CONtrolled Focal Fibrous Band Release Method Study
Phase: NA
Conditions: Cellulite
Sponsor: Revelle Aesthetics, Inc

CM-276, V1 
Abbreviated CONFFIRM Protocol 
 
CONFIDENTIAL 
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CONtrolled Focal Fibrous Band Release Method Study  
 
(CONFFIRM Study) 
 
Abbreviated Protocol 
 
 
 
Protocol Version Number: CP-10472, V6 
April 29, 2021 
 
 
 
Sponsored by: 
Revelle Aesthetics Inc., (Formerly NC8, Inc.) 
2570 W. El Camino Real, Suite 310, Mountain View, CA 
94040 
 
 
 
 

CM-276, V1 
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Table of Contents 
1 
PROTOCOL SYNOPSIS .......................................................................................... 5 
2 
STUDY POPULATION ............................................................................................. 7 
2.1 
Inclusion Criteria ............................................................................................................... 7 
2.2 
Exclusion Criteria .............................................................................................................. 7 
3 
STUDY PROCEDURES ............................................................................................ 8 
3.1 
Schedule of Events ............................................................................................................ 8 
4 
Questionnaire Categories ........................................................................................ 11 
4.1 
Medical Photography ...................................................................................................... 11 
4.1.1 
Study Photography ................................................................................................... 12 
4.2 
Independent Image Evaluation ........................................................................................ 12 
4.2.1 
Selection and Qualification of Evaluators ................................................................ 12 
4.2.2 
Frequency and Order of Evaluations ........................................................................ 12 
4.2.3 
Study Image Evaluation ........................................................................................... 13 
4.2.4 
Blinding plan – unblinding plan ............................................................................... 13 
4.2.5 
Cellulite Severity Score (CSS) ................................................................................. 14 
4.2.6 
Global Aesthetic Improvement Scale (GAIS) Evaluation ....................................... 14 
5 
CLINICAL EVENTS ............................................................................................... 15 
5.1 
Adverse Event Types and Definitions ............................................................................. 15 
5.1.1 
Adverse Event .......................................................................................................... 15 
5.1.2 
Serious Adverse Events (SAEs) ............................................................................... 15 
5.1.3 
Anticipated Adverse Events ..................................................................................... 16 
5.1.4 
Unanticipated Adverse Events ................................................................................. 16 
5.1.5 
Adverse Device Effect (ADE) ................................................................................. 17 
5.2 
Not Considered Adverse Event ....................................................................................... 17 
5.3 
Adverse Event Assessment.............................................................................................. 17 
5.3.1 
Adverse Event Evaluation and Categorization ......................................................... 17 
5.3.2 
Severity (Grades) ..................................................................................................... 18 
5.3.3 
Determination of the Relationship (Causality) ......................................................... 18 
5.4 
Reporting Requirements for SAEs or UADEs ................................................................ 19 
5.5 
Medical Treatment for AEs, SAEs and UADEs.............................................................. 19 
5.6 
Medical Monitor .............................................................................................................. 20 
6 
STATISTICAL METHODS ................................................................................... 20 
6.1 
Statistical and Analytical Plans ....................................................................................... 20 

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6.1.1 
Analysis Cohorts ...................................................................................................... 20 
6.2 
Safety Analysis ................................................................................................................ 21 
6.2.1 
Primary Safety Endpoint .......................................................................................... 21 
6.2.2 
Adverse Events......................................................................................................... 21 
6.3 
Primary Effectiveness Endpoint ...................................................................................... 21 
6.3.1 
Endpoint Definition .................................................................................................. 21 
6.3.2 
Hypothesis ................................................................................................................ 22 
6.3.3 
Analysis cohort......................................................................................................... 22 
6.3.4 
Statistical Analyses .................................................................................................. 22 
6.3.5 
Definition of Success ............................................................................................... 23 
6.3.6 
COVID-19 Contingency .......................................................................................... 23 
6.3.7 
Determination of Sample Size ................................................................................. 23 
6.3.8 
Poolability Analysis ................................................................................................. 23 
6.3.9 
Covariate Adjustment and Exploration .................................................................... 23 
6.4 
Handling Missing Data .................................................................................................... 24 
6.5 
Secondary Effectiveness Endpoints ................................................................................ 24 
6.5.1 
Hierarchical testing .................................................................................................. 24 
6.5.2 
Secondary Endpoint 1 (Inferential) – CSS Responders at 3 months ........................ 25 
6.5.3 
Power calculation:  The sample size for this trial is based upon the primary 
endpoint.  With an observed performance of 81% responder in initial pilot data and expected 
sample size of 54, a one-sided alpha of 0.025 and performance goal of 60%, there will be > 
90% power to test this hypothesis.Secondary Endpoint 2 (Inferential) – Improvement in 
GAIS at 3 months ................................................................................................................... 25 
6.5.4 
Secondary Endpoint 3 (Inferential) – Patient Satisfaction at 3 months ................... 26 
6.5.5 
Secondary Endpoints (Descriptive) .......................................................................... 26 
6.6 
Additional Outcome Measures ........................................................................................ 27 
6.6.1 
Learning Curve Analysis .......................................................................................... 27 
6.7 
Exploratory Analysis ....................................................................................................... 27 
6.8 
Participant Accountability ............................................................................................... 27 
6.9 
Other Study Summaries ................................................................................................... 28 
6.10 
Data Collection and Electronic Case Report Form (eCRF) Completion ..................... 28 
7 
INVESTIGATOR RESPONSIBILITIES .............................................................. 28 
7.1 
Investigator Files ............................................................................................................. 28 
7.2 
Institutional Review Board Protocol/ Human Research Ethics Committee and Informed 
Consent Approvals ..................................................................................................................... 29 
7.3 
Protocol Deviations ......................................................................................................... 29 
7.3.1 
Investigator Reporting .............................................................................................. 30 
7.4 
Study Devices .................................................................................................................. 30 

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7.4.1 
Labeling ................................................................................................................... 30 
7.4.2 
Ordering and Storing Study Device ......................................................................... 30 
7.4.3 
Study Device Accountability ................................................................................... 30 
7.4.4 
Device Disposal or Return ....................................................................................... 31 
7.5 
Financial Disclosure ........................................................................................................ 31 
7.6 
Participant Privacy .......................................................................................................... 31 
8 
SPONSOR RESPONSIBILITIES .......................................................................... 32 
8.1 
General Duties ................................................................................................................. 32 
8.2 
Selection of Sites and Investigators ................................................................................. 32 
8.3 
Site Training .................................................................................................................... 32 
8.4 
Device Training ............................................................................................................... 32 
8.5 
Monitoring ....................................................................................................................... 32 
8.5.1 
Site Monitoring Procedures ...................................................................................... 32 
8.6 
On-Site Audits and Inspections ....................................................................................... 33 
8.7 
Protocol Amendments ..................................................................................................... 34 
8.8 
Submitting Reports .......................................................................................................... 34 
8.9 
Maintaining Records ....................................................................................................... 34 
8.10 
Confidentiality ............................................................................................................. 34 
9 
TRIAL TERMINATION ......................................................................................... 34 
10 
PUBLICATION POLICY .................................................................................... 35 
 

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1 
PROTOCOL SYNOPSIS 
Title 
Controlled Focal Fibrous Band Release Method 
Short Title 
CONFFIRM 
IDE No. 
G200312 
Study Device 
Avéli (formerly Deployable Hook) 
Intended Use 
The intended use of the subject device is to separate tissue (fibrous septa) and 
provide transillumination for anatomical navigation. 
Proposed Indications 
for Use 
Avéli is indicated for temporary reduction in the appearance of cellulite in the 
buttocks and thigh areas of adult females as supported by clinical data 
demonstrating benefits through three months of observation.   
Study Design 
Single arm, multicenter, open label pivotal study 
Study Objective 
Demonstrate safety and effectiveness of the deployable hook in reducing the 
appearance of cellulite 
Study Duration 
1-year participant follow-up  
Number of Sites 
7 sites in United States and 2 sites in Australia  
Enrollment 
74 participants, including 6 roll-in patients  
Primary Effectiveness 
Endpoint 
Mean change (improvement) from baseline in the Cellulite Severity Scale (CSS) 
1 is ≥1 point at 3 months. 
Primary Safety 
Measure 
Absence of device related Serious Adverse Events (SAEs) directly attributable 
to the device at 30 days. 
 
1 CSS = CSS-A (Number of Evident Depressions) + CSS-B (Average Depth of Depressions) – 1  

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Secondary Inferential 
Effectiveness 
Endpoints 
 
The CSS score at 3 months. A participant is considered a responder if 
the 3 month CSS score has improved by at least 1 point from the 
baseline CSS score. 
 
The GAIS score at 3 months as determined by blinded and independent 
evaluators. A participant is considered improved if the GAIS assessment 
is improved (1), much improved (2) or very much improved (3). 
 
The patient satisfaction assessment measured at 3 months. Patient 
satisfaction is collected using an evenly balanced scale with 5 
categories: very satisfied, satisfied, neither satisfied nor dissatisfied, 
dissatisfied, very dissatisfied. The general “Satisfied” category is 
defined as those that indicated they were satisfied or very satisfied with 
their outcome. 

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2 
STUDY POPULATION 
2.1 
INCLUSION CRITERIA 
Participants eligible for inclusion in this study must fulfill the following criteria: 
1. Female age 21 to 55 years 
2. Moderate to severe cellulite in the thighs and/or buttocks2, with a minimum of 5 
depressions of moderate (or more severe) depth    
3. Cellulite Severity Score (CSS) ≥ 3  
4. Will commit to not trying any other cellulite treatments through 12-month follow-up 
5. Ability and willingness to provide written informed consent in English 
6. Negative urine pregnancy test  
2.2 
EXCLUSION CRITERIA  
Participants will be excluded from this study if they meet any of the following criteria: 
1. In the last 12 months, underwent a cellulite procedure on the buttocks and/or thighs    
2. Previous liposuction on the buttocks and/or thighs 
3. Intends to lose greater than 10% of body weight during study follow-up 
4. Greater than 10% increase or decrease in body weight within the last six (6) months or 
any history of weight loss greater than 60 kg/132 lb.  
5. Physician assessed severe skin laxity, flaccidity, and/or sagging in targeted regions.  
6. Has taken any of the following within 14 days of study procedure: 
a. NSAIDs (aspirin, ibuprofen, naproxen); or,  
b. Vitamin E, herbal teas or dietary supplements (e.g. Gingko Biloba, Willow Bark) 
7. Intends to take the following medications within 14 days after procedure 
a. NSAIDs (aspirin, ibuprofen, naproxen); or,  
b. Vitamin E, herbal teas or dietary supplements (e.g. Gingko Biloba, Willow Bark) 
8. Known clotting defects, bleeding disorders, or severe anemia (≥ Grade 3, NCI3) 
9. Active dermatologic condition including rash, eczema, psoriasis, or skin cancer in target 
regions 
10. BMI ≥30.0 
11. Evidence of an active infection or fever greater than 38oC/100.4oF on day of index 
procedure.  
12. Current or recent smoker, or use of nicotine (within 6 months) 
13. History of cardiopathy, hypertension, diabetes or hypoglycemia, or pneumopathy 
 
2 Participants can be treated unilaterally or bilaterally 
3 ≤ 7.9 g/dL hemoglobin 

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14. History of peripheral vascular disease, large varicose veins, pedal edema, reduced lower 
extremity pulses, personal history of connective tissue disease, or family history of Ehlers 
Danlos disease 
15. Planning to get pregnant in next year, or currently pregnant or breastfeeding 
16. Has atrophic scars, or a history of atrophic scars or keloids 
17. Any participant who is currently participating or considering participation in any other 
research of an investigational drug or device which may overlap study follow-up 
18. Any condition(s) that in the Investigator’s opinion, might indicate the participant to be 
unsuitable for the study, such as co-existing psychiatric illness.  
19. Unable to complete data entry into patient health questionnaires due to unwillingness, no 
computer or internet ready device, or, cannot gain access to internet, or, does not speak 
English. 
3 
STUDY PROCEDURES 
3.1 
SCHEDULE OF EVENTS   
The summary of required visits and testing is provided in Table 1.  

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Table 1 Schedule of Events   
       
Protocol Requirements        
Screening / 
Baseline 
 
Pre-
Procedure 
Procedure 
24-hours 
7 Days 
1 Month4 
3 Months5 
6 Months 
12 months 
 
 
Day 0 
Day 0 
18-48 hours 
Remote 
± 3 days 
Remote or 
Clinic 
+ 2 weeks 
Clinic 
-2 weeks-+ 4 weeks 
Clinic 
± 4 weeks 
Clinic 
± 4 weeks 
Clinic 
Informed Consent 6  
X 
 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
 
Inclusion/Exclusion Criteria  
X 
X 
 
 
 
 
 
 
 
Medical and surgical history 
X 
 
 
 
 
 
 
 
 
BMI 
X 
 
 
 
 
X 
X 
X 
X 
Participant Reported 
Questionnaires7: 
  
 
 
 
 
 
 
 
  
Procedure Goals 
X 
 
 
 
 
 
X 
X 
X 
Recovery8 
 
 
 
X 
If indicated
If indicated
If indicated
If indicated
If indicated
 Discomfort and Soreness, Pain 
VAS9 
 
 
X10 
X 
X 
X 
X 
If indicated 
If indicated 
QOL and Satisfaction 
 
 
 
 
 
 
X 
X 
X 
Participant Symptom Diary11 
 
 
 
X 
X 
X 
 
 
 
 
4 30 days is also referred to as 1-month visit 
5 For purposes of scheduling, the protocol definition of a month is 30 days. Week refers to 7 days.  
6 Prior to any study specific procedures; participant may need to be re-consented if protocol is amended.  
7 Participants should complete via their private ePRO login with the exception of Pain VAS at procedure and Discomfort, Soreness Pain VAS questionnaires if indicated after 3M visit.  
8 Administered until participant returns to normal activities. 
9 Daily completion of Discomfort, Soreness and Pain VAS through 7 days post-procedure. 
10 Only VAS Numeric Pain Distress Scale administered during and after the procedure (before discharge).  
11 Participants to complete weekly, four (4) times through 28 days post-procedure.  

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Protocol Requirements        
Screening / 
Baseline 
 
Pre-
Procedure 
Procedure 
24-hours 
7 Days 
1 Month4 
3 Months5 
6 Months 
12 months 
 
 
Day 0 
Day 0 
18-48 hours 
Remote 
± 3 days 
Remote or 
Clinic 
+ 2 weeks 
Clinic 
-2 weeks-+ 4 weeks 
Clinic 
± 4 weeks 
Clinic 
± 4 weeks 
Clinic 
Physical Exam 12  
X 
 
 
 
 
 
 
 
 
Standard Photography 
 If done
 
 
 
If Clinic13 
 
 
 
 
Study Photography  
 
X14 
 
 
  
X 
X 
X 
X 
Marking the insertion sites and 
depressions to be treated 
 
X 
 
 
 
 
 
 
 
Pregnancy test15 
 
X 
 
 
 
 
 
 
 
Vitals 
 
X 
 
 
 
 
 
 
 
Deployable Hook Procedure 
 
 
X 
 
 
 
 
 
 
Con. Medications/ Treatments 
Captured and Updated From -30 days to Study Exit 
Adverse Event16 Assessment 
 
 
Monitored throughout study 
Study Exit 
 
 
 
 
 
 
 
 
X 17 
Independent Evaluators 
CSS A and B 
 
 
 
 
 
 
X 
X 
X 
Blinded ‘After’  
Assessment 
 
 
 
 
 
 
X 
X 
X 
GAIS 
 
 
 
 
 
 
X 
X 
X 
 
12 Includes physical examination on target areas for severity assessments in laxity and depressions, and exclusionary abnormalities. In follow-up, this activity is covered under AE 
assessment. 
13 If visit done at clinic, photos per the clinic standard of care should be captured 
14 Must be done before and after markings and always before the procedure 
15 Required only for fertile, pre-menopausal women.       
16 Adverse Event collection starts when the Deployable Hook procedure is initiated.  At each visit, ongoing AEs should be assessed along with participant interview/examination for 
potential new AEs 
17 At completion of 1 year, or earlier if participant withdrawn 

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4 
QUESTIONNAIRE CATEGORIES 
The set of participant questionnaires developed for this study address a range of clinically 
important issues (Table 2) including behavioral/perception impact, procedure and recovery 
experience, along with cellulite treatment results satisfaction and expectations.  The time to 
complete the questionnaires is  <20 minutes.  
Table 2 Participant Questionnaire Concepts  
Concept 
Time to complete 
When to complete  
1. Procedure objectives /goals 
<5 minutes 
Baseline, 3, 6, and 12 months 
2. Recovery duration 
1 minute 
Every visit until return to pre-
procedure activity is reported 
3.
Soreness/discomfort in 
recovery 
1 minute 
Daily for 7 days post-
procedure; 30 day, 3 month, 
and thereafter will be 
administered by site if 
indicated* 
4.
VAS Numerical Pain Distress 
Scale  
1 minute 
During and after the procedure 
(before discharge) and daily 
for 7 days post-procedure; 30 
day, 3 month, and thereafter 
will be administered by site if 
indicated* 
5. Behavioral impact of cellulite  <5 minutes 
3, 6 and 12 months 
6.
Outcome satisfaction and 
procedure experience 
1 minute 
3, 6, and 12 months 
7. Participant symptom diary 
3 minutes 
Once a week for the first 4 
weeks after index procedure.  
* Administered by study personnel, will not be in ePRO 
4.1 
MEDICAL PHOTOGRAPHY 
Digital photography will be utilized in the assessment of the primary endpoint and other efficacy 
measurements at the intervals outlined in Table 1. The evaluations will occur in advance of each 
planned interim analysis as outlined in Table 3, and will follow the order outlined to ensure no 
pre-mature unblinding of the before/after that is required for the GAIS evaluation.    
The medical photography which the independent evaluators will use, with a prescribed 
methodology, is distinguished here with name “Study Photography”, is described below.   

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Photographs captured outside of the study photography protocol, using methods normally used if 
not in a trial, will be included in the study dataset, but not utilized for endpoints, and will be 
referred to as “Standard photography”.   
4.1.1 
Study Photography 
The study endpoint relies on quality and consistent imaging.  As such, it is imperative the images 
are taken under strict, standardized environments with only qualified photographers that are 
trained to the same methods. The Sponsor will ensure photographers are available for each site 
throughout the study and, if necessary, provide a contracted medical photographer.  A chief 
photographer will be identified to develop and conduct training for all study site photographers. 
The training manual will outline the specific set-up including equipment, lighting, participant 
angles, and camera positioning.     
Participants will be given reminders to wear loose fitting clothes without seams on the buttock or 
posterior thigh portions of the clothes before each required study photography visit and to prepare 
to stand until compression lines disappear, if present. 
Prior to uploading images into the study database, the image metadata will be modified to include 
the participant ID and any date, location. PHI will be redacted.   
For each photo session, the participant will stand and wear the provided standardized 
photographic garment as described in the CONFFIRM imaging protocol. The participant will be 
instructed to relax muscles and stand at ease.   
All study photography from this study are the property of the Sponsor and may be utilized for 
clinical development, scientific communication, marketing, regulatory purposes, and/or legal 
applications as required/desired by the Sponsor. 
4.2 
INDEPENDENT IMAGE EVALUATION 
4.2.1 
Selection and Qualification of Evaluators 
The primary endpoint and other effectiveness outcomes involving study photography will be 
independently evaluated by three (3) physicians with medical aesthetics specialty, cellulite or 
body contouring experience. The evaluators will not participate in the study, will not be on staff 
of any CONFFIRM study sites, and will have no financial interest in study sponsor. The panel of 
evaluators will be selected by a third party.  In addition to meeting the qualifications criteria, each 
must have the ability to pass the initial Cellulite Severity Scoring (CSS) post-training test.     
The following will not be disclosed to the evaluators:    
1. Study device 
2. Site names  
3. Participant information 
4.2.2 
Frequency and Order of Evaluations 
The evaluations will occur in advance of each planned interim analysis as outlined in Table 3 and 
will follow the order outlined to ensure no pre-mature unblinding of the before/after that is 
required for the GAIS evaluation.    

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Table 3 Independent Image Evaluation Scope 
Evaluation session 
number 
Assessment 
type 
Visit Time Points 
Blinded 
#1, at 3-month 
analysis 
CSS 
ID of BL 
Baseline and 30-day 
Baseline and 3-month 
 
Yes, time point 
redacted 
#1, at 3-month 
analysis, after CSS 
GAIS 
Baseline and 30-day 
Baseline and 3-month 
No, improvement 
intentionally assessed 
#2, at 6-month 
analysis  
CSS 
ID of BL 
Baseline and 6-month 
Yes, time point 
redacted 
#2, at 6-month 
analysis, after CSS 
GAIS 
Baseline and 6-month 
No, improvement 
intentionally assessed 
#3, at 12-month 
analysis 
CSS 
ID of BL 
Baseline and 12-month 
Yes, time point 
redacted 
#3, at 12-month 
analysis, after CSS 
GAIS 
Baseline and 12-month 
No, improvement 
intentionally assessed 
   
4.2.3 
Study Image Evaluation 
At study photography visits, each participant will be photographed per the study photography 
manual to generate a minimum of three (3) images from a minimum of three (3) different angles 
(Section 4.1).  The images for each participant will be available for the evaluator to assess per 
visit.  The CONFFIRM effectiveness outcomes are specific to the treated regions only, therefore, 
scoring will be considered on a participant level, but include scoring of the treated regions only.  
The treated regions will be disclosed to the evaluator by sextant (right buttock, right posterior 
thigh, right lateral thigh, left buttock, left posterior thigh, left lateral thigh) as well as a 
supplemental image set with an outline around the treated region per sextant. The training will 
also mimic this approach.    
Evaluators will always be blinded to any participant ID, and for the CSS, the evaluator will not 
know which of the two (2) sets of images is before or after the index procedure.  To further 
reduce bias, images will be scored under a different photo ID to ensure blinding is maintained.  
Evaluators will also be presented with two (2) sets of images where the set of three (3) angles of 
the same pre-treatment visit and three (3) angles of the post-treatment visit in a randomly 
assigned order (e.g., 3 pre-images on top of screen, 3 post images on bottom of screen or vice 
versa). Evaluators will be asked to identify which image is before and after the index procedure. 
4.2.4 
Blinding plan – unblinding plan 
When assigning the CSS, the evaluators will be blind to the image time point and therefore, will 
not know whether the image is prior to or post-procedure.  The evaluators will not know which 
image is baseline or follow-up and will be asked to identify the baseline.  
Once the CSS and baseline image estimates are completed, the image pairs will then be presented 
with the baseline and follow-up known for the GAIS in the unblinded assessment.   

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4.2.5 
Cellulite Severity Score (CSS) 
Severity scoring by the independent, blinded assessors 
PART A- Number of evident depressions 
0 
None 
1 
Mild (≤4 depressions) 
2 
Moderate (5 to 9 depressions) 
3 
Severe (≥ 10 depressions) 
PART B – Average depth of depressions 
0 
None  
1 
Mild (1-2 mm) 
2 
Moderate (3-4 mm) 
3 
Severe (≥5 mm) 
TOTAL CSS 
SCORE 
= (PART A + PART B) – 1 
Note: If both CSS A and CSS B have classifications of 
0, the CSS total score will be 0. 
 
4.2.6 
Global Aesthetic Improvement Scale (GAIS) Evaluation 
The evaluators will rate the overall improvement on the follow-up image according to the GAIS, 
per the scale outlined below. 
Table 4 GAIS Categories 
Rating 
Assessment 
Description 
-3 
Very much worse 
The treated area appearance is 
obviously worse than before 
procedure 
-2 
Much Worse 
The treated area appearance is 
markedly (or significantly) worse 
than before procedure 
-1 
Worsened 
 The treated area appearance is 
slightly worse than before procedure 
0 
Unaltered (no change) 
The treated area appearance is 
essentially the same 

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Rating 
Assessment 
Description 
+1 
Improved 
Noticeable improvement in 
appearance of the treated areas, but 
subtle in magnitude 
+2 
Much improved 
Marked or significant improvement 
in appearance in the treated areas 
+3 
Very much improved 
Optimal cosmetic result in the 
treated areas for this subject. No 
additional treatment is indicated. 
5 
CLINICAL EVENTS  
At each evaluation, the investigator will determine whether any adverse events (AEs) have 
occurred. For the purpose of this protocol, an adverse event is any undesirable medical 
occurrence in a device user or participant. This definition does not depend on a causal 
relationship with the device or the protocol requirements. Adverse events reporting will begin at 
the time the deployable hook procedure is initiated and through participant exit. An adverse event 
eCRF will be completed for each diagnosed adverse event and followed through resolution or 
study exit.   
5.1 
ADVERSE EVENT TYPES AND DEFINITIONS   
5.1.1 
Adverse Event 
For the purpose of this protocol, to simplify across USA and Australia, an adverse event will be 
defined broadly as any undesirable medical occurrence in a device user or participant.   
Only procedure-emergent adverse events will be captured.  Therefore, all adverse events or pre-
existing events that worsen in severity will only be captured after the index procedure.  
5.1.2 
Serious Adverse Events (SAEs) 
An adverse event that led to any of the following: 
a) Death 
b) Serious deterioration in the health of the participant, users, or other persons as defined by 
one or more of the following: 
1) A life-threatening illness or injury, or 
2) A permanent impairment of a body structure or a body function including chronic 
diseases, or 
3) In-patient or prolonged hospitalization, or  
4) Medical or surgical intervention to prevent life-threatening illness or injury, or 
permanent impairment to a body structure or a body function, 
c) Fetal distress, fetal death, a congenital abnormality, or birth defect including physical or 
mental impairment 

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5.1.3 
Anticipated Adverse Events 
The anticipated risks associated with body contouring procedures in general are listed in Table 5. 
There are no additional unique risks associated with this procedure. The list covers the scope of 
risks anticipated for device use and procedure. Therefore, these could potentially be associated 
with anesthesia infiltration, subcutaneous tissue release, liposuction, cellulite reduction 
procedures and other methods of body contouring in general.  
Table 5 Anticipated Adverse Effects   
Anticipated Adverse Effects List 
Abscess  
Inflammation / generalized redness 
Anetoderma  
Nausea/vomiting  
Anxiety (nervousness, apprehension)  
Numbness, tingling, or sensitivity change  
Blanching (generalized whiteness)  
Red Spots (from needle punctures related to 
anesthesia delivery)  
Bleeding  
Redness, erythema, or rash  
Blurred or double vision  
Scarring or keloid formation  
Dizziness, drowsiness, confusion, fainting  
Sensations of heat or cold  
Ecchymosis/bruising  
Seroma  
Fluid extravasation (leakage of fluid) 
Skin necrosis  
Hematoma or hard bruise 
Skin surface convexity, depression or other 
irregularity  
Hemosiderosis  
Soreness or discomfort (pain) 
Hyperpigmentation  
Swelling/edema  
Hypopigmentation 
Tinnitus  
Induration, fibrosis  
Toxic, allergic, or other reaction from the 
injected anesthetic  
Infection  
----- 
 
5.1.4 
Unanticipated Adverse Events 
5.1.4.1 
 Unanticipated Adverse Device Effects (UADEs) For sites in the United States 
Any serious adverse effect on health or safety, any life-threatening problem or death caused by, 
or associated with a device, if that effect, problem, or death was not previously identified in 
nature, severity, or degree of incidence in the application; or any other unanticipated serious 

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problem associated with a device that relates to the rights, safety, or welfare of participants per 21 
CFR 812.3. 
5.1.5 
Adverse Device Effect (ADE)  
This type of AE is specifically related to the use of an investigational medical device. This 
definition includes adverse events resulting from insufficient or inadequate instructions for use, 
deployment, implantation, installation, or operation, or any malfunction. This definition includes 
any event resulting from use error or from intentional misuse of the investigational medical 
device.   
It is important to point out the difference between a device related AE and an ADE.  A device 
related AE could also qualify as an ADE, with ADE being a subset of device related AEs.  For 
example, mild to moderate bruising is a device related AE, but is a part of a normal recovery 
course for a cellulite procedure.        
5.2 
NOT CONSIDERED ADVERSE EVENT 
 
Pre-existing Conditions:  Any condition that is recorded in medical records and diagnosed 
prior to the deployable hook procedure, is considered a pre-existing condition. This 
condition is not considered an adverse event unless there is a clinically significant 
worsening of that condition in terms of nature, severity, or degree of incidence.   
 
Device Deficiencies or Malfunctions:  An undesirable technical event during procedure is 
not an adverse event in itself.  However, if a device deficiency or malfunction leads to a 
medically undesirable situation, then that event must be reported on an Adverse Event 
Form and is an Adverse Device Effect (ADE). 
 
Lack of improvement of cellulite is not considered an adverse event.  
 
Pre-planned hospitalization for any pre-existing condition. 
 
Any procedure the participant undergoes after the deployable hook is not considered an 
adverse event, however, the condition leading to the procedure is an adverse event.  
5.3 
ADVERSE EVENT ASSESSMENT 
5.3.1 
Adverse Event Evaluation and Categorization  
All AEs will be assessed by the investigator(s). The study will use the Common Terminology 
Criteria for Adverse Events (CTCAE) Version 5 for AE terminology and severity grading.  In 
addition, the investigator will assess relatedness (device or procedure, none). Guidelines for 
Investigators follow.  
Table 6 CTCAE Guidance and Database Access 
Search database 
https://safetyprofiler-ctep.nci.nih.gov/CTC/CTC.aspx 
Printable Quick Reference 
https://ctep.cancer.gov/protocolDevelopment/electronic_appli
cations/docs/ 
CTCAE_v5_Quick_Reference_8.5x11.pdf 

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Clean, Tracked and Mapping 
Document 
Will be provided by Sponsor in study files 
5.3.2 
Severity (Grades)  
Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; 
intervention not indicated.  
Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate 
instrumental activities of daily living (ADL).  
Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or 
prolongation of hospitalization indicated; disabling; limiting self-care ADL.  
Grade 4 Life-threatening consequences; urgent intervention indicated.  
Grade 5 Death related to AE. 
Table 7 CTCAE Library Example 
CTCAE 
TERM 
GRADE 1 
GRADE 2 
GRADE 3 
GRADE 4 
GRADE 5 
Seroma 
Asymptomatic; 
clinical or 
diagnostic 
observations 
only; 
intervention 
not indicated
Symptomatic; 
simple 
aspiration 
indicated 
Symptomatic, 
elective 
invasive 
intervention 
indicated 
- 
- 
Bruising 
Localized or in 
a dependent 
area
Generalized 
- 
- 
- 
Pain of skin 
(characterized 
by a sensation 
of marked 
discomfort in 
the skin)
Mild pain 
Moderate 
pain; limiting 
instrumental 
ADL 
Severe pain; 
limiting self-
care ADL 
- 
- 
 
5.3.3 
Determination of the Relationship (Causality) 
The Investigator, on the basis of his or her clinical judgment, should determine whether there is a 
reasonable possibility the study device or procedure caused or contributed to the event.  
Guidelines to assess AE/SAE/UADE are provided below: 
Not related:  The adverse event is determined to be solely caused by the underlying disease, 
disorder or condition of the participant, or attributable solely to other extraneous causes 
(unrelated to the device, device malfunction, or the procedure). 

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Unlikely related:  The adverse event has onset within a clinically relevant temporal 
relationship to exposure to the device or procedure and is plausibly at least partially caused 
by or aggravated by the use of the device, device malfunction, or the procedure. It must also 
meet one of the following criteria: (1) follows a known or easily foreseen pattern of response 
to device use or procedure and (2) is not fully attributable to the underlying disease, disorder 
or condition of the participant, or attributable to other extraneous causes. 
Possibly related:  The adverse event has onset within a clinically relevant temporal 
relationship to exposure to the device or procedure and is more likely than not to be at least 
partially caused by or aggravated by the use of the device, device malfunction, or the 
procedure. It must also meet both of the following criteria: (1) follows a known or easily 
foreseen pattern of response to device use or procedure; and (2) is not fully attributable to 
the underlying disease, disorder or condition of the participant, or attributable to other 
extraneous causes. In addition, if the adverse effect is reversible upon reoperation or device 
exchange, and such a procedure is done, the effect disappears or lessens in severity within 
the expected time interval. 
Probably/highly probably related:  The adverse event is clearly caused by the use of the 
device, device malfunction, or the procedure. It must meet all the following criteria: (1) has 
a clear temporal relationship between device exposure and onset of the event; (2) follows a 
known pattern of response to device use or procedure; and (3) is not reasonably attributable 
to the underlying disease, disorder or condition of the participant, or attributable to other 
extraneous causes. In addition, if the adverse effect is reversible upon reoperation or device 
exchange, and such a procedure is done, the effect disappears or lessens in severity within 
the expected time interval. 
5.4 
REPORTING REQUIREMENTS FOR SAES OR UADES  
It is the responsibility of the Principal Investigator to report SAEs or UADEs to the sponsor 
within 24 hours. Reporting of the event to applicable regulatory bodies should occur per the 
established reporting criteria. For UADE reports, investigators are required to submit a report of a 
UADE to the sponsor and the reviewing IRB as soon as possible, but in no event later than 10 
working days after the Investigator first learns of the event (§ 812.150(a)(1)).  Sponsors must 
immediately conduct an evaluation of a UADE and must report the results of the evaluation to 
FDA, all reviewing IRBs, and participating investigators within 10 working days after the 
sponsor first receives notice of the effect (§§ 812.46(b), 812.150(b)(1)). 
5.5 
MEDICAL TREATMENT FOR AES, SAES AND UADES 
Medical treatment for adverse events during and following the study procedure will be at the 
discretion of the Investigator.  

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5.6 
MEDICAL MONITOR 
The Medical Monitor (independent of the study sites or Sponsor) with dermatologic or plastic 
surgery expertise will oversee the safety aspects of this study. Review and MedDRA coding of all 
AEs and assessment or identification of UADEs will be performed throughout study.   
6 
STATISTICAL METHODS 
6.1 
STATISTICAL AND ANALYTICAL PLANS 
6.1.1 
Analysis Cohorts 
 
Modified Intent-to-Treat (mITT) Cohort:  
The modified intent-to-treat mITTdata set will include all enrolled participants that 
underwent the DH procedure but exclude any roll-in18 participants. The mITT analysis 
cohort will be used for all described analyses.  
 
Per Protocol (PP) Cohort: 
The PP cohort will be used as a secondary support of the primary effectiveness m-ITT 
analysis and may be used in exploratory analysis.    
The PP analysis set will exclude participants with the following significant protocol 
deviations: 
1) 
Participants with significant violations of the inclusion and exclusion criteria, 
including: 
 Mild cellulite 
 Impactful co-morbidity outlined in eligibility criteria 
 BMI >30.1 
 Pregnancy or weight gain/loss >10% of baseline weight 
2) Participants who do not have images for primary effectiveness endpoint (missed, 
COVID-19, etc.) 
Overall, protocol deviations for active participants will be summarized by severity (major/minor), 
type by visit, and by site.  Any deviations or issues reported to IRB/HREC and will be described.  
Roll-In and Intent-To-Treat Cohorts: 
All roll-in cohort data will be summarized separately using descriptive statistics. In addition, an 
intent-to-treat (ITT) data set of all enrolled participants including any roll-in19 participants that 
underwent the DH procedure will be analyzed to see whether there is a learning curve that effects 
the data. 
 
18 The Investigators without prior Deployable Hook experience will perform up to two (2) roll-in, or “training” 
procedures.    
19 The Investigators without prior Deployable Hook experience will perform up to two (2) roll-in, or “training” 
procedures.    

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6.2 
SAFETY ANALYSIS 
6.2.1 
Primary Safety Endpoint      
Safety will be demonstrated by the absence of device related Serious Adverse Events (SAEs) 
directly attributable to the device through 30 days post-procedure.  All participants that 
underwent the index procedure will be included in this analysis.  
6.2.2 
Adverse Events 
Procedure-emergent adverse events will be analyzed. All adverse events, new or worsening of 
pre-existing conditions, starting at the initiation of, or after, the deployable hook procedure, will 
be summarized. Adverse events will be coded using MedDRA and CTCAE severity grades.    
Unless otherwise specified, at each level of participant summarization, a participant is counted 
once if she reported one or more events.  Percentages will be calculated based on the number of 
participants.   
The following specific AE summaries will be generated:  
 Overall AEs by study visits, event type, relatedness, ADEs, SAEs, by CTCAE grades 
 Grade 3 and higher AEs and related Grade 3 and higher AEs 
 SAEs by relatedness (narratives will be provided) 
 Unanticipated AEs and UADEs 
6.3 
PRIMARY EFFECTIVENESS ENDPOINT   
6.3.1 
Endpoint Definition  
The primary effectiveness endpoint is the change in CSS score at 3 months from baseline.  
The CSS includes a 6-point (range of 0–5) ( 
Table 8) and will be determined by three (3) independent, blinded physician assessors of 
participant images obtained before and 3-months after treatment.  For clarity, the 
endpoint will test the mean of the changes for each treated participant, not a 1 point 
change between mean score of the group at baseline versus 3 months. Success is achieved 
when the mean change across all treated participants is at least one point. 
Long term success:  The change in CSS and proportion of responders will be summarized 
at the 12 month visit. The 95% confidence intervals are intended to support long-term 
performance claims. 

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Table 8 Cellulite Severity Score  
Severity scoring by the independent, blinded assessors 
PART A- Number of evident depressions 
0
None 
1
Mild (≤4 depressions) 
2
Moderate (5 to 9 depressions) 
3
Severe (≥ 10 depressions) 
PART B – Average depth of depressions 
0
None  
1
Mild (1-2 mm) 
2
Moderate (3-4 mm) 
3
Severe (≥5 mm) 
TOTAL CSS 
SCORE
=(PART A + PART B) – 1 
One CSS is rendered per participant.  Part A is the 
number of depressions across all treated regions, and Part 
B the average across all treated regions.  This study does 
not prescribe if participant treated unilaterally or 
bilaterally.    
 
6.3.2 
Hypothesis 
Ho: D < 1 
Ha: D ≥ 1, 
where D = reduction in the CSS score from baseline to 3 months, and 1 is the performance 
goal. 
6.3.3 
Analysis cohort 
The mITT cohort will be the primary analysis, but supplemental analysis will also be 
performed using the PP cohort. 
6.3.4 
Statistical Analyses  
The reduction in CSS will be calculated and descriptive statistics including mean, 
standard deviation, median and range will be summarized. The 2-sided 95% confidence 
interval for the mean reduction in CSS20 will be calculated along with the corresponding 
p-value (Student’s t-test).   
 
20 CSS = CSS-A (Number of Evident Depressions) + CSS-B (Average Depth of Depressions) – 1  

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6.3.5 
Definition of Success  
If the lower bound of the two-sided 95% confidence interval is greater than or equal to 1 
then we will reject the null hypothesis and conclude the device performs effectively. 
6.3.6 
COVID-19 Contingency 
 As outlined in section Error! Reference source not found., before blinded photometric 
evaluation of CSS, the number of participants with images available for the 3-month 
endpoint will be confirmed.  If the number of participants with images cannot adequately 
power the endpoint (N=54) due to excessive 3-month COVID 19 related missed visits, 
the primary endpoint time point will be changed to 6-month.  Of note, the inferential 
secondary endpoints will similarly change to 6-month (section 6.5). 
6.3.7 
Determination of Sample Size 
 
Sample size calculations were estimated using PASS 14 (Kaysville, Utah, USA), using 
Wilcoxon Signed Rank test for superiority by a margin (the more conservative approach 
compared to t-test) 
Hypothesis: 
 
Ho: D < 1 
 
Ha: D ≥ 1, 
where D = improvement in the CSS score from baseline to 3 months, and 1 is the 
performance goal. 
The endpoint with a sample size of 54 participants will be adequately powered with at 
least 90% power to test the hypothesis that the mean reduction at 3-months is equal to or 
greater than 1.  This study's sample size will be increased by 25% for a total N of 68 to 
account for the potential of missed visits amid the pandemic.    
6.3.8 
Poolability Analysis 
Analyses of the primary effectiveness endpoint will be performed to assess the 
comparability of study sites.  Sites with fewer than 5 participants each will be pooled into 
a composite site.  
Change in CSS will be analyzed by ANOVA to assess if the improvement in CSS differs 
among study sites.  If the study sites have a difference (p<0.15), then additional analyses 
will be performed to explore the cause of the difference, in particular, if the differences 
are caused by differences in some baseline factor. 
6.3.9 
Covariate Adjustment and Exploration 
An ANCOVA model, which allows adjusting for covariates, will be used on the 3-month 
endpoint to uncover important prognostic factors.  If any of the following factors: age, race, 
baseline BMI, indicator variable of change in body weight of ±10% (compared to baseline), or, 
number of regions treated are not significant (p-value ≥0.10), they will be dropped from the 

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model.  This is not intended to be the primary analysis of the 3-month endpoint, it is only an 
exploratory analysis that will be used to look for possible important prognostic factors. This 
analysis may be repeated on the change in CSS data at 6 and 12-month visits once data are 
complete. 
6.4 
HANDLING MISSING DATA 
Every effort will be made to collect all data points in the study.  The sponsor plans to 
minimize the amount of missing data by appropriate management of the prospective 
clinical trial, proper screening of study participants, and training of participating 
investigators, monitors and study coordinators.    
A sensitivity analysis will be performed for the primary effectiveness endpoint where a 
missing 3-month assessment of CSS will be replaced using the following imputations for 
calculating the improvement in CSS: 
 Worst case (highest CSS score observed for all follow-ups available) 
 
Last observation carried forward (30 day or baseline assessment). 
 
Best case (lowest CSS score observed for all follow-ups available for a subject) 
Imputations will not be made on secondary endpoint data, but all data available will be 
summarized. 
6.5 
SECONDARY EFFECTIVENESS ENDPOINTS 
Descriptive statistics will be used to summarize the secondary endpoints including mean, 
standard deviation, median, range for continuous data and frequency and percentage for 
categories values.  
The secondary endpoints will be split into two categories, either Inferential or simply Descriptive.  
The inferential secondary endpoints will be tested using the hierarchical approach of gatekeeping 
to ensure the overall alpha for the trial is maintained.  Descriptive secondary endpoints will not 
have any hypothesis testing performed. 
In additional to regular annual reports, there are expected to be 3 reports prepared (3-month, 6 
month, final – see Section Error! Reference source not found.), and the first report will have the 3 
month results including the primary endpoint and all inferential secondary endpoints tested.  The 
6 month and final reports will include 95% confidence intervals for the endpoints that were used 
in the primary and inferential secondary endpoints for the longer-term visits to provide support 
for longer-term performance of these same endpoints. 
6.5.1 
Hierarchical testing 
If the primary endpoint passes, a subset of the secondary endpoints (inferential) will have 
hypothesis tests performed for potential labeling claims.  These endpoints will be tested the 
specific order presented below.  If the first secondary endpoints passes the hypothesis test (rejects 
the null hypothesis), then the next secondary endpoint will be tested.  Testing will continue up to 
the point that a hypothesis test fails.  Endpoints that follow will then simply use descriptive 
statistics and no p-values will be presented.  Since this testing relies first on the primary endpoint 

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passing, the 6-month data will be used instead should 3-month COVID 19 related missed visits 
reduce the evaluable data to <54. 
6.5.2 
Secondary Endpoint 1 (Inferential) – CSS Responders at 3 months 
Endpoint Definition: The CSS score at 3 months. A participant is considered a responder if the 3-
month CSS score has improved by at least 1 point from the baseline CSS score. 
Hypothesis: 
Ho:  p <= 60% 
Ha:  p > 60%, 
where p=proportion of responders and 60% is the same performance goal that Cellfina 
used to achieve approval. 
Analysis cohort: The mITT cohort. 
Statistical Analyses: The count and proportion of responders will be summarized along with a 
exact binomial 2-sided 95% confidence interval for the proportion of responders along with a p-
value.  
Definition of Success: If the lower bound of the 2-sided 95% confidence interval is greater than 
or equal to 0.6 then we will reject the null hypothesis and declare proportion of responders are 
greater than 60%. 
6.5.3 
Power calculation:  The sample size for this trial is based upon the primary endpoint.  
With an observed performance of 81% responder in initial pilot data and expected 
sample size of 54, a one-sided alpha of 0.025 and performance goal of 60%, there will 
be > 90% power to test this hypothesis.Secondary Endpoint 2 (Inferential) – 
Improvement in GAIS at 3 months 
Endpoint Definition: The GAIS score at 3 months as determined by a blinded and independent 
evaluator.  A participant is considered improved if the GAIS assessment is improved (1), much 
improved (2) or very much improved (3). 
Hypothesis: 
Ho:  p <= 60% 
Ha:  p > 60%, 
where p=proportion of Improved and 60% is an assumed acceptable performance goal for 
this endpoint and trial size. 
Analysis cohort: The mITT cohort. 
Statistical Analyses: The count and proportion of participants with GAIS evaluations of improved 
will be summarized along with an exact binomial 2-sided 95% confidence interval for the 
proportion of responders along with a p-value. Additionally, count and proportions will be 
summarized for each of the 7 categories of GAIS. 

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Definition of Success: If the lower bound of the 2-sided 95% confidence interval is greater than 
or equal to 0.6 then we will reject the null hypothesis and declare proportion of responders are 
greater than 60%. 
Power calculation:  The sample size for this trial is based upon the primary endpoint.  With an 
observed performance of >95% improved in initial pilot data and expected sample size of 54, a 
one-sided alpha of 0.025 and performance goal of 60%, there will be > 90% power to test this 
hypothesis. 
Long term success:  The change in GAIS and proportion of responders will be summarized at the 
12 month visit. The 95% confidence intervals are intended to support long-term performance 
claims. 
6.5.4 
Secondary Endpoint 3 (Inferential) – Patient Satisfaction at 3 months 
Endpoint Definition: The patient satisfaction assessment measured at 3 months.  Patient 
satisfaction is collected using an evenly balance scale with 5 categories: very satisfied, satisfied, 
neither satisfied nor dissatisfied, dissatisfied, very dissatisfied. The general “Satisfied” category is 
defined as those that indicated they were satisfied or very satisfied with their outcome. 
Hypothesis: 
Ho:  p <= 60% 
Ha:  p > 60%, 
where p=proportion satisfied and 60% is an assumed acceptable performance goal for this 
endpoint and trial size. 
Analysis cohort: The mITT cohort. 
Statistical Analyses: The count and proportion of participants satisfied with their outcome will be 
summarized along with an exact binomial 2-sided 95% confidence interval for the proportion of 
responders along with a p-value. Additionally, count and proportions will be summarized for each 
of the 5 levels of patient satisfaction. 
Definition of Success: If the lower bound of the 2-sided 95% confidence interval is greater than 
or equal to 0.6 then we will reject the null hypothesis and declare proportion of responders are 
greater than 60%. 
Power calculation:  The sample size for this trial is based upon the primary endpoint.  With an 
observed performance of 67% satisfied in initial pilot data and expected sample size of 54, a one-
sided alpha of 0.025 and performance goal of 60%, there will be ~17% power to test this 
hypothesis, however it is believed performance will be better in this trial. 
6.5.5 
Secondary Endpoints (Descriptive) 
Descriptive statistics were used to summarize other secondary endpoints including mean, 
standard deviation, median, range for continuous data and frequency and percentage for 
categories values. 

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6.6 
ADDITIONAL OUTCOME MEASURES 
6.6.1 
Learning Curve Analysis 
To explore the potential for possible learning curves, descriptive analyses will be made using 
sites with at least 5 participants enrolled (including roll-in participants).  Note that if more than 
one investigator should be active at a site, for this analysis each investigator will be treated as a 
site, but it is not expected. 
The following summaries will be prepared in sequentially treated participants across these sites 
for 1st participant, 2nd participant, 3rd participant, etc.: 
 
Mean Baseline CSS 
 
Mean Change in CSS at 3 months 
 
Proportion of participants with device related AE 
 
Proportion of participants with serious device related AE 
Because multiple procedures may occur on the same day, additional descriptive analyses will 
summarize these same values for sequentially treated participants across these same sites for 1st 
procedure date, 2nd procedure date, 3rd procedure date, etc. 
6.7 
EXPLORATORY ANALYSIS 
Additional exploratory statistical analysis may be performed including subgroup analyses and 
participant reported outcomes.    
6.8 
PARTICIPANT ACCOUNTABILITY 
The disposition of participants will include the number and percentages of participants for the 
following categories: 
 
Participants who enrolled 
 
Participants who screen failed 
 
Participants who underwent the deployable hook procedure in the ITT 
 
Participants who are in the mITT 
 
Participants who are in the PP 
All percentages will be based on the number of subjects who underwent the deployable hook 
procedure. The primary reason for screen failure and early termination will also be summarized. 
The participant accountability for each study follow-up will be presented.  The following 
categories will be included: 
 
Theoretical number of participants  
 
Active (not terminated) participants or expected 
 
Number of participants who completed (at least partially) the visit  
 
Participants included in effectiveness data 
 
Participants included in safety data 
 
Participants who missed a visit 
 
Participants who terminated prior to the 12-month visit 

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The reasons for terminating early will be listed, as will the participants and visits that were 
affected by COVID-19.  
6.9 
OTHER STUDY SUMMARIES  
 
Protocol Deviations 
o Minor and major deviations will be summarized together and separately  
 
The following will be tabulated with appropriate summary statistics:  
 
Demographics/Ethnicity 
 
Medical History 
 
Procedural Data 
6.10 DATA COLLECTION AND ELECTRONIC CASE REPORT FORM (ECRF) COMPLETION 
The Investigator, or designee, will enter data from the clinic’s medical records and study source 
worksheets into an online electronic data capture (EDC) system.  The data will remain secure as  
study personnel will be trained to use a password protected login. Sponsor designated monitors 
will perform clinical monitoring, including verification of eCRFs and the source documentation. 
Data entry should occur in a timely manner for accuracy, but, especially for complying with 
regulations if unanticipated or serious adverse event occurs (within 24 hours). If significant 
delays in entry occur frequently, formal corrective plan will be established.  
7 
INVESTIGATOR RESPONSIBILITIES 
7.1 
INVESTIGATOR FILES 
For the study duration the Investigator will: 
 
maintain complete and accurate documentation, including but not limited to, medical 
records, study progress records, laboratory reports, CRFs,  
 
signed and dated informed consent forms,  
 
all correspondence with the IRB/HREC, 
 
Sponsor personnel/representatives, and other regulatory agencies,  
 
the protocol, and  
 
documentation for each deviation from the protocol,  
 
records of receipt, use, or disposition of each device,  
 
record of the exposure to the study device,  
 
adverse event records,  
 
information regarding participant discontinuation or completion of the study,  
 
any other supporting data, and  
 
any other records that FDA or local regulation requires to be maintained  

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7.2 
INSTITUTIONAL REVIEW BOARD PROTOCOL/ HUMAN RESEARCH ETHICS COMMITTEE 
AND INFORMED CONSENT APPROVALS 
The ICFs that are used should be in accordance with the current guidelines as outlined by local 
regulations (i.e.21CFR Part 50, Good Clinical Practices (GCP) guidelines and ISO 14155). 
The Investigator must have a written approval from the IRB/HREC prior to recruiting participants 
in the study.  Any materials used for recruitment, as well as any other participant facing materials 
such as questionnaires, must also be approved by IRB/HREC. A copy of the written approval 
must be provided to the study sponsor and should include the following. 
 
A statement of IRB/HREC approval for the proposed study at the institution 
 
The date the study was approved  
 
A statement that the informed consent document (version date referenced) has been 
approved (may be a separate documented letter) 
 
A listing of any conditions or requirements attached to the approval imposed by the 
IRB/HREC 
 
Identification of the approved Principal Investigator 
 
The signature of the IRB/HREC chairperson 
If the Investigator or Sub-Investigator is a member of the IRB/HREC, the letter should state that 
he/she did not participate in the review or approval of the protocol or informed consent (may be 
provided under a separate letter). 
Until the study is completed, the Investigator will advise their IRB/HREC of the study progress, 
minimally, on an annual basis.  Written approval must be obtained yearly to continue the study.  
Any amendments to the protocol, as well as associated consent form changes and participant 
facing materials, will be submitted to the IRB/HREC and written approval obtained prior to 
implementation.  Serious adverse event reports will be submitted as requested by the Sponsor and 
per IRB/HREC policies and regulations. 
The potential participant must sign the consent form that is currently approved by the study site's 
IRB/HREC. Failure to provide informed consent renders the participant ineligible for the study.  
7.3 
PROTOCOL DEVIATIONS 
A protocol deviation is defined as an event where the Investigator or site personnel did not 
conduct the study according to the protocol or a failure to adhere to the IRB/HREC reporting 
procedures and policies. 
The study sponsor reserves the right to terminate an investigator/investigational site for any of the 
following reasons: 
 
Failure to secure participant informed consent including protection of personal data prior 
to enrollment. 
 
Failure to report serious adverse device effects within 24 hours of discovery. 
 
Repeated investigational plan deviations. 
 
Repeated failure to appropriately complete case report forms. 

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 
Failure to enroll participants within the planned enrollment period. 
 
Loss of or unaccounted for investigational product inventory. 
7.3.1 
Investigator Reporting 
Deviations must be reported regardless of whether medically justifiable or taken to protect the 
subject in an emergency.  Participant specific deviations will be reported on the Protocol 
Deviation eCRF.  Non-subject specific deviations, (e.g. unauthorized use of a study device 
outside the study, unauthorized use of a study device by a physician who has not signed an 
Investigator agreement or not been trained in the use of the device, etc.), will be reported to 
directly to the study sponsor.  Any serious breaches of the protocol or the conditions and 
principles of GCP in connection to this trial will be reported to the IRB/HREC in accordance with 
their reporting policies and procedures.  A serious breach is likely to impact to a significant 
degree: (a) the safety or physical well-being of the participants of the trial; or (b) the scientific 
value of the trial.  
All major deviations will be reported to the Sponsor within 24 hours of the Investigator becoming 
aware. 
Protocol deviations to the inclusion/exclusion criteria and deviations that affect the primary 
endpoints are considered major protocol deviations. Protocol deviations that may affect the 
secondary endpoints are considered minor protocol deviations.   
7.4 
STUDY DEVICES 
7.4.1 
Labeling 
The study sponsor will label all study devices in accordance with FDA regulations per 21CFR 
812.5 and other local regulatory requirements where the study is being conducted.  
7.4.2 
Ordering and Storing Study Device 
 
Study devices will be stored in a secure area, where only study personnel can access.  The PI or 
designee will be responsible for maintaining control of and verifying each device’s disposition. 
7.4.3 
Study Device Accountability 
The Investigator shall maintain adequate records of the receipt, use, and disposition of the study 
device.  
Study devices will only be used with this clinical investigation.  The PI or an authorized designee 
shall keep device accountability log tracking documenting the receipt, use, return and disposal of 
the study devices, which shall include: 
a) the date of receipt and the signature of the individual who received the product(s), 
b) identification of each study device (batch number/serial number or unique code), 
c) the expiry date, if applicable, 
d) the date or dates of use, 

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e) unique participant identification number, 
f) date when the study device was returned (for any reason), and 
g) the date of return of unused, expired or malfunctioning study devices, if applicable. 
This log must be maintained at each investigational site and must be filed in the regulatory binder.  
At the end of enrollment, the study sponsor or designee shall ensure that documentation of the final 
reconciliation of all devices is signed or initialed by the PI or authorized designee.     
7.4.4 
Device Disposal or Return 
Devices are to be disposed of utilizing clinic specific biohazard procedures unless return is 
required or requested by the sponsor.  Details outlining study sponsor returned goods policy will 
be provided in the training materials.  The site will return all unused devices remaining at the end 
of the enrollment period. 
7.5 
FINANCIAL DISCLOSURE 
All Investigators must provide the sponsor with documentation of financial interest related to the 
study sponsor. Investigators must complete and provide Financial Disclosure in compliance with 
21CFR 812.43 (c) (5) to the sponsor during the approval process of the site and maintain this 
documentation throughout the study and for 1 year following completion of the study. 
7.6 
PARTICIPANT PRIVACY 
The Investigator agrees to comply with all applicable local regulations relating to the privacy of 
participants’ health information, including, but not limited to, the Standards for Individually 
Identifiable Health Information, 45 CFR Parts 160 and 164 and in accordance with the Health 
Insurance Portability and Accountability Act of 1996 (HIPAA), which states all participants 
should be informed of potential uses and disclosures of their medical information for research 
purposes, and their rights to access information about them by covered entities.  Each Investigator 
will follow the procedures for securing HIPAA compliance as directed by their respective 
IRB/HREC or Privacy Board, and to obtain written authorization to use and disclose participant 
information for all clinical research and research involving questioning of the participant’s or 
participants’ physician(s).  Per individual site procedures, this authorization may be included as 
part of the participant informed consent form. 
The Investigator agrees to maintain all essential study documents and source documentation, in 
original format, that support the data collected on the study participants in compliance with the 
ICH/GCP guidelines (the Investigator’s File, including signed Informed Consent forms and 
participant-related materials) in a location that is secure and to which access can be gained if 
required.  
Participant confidentiality will be maintained throughout the clinical investigation in a way that 
ensures the information can always be tracked back to the source data. For this purpose, a unique 
participant identification code will be used that allows identification of all data reported for each 
participant. Data relating to the clinical investigation might be made available to third parties (for 

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example in case of an audit performed by regulatory authorities) provided the data are treated 
confidentially and that the participant’s privacy is guaranteed 
8 
SPONSOR RESPONSIBILITIES 
8.1 
GENERAL DUTIES 
Prior to shipping devices, the study sponsor is responsible for selecting Investigators, obtaining 
and reviewing copies of IRB/HREC approvals.  It is the study sponsor’s responsibility to ensure 
that the study is conducted according to Good Clinical Practice (GCP), the Declaration of 
Helsinki, and other applicable regulatory requirements, the Study Protocol, or any conditions of 
approval imposed by the IRB/HREC or local regulatory authorities.  Additionally, the study 
sponsor will ensure proper clinical site monitoring, and ensure study subject informed consent is 
obtained. 
8.2 
SELECTION OF SITES AND INVESTIGATORS 
The investigators have been selected because of their medical qualifications, education and 
training, interest in participation, ability to conduct and document the results of the study, ability 
to accrue participants, and expertise in the therapeutic area.  
The sponsor will ascertain the suitability of the Investigator to conduct the study according to 
applicable guidelines and local regulations.   
8.3 
SITE TRAINING 
The initial training of appropriate clinical site personnel to the study will be the responsibility of 
the study sponsor or their designee.   
8.4 
DEVICE TRAINING  
Investigators responsible for treating participants with the deployable hook device will receive 
sufficient training to ensure competence in the execution of all aspects of the procedure. Training 
will include demonstration videos, didactic presentation, and as may include hands-on experience. 
Training will also include all of the elements in the Instructions for Use (IFU).  Training for first 
use will be conducted before the first cases, and subsequent cases preceded by refresher training as 
necessary.  
Investigators without prior deployable hook experience will perform up to two (2) training cases, 
depending on the Investigator comfort level.  As well, these Investigators should plan at least 2 
stacked cases in one day for good technique adoption.  
8.5 
MONITORING 
8.5.1 
Site Monitoring Procedures 
All study monitoring activities will be managed and performed by the Sponsor or designee 
monitors.  eCRFs will be source-document verified according to the monitoring plan.  The extent, 
nature, and frequency of on-site visits will be based on considerations such as study objectives 

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and/or endpoints, study design and complexity, and enrollment rate.  These tasks will be 
performed according to relevant SOPs and the detailed study monitoring plan.  The detailed 
monitoring plan will describe who will conduct the monitoring and at what frequency, and 
distribution of monitoring reports. It will focus on preventing or mitigating non-compliance and 
identify risks to critical data and processes. 
At regular intervals during the study, the study monitors will contact the study sites via on-site 
visits, video/audio calls, emails and/or letters in order to review the study progress, CRF 
completion and to address any concerns or questions regarding study conduct.  By verifying 
compliance, these activities will ensure: 
 
The study is conducted in accordance with the study protocol, relevant Good Clinical 
Practice (GCP) and International Conference on Harmonization (ICH) guidelines, as well 
as in conjunction with 21 CFR Part 812, 50, 54, 56 and ISO 14155;  Protection of Human 
Patients (Informed Consent) (21 CFR Part 50), Financial Disclosure by Clinical 
Investigators (21 CFR Part 54), Institutional Review Boards (21 CFR Part 56), 
Investigational Device Exemptions (21 CFR Part 812), the Declaration of Helsinki, the 
privacy requirements of the Health Information Portability and Accountability Act 
(HIPAA);  
 
Adequate protection of the rights and safety of the informed patients involved in the 
study by thoroughly providing accurate and complete data; and 
 
Quality and integrity of the data. 
The frequency and scope of periodic site visits will be determined according to the site 
performance, enrollment, and public health emergency status.  There will be remote or on-site 
monitoring in advance of data locks in preparation of clinical study reports.  
Monitoring activities will include: review of the informed consent process and research 
authorization confirmation, regulatory document review, overall investigational plan adherence, 
GCP/ICH compliance, facility assessment, study staff assessment and additional study related 
functions that contribute to the safety of study Patients and the integrity of study data.  
Investigators must provide adequate time and resources to comply with the study protocol and 
will be available to the study monitor and/or designee via telephone, and in person during site 
visits.  The Investigator will also provide the study monitor with a suitable working environment 
for review of study-related documents.  
8.6 
ON-SITE AUDITS AND INSPECTIONS  
The study sponsor, or designee, a regulatory authority, or an IRB/HREC representative may visit 
the study site at any time during the study or after completion of the study to perform audits or 
inspections.  The purpose of these audits or inspections is to examine systematically and 
independently all study-related activities and documents to determine whether they were 
conducted in accordance to the protocol, GCP, and any other applicable regulatory requirements.  
In the event that an Investigator is contacted by a Regulatory Agency in relation to this study, the 
Investigator shall notify the study sponsor immediately.  

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The Investigator and/or designee must be available to respond to reasonable requests and audit 
queries made by authorized regulatory representatives during the audit process.  The Investigator 
must provide the study sponsor with copies of all correspondence that may affect the review of 
the current study (e.g., inspection observations) or their qualification as an Investigator in studies 
conducted by the study sponsor.  The study sponsor will provide any needed assistance to 
regulatory inspections or correspondence. 
8.7 
PROTOCOL AMENDMENTS 
Any amendments to the study protocol will be written by sponsor. Amendments cannot be 
implemented without prior written IRB/HREC approval and FDA approval (if required).   
8.8 
SUBMITTING REPORTS 
The study sponsor will submit the appropriate reports identified by local regulations. This 
includes unanticipated adverse device effects, withdrawal of IRB approval or FDA approval, 6-
month update, annual progress reports, recall information, final reports and device use without 
informed consent.  
8.9 
MAINTAINING RECORDS 
The study sponsor will maintain copies of correspondence, data, shipment of devices, 
unanticipated adverse device effects and other records related to the clinical study.  In addition, 
the study sponsor will maintain records related to the signed Investigator agreements according to 
requirements set forth by GCP. 
All clinical sites in the United States will be instructed to maintain study records for at least 2 
years after the study is terminated or per the requirements of the clinical investigation research 
agreement (as dictated by local regulations).   
Study records are to be discarded only upon notification by the study sponsor unless the 15-year 
period has not been reached. The Investigator must contact the study sponsor before the 
destruction of any records and reports pertaining to the study to ensure they no longer need to be 
retained. In addition, the sponsor should be contacted if the Investigator plans to leave the 
investigational site. 
8.10 CONFIDENTIALITY 
All data and information collected during this study will be considered confidential by the study 
sponsor. All data used in the analysis and summary of this study will be anonymized, and without 
reference to specific study subject names.  Access to study subject files will be limited to 
authorized personnel of the study sponsor, the Investigator, and research staff.  Authorized 
regulatory personnel have the right to inspect and copy all records pertinent to this study.   
9 
TRIAL TERMINATION 
If Sponsor, Investigator, or officials from regulatory agencies discover conditions arising during 
the study that indicate the study should be halted or that the study site should be closed, this action 

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may be taken after appropriate consultation between Sponsor and Investigator. If the study is 
prematurely terminated or suspended, the Principal Investigator will promptly inform the 
IRB/HREC and provide reason(s) for the termination or suspension and the plan for continued 
follow-up of participants. Conditions that may warrant termination of the study include, but are not 
limited to: 
 
Discovery of an unexpected, serious, or unacceptable risk to potential participants or to the 
participants already enrolled in the study 
 
Submission of knowingly false information from the research facility to sponsor, study 
monitor, or regulatory agencies.  
 
Deliberate or repeated failure of the Investigator to comply with GCP (e.g., ICH guidelines, 
regulatory agency guidelines). 
 
Insufficient adherence to protocol requirements or unacceptable high rate of missing, 
erroneous, or improperly collected data.  
 
A decision from sponsor to suspend or discontinue testing evaluation or development of 
the product. 
 
Failure of the Investigator to enroll participants into the study at an acceptable rate. 
10 PUBLICATION POLICY 
All information and data generated in association with this study will be held in strict confidence 
and remains the sole property of the study sponsor.  The Investigator agrees to use this 
information for the sole purpose of completing this study and for no other purpose without 
written consent from the study sponsor. 
At the conclusion of this study, a multi-center abstract reporting the primary results may be 
prepared by the Lead Principal Investigator and the study sponsor and/or presented in an 
appropriate international forum.  A multi-center peer-reviewed manuscript may also be prepared 
for publication in a scientific journal.  The publication of the principal results from any single 
center experience within the study will be coordinated with the study sponsor.