness, dizziness, nausea, 
sweating, near-syncope, or syncope (fainting).
Allergic/irritant contact 
dermatitis
Itchy rashes and skin peeling that may result from prolonged exposure to gel 
pad or applicator pressure
Subcutaneous induration 
Hardness within the treatment area, either as general firmness or discrete 
nodules.
Paradoxical adipose 
hyperplasia
Visibly enlarged tissue volume within the treatment area which may become 
evident 2-5 months after treatment.
Hernia 
Creation or exacerbation of hernia. Hernia is defined as a protrusion of an organ 
or the fascia of an organ through the wall of the cavity that normally contains it.
Treatment area demarcation 
Treatment area demarcation: excessive fat removal in the treatment area causing 
unwanted indentation.
Other 
Any other untoward medical event determined by the investigator to be an AE, 
regardless of the relationship to the device or treatment.
 

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3. 
Objectives and Measures 
Objectives 
Measures 
To evaluate participant satisfaction and 
effectiveness of the CoolSculpting Elite 
System using CoolSculpting Elite applicators 
for non-invasive subcutaneous fat reduction of 
the abdomen and flanks, upper arms, inner 
thighs, outer thighs and submental area 
 
Cryolipolysis Satisfaction Questionnaire (CSQ)-
Midsection (abdomen and flanks) 
 
CSQ-Overall (if additional body area(s) beyond abdomen 
and flanks are treated) 
 
CSQ for individual additional body areas treated (upper 
arms, inner thighs, outer thighs, submental area) 
 
Cryolipolysis General Procedure Questionnaire (CGPQ) 
 
Cryolipolysis Psychosocial Impact Questionnaire (CPIQ) 
 
 Participant Evaluation of Noticeable Improvement 
 
Photography and independent photography review (IPR) 
 
3D imaging of change in volume of fat
To evaluate safety of the CoolSculpting Elite 
System using CoolSculpting Elite applicators 
for non-invasive subcutaneous fat reduction of 
the abdomen and flanks, upper arms, inner 
thighs, outer thighs and submental area 
 
Adverse events (AEs) and adverse device effects (ADEs); 
serious adverse events (SAEs), serious adverse device 
effects (SADEs) 
 
Unanticipated AEs or SAEs (previously unknown to the 
device) 
 
Pain assessment
 

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4. 
Study Design 
4.1. 
Overall Design 
This is a global, multicenter, multi-country, prospective, open-label, nonrandomized, 
interventional cohort, medical device post-marketing study evaluating the use of CoolSculpting 
Elite and CoolSculpting Elite applicators for noninvasive subcutaneous fat reduction of the 
abdomen, flanks, upper arms, inner thighs, outer thighs, and/or submental area in healthy 
volunteers. Participants will be enrolled at approximately 9 study sites.  
Participants are eligible to receive up to two treatment sessions separated 8 weeks apart for the 
body areas eligible for treatment. Assessments will be completed 12 weeks after the final 
treatment session.  
 If a participant receives only one treatment session for specific body area(s), the 
participant will return at Visit 8 for the 12-week post-treatment session 1 follow-up 
assessment and study exit.  
 If a participant receives two treatment sessions for specific body area(s), the participant 
will return at Visit 9 for the 12-week post-treatment session 2 follow-up assessment and 
study exit. 
 If a participant receives only one treatment session to a specific body area and two 
treatment sessions to another specific body area, the participant will return for both 12-
week follow-up visits: Visit 8 for the 12-week post-treatment session 1 assessment of the 
body area that received only one treatment session and Visit 9 for the 12-week post 
treatment session 2 assessment of the body area receiving two treatment sessions; Visit 9 
will also be the study exit visit for this participant. 
Participant body areas selected for treatment during the study must be treated during the first 
treatment visit (Visit 2) and no new body areas may be treated at Visit 6. Participants planning to 
receive only one treatment session to a specific body area must have this treatment in Visit 2 
during the first treatment session. Per investigator discretion, body areas identified for treatment 
may be treated simultaneously or sequentially. If sequential or simultaneous treatment is 
performed, there will be no difference in other treatment activities. Skin preparation, pain 
assessment, treatment site assessment, and post-massage, etc. will be identical in either case. 
The study duration is up to approximately 20 weeks and consists of up to 7 scheduled study 
visits and 2 phone follow-ups per participant:  
 Visit 1 (screening, Days -7 to 1) 
 Visit 2 (treatment session #1, Day 1 + 3 days)  
Note: Treatment plan may be completed within a 7-day window from the day when the 
initial treatment is administered for this visit. The entire treatment session #1 plan for all 
the body areas selected for treatment must be completed within these 7 days. 
 Visit 3 (1-week phone follow-up from last treatment day for participants who received 
treatment session #1 on any body area)  
 
 
  

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Note: If any of the following local effects of erythema, bruising, swelling, and/or sensory 
alteration are reported during Visit 3, additional phone follow-up (or in-person visit if 
aligned to planned study visit) will be scheduled in accordance with the time criteria 
outlined in Table 2-1 for potential AE categorization. 
 Visit 4 (4-week follow-up after treatment session #1, Day 28 + 10 days) 
 Visit 5 (8-week follow-up after treatment session #1, Day 56 + 14 days) 
 Visit 6 (treatment session #2 [optional], Day 56 + 14 days, can be completed on the same 
day as Visit 5) 
Note: Only body area(s) that were treated at Visit 2 and that require a second treatment 
session are to be treated at Visit 6. The treatment plan for specific body area(s) may be 
completed within a 7-day window from when the initial treatment is administered for this 
visit. The entire treatment session #2 plan for the body area(s) selected for a second 
treatment must be completed within these 7 days.  
 Visit 7 (1-week phone follow-up from last treatment day for participants who received 
treatment session #2 on any body area) 
Note: If any of the following local effects of erythema, bruising, swelling, and/or sensory 
alteration are reported during this Visit, additional phone follow-up (or in-person visit if 
aligned to planned study visit) will be scheduled in accordance with the time criteria 
outlined in Table 2-1 for potential AE categorization. 
 Visit 8 (12-week follow-up/exit for participants with any body area that underwent 
only treatment session 1 at Visit 2, Day 84 + 14 days). If the participant receives only one 
treatment session to all body areas, this visit is also the study exit visit.  
Note: If the participant receives only one treatment session to a specific body area and 
two treatment sessions to another specific body area, the body area that received only one 
treatment session will be assessed at this visit. The participant will return at Visit 9 for 
assessment of body area that received two treatment sessions and study exit.  
 Visit 9 (20-week follow-up/exit, corresponding to 12-week follow up for participants with 
any body area that underwent treatment session 2 at Visit 6, Day 140 + 14 days). If the 
participant receives two treatment sessions to any or all treated body areas, this visit is 
also the study exit visit. 
Approximately 110 participants will be enrolled and approximately 96 participants are expected 
to complete the primary endpoint assessment based on an anticipated attrition rate of 12% or 
less.  
During the course of the study, should it ever become necessary to remain isolated at home or to 
shelter-in-place per local, regional, or state pandemic-related orders, the sponsor will engage 
with study site staff in efforts to ensure the safety of participants, maintain protocol compliance, 
and minimize risks to the integrity of the study while trying to best manage participant continuity 
of care. This may include alternative methods for assessments (eg, phone contacts or virtual site 
visits) in agreement with the sponsor. In all cases, these alternative measures must be allowed by 
local regulations and permitted by the Independent Review Board (IRB)/Independent Ethics 
 
 
  

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Committee (IEC). Investigators should notify the sponsor if any urgent safety measures are taken 
to protect the participants against any immediate hazard. 
4.2. 
Scientific Rationale for Study Design 
 
 There is a need to generate more 
information regarding the use of CoolSculpting when multiple body areas beyond midsection or 
torso are included for evaluation. In addition, there is no patient outcome reported data reflecting 
patient experience when multiple body areas are treated. In addition, this study will evaluate 
effectiveness by correct identification of baseline vs post-treatment images of the treated body 
area(s) by at least two out of three blinded, independent reviewers which is consistent with prior 
CoolSculpting studies for the specified treatment areas. The use of 3D imaging will also provide 
for evaluation of volumetric changes as a result of treatment. Therefore, there is a need to further 
evaluate the safety, effectiveness, and patient satisfaction with the CoolSculpting Elite System 
when cryolipolysis cycles are applied simultaneously or sequentially for noninvasive 
subcutaneous fat reduction for multiple body areas at an expanded number of clinical sites and 
across different patient populations. 
4.3. 
Justification for Dose 
For this device, the term “dose” refers to a single CoolSculpting Elite treatment cycle. A 
treatment cycle is defined as the attachment of a single applicator on body area delivering a 
timed segment of cooling. One or more treatment cycles will be delivered at the investigator’s 
discretion at each treatment session. Treatment cycles can be delivered simultaneously or 
sequentially at investigator discretion. Study site investigators will administer treatment cycles to 
participants according to the CoolSculpting Elite System User Manual. Up to 2 treatment 
sessions may be delivered for the abdomen and flanks, in addition to one or more of the optional 
body areas of treatment (upper arms, inner thighs, outer thighs, and submental area). Additional 
information regarding treatment cycles in provided in Section 6. 
4.4. 
End of Study Definition 
A participant is considered to have completed the study if he/she has completed all phases of the 
study including the final visit of the study which is 12 weeks post final treatment. [see the SoA in 
Table 1-1 or the study schema in Figure 1-1]). 
The end of the study is defined as the date of the last visit of the last participant in the study. 
If the participant is not able to present in person to the site for the Study Exit visit due to national 
or regional travel restrictions, site closure as a result of these restrictions, or a participant 
declines an in‐clinic visit due to pandemic or natural disaster-related health concerns, a phone 
visit or alternate remote option is permitted. 
 
 
  

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5. 
Study Population 
Prospective approval of protocol deviations to recruitment and enrollment criteria, also known as 
protocol waivers or exemptions, is not permitted. 
5.1. 
Inclusion Criteria 
Participants are eligible to be included in the study only if all of the following criteria apply: 
1. Participant must be in good health as determined by medical history, physical 
examination, vital signs, and investigator’s judgment, including no known active 
pandemic infection. 
2. Participant (healthy volunteers) has read and signed the study written ICF. 
3. Male or female participant 22 to 65 years of age inclusive at screening. 
4. Participant has clearly visible and palpable fat in the abdomen and flanks, and participant 
may also be assessed for visible and palpable fat in one or more of the following body 
areas: left and right lower aspects of the upper arms, left and right inner thigh, left and 
right outer thigh, or submental area, which in the investigator’s opinion is appropriate for 
and may benefit from treatment. 
5. Participant agrees to receive treatment of the abdomen and flanks (collectively, the 
midsection) and has option to receive treatment to at least 1 additional body area listed in 
criterion 4. 
6. Participant has not had weight change fluctuations exceeding 5% of body weight in the 
preceding month. 
7. Participant has a BMI of ≥ 18.5 and < 30. BMI is defined as weight in kilograms divided 
by height in meters squared (kg/m2). 
8. Participant agrees to maintain weight (ie, within 5% of body weight) by not making any 
changes in diet or exercise routine during the course of the study. 
9. Participant agrees to have photographs taken of the treatment area(s) during the scheduled 
time periods. 
5.2. 
Exclusion Criteria 
Participants are excluded from the study if any of the following criteria apply: 
1. Participant has a history of an invasive fat reduction procedure (eg, liposuction, surgery, 
lipolytic agents, etc) within or adjacent to the area being considered for treatment.  
2. Participant has implants (eg, breast implants) in or immediately adjacent to the area of 
intended treatment. 
3. Participant has a history of prior surgery or scar tissue related to the area being considered 
for treatment. 
4. Participant has a known history of cryoglobulinemia, cold urticaria, cold agglutinin 
disease, or paroxysmal cold hemoglobinuria. 
 
 
  

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5. Participant has a known sensitivity to cold or has any condition with a known response to 
cold exposure that limits blood flow to the skin, such as cold urticaria, Raynaud’s disease, 
or chilblains (pernio). 
6. Participant with a clinically significant bleeding disorder, or concomitant use of blood 
thinners, or is taking any medication that, in the investigator’s opinion, may significantly 
increase the participant’s risk of bruising or bleeding. Participant on low dose aspirin for 
medical condition is excluded if the medical history suggests significant risk of bruising or 
bleeding per investigator’s clinical judgement. 
7. Participant has a history of carpal tunnel syndrome, compartment syndrome, or deep vein 
thrombosis in the upper or lower extremities (only applicable for participants receiving 
treatment to the upper arms or thighs). 
8. Participant is currently taking or has taken diet pills or weight control supplements within 
the past 6 months. 
9. Participant has any skin conditions, such as moderate to excessive skin laxity, open 
wound, or scars, and active infection, eczema, dermatitis or rashes in the location of the 
treatment sites that may interfere with the treatment or evaluation (stretch marks are not 
an exclusion).  
10. Participant has an active implanted device such as a pacemaker, defibrillator, drug 
delivery system, or any other metal-containing implant, within or adjacent to the area 
being considered for treatment. 
11. Participant (WOCBP) is pregnant or intending to become pregnant in the next 3 to 6 
months and does not agree to use reliable contraception during the study. 
12. Participant is lactating or has been lactating in the past 6 months. 
13. Participant is unable or unwilling to comply with the study requirements. 
14. Participant is currently enrolled in a clinical study of any unapproved investigational 
device, investigational product, or any other type of medical research judged not to be 
scientifically or medically compatible with this study. 
15. Participant has any other condition or laboratory value that would, in the professional 
opinion of the investigator, potentially affect the participant’s response or the integrity of 
the data or would pose an unacceptable risk to the participant. 
16. Participant has had a non-invasive fat reduction and/or body contouring procedure in the 
area(s) of intended treatment within the past 12 months.  
17. Participant needs to administer, or has a known history of subcutaneous injections, into 
the area(s) of intended treatment (eg, cortisone, heparin, insulin) within the past 6 months. 
18. Participant with known sensitivity or allergy to fructose, glycerin, isopropyl alcohol, or 
propylene glycol. 
19. Participant has impaired peripheral circulation in the area to be treated. 
20. Participant has neuropathic disorders such as post-herpetic neuralgia or diabetic 
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21. Participant has impaired skin sensation in or immediately adjacent to the treatment area(s). 
22. Participant has a history of hernia in or immediately adjacent to the treatment area(s). 
23. Participant diagnosed with a systemic fibrosing disease or fibrosis in the area intended or 
adjacent to the area to be treated. 
5.3. 
Lifestyle Considerations 
Lifestyle considerations are not applicable to this study. 
5.4. 
Screen Failures 
Screen failures are defined as participants who consent to participate in the clinical study but are 
not subsequently entered in the study. A minimal set of screen failure information is required to 
ensure transparent reporting of screen failure participants to meet the CONSORT publishing 
requirements and to respond to queries from regulatory authorities. Minimal information 
includes demography, screen failure details, eligibility criteria, and any AE. 
 
 
  

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6. 
Study Intervention 
Study intervention is defined as the medical device (CoolSculpting Elite System and 
CoolSculpting Elite applicators) intended to be administered to a study participant according to 
the study protocol. 
6.1. 
Study Intervention Administered (CoolSculpting Elite System) 
Participants will undergo a CoolSculpting Elite treatment in an outpatient clinical setting. A 
treatment is comprised of timed segments of cooling (treatment cycle) followed by 2 minutes of 
manual massage. Treatments will be administered according to the CoolSculpting Elite user 
manual that has been prepared for specific countries and provided to the study sites. All device 
deficiencies (including malfunction and use error) shall be documented and reported by the 
investigator throughout the clinical investigation (see Section 8.3.8) and appropriately managed 
by the sponsor. 
6.1.1. 
Identity of the CoolSculpting Elite System 
The CoolSculpting Elite System is a portable thermoelectric cooling and heating device that 
applies controlled cooling or heating to a treatment site on the participant’s skin. The system has 
two umbilicals attaching the applicators to the control unit to allow dual applicator use at the 
same time. The system is comprised of a control unit, applicators, and supplies such as cards, 
gelpads, pretreatment skin wipes, liners, foam borders, securement grip, support arm and comfort 
straps. The applicators, gelpads, pretreatment skin wipes, liners, foam borders, and comfort 
straps are parts applied to patient. During a treatment, the operator applies a gelpad and 
applicator to the patient’s skin. For a treatment where two or more applicators are used 
simultaneously, additional applicators are applied with another gelpad. The applicator(s) draw 
tissue into the applicator cup(s) and hold(s) the tissue against the cooling surfaces of the 
applicator(s). The operator then starts the treatment. The Surface S150 applicator does not draw 
in tissue and does not have a cup. The treatment card (can be referred to as “Standard” card or 
“SOLO” card depending on country) provides treatments and profiles for use with the system. 
During the cooling treatment, sensors in the cooling surfaces of the applicator(s) monitor the skin 
surface and provide feedback 
. The gelpad(s) protect the skin by 
providing thermal coupling at the interface between the cooling surfaces of the applicator(s) and 
the skin.  
The CoolSculpting Elite System operates applicators at temperatures below 0°C. Therefore, the 
system monitors tissue during cooling and employs multiple safety features, including the Freeze 
Detect system, to minimize the risk of damage to tissue. In spite of these multiple safety features, 
on rare occasions, a possible freeze condition may occur that can be detected by the Freeze 
Detect System. 
The Freeze Detect system is comprised of several features, including thermal sensors and 
proprietary algorithmic software. Freeze Detect is an integral part of the CoolSculpting System 
and is automatically employed when a treatment is initiated. When the Freeze Detect system 
detects a possible freeze condition, it stops the treatment and displays a Z409 message. If this 
message is received, remove the applicator and gel pad or gel, and assess the tissue before taking 
further action. The current recommended practice is to wait at least 24 hours before retreating the 
 
 
  

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area relating to a Z409 error message. Failure to follow instructions could result in injury to the 
participant, including first- or second-degree burns. Second-degree burns or complications of 
second-degree burns may result in hyper- or hypopigmentation. 
6.1.2. 
Control Unit 
The control unit is shown in Figure 6-1. For additional detail, please see the CoolSculpting Elite 
System user manual. 
Figure 6-1 
CoolSculpting Elite Control Unit 
 
 (A) Touchscreen display: The touchscreen displays system controls, information about the 
status of the system, information about the treatment, and messages for the operator. You 
can rotate or tilt the display to accommodate better access. 
 (B) Card Slot: The card slot accepts treatment cards. You must insert an appropriate 
SOLO treatment card with active treatments in order to begin the procedure. 
 (C) Casters and locks: The control unit has four casters that swivel. Each caster has a lock. 
Always engage all four caster locks when the unit is stationary. Disengage the caster locks 
to move the unit. 
 (D) Bucket: The bucket is a storage area for applicators and/or consumables. You can 
remove the bucket from the control unit for cleaning. 
 (E) Top cap lip: When the applicator is resting on top of the control unit, the top cap lip 
helps keep the applicator in place. 
 (F) Access panel: The access panel covers vents, a USB port, and the chiller tank cap. 
 
 
 
 
 
 

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 (G) Power receptacle and power switch: The power receptacle houses the plug for the 
power cord. The power switch controls the power to the control unit and system 
components. Contact customer service if the power entry mode appears to be broken. 
 (H) Connector ports for umbilical cords for applicators A and B: The control unit has two 
connector ports where two umbilical cords attach to perform a simultaneous treatment. 
Simultaneous treatment is an option, but not necessary. 
 (I) Vents: Vents provide airflow that reduces heat build-up inside the control unit. Ensure 
that all vents are free from obstructions when the control unit is in operation. 
 (J) Soft power button: The display includes a soft power button at the lower right corner, 
which is used to power on the system, after turning the power switch on the rear of the 
system to the “On” position. The soft power button may also be used to power off the 
system. 
6.1.3. 
Applicators 
The applicator delivers controlled cooling to the treatment site. The applicator consists of the 
applicator connector, the applicator cable, and the applicator head. The applicator is used with 
supplies provided by the sponsor.  
Always use gelpads with the applicator. The applicators are designed to treat most body areas. 
Investigators should consider all physical aspects of the area to be treated and use the applicator 
that will fit best for each participant and body area being treated.  
The CoolSculpting Elite applicators available in this study depend on country clearances and can 
include Curve 240, Curve 150, Curve 120, Flat 165, Flat 125, Surface 150, and Curve 80. 
For additional details regarding applicators, please see the CoolSculpting Elite user manual. 
6.2. 
Additional Study Intervention Supplies 
The following supplies will be provided to support use of the CoolSculpting Elite System: 
 Card: Provides treatment cycles and profiles for use with the system 
o Profiles define the number of timed segments of cooling  
o Each treatment cycle provides a single treatment 
 Coolant: The control unit requires an adequate supply of coolant (from the manufacturer). 
When the coolant level is low, the system displays a recoverable exception message. 
 Gelpad: Provides thermal contact between the applicator and the participant’s skin and 
mitigates minor variances in device-to-skin contact (note: this is a single-use item; use a 
new gelpad for each treatment). 
 Gel trap: Fits into the slot of the applicator and prevents the ingress of gel into the vacuum 
system (note: this is a single-use item, use a new gel trap for each treatment). 
 Pretreatment skin wipe: Use the pretreatment skin wipe to prepare the treatment site 
before applying a gelpad (note: this is a single-use item; use a new pretreatment skin wipe 
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 Securement system: minimizes movement of the applicator during treatment. 
 Liner (applies to Surface 150 applicator only): provides an interface between the gelpad 
and applicator.  
 Foam border (applies to Surface 150 applicator only): minimizes movement of the surface 
applicator during treatment. 
 Securement grip (applies to Surface 150 applicator only): minimizes movement of the 
surface applicator during treatment. 
 Support arm (applies to Curve 80 applicator only): intended for use in supporting the C80 
applicator head during treatment. 
For additional details, please see the CoolSculpting Elite user manual. 
6.3. 
Randomization and Blinding 
Blinding is not applicable to this open-label, nonrandomized study. Blinding will only be 
employed for photograph review by an independent panel of physician reviewers with expertise 
in the areas of dermatology and/or plastic surgery. 
At screening, after the participant has signed the ICF, the participant will be assigned a 
participant number sequentially based on the order in which the participant is screened into the 
study. This participant number will serve as the participant identification number on all study 
documents. 
6.4. 
Study Intervention Compliance 
When participants are treated at the study site, they will receive study intervention directly from 
the investigator or designee, under medical supervision. The date and time of each treatment 
session administered in the clinic will be recorded in the source documents and the eCRF.  
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 
A violation is any non-adherence to the protocol that may result in significant additional risk to 
the participant (eg, enrollment of a participant who does not meet the study criteria). A protocol 
violation can also be an event of non-adherence to GCPs that may impact participant safety (eg, 
failure to obtain proper consent before performing study procedures). Violations should be 
reported to the study sponsor and the IRB within 5 working days if they occur. 
Protocol Deviation 
A deviation is any non-adherence to study procedures that does not result in additional risk to the 
participant (eg, participant missed a visit). Protocol deviations are not required to be reported to 
the IRB; however, they must be recorded on the study eCRFs and may be reported and reviewed 
in conjunction with the progress report as part of the annual review process. 
 
 
  

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6.5. 
Concomitant Therapy 
All concomitant medications including vaccinations and procedures will be recorded on the 
eCRFs. Concomitant medications that are part of routine care are allowed and can be used during 
the study.  
6.5.1. 
Prohibited Therapy 
Diet pills or weight control supplements are not permitted (see Section 5.2, exclusion criterion 
# 8). Concomitant use of blood thinners, or any medication or dietary supplement that increases 
the risk of bruising such as fish oil, garlic, ginkgo, and vitamin E are not permitted. Participant 
on low dose aspirin for medical condition is excluded if the medical history suggests significant 
risk of bruising or bleeding per investigator’s clinical judgement. Concomitant use of surgical or 
nonsurgical fat reduction or body contouring procedures (eg, radiofrequency lipolysis, low-level 
laser therapy, high-intensity focused ultrasound, electromagnetic muscle stimulation) or 
injectable lipolytic agents during the course of the study are not permitted (see Section 5.2, 
exclusion criterion #1, 16).  
Additionally, at the discretion of the investigator, any topical creams or other medications that 
may impact the safety or effectiveness of the treatment are not permitted. 
6.6. 
Dose Modification 
For this device, the term “dose” refers to a CoolSculpting Elite treatment cycle. One or more 
treatment cycles will be delivered at the investigator’s discretion at each treatment session. 
Treatment cycles can be delivered simultaneously or sequentially at investigator discretion 
during a treatment session. Study site investigators will administer up to 2 treatment sessions to 
the treatment areas in accordance with the CoolSculpting Elite System User Manual.  
All participants entered into the study will receive a CoolSculpting treatment session (Visit 2) for 
the body areas selected for treatment. A participant may receive an additional treatment session 
at Visit 6 for body areas that were treated at Visit 2 as determined by the investigator. 
Guidance for the recommended/required range of treatment sessions and treatment cycles by 
body area, and overall, is presented in Table 6-1. 
 
 
  

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Table 6-1 
Guidance for Number of Treatment Sessions and Treatment Cycles Per Body Area 
Body Area 
Minimum 
Number of 
Treatment 
Sessions 
Maximum 
Number of 
Treatment 
Sessions 
Maximum 
Number of 
Treatment 
Cycles Per 
Treatment 
Session 
Maximum 
Total Number 
of Treatment 
Cycles 
Abdomen and 
flanks 
(Midsection) 
1 
2 
8 
16 
Upper Arms 
(inclusive of 
both left and 
right arm) 
0 
2 
4 
8 
Inner Thighs 
(inclusive of 
both left and 
right inner 
thigh) 
0 
2 
4 
8 
Outer Thighs 
(inclusive of 
both left and 
right outer 
thigh) 
0 
2 
4 
8 
Submental 
0 
2 
2 
4 
 
6.7. 
Intervention after the End of the Study 
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7. 
Discontinuation of Study Intervention and Participant 
Discontinuation/Withdrawal 
A premature discontinuation will occur if a participant who signs the ICF and receives study 
intervention ceases participation in the study, regardless of circumstances, before the completion 
of the protocol-defined study procedures. 
Notification of early participant discontinuation from the study and the reason for 
discontinuation will be made to the sponsor and will be clearly documented on the appropriate 
eCRF. 
Reasons for discontinuation from the study intervention and/or the study may include the 
following commonly used or other acceptable terms: 
Commonly Used Terms 
Other Acceptable Terms 
Adverse event 
Death 
Lost to follow-up 
Disease relapse 
Other 
Progressive disease 
Physician decision 
Technical problems 
Pregnancy 
 
Protocol deviation 
 
Screen failure 
 
Site terminated by sponsor 
 
Study terminated by sponsor 
 
Withdrawal by participant 
 
 
 
 
7.1. 
Discontinuation of Study Intervention 
During the treatment, study intervention may be discontinued due to significant discomfort, 
wellness issues, psychological issues, or the participant’s refusal to continue the treatment. 
7.2. 
Participant Discontinuation/Withdrawal from the Study 
 A participant may withdraw from the study at any time at his/her own request, or may be 
withdrawn at any time at the discretion of the investigator for safety, behavioral, 
compliance, or administrative reasons. This is expected to be uncommon. 
 At the time of discontinuing from the study, if possible, an early discontinuation visit 
should be conducted. The following data should be collected at the time of study exit and 
follow-up and for any further evaluations that need to be completed: 
o Date of discontinuation from the study 
o Reason for discontinuation/withdrawal from the study 
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o If discontinued due to AE or device deficiency, complete the relevant eCRF and 
SAE/Device forms 
o If discontinued due to pregnancy, complete the Pregnancy form 
o Clinical assessment of treated areas for potential AEs.  
o Participants withdrawing from the study will be encouraged to complete the same 
final evaluations as participants completing the study according to this protocol, 
particularly safety evaluations. The aim is to record data in the same way as for 
participants who completed the study. 
 The participant will be permanently discontinued both from the study intervention and 
from the study at that time. 
 If the participant withdraws consent for disclosure of future information, the sponsor may 
retain and continue to use any data collected before such a withdrawal of consent. 
 During the course of the study, it may be necessary to employ mitigation strategies to 
enable the investigator to ensure participant safety and continuity of care. Acceptable 
mitigation strategies are identified and included in Section 8. 
The investigator should contact the sponsor before discontinuing a participant from the study 
for a reason other than "planned per protocol," to ensure all acceptable mitigation steps have 
been explored. 
7.3. 
Lost to Follow-up 
A participant will be considered lost to follow-up if he or she repeatedly fails to return for 
scheduled visits and is unable to be contacted by the study site. 
The following actions must be taken if a participant fails to return to the clinic for a required 
study visit: 
 The site must attempt to contact the participant and reschedule the missed visit as soon as 
possible and counsel the participant on the importance of maintaining the assigned visit 
schedule and ascertain whether or not the participant wishes to and/or should continue in 
the study. 
 Before a participant is deemed lost to follow-up, the investigator or designee must make 
every effort to regain contact with the participant (where possible, 3 phone calls and, if 
necessary, a certified letter to the participant’s last known mailing address or local 
equivalent methods). These contact attempts should be documented in the participant’s 
medical record. 
 Should the participant continue to be unreachable, he/she will be considered to have 
withdrawn from the study.  
Discontinuation of specific sites or of the study as a whole is discussed in Section 10.1.8. 
 
 
  

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8. 
Study Assessments and Procedures 
 Study procedures and their timing are summarized in the SoA (Table 1-1). Protocol 
waivers or exemptions are not allowed. 
 Immediate safety concerns should be discussed with the sponsor immediately upon 
occurrence or awareness to determine if the participant should continue or discontinue 
study intervention. 
 Adherence to the study design requirements, including those specified in the SoA, is 
essential and required for study conduct. 
 All screening evaluations must be completed and reviewed to confirm that potential 
participants meet all eligibility criteria. The investigator will maintain a screening log to 
record details of all participants screened and to confirm eligibility or record reasons for 
screening failure, as applicable. 
 If the participant is not able to present in person to the site for the Study Exit visit due to 
national or regional travel restrictions, site closure as a result of these restrictions, or a 
participant declines an in‐clinic visit due to pandemic or natural disaster-related health 
concerns, a phone visit or alternate remote option is permitted. 
8.1. 
Effectiveness Assessments 
Effectiveness assessments will include the CSQ (6 versions), CGPQ, CPIQ, Participant 
Evaluation of Noticeable Improvement, independent photo review of 2D participant before and 
after photos, and 3D imaging to assess volumetric change of treated area, where available. 
 
 
Planned time points for all effectiveness assessments are provided in the SoA (Table 1-1).  
If travel restrictions or other changes in local regulations in the case of a pandemic or natural 
disaster prevent the participant from in-person visits, some study assessments may be conducted 
remotely or via phone or video conference. 
8.1.1. 
Patient-reported Outcomes 
Participant satisfaction, experience with procedure, and psychosocial impact data will be 
collected via paper questionnaires. These questionnaires have been developed and modified 
following additional qualitative research based on questions used in previous CoolSculpting 
studies. The questionnaires include the CSQ-Midsection (Section 10.6), CSQ-Overall 
(Section 10.7), CSQ-Upper Arms (Section 10.10), CSQ-Inner Thighs (Section 10.9), CSQ-Outer 
Thighs (Section 10.8), CSQ-Fat under chin (Section 10.11), CGPQ (Section 10.12), and CPIQ 
(Section 10.13). 
The CSQ-Midsection is a 2-item PRO instrument that measures participant satisfaction with 
results of CoolSculpting treatment and improvement in fit of clothing. CSQ-Overall and the CSQ 
specific for body area are 1-item PRO instruments that measure participant satisfaction with 
results of treatment when considering all body areas treated and individual body area, 
respectively. The CGPQ is a 5-item PRO instrument that assesses participant experience with the 
CoolSculpting treatment procedure. The questionnaire assesses participant comfort with the 

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treatment, likelihood of having another fat reduction procedure on a different part of the body, 
likelihood of recommending the procedure to a friend, and satisfaction with length of time to 
complete the procedure and achieve visible results. The CPIQ is a 5-item PRO instrument that 
assesses the psychosocial impact of CoolSculpting treatment, including self-confidence, feeling 
unhappy, feeling anxious, feeling bothered, and avoiding certain places or situations. 
An additional participant question (Participant Evaluation of Noticeable Improvement) will be 
administered 4 weeks after the first treatment session to assess whether participant starts to 
observe noticeable improvement with CoolSculpting Elite on the treated body areas at this earlier 
timepoint (Section 10.14).  
8.1.2. 
Photography 
A series of baseline and follow-up 2D photographs of the treatment areas will be taken using 
standardized set-up, lighting, and camera settings to ensure consistency. Where participant 
identifiable markings are seen within the treatment area, the images containing these markings 
will be masked for the purpose of publications but kept as part of the study record in the trial 
master file. The photographs may be cropped or re-sized for comparison purposes but otherwise 
will not be re-touched or altered in any way. Image files will be stored electronically by the 
sponsor in addition to Canfield Scientific (Parsippany, New Jersey, USA) and indexed by 
participant identifier. Participant photographs will be filed at the clinical site.  
Photos will be reviewed by a blinded independent panel of three physician reviewers with 
expertise in the areas of dermatology and/or plastic surgery. All photographs will be blinded by 
removing the participant identification and dates of the photographs. The reviewers will be 
presented with two series of photographs for each treatment area, the pre-treatment and the post-
treatment series, and asked to select the series representing the pre-treatment photographs. Post-
treatment images will correspond to 4-weeks post treatment session 1 and 12-weeks post final 
treatment session for the respective treated body areas. The order in which the photographs are 
presented will be randomized by participant. The order in which the pre- and post-treatment 
series are presented will also be randomized. The reviewers will be asked to select the baseline 
photograph series for each treatment area and record their data on individual data collection 
forms provided by the sponsor.  
Select study sites that have access to Canfield 3D imaging system will also capture 3D images 
for purposes of assessment of volumetric changes. The 3D imaging system will be used to obtain 
a 360 degree image of the body to allow quantification of the treated areas, specifically, 
volumetric changes from baseline. 
For additional detail regarding participant photography, please see documentation created by 
Canfield Scientific (imaging vendor). 
8.1.3. 
Other Assessments 
 
 
 
  
 
 
  

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If travel restrictions or other changes in local regulations in case of a pandemic or natural disaster 
prevent the participant from in-person visits, some study assessments may be conducted 
remotely or via phone or video conference.  
8.2. 
Safety Assessments 
Safety assessments will include pain assessments, AEs, SAEs, ADEs, SADEs, and unanticipated 
AEs or ADEs. 
Planned time points for all safety assessments are provided in the SoA (Table 1-1). If travel 
restrictions or other changes in local regulations in light of a pandemic or natural disaster prevent 
the participant from in-person visits, participant visits may be conducted via phone or video 
conference or at an alternative location. The investigator should contact the sponsor in advance, 
if possible, to discuss how vital signs should be handled. 
8.2.1. 
Pain Assessment Score 
At Visits 2 and 6 (treatment session 1 and 2 visits), participant pain will be assessed 10 minutes 
after starting the cooling treatment using a standard scale of 0 to10, 0 being no pain and 10 being 
the worst pain imaginable during the treatment cycle. If the pain score worsens during the 
treatment, this will also be recorded. If discomfort is intolerable, the treatment will be 
discontinued until the participant is comfortable and treatment, at the discretion of the 
investigator, can be resumed. Discomfort that results in either a temporary or permanent 
cessation of the treatment is to be documented as an AE (for additional detail, see Table 2-1 
[guidance for anticipated device effects] and Section 8.3 [AEs]). 
At Visits 3, 4, 5, 6, 7, and 8, 9 (all other study visits), participant pain will be assessed using a 
standard scale of 0 to 10, 0 being no pain and 10 being the worst pain imaginable. 
8.2.2. 
Treatment Site Assessment 
Immediately post treatment and prior to massage, the treatment site(s) will be examined for any 
epidermal, dermal, or subcutaneous findings (eg, blanching, erythema, bruising, swelling); 
alterations in sensation (eg, numbness, tingling). For additional detail, please see Table 2-1 
(guidance for anticipated device effects) and Section 8.3 (AEs). 
8.2.3. 
Other Laboratory Assessments 
Screening for pregnancy will be performed (urine β-HCG) for WOCBP and a negative result 
must be achieved before initiating treatment. 
8.2.4. 
Suicidal Ideation and Behavior Risk Monitoring 
Suicidal ideation and behavior risk monitoring are not applicable to this study. 
8.3. 
Adverse Events and Serious Adverse Events 
The definitions of an AE or SAE can be found in Section 10.5. The definitions of device-related 
safety events (ADEs and SADEs) can be found in Section 10.5. Device deficiencies are covered 
in Section 8.3.8. 
 
 
  

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AEs will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the 
participant's legally authorized representative). 
The investigator and any qualified designees are responsible for detecting, documenting, and 
recording events that meet the definition of an AE, ADE, SAE, SADE, and any other study-
specific terms as relevant and remain responsible for following up AEs that are serious, 
considered related to the study intervention or study procedures, or that caused the participant to 
discontinue the study (see Section 7). 
8.3.1. 
Time Period and Frequency for Collecting AE and SAE Information 
All AEs/SAEs will be recorded in the AE sections of the eCRF throughout the study 
periodTable 1-1 as observed or reported spontaneously by study participants. 
Medical occurrences that begin before the start of study intervention but after obtaining informed 
consent will be recorded in the AE section of the eCRF and will be considered pretreatment AEs. 
All SAEs will be recorded in the CRF and reported to the sponsor or designee using a SAE form 
immediately; and under no circumstance should this exceed 24 hours, as indicated in 
Section 10.5. The investigator will submit any updated SAE data to the sponsor within 24 hours 
of it being available. 
Investigators are not obligated to actively seek all AE or SAE information after conclusion of the 
study participation. However, if the investigator learns of any SAE, including a death, at any 
time after a participant has been discharged from the study, and he/she considers the event to be 
reasonably related to the study intervention or study participation, the investigator must promptly 
notify the sponsor. 
Pandemic infections should be captured as AEs. If the event meets the criteria for an SAE, then 
follow the SAE reporting directions per the protocol. 
8.3.2. 
Method of Detecting AEs and SAEs 
The method of recording, evaluating, and assessing causality of all AEs and SAEs and the 
procedures for completing and transmitting SAE reports are provided in Section 10.5. 
Care will be taken not to introduce bias when detecting all AEs and/or SAEs. Open-ended and 
non-leading verbal questioning of the participant is the preferred method to inquire about 
AE occurrences. 
8.3.3. 
Follow-up of All AEs and SAEs 
After the initial AE/SAE report, the investigator is required to proactively follow up with each 
participant at subsequent visits/contacts. All SAEs will be followed until resolution, stabilization, 
the event is otherwise explained, or the participant is lost to follow-up (as defined in 
Section 7.3). Further information on follow-up procedures is provided in Section 10.5. 
8.3.4. 
Regulatory Reporting Requirements for SAEs 
 Prompt notification by the investigator to the sponsor of an SAE is essential so that legal 
obligations and ethical responsibilities towards the safety of participants and the safety of 
a study intervention under clinical investigation are met.  
 
 
  

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 The sponsor has a legal responsibility to notify both the local regulatory authority and 
other regulatory agencies about the safety of a study intervention under clinical 
investigation. The sponsor will comply with country-specific regulatory requirements 
relating to safety reporting to the regulatory authority, IRB/IEC, and investigators.  
 An investigator who receives an investigator safety report describing an SAE or other 
specific safety information (eg, summary or listing of SAEs) from the sponsor will review 
and then file it along with other documents and will notify the IRB/IEC, if appropriate, 
according to local requirements. 
8.3.5. 
Pregnancy 
 Female participants will be instructed that known or suspected pregnancy occurring 
during the study should be confirmed and reported to the investigator. If a pregnancy is 
reported, the investigator should inform the sponsor within 24 hours of learning of the 
pregnancy using the Pregnancy Surveillance Form and should follow the procedures 
outlined in Section 10.4. 
 Abnormal pregnancy outcomes (eg, spontaneous abortion, fetal death, stillbirth, 
congenital anomalies, ectopic pregnancy) or genetic abnormalities (whether leading to an 
elective abortion or not) are considered SAEs and should follow the SAE reporting 
procedure outlined in Section 10.4. 
8.3.6. 
Protocol-specific AEs 
Not applicable. 
8.3.7. 
Adverse Events of Special Interest 
Not applicable. 
8.3.8. 
Medical Device Deficiencies 
Medical devices (CoolSculpting Elite System and CoolSculpting Elite applicators) are being 
provided for use in this study as the study intervention. In order to fulfill regulatory reporting 
obligations worldwide, the investigator is responsible for the detection and documentation of 
events meeting the definitions of device deficiency that occur during the study with such devices. 
The definition of a medical device deficiency can be found in Section 10.5. Examples of 
commonly reported device deficiencies are: warnings of thermal events/freeze detect, applicator 
errors, system shutting down spontaneously during the treatment, lost cycle error, burning smell 
or smoke from the device, and multiple (>1) pop offs with the same applicator. Single applicator 
pop off events should not be reported as a device deficiency. 
NOTE: Deficiencies associated with the definition of an AE/SAE will also follow the processes 
outlined in Section 8.3.3 and Section 10.5 of the protocol. 
Additional guidance for thermal events and pop offs is provided in Table 8-1. 
 
 
  

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Table 8-1 
Investigator guidance for thermal events and pop offs 
Event 
Guidance 
Thermal event 
Report all thermal events as device deficiencies. If a 
thermal event is associated with an AE (eg, burn), AE 
should also be reported. 
Pop off 
Multiple pop offs with the same applicator during the 
treatment session, irrespective of body area, should be 
reported as a device complaint. Single pop off during a 
treatment session should not be reported as a device 
complaint. 
 
8.3.8.1. 
Time Period for Detecting Medical Device Deficiencies 
Medical device events or malfunctions of the device that result in an incident will be detected, 
documented, and reported during all periods of the study in which the medical device is used. 
The method of documenting a medical device deficiency is provided in Section 10.5. 
8.3.8.2. 
Follow-up of Medical Device Deficiencies 
 AEs resulting from medical device deficiencies will be followed up.  
 Follow-up applies to all participants, including those who discontinue study intervention 
or the study. 
 The investigator is responsible for ensuring that follow-up includes any supplemental 
investigations as indicated to elucidate the nature and/or causality of the deficiency. 
 New or updated information will be recorded on the originally completed form with all 
changes signed and dated by the investigator. 
8.3.8.3. 
Prompt Reporting of Device Deficiencies to Sponsor 
 Device deficiencies will be recorded on the eCRF and reported to the sponsor within 
24 hours after the investigator determines that the event meets the protocol definition of a 
medical device deficiency. 
  If a device deficiency is associated with an SAE, the Medical Device Deficiency section 
on the SAE Form will be sent to the sponsor by email in addition to recording in the 
eCRF. If email is unavailable, then fax should be utilized. 
 Device deficiencies not associated with AEs will be recorded on the eCRF. A non-medical 
complaint form will be emailed to the sponsor as specified in Section 10.5. 
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8.3.8.4. 
Regulatory Reporting Requirements for Device Deficiencies 
 The investigator will promptly report all device deficiencies occurring with any medical 
device provided for use in the study in order for the sponsor to fulfill the legal 
responsibility to notify appropriate regulatory authorities and other entities about certain 
safety information relating to medical devices being used in clinical studies. 
 The investigator, or responsible person according to local requirements (eg, the head of 
the medical institution), will comply with the applicable local regulatory requirements 
relating to the reporting of device deficiencies to the IRB/IEC. 
8.4. 
Treatment of Overdose 
Treatment of overdose is not applicable to this study. 
8.5. 
Pharmacokinetics 
Pharmacokinetics is not applicable to this study. 
8.6. 
Pharmacodynamics 
Pharmacodynamic parameters are not applicable to this study. 
8.7. 
Genetics 
Genetics are not applicable to this study. 
8.8. 
Biomarkers 
Biomarkers are not applicable to this study. 
8.9. 
Immunogenicity Assessments 
Immunogenicity assessments are not applicable to this study. 
8.10. 
Health Economics  
Health economics are not applicable to this study. 
 
 
  

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9. 
Statistical Considerations 
The SAP will be developed and finalized before database lock and will describe the participant 
populations to be included in the analyses and procedures for accounting for missing, unused, 
and spurious data. This section is a summary of the planned statistical analyses. 
9.1. 
Statistical Hypotheses 
No statistical hypotheses are planned to be tested. 
9.2. 
Sample Size Determination 
The sample size will be based on providing reasonable precision for the estimate of the overall 
satisfaction rate. The estimate is based on overall satisfaction rates of the various body areas 
treated with CoolSculpting. 
Previous studies conducted on participants undergoing flank or abdominal fat reduction using the 
CoolSculpting device reported moderately high overall satisfaction rate. 
 
 
 
 
 A sample size of 96 participants would 
provide a two-sided 95% confidence interval (CI) with a width equal to 0.2 when the overall 
satisfaction rate is 63.9%. Exact (Clopper-Pearson) method from the commercial software PASS 
2008 was used for the sample size calculation. Allowing for a 12% attrition rate during the study 
period, approximately 110 participants will be needed for recruitment into the study.  
If local guidelines are in effect to prevent and mitigate the effects of a pandemic or natural 
disaster, it is possible that some participants may not be able to complete all site visits as 
indicated per protocol. To preserve the sample size calculation, additional participants may be 
enrolled if more than 12% of the participants fail to complete the CSQ-Midsection Item 1 at 12 
weeks after the final treatment. 
 
 
  

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9.3. 
Populations for Analyses 
The following populations are defined for statistical analyses: 
Population 
Description 
Enrolled 
The enrolled population will consist of all participants who sign 
the informed consent. 
Safety 
The safety population will consist of all enrolled participants 
who receive a cryolipolysis treatment cycle (started or 
completed). 
Evaluable 
 The evaluable population for the primary endpoint will 
consist of all treated participants who completed the 
cryolipolysis treatment plan to the midsection and who 
completed the CSQ-Midsection Item 1 at 12 weeks after the 
final treatment measured at Visit 8 (Week 12) for participants 
who receive 1 treatment session and at Visit 9 (Week 20) for 
participants who receive 2 treatment sessions.  
 The evaluable population for other effectiveness endpoints 
will consist of all treated participants who completed the 
cryolipolysis treatment plan for any other body areas 
(whether midsection treatment completed or not).
9.4. 
Statistical Analyses 
The SAP will be finalized prior to database lock and will include a more technical and detailed 
description of the statistical analyses described in this section. This section is a summary of the 
planned statistical analyses of the most important endpoints including primary, secondary, and 
exploratory endpoints. 
9.4.1. 
General Considerations 
In general, disposition data will be summarized for all enrolled participants, and participant 
baseline and characteristics data, and concomitant therapy data will be summarized descriptively 
for the safety population. The categorical variables will be presented with number and proportion 
while the continuous variables will be presented with mean, standard deviation, median, 
minimum, and maximum. 
The effectiveness analyses will be based on the evaluable population and the safety analyses will 
be based on the safety population. Baseline for effectiveness is defined as the last non-missing 
effectiveness assessment before the first treatment session. All CIs will be 2-sided 95% CIs, 
unless stated otherwise. 
9.4.1.1. 
Main Analytical Approach 
Participants who have reported “satisfied” and “very satisfied” will be categorized as ‘Satisfied.’ 
The counts and percentages will be summarized and the 95% CI on the percentage will be 
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9.4.2. 
Primary Effectiveness Endpoint 
The primary effectiveness endpoint is the proportion of participants with “satisfied” or “very 
satisfied” on the item 1 for the CSQ-Midsection, measured at Week 12 (Visit 8) for participants 
who receive 1 treatment session, or at Week 20 (Visit 9) for participants who receive 2 treatment 
sessions.  
9.4.3. 
Secondary Effectiveness Endpoints 
 The proportion of participants who received treatment to abdomen and flank and one or 
more additional body areas for treatment with “satisfied” or “very satisfied” on CSQ-
Overall Item 1 measured at Week 12 (Visit 8,12-week follow-up for participants who 
receive only 1 treatment session to all treated body areas) or at Week 20 (Visit 9, 12-week 
follow-up for participants who receive 2 treatment sessions to any or all treated body 
areas). 
 The proportion of participants with “satisfied” or “very satisfied” on individual treated 
body area (upper arms, inner thighs, outer thighs, fat under chin) CSQ Item 1 measured at 
Week 12 (Visit 8, 12-week follow-up for participants who receive only 1 treatment 
session) or at Week 20 (Visit 9,12-week follow-up for participants who receive 2 
treatment sessions) for the respective treated body areas. 
 Correct identification of baseline vs 12-week post-final treatment images of the treated 
body area(s) by at least two out of three blinded, independent reviewers for the following 
body areas: 
o Midsection 
o Upper arms 
o Inner thighs 
o Outer thighs 
o Submental area 
Success will be defined as at least 70% correct identification of the pre-treatment images. 
9.4.4. 
Exploratory Effectiveness Endpoints 
The analyses on the exploratory endpoints will include: 
 Psychosocial impact for non-invasive fat reduction in CoolSculpting participants using the 
CPIQ 
 Experience with fat reduction procedure using the CGPQ  
 Improvement in fit of clothing using CSQ-Midsection Item #2  
 Proportion of participants reporting noticeable improvement at 4-weeks post treatment 
session 1 
 3D volumetric change from baseline  
 
 
 

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 Correct identification of baseline vs 4-week post treatment session 1 images of the treated 
body area(s) by at least two out of three blinded, independent reviewers for the following 
body areas:  
o Midsection 
o Upper arms 
o Inner thighs 
o Outer thighs 
o Submental area 
Success will be defined as at least 70% correct identification of the pre-treatment images. 
Exploratory effectiveness endpoints will be summarized similar to the primary effectiveness 
endpoint with 95% CIs. 
9.4.5. 
Safety Analyses 
The numbers and proportions of participants with AEs, SAEs, ADEs, SADEs, and unanticipated 
AEs or ADEs will be summarized. Additional details pertaining to safety analyses will be 
provided in the SAP. 
9.4.5.1. 
Adverse Events 
An AE will be considered a TEAE if the AE began or worsened (increased in severity or became 
serious) on or after the date (and time, if known) of the first dose of study intervention.  
An AE will be considered a TESAE if it is a TEAE that additionally meets any SAE criterion. 
The number and percentage of participants with TEAEs will be tabulated by system organ class 
and preferred term and by system organ class, preferred term, and severity. 
The number and percentage of participants with TEAEs will be tabulated by system organ class 
and preferred term. 
If more than 1 AE is coded to the same preferred term for the same participant, the participant 
will be counted only once for that preferred term using the most severe and most related 
occurrence for the summarizations by severity and by relationship to study intervention. 
Summary tables will be provided for participants with TESAEs, TESADEs, TEADEs, and 
participants with TEAEs leading to discontinuation if these occurred in 5 or more participants. 
Listings of all AEs, SAEs, SADEs, ADEs, device deficiencies, and AEs leading to 
discontinuation by participant will be presented. 
9.4.5.2. 
Pain Assessment 
Pain assessment 10 minutes after starting the cryolipolysis treatment using a standard scale of 0 
(no pain) to10 (10 being the worst pain imaginable) will be summarized descriptively (number 
and percentage of participants who experienced pain level). 
9.4.5.3. 
Medical Device Deficiencies 
The numbers and proportions of participants with anticipated device effects will be summarized 
descriptively. 
 
 
  

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9.4.6. 
Subgroup Analyses 
Subgroup analyses will be defined and documented in the SAP. 
9.5. 
Interim Analyses 
No interim analyses are planned for this study. 
9.6. 
Data Monitoring Committee 
Not applicable. 
 
 
  

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10. 
Supporting Documentation and Operational Considerations 
 
 
  

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10.1. 
Appendix 1: Regulatory, Ethical, and Study Oversight 
Considerations 
10.1.1. 
Regulatory and Ethical Considerations 
 This study will be conducted in accordance with the protocol and with the following: 
o Consensus ethical principles derived from international guidelines including the 
CIOMS International Ethical Guidelines 
o Applicable ICH/ISO GCP Guidelines 
o Applicable laws and regulations 
 The protocol, protocol amendments, ICF, Investigator Brochure, and other relevant 
documents (eg, advertisements) must be submitted to an IRB/IEC by the investigator and 
reviewed and approved by the IRB/IEC before the study is initiated.  
 Any amendments to the protocol will require IRB/IEC approval before implementation of 
changes made to the study design, except for changes necessary to eliminate an immediate 
hazard to study participants. 
 The investigator will be responsible for the following: 
o Providing written summaries of the status of the study to the IRB/IEC annually or 
more frequently in accordance with the requirements, policies, and procedures 
established by the IRB/IEC 
o Notifying the IRB/IEC of SAEs or other significant safety findings as required by 
IRB/IEC procedures 
o Providing oversight of the conduct of the study at the site and adherence to 
requirements of 21 CFR, ICH guidelines, the IRB/IEC, European regulation 536/2014 
for clinical studies (if applicable), European Medical Device Regulation 2017/745 for 
clinical device research (if applicable), and all other applicable local regulations 
 During the course of the study, should it ever become necessary to remain home or to 
shelter-in-place per local, regional, or state orders, the sponsor will engage with study site 
staff in efforts to ensure the safety of participants, maintain protocol compliance, and 
minimize risks to the integrity of the study while trying to best manage participant 
continuity of care. This may include alternative methods for assessments (eg, phone 
contacts or virtual site visits) in agreement with the sponsor. In all cases, these alternative 
measures must be allowed by local regulations and permitted by IRB/IEC. Investigators 
should notify the sponsor if any urgent safety measures are taken to protect the 
participants against any immediate hazard. 
10.1.2. 
Financial Disclosure 
Investigators and sub-investigators will provide the sponsor with sufficient, accurate financial 
information as requested to allow the sponsor to submit complete and accurate financial 
certification or disclosure statements to the appropriate regulatory authorities. Investigators are 
 
 
  

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responsible for providing information on financial interests during the course of the study and for 
1 year after completion of the study. 
10.1.3. 
Informed Consent Process 
 The investigator or his/her representative will explain the nature of the study to the 
participant and answer all questions regarding the study. 
 Participants must be informed that their participation is voluntary. Participants will be 
required to sign a statement of informed consent that meets the requirements of 21 CFR 
50, local regulations, ICH guidelines, privacy and data protection requirements, and the 
IRB/IEC or study center. 
 The medical record must include a statement that written informed consent was obtained 
before the participant was enrolled in the study and the date the written consent was 
obtained. The authorized person obtaining the informed consent must also sign the ICF. 
 Participants must be re-consented to the most current version of the ICF(s) during their 
participation in the study. 
 A copy of the ICF(s) must be provided to the participant. 
 In the event of a pandemic or natural disaster, it is possible that additional protocol 
modifications not outlined in this protocol may become necessary. If this situation arises, 
in addition to the study informed consent, additional verbal consent may be obtained prior 
to these adaptations or substantial changes in study conduct in accordance with local 
regulations. Any verbal consent must be dated and documented in the source document. 
10.1.4. 
Data Protection 
 
Participants will be assigned a unique identifier by the sponsor. Any participant records or 
datasets that are transferred to the sponsor will contain the identifier only; any identifiable 
participant information will only be transferred in accordance with the signed Informed 
Consent provisions. 
 The participant must be informed that his/her personal study-related data will be used by 
the sponsor in accordance with local privacy and data protection laws. The level of 
disclosure must also be explained to the participant who will be required to give consent 
for their personal data to be used as described in the informed consent. 
 The participant must be informed that his/her medical records may be examined by 
Clinical Quality Assurance auditors or other authorized personnel appointed by the 
sponsor, by appropriate IRB/IEC members, and by inspectors from regulatory authorities. 
 
Management of privacy incidents relating to clinical trial participant personal data, as well 
as handling of data participant rights requests (if applicable), should be handled in 
accordance with the agreed-upon Clinical Trial Agreement (CTA) provisions. 
 
 
  

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10.1.5. 
Dissemination of Clinical Study Data 
 Study data and information may be published in nonpromotional, peer-reviewed 
publications either by or on behalf of the sponsor.  
 Clinical study reports, safety updates, and annual reports will be provided to regulatory 
authorities as required. 
 Company-sponsored study information and tabular study results will be posted on the 
United States National Institutes of Health's website www.ClinicalTrials.gov and other 
publicly accessible sites. 
10.1.6. 
Data Quality Assurance 
 All participant data relating to the study will be recorded on printed or electronic CRF 
unless transmitted to the sponsor or designee electronically (eg, laboratory data). The 
investigator is responsible for verifying that data entries are accurate and correct by 
physically or electronically signing the CRF. 
 The investigator must maintain accurate documentation (source data) that supports the 
information entered in the CRF. 
 The investigator must permit study-related monitoring, audits, IRB/IEC review, and 
regulatory agency inspections and provide direct access to source data documents. 
 Monitoring details describing strategy (eg, risk-based initiatives in operations and quality 
such as Risk Management and Mitigation Strategies and Analytical Risk-Based 
Monitoring), methods, responsibilities and requirements, including handling of 
noncompliance issues and monitoring techniques (central, remote, or on-site monitoring) 
are provided in the contracts. 
 The sponsor or designee is responsible for the data management of this study including 
quality checking of the data. 
 The sponsor assumes accountability for actions delegated to other individuals (eg, 
Contract Research Organizations). 
 Study monitors will perform ongoing source data verification to confirm that data entered 
into the CRF by authorized site personnel are accurate, complete, and verifiable from 
source documents; that the safety and rights of participants are being protected; and that 
the study is being conducted in accordance with the currently approved protocol and any 
other study agreements, ICH GCP, and all applicable regulatory requirements. 
 Records and documents, including signed ICFs, pertaining to the conduct of this study 
must be retained by the investigator as stated in the clinical trial agreement. No records 
may be destroyed during the retention period without the written approval of the sponsor. 
No records may be transferred to another location or party without written notification to 
the sponsor. 
 In the event of a pandemic or natural disaster, remote monitoring of data may be 
employed if allowed by the local regulatory authority, IRB/IEC, and the study site. 
 
 
  

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10.1.7. 
Source Documents 
 Source documents provide evidence for the existence of the participant and substantiate 
the integrity of the data collected. Source documents are filed at the investigator’s site. 
 Data reported on the CRF or entered in the eCRF that are transcribed from source 
documents must be consistent with the source documents or the discrepancies must be 
explained. The investigator may need to request previous medical records or transfer 
records, depending on the study. Also, current medical records must be available. 
 Definition of what constitutes source data can be found in Section 4.0 of ICH E6, GCP: 
Consolidated Guidance and records must be attributable, legible, contemporaneous, 
original, and accurate. 
10.1.8. 
Study and Site Start and Closure 
For the purpose of clinical trial registries, the study start date is the date on which the clinical 
study will be open for recruitment of participants. 
The first act of recruitment is first patient first visit and is considered the first act of recruitment 
and will be the study start date. 
The sponsor or designee reserves the right to close the study site or terminate the study at any 
time for any reason at the sole discretion of the sponsor. Study sites will be closed upon study 
completion. A study site is considered closed when all required documents and study supplies 
have been collected and a study-site closure visit has been performed. 
The investigator may initiate study-site closure at any time, provided there is reasonable cause 
and sufficient notice is given in advance of the intended termination. 
Reasons for the early closure of a study site by the sponsor or investigator may include but are 
not limited to: 
 Failure of the investigator to comply with the protocol, the requirements of the IRB/IEC 
or local health authorities, the sponsor's procedures, or GCP guidelines 
 Inadequate recruitment of participants by the investigator 
 Discontinuation of further study intervention development 
If the study is prematurely terminated or suspended, the sponsor shall promptly inform the 
Investigators, the IRBs/IECs, the regulatory authorities, and any contract research 
organization(s) used in the study of the reason for termination or suspension, as specified by the 
applicable regulatory requirements. The investigator shall promptly inform the participant and 
should assure appropriate participant therapy and/or follow-up. If a premature termination or 
suspension occurs, the sponsor shall remain responsible for providing resources to fulfill the 
protocol obligations and existing agreements for follow-up of participants enrolled in the study, 
and each investigator or authorized designee shall promptly inform enrolled participants, if 
applicable. 
 
 
  

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10.1.9. 
Publication Policy 
 The sponsor has proprietary interest in this study. Authorship and manuscript composition 
will reflect joint cooperation between multiple investigators and sites and sponsor 
personnel. Authorship will be established prior to the writing of the manuscript. 
 The sponsor will comply with the requirements for publication of study results. 
 Authorship will be determined by mutual agreement and in line with International 
Committee of Medical Journal Editors authorship requirements. 
10.1.10. 
Compliance with Protocol 
The investigator is responsible for compliance with the protocol at the investigational site. A 
representative of the sponsor will make frequent contact with the investigator and his/her 
research staff and will conduct regular monitoring visits at the site to review participant and 
study intervention accountability records for compliance with the protocol. Protocol deviations 
will be discussed with the investigator upon identification. Significant protocol deviations will be 
reported to the IRB/IEC according to the IRB/IEC’s reporting requirements including those that 
may be due to a pandemic or natural disaster. 
 
 
  

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10.2. 
Appendix 2: Abbreviations 
Abbreviation 
Definition 
ADE
adverse device effect
AE
adverse event
AESI 
BMI
Adverse event of special interest 
body mass index
CDISC
Clinical Data Interchange Standards Consortium
CE
Conformité Européenne
CGPQ
Cryolipolysis General Procedure Questionnaire
CI
confidence interval
CIOMS 
Declaration of Helsinki and Council for International Organizations of Medical 
Sciences
CONSORT
Consolidated Standards of Reporting Trials
CPIQ
Cryolipolysis Psychosocial Impact Questionnaire
CRF
case report form
eCRF
electronic case report form
CSQ
Cryolipolysis Satisfaction Questionnaire
FDA
Food and Drug Administration
FSH 
GCP
follicle-stimulating hormone 
Good Clinical Practice
HCG
human chorionic gonadotropin
HRT 
ICF
hormone replacement therapy 
informed consent form
ICH
International Council on Harmonisation
IEC
independent ethics committee
IPR
independent photography review
IRB
institutional review board
ISO
International Organization for Standardization
IUD 
IUS 
NCI 
PRO
Intrauterine device 
Intrauterine system 
National Cancer Institute 
patient-reported outcome
SADE
serious adverse device effect
SAE
serious adverse event
SAP
statistical analysis plan
SoA
schedule of activities
TEADE
treatment-emergent adverse device event
TEAE
treatment-emergent adverse event
TESADE
treatment-emergent serious adverse device event
TESAE
treatment-emergent serious adverse event
UADE
unanticipated adverse device effect
USADE
unanticipated serious adverse device effect
WOCBP
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10.3. 
Appendix 3: Standard Discontinuation Criteria 
This table provides participant discontinuation criteria for this protocol. CDISC terminology is 
used, and thus subject or patient is used instead of participant (as used elsewhere in this 
protocol). These terms are interchangeable. 
CDISC Submission Value 
CDISC Definition 
AE 
Any untoward medical occurrence in a patient or clinical 
investigation subject administered a pharmaceutical product and 
which does not necessarily have a causal relationship with this 
treatment. An AE can therefore be any unintended sign (including 
an abnormal laboratory finding), symptom, or disease temporally 
associated with the use of a medicinal (investigational) product, 
whether or not related to the medicinal (investigational) product. 
For further information, see the ICH Guideline for Clinical Safety 
Data Management: Definitions and Standards for Expedited 
Reporting (modified from ICH E2A) Synonyms: side effect, 
adverse experience. See also SAE, serious adverse experience. 
(CDISC glossary) 
Completed 
To possess every necessary or normal part or component or step; 
having come or been brought to a conclusion (NCI) 
Death 
The absence of life or state of being dead (NCI) 
Disease relapse 
The return of a disease after a period of remission 
Failure to meet randomization criteria 
An indication that the subject has been unable to fulfill/satisfy the 
criteria required for assignment into a randomized group 
Lack of efficacy 
The lack of expected or desired effect related to a therapy (NCI) 
Lost to follow-up 
The loss or lack of continuation of a subject to follow-up 
Non-compliance with study drug 
An indication that a subject has not agreed with or followed the 
instructions related to the study medication (NCI) 
Other 
Different than the one(s) previously specified or mentioned (NCI) 
Physician decision 
A position, opinion, or judgment reached after consideration by a 
physician with reference to subject (NCI) 
Pregnancy 
Pregnancy is the state or condition of having a developing embryo 
or fetus in the body (uterus), after union of an ovum and 
spermatozoon, during the period from conception to birth (NCI). 
Progressive disease 
A disease process that is increasing in extent or severity (NCI) 
Protocol deviation 
An event or decision that stands in contrast to the guidelines set out 
by the protocol (NCI) 
Recovery 
A healing process and/or an outcome implying relative health. The 
term is typically used in the context of direct and indirect effects of 
sickness or injury (NCI) 
Screen failure 
The potential subject who does not meet one or more criteria 
required for participation in a trial 
Site terminated by sponsor 
An indication that a clinical study was stopped at a particular site 
by its sponsor (NCI) 
Study terminated by sponsor 
An indication that a clinical study was stopped by its sponsor 
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CDISC Submission Value 
CDISC Definition 
Technical problems 
A problem with some technical aspect of a clinical study, usually 
related to an instrument (NCI) 
Withdrawal by parent/guardian 
An indication that a study participant has been removed from the 
study by the parent or legal guardian 
Withdrawal by subject 
An indication that a study participant has removed itself from the 
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10.4. 
Appendix 4: Contraceptive Guidance and Collection of Pregnancy 
Information 
10.4.1. 
Definitions 
10.4.1.1. 
Woman of Childbearing Potential 
A woman is considered fertile following menarche and until becoming postmenopausal unless 
permanently sterile (see below). 
If fertility is unclear (eg, amenorrhea in adolescents or athletes) and a menstrual cycle cannot be 
confirmed before first dose of study intervention, additional evaluation should be considered. 
Women in the following categories are not considered WOCBP 
1. Premenarchal 
2. Premenopausal female with one of the following: 
 Documented hysterectomy 
 Documented bilateral salpingectomy 
 Documented bilateral oophorectomy 
For individuals with permanent infertility due to an alternate medical cause other than the above 
(eg, mullerian agenesis, androgen insensitivity), investigator discretion should be applied to 
determining study entry. 
Note: Documentation can come from the site personnel’s review of the participant’s medical 
records, medical examination, or medical history interview. 
3. Postmenopausal female 
 A postmenopausal state is defined as no menses for 12 months without an alternative 
medical cause. 
o A high FSH level in the postmenopausal range may be used to confirm a 
postmenopausal state in women not using hormonal contraception or HRT. 
However, in the absence of 12 months of amenorrhea, confirmation with more than 
1 FSH measurement is required. 
 Females on HRT and whose menopausal status is in doubt will be required to use one 
of the non-estrogen hormonal highly effective contraception methods if they wish to 
continue their HRT during the study. Otherwise, they must discontinue HRT to allow 
confirmation of postmenopausal status before study enrollment. 
10.4.2. 
Contraception Guidance 
Female Participants 
Female participants of childbearing potential are eligible to participate if they agree to use a 
highly effective or acceptable method of contraception consistently and correctly as described in 
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Table 10-1 
Highly Effective and Acceptable Contraceptive Methods 
Highly Effective Contraceptive Methods That Are User Dependenta 
Failure rate of < 1% per year when used consistently and correctly 
Combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of 
ovulationb 
 
Oral 
 
Intravaginal 
 
Transdermal
Progestogen-only hormonal contraception associated with inhibition of ovulation 
 
Oral 
 
Injectable
Highly Effective Methods That Are User Independenta 
 
Implantable progestogen-only hormonal contraception associated with inhibition of ovulationb 
 
IUD 
 
IUS 
 
Etonogestrel implant (ie, Nexplanon®) 
 
Bilateral tubal occlusion (eg, Essure®, bilateral tubal ligation) 
 
Intrauterine copper contraceptive (ie, ParaGard®)
Vasectomized Partner 
A vasectomized partner is a highly effective contraception method provided that the partner is the sole male 
sexual partner of the WOCBP and the absence of sperm has been confirmed. If not, an additional highly effective 
method of contraception should be used.
Sexual Abstinence 
Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual 
intercourse during the entire period of risk associated with the study intervention. The reliability of sexual 
abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of 
the participant.
Acceptable Methods  
Acceptable birth control methods that result in a failure of more than 1% per year include:
 
Progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of 
action 
 
Male or female condom with or without spermicide 
 
Cap, diaphragm, or sponge with spermicide 
 
Nonhormonal intrauterine device 
A combination of male condom with either cap, diaphragm, or sponge with spermicide (double-barrier methods) 
are also considered acceptable, but not highly effective, birth control methods.
a Typical use failure rates may differ from those when used consistently and correctly. Use should be consistent 
with local regulations regarding the use of contraceptive methods for participants participating in clinical studies. 

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10.4.3. 
Pregnancy Testing 
Pregnancy testing will be performed (urine β-HCG) for WOCBP and a negative result must be 
achieved before initiating treatment. 
Collection of Pregnancy Information 
Female participants who become pregnant 
 The investigator will collect pregnancy information on any female participant who 
becomes pregnant while participating in this study. The initial information will be 
recorded on the appropriate form and submitted to the sponsor within 24 hours of learning 
of a participant's pregnancy. 
 The participant will be followed to determine the outcome of the pregnancy. The 
investigator will collect follow-up information on the participant and the neonate and the 
information will be forwarded to the sponsor. Generally, follow-up will not be required for 
longer than 6 to 8 weeks beyond the estimated delivery date. Any termination of 
pregnancy will be reported, regardless of fetal status (presence or absence of anomalies) 
or indication for the procedure. 
 While pregnancy itself is not considered to be an AE or SAE, any pregnancy complication 
will be reported as an AE or SAE. 
 Abnormal pregnancy outcomes (eg, spontaneous abortion, fetal death, stillbirth, 
congenital anomalies, ectopic pregnancy) or genetic abnormalities (whether leading to an 
elective abortion or not) are always considered to be SAEs and will be reported as such. 
 Any post-study pregnancy related SAE considered reasonably related to the study 
intervention by the investigator will be reported to the sponsor as described in 
Section 8.3.4. While the investigator is not obligated to actively seek this information in 
former study participants, he or she may learn of an SAE through spontaneous reporting. 
 
Any female participant who becomes pregnant while participating in the study will be 
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 The investigator may change his/her opinion of causality in light of follow-up 
information and send an SAE follow-up report with the updated causality assessment. 
 The causality assessment is one of the criteria used when determining regulatory 
reporting requirements. 
Assessment of Device Relationship 
Relationship to a device refers to a determination of the relationship (if any) between an AE 
and the device. A causal relationship is present if the investigator determines that there is a 
reasonable possibility that the AE may have been caused by the device. An AE could be 
considered procedure-related when, in the judgment of the investigator, it is reasonable to 
believe that the event is associated with the procedure, regardless of the relationship to the 
study device. Procedure-related causes that contribute to the occurrence of the event can be 
attributed to other products, surgical techniques, or medications required specifically for the 
procedure. Every effort will be made by the investigator to assess the relationship of the AE, if 
any, to the device and/or study procedure. Causality should be assessed using the categories 
presented in the following table: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
  
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
  
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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10.6. 
 
 
 
 
 
 
 
 
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
  
  
 
  
 
 
  
 
 
  
 
 
 
 
 
  

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10.7. 
  
 
 
 
 
 
 
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
 
  

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10.8. 
 
 
 
 
 
 
 
 
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
 
  

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10.9. 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
 
  

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10.10. 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
 
  

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10.11. 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
 
  

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10.12. 
 
 
 
 
 
 
 
 
  
 
 
  
 
 
  
 
 
  
 
  
 
 
 
  
 
 
  
 
 
  
 
 
  
  
 
 
  
 
 
  
 
 
 
  

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10.13. 
 
 
 
 
 
 
 
 
 
  
  
 
  
  
 
  
  
 
  
  
 
  
 
 
 
 
  
  
 
  
  
 
  
 
 
  
 
 
  
 
 
 
  

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10.14. 
  
 
  
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
 
 
 
  

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10.15. 
 
 
 
 
  
 
 
  
 
 
 
 
 
 
 
  
 
  
 
 
 
 
  
 
 
 
 
 
 
  
 
 
  
 
 
  
 
 
  
 
  
 
 
  
  
 
 
  

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10.16. 
Appendix 16: Investigator Signature Page 
Protocol Title: 
CoolSculpting® Elite: Multi-Country Study to Evaluate Patient 
Satisfaction for Non-Invasive Fat Reduction in Abdomen, Flanks, Upper 
Arms, Inner Thighs, Outer Thighs, and Submental Area 
 
Protocol Number: 
MED-MA-PLS-0647 
Confidentiality and Current GCP Compliance Statement 
I, the undersigned, have reviewed this protocol (and amendment[s], if applicable), including 
appendices, and I will conduct the study as described in compliance with this protocol (and 
amendments), GCP, and relevant regulatory guidelines. 
Once the protocol has been approved by the IEC/IRB, I will not modify this protocol without 
obtaining prior approval of Allergan and of the IEC/IRB. I will submit the protocol amendments 
and/or any ICF modifications to Allergan and IEC/IRB, and approval will be obtained before any 
amendments are implemented. 
I understand that all information obtained during the conduct of the study with regard to the 
participants’ state of health will be regarded as confidential. No participants’ names will be 
disclosed. All participants will be identified by assigned numbers on all CRFs, laboratory 
samples, or source documents forwarded to the sponsor. Clinical information may be reviewed 
by the sponsor or its agents or regulatory agencies. Agreement must be obtained from the 
participant before disclosure of participant information to a third party. 
Information developed in this clinical study may be disclosed by Allergan, to other clinical 
investigators, regulatory agencies, or other health authority or government agencies as required. 
 
 
 
Investigator Signature 
 
Date 
 
 
 
Printed Name 
 
 
 
 
 
Institution 
 
 
 

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10.17. 
References 
Beacham BE, Cooper PH, Buchanan CS, Weary PE. Equestrian cold panniculitis in women. 
Arch Dermatol. 1980;116(9):1025-1027. 
Bernstein EF, Bloom JD, Basilavecchio LD, Plugis JM. Non-invasive fat reduction of the flanks 
using a new cryolipolysis applicator and overlapping, two-cycle treatments. Lasers Surg Med. 
2014;46(10):731-735. 
Epstein EH Jr, Oren ME. Popsicle panniculitis. N Engl J Med. 1970;282(17):966-967. 
Manstein D, Laubach H, Watanabe K, Farinelli W, Zurakowski D, Anderson RR. Selective 
cryolysis: a novel method of non-invasive fat removal. Lasers Surg Med. 2008;40(9):595-604. 
Zelickson B, Egbert BM, Preciado J, Allison J, Springer K, Rhoades RW, Manstein D. 
Cryolipolysis for noninvasive fat cell reduction: initial results from a pig model. Dermatol Surg. 
2009;35(10):1462-1470.