Prospective Clinical Study To Evaluate The Safety And Efficacy Of The MyEllevate® Procedure
Phase: NA
Conditions: Soft Tissue Approximation, Elevation of Subdermis, Elevation of Underlying Muscle
Sponsor: Cynosure, Inc.

PROTOCOL #: 7053-PL01-2022 
 
 
 
   
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ID: 7053-PL01-2022 
 
 
 
Study To Evaluate The Safety And Efficacy Of The MyEllevate® Procedure 
                                                                              NCT05590039 
 
 
Document Date: June 14, 2022 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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INVESTIGATIONAL PLAN 
 
PROTOCOL #: 7053-PL01-2022 
 
PROSPECTIVE CLINICAL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF 
THE MYELLEVATE® PROCEDURE 
 
 
 
 
CONFIDENTIAL 
 
THIS INVESTIGATIONAL PLAN CONTAINS CONFIDENTIAL INFORMATION FOR USE BY 
THE INVESTIGATORS AND THEIR DISIGNATED REPRESENTITIVES PARTICIPATING IN 
THIS STUDY.  IT SHOULD BE HELD CONFIDENTIAL AND MAINTAINED IN A SECURE 
LOCATION.  IT SHOULD NOT BE COPIED OR MADE AVAILABLE FOR REVIEW BY ANY 
UNAUTHORIZED ENTITY. 
 
 
 
 
 
 
 
SPONSOR: 
CYNOSURE, LLC 
5 CARLISLE ROAD 
WESTFORD, MA 01886 
PHONE: 800-886-2966 
FAX: 978-256-6556 
 
 
 

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PROSPECTIVE CLINICAL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF THE MYELLEVATE® 
PROCEDURE 
 
INVESTIGATOR AGREEMENT 
 
I agree to conduct the study in accordance with the relevant, current protocol and will only make changes in a protocol after notifying the 
sponsor, except when necessary to protect the safety, rights, or welfare of subjects. 
 
I agree to personally conduct or supervise the described investigation. 
 
I agree to inform any patients, or any persons used as controls if applicable, that the device(s) is/are being used for investigational purposes 
and I will ensure that the requirements relating to obtaining informed consent in and institutional review board (IRB) review and approval 
are met. 
 
I agree to report to the sponsor adverse experiences that occur in the course of the investigations.  I have read and understand the information 
in the device manual, including the potential risks and side effects of the device. 
 
I agree to ensure that all associates, colleagues, and employees assisting in the conduct of the study are informed about their obligations in 
meeting the above commitments.  
 
I agree to maintain adequate and accurate records and to make those records available for inspection. I further agree that Cynosure, Inc. or 
their designees shall have access to any source documents from which case report form information may have been generated. 
 
I will ensure that an IRB that complies with the requirements of 21 CFR Part 56 will be responsible for the initial and continuing review 
and approval of the clinical investigation. I also agree to promptly report to the IRB all changes in the research activity and all unanticipated 
problems involving risks to human subjects or others.  Additionally, I will not make any changes in the research without IRB approval, 
except where necessary to eliminate apparent immediate hazards to human subjects. 
 
I agree to comply with all other requirements regarding the obligations of clinical investigators. 
 
I will comply with the International Conference on Harmonization (ICH), Good Clinical Practice (GCP) guidance E6, FDA Good Clinical 
Practice Regulations (21 CFR parts 50, 56, and 812), Declaration of Helsinki (DoH) and the Health Human Service (HHS) Belmont Study 
Principals and Guidelines during the conduct of this study. 
 
I have read the foregoing protocol and agree that it contains all necessary details for carrying out this study. I will conduct the study as 
outlined herein and will complete the study within the time designated. 
 
I will provide copies of the protocol and all pertinent information to all individuals responsible to me who assist in the conduct of this 
study.  I will discuss this material with them to ensure they are fully informed regarding the study device the conduct of the study.  
 
I will disclose financial arrangements and interests in accordance with Financial Disclosure Rules (21 CFR part 54) and FDA Form 3455. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Investigator’s Signature 
 
 
 
 
 
Date 
 
 
 
 
 
 
 
 
 
 
 
Name of Investigator (Typed or Printed) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
       Address of Investigator (Typed or Printed) 
 
 

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SITE #1 CONTACT INFORMATION: 
Principal Investigator Information: 
John W. Decorato. M.D 
Aesthetic Pavilion Ambulatory Surgery Center 
531 W 2777 Hylan Blvd 
Staten Island, NY 10306 
Phone: 718-987-0300 
Email: jwd@DrDecorato.com  
 
SITE #2 CONTACT INFORMATION: 
Principal Investigator Information: 
Barry DiBernardo, M.D 
New Jersey Plastic Surgery 
29 Park Street 
Montclair, NJ 07042 
Phone: 973-509-2000 
Email: drd@njpsmd.com 
 
SPONSOR CONTACT INFORMATION: 
David Canavan 
Sr. Clinical Project Manager 
Westford, MA 01886 
Phone: 978-551-5786 
Email: David.Canavan@cynosure.com 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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TABLE OF CONTENTS 
1.0 
PURPOSE  
1.1 
Name and Intended Use 
1.2 
Objectives  
1.3 
Duration of the Investigation 
2.0 
PROTOCOL  
2.1 
Protocol Methodology and Analysis 
2.2 
Protocol Study Design  
2.3 
Subject Selection Criteria 
2.4 
Screening 
2.5 
Informed Consent Process and Enrollment 
2.6 
Pre-Treatment Procedures 
2.7 
Treatment Procedures 
2.8 
Post Treatment Procedures 
2.9 
Follow Up 
2.10 
Unscheduled Visits  
2.11 
Replacement of Subjects 
2.12 
Schedule of Visits and Procedures  
2.13 
Evaluation Methods 
2.14 
Adverse Event Recording  
2.15 
Statistical Analysis 
3.0 
RISK ANALYSIS AND MANAGEMENT  
4.0 
DEVICE DESCRIPTION AND SPECIFICATIONS  
5.0 
MONITORING PROCEDURES  
6.0 
LABELING  
7.0 
CONSENT MATERIALS 
8.0 
INSTITUTIONAL REVIEW BOARD INFORMATION 
9.0 
OTHER INSTITUTIONS  
10.0 
ADDITIONAL RECORDS AND REPORTS 
11.0 
PREGNANCY 
12.0 
SUBJECT WITHDRAWAL 
13.0 
PHOTOGRAPHY 
14.0 
ADVERSE REACTIONS DEFINITIONS AND REPORTING REQUIREMENTS 
15.0 
PROTOCOL DEVIATIONS 
16.0 
CONFIDENTIALITY AND DISCLOSURE OF MEDICAL INFORMATION 
17.0 
CLINICAL RESEARCH CONDUCT  
18.0 
REPORTING FOR THE STUDY 
19.0 
DISCLOSURE 
20.0 
RESPONSIBILITY OF THE INVESTIGATOR 
21.0 
PROCEDURE FOR AMMENDMENTS TO PROTOCOL  
22.0 
TERMINATION OF STUDY 
23.0 
DATA SECURITY 
24.0 
REPORT OF PRIOR INVESTIGATIONS 
 
APPENDICES 
A. 
Protocol Revisions Tracker 
B. 
Universal Pain Assessment Tool 
 
 

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ATTACHMENTS/REFERENCES 
I. 
Instructions for Use manual for MyEllevate 
II. 
Informed Consent Form  
III. 
Post Treatment Instructions 
 

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1.0       PURPOSE 
1.1 Name and Intended Use  
The procedure used in this study is called the MyEllevate® procedure.  
 
The intended purpose of the MyEllevate® procedure used in this study is to assess the safety and 
efficacy of the procedure for soft tissue approximation and elevation of sub dermis and underlying 
muscle of the submentum & jawline.  
 
1.2 Objectives   
1. Primary Objective:  
 Safety assessment through the collection of Adverse Events. 
2. Optional Assessments: 
 Collection of digital 2-D and/or 3-D photography. 
 Photographic evaluation with correct identification of pre-treatment images when 
compared to the 30 and 90 day follow-up images performed by blinded reviewers. 
 Principle Investigator assessment using the Global Aesthetic Improvement Scale 
(PGAIS) at the 30 and 90 day follow up visit. 
 Subject assessment using the Global Aesthetic Improvement Scale (SGAIS) at the 
30 and 90 day follow up visit. 
 Subject satisfaction rates at the 30 and 90 day follow-up visit.  
 
3. Additional Safety Objectives: 
 Collection of Discomfort/Pain Scores 
 
1.3 Duration of the Investigation 
The sponsor anticipates that all subjects can be enrolled within 3 months.  If subject participates in 
all required visits, then the subject’s participation in this study may last up to 4 months. It is 
anticipated that it will take approximately 3 months to analyze the data collected during this study. 
The total duration of this study is anticipated to last approximately 10 months. 
 
2.0 
PROTOCOL 
2.1 Protocol Methodology and Analysis 
Methodology: 
Subjects are to be enrolled in this clinical study if they are a healthy male or female between the 
age of 18 – 65. Up to 10 subjects will be enrolled at 2 study centers. All subjects will attend a 
screening/pre-procedure visit which may be performed on the same day as the procedure visit but 
no more than 30 days prior to their procedure. Subjects will receive a phone call 1 week (1-10 
days) after their procedure to record side effects. Subjects will return for follow up visits at 30 and 
90 days post their procedure for efficacy and side effects assessments.  
 
An unscheduled visit or phone call may be performed at any time during the study at the request of 
the subject or as deemed necessary by the site Investigator. 
 
 
 
 
 

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Analysis: 
Upcoming generations are proving to have an interest in aesthetic treatments and will drive 
demand for innovated products, procedures, and practice design.i Due to this shift in patient base, 
practices need to evolve to adapt to the newer generational ideologies. There have been rapid 
advances in minimally invasive neck rejuvenation over the past few years and using innovative 
procedure offers great promise to our aging population. The MyEllevate® procedure used for soft 
tissue approximation and elevation of sub dermis and underlying muscle of the submentum and 
jawline needs to be further investigated to collect additional data to support the safety and efficacy 
of the procedure.  
 
Relevance: 
According to the 2020 Plastic Surgery Statistics Report, neck lifts are in the top 10 cosmetic 
surgical procedures performed, with over 160,000 surgeries performed despite the average 8.1 
weeks most surgeons stopped performing elective surgical procedures for due to the COVID-19 
pandemic.ii  There was also a survey conducted by American Society of Plastic Surgeons (ASPS) 
during the pandemic which found that 11% of women surveyed indicated they are more interested 
in cosmetic plastic surgery or non-surgical procedures now than before COVID-19. iii  Currently, 
the comparable procedures and/or treatments available for visible platysma bands, glands and/or 
sagging in the submentum, jawline and/or neck include, but not limited to, NeckTite and a neck 
lift. The limitations of current products on the market include different side effect profiles and how 
invasive the procedure is. 
 
Testability: 
The MyEllevate® device, had been previously cleared for use for use in soft tissue approximation 
and elevation of subdermis and underlying muscle. (FDA 510(k) K091061). This study will utilize 
the collection of photography and side effect data to assess the safety and efficacy of the 
procedure. 
 
Compatibility: 
Due to the increasing demand for aesthetic procedures, there is a need to treat visible platysma 
bands, glands and/or sagging in the submentum, jawline and/or neck in its earlier stages to 
optimize treatment outcomes. As a subject gets older or the condition worsens, their treatment may 
need to be more aggressive to get their body to respond the same way that a younger subject or less 
severe case may be able to respond. 
 
Predictive power: 
Although previous studies found this procedure to be effective for neck rejuvenation with few 
complicationsiv, data collection of the side effect profile of this procedure needs to be further 
investigated to confirm the safety of this approach. Assuming that there is significant 
improvement, it would be appropriate to expect results in different areas where other procedures 
and devices have significant results. 
 
2.2 Protocol Study Design 
This is a prospective, open label, multi-center clinical study to collect safety and efficacy data on 
the MyEllevate® device. 
 

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2.3 Subject Selection Criteria 
 
Subjects will meet the criteria described below: 
 
Inclusion Criteria: 
 A healthy male or female between the age of 18 – 65. 
 Must have any or all the following: visible platysma bands, glands and/or sagging in the 
submentum, jawline and/or neck.  
 Reads and understands English. 
 Understands and accepts obligation not to receive any other procedures on the treatment 
area through the length of the study. 
 Understands and accepts the obligation and is logistically able to be present for all visits. 
 Is willing to comply with all requirements of the study and sign the informed consent 
document. 
 
Exclusion Criteria: 
 Is pregnant or of childbearing potential and not using medically effective birth control, or 
has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy 
during the study. 
 Is currently enrolled in an investigational drug or device trial, or has received an 
investigational drug or been treated with an investigational device within in the area to be 
treated 6 months (or at the discretion of the Investigator) prior to entering this study. 
 Have received any treatments or procedures (including injectables such as Botox or fillers) 
in the area to be treated at least 4 months prior to treatment. 
 Take antiplatelets, anticoagulants, thrombolytics, or anti-inflammatories.  
 Have an active localized or systemic infection. 
 Have an open wound in area being treated. 
 Have a significant systemic illness or an illness localized in area being treated.  
 Have had recent surgeries or problems in the treatment area (e.g. neck fracture, neck sprain, 
pinched nerve, spondylosis, arthritis in the neck). 
 Have a history of thrombophlebitis.  
 Have a history of heart failure or kidney disease. 
 Have a history of allergic reaction or intolerance to the anesthesia used during the 
procedure. 
 Have a history of poor wound healing. 
 Have a history of poor circulation.  
 Have a systemic autoimmune disease known to impair wound healing.  
 Have a history of keloid formation.  
 Currently enrolled in an investigational drug or device trial, or has received an 
investigational drug or been treated with an investigational device within the area to be 
treated 6 months (or at the discretion of the Investigator) prior to entering this study. 
 Has any condition or is in a situation which in the investigators opinion may put the subject 
at significant risk, may confound study results or may interfere significantly with the 
subject’s participation. 
 

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Be sure to list all concomitant medications taken or procedures performed before, during and after 
the trial  
 
Subjects will be recruited for the study through the existing patient database and may also be 
recruited through advertisements. 
 
Subject populations will not be eligible to participate in the study if they are vulnerable 
populations such as children, pregnant women, prisoners, institutionalized individuals, and any 
persons requiring a legally authorized representative as part of the consenting process. 
 
Subject population characteristics that will not be eligible to participate in participate in the study 
include non-English speaking individuals and people who cannot read or comprehend English. 
Employees of the Investigator will be participating in the study.  
 
2.4 Screening  
Subjects will be asked questions about their medical history, may have a limited physical and their 
inclusion/exclusion criteria will be verified.  Discontinuation of any concomitant medications 
(such as aspirin, NSAIDS, herbals, vitamins, diet pills) will be discussed, and post treatment 
instruction will be reviewed with the subject.  
 
Procedure for the Limited Physical Exam: 
If the investigator determines that a limited exam is necessary, the exam will be like a basic annual 
physical exam performed by a primary care doctor to determine general overall health. The limited 
medical exam may include all or any of the following; vital signs such as blood pressure, heart 
rate, respiratory rate and body temperature, general appearance, listening to the heart, lungs and 
abdomen with a stethoscope, head and neck exam, in addition to examining the throat, tonsils, 
teeth, ears, eyes and nose as well as a neurological exam such as testing muscle strength, reflexes, 
balance, sensory changes of the extremities and mental state. 
 
2.5 Informed Consent Process and Enrollment 
Subjects will be asked to review the post treatment instructions prior to signing the informed 
consent form and their involvement in the study. The Investigator will be responsible for assuring 
the subject understands how to use each support device (neck brace and chin strap) and 
understands all requirements of the post treatment instructions.  Subjects will be informed of site’s 
COVID-19 procedures that adhere to federal and state guidelines at this time. Subjects who sign 
the informed consent will be screened to confirm eligibility and, if eligible, will be assigned a 
subject identification number. Subjects will be de-identified through their subject identification 
number, which will be stored in a secure location.  Subject identification numbers will be 
generated chronologically and assigned only to subjects who have met all the study selection 
criteria and have signed the informed consent form.  The informed consent will be obtained prior 
to a subject’s involvement in any study related procedures. A subject will be considered enrolled in 
the study once they have signed the informed consent form.  
 
The following post treatment instructions will be reviewed:  
 Resting: 

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When sleeping or lying down, should be positioned at a minimum incline of 45 degrees for 
first 10 days of recovery. 
 Chin strap: 
Wear at all times for 3 days. 
 Neck brace:  
Wear for 10 days while reading/watching TV/working on computer/looking down at 
phone. 
Secure neck brace every night before sleeping (to always keep head in neutral position). 
 Icing: 
Remove dressings to ice the procedure area using frozen peas for 20 minutes every hour 
while awake. Don’t apply directly on tissue use protective barrier i.e., paper towel. 
 Bathing/ Hygiene: 
May shower, using mild soaps or baby shampoo (not streaming directly on face, shower 
with back facing shower head). No shaving for 10 days but trimming or clipping hair is 
acceptable. 
 Avoid all alcohol consumption for 2 weeks after procedure. 
 
2.6 Pre-Treatment Procedures 
If the subject is of childbearing potential (i.e. females not post-menopausal or not surgically 
sterile), pregnancy verification will be required prior to their MyEllevate® procedure. Pregnancy 
verification will be performed by asking the subject if they are pregnant, the date of their last 
menstrual cycle, and be required to perform a urine pregnancy test at the site. A urine pregnancy 
test may also be conducted at the Investigator/clinician’s discretion at any time during the study at 
the study center. If a urine pregnancy test is conducted, then a negative result must be obtained. 
 
Urine Pregnancy Test Procedure: 
1. A urine sample is tested mid-stream or by cup sample with an indicator stick.  
2. Negative results are indicated on the indicator stick.  
 
 Photographs will be taken prior to the procedure.  
 
2.7 Treatment Procedures 
 The defined study area will be identified and may be marked with a surgical marker. 
 A local tumescent anesthetic, such as lidocaine, will be injected to the area prior to the 
procedure. 
 The MyEllevate® device will be used in accordance with the Instructions for Use (IFU) 
manual. 
 Subjects will be asked to report the general level of treatment discomfort/pain on a scale of 0 
(none) to 10 (maximum intolerable pain). 
 Photographs may be taken during treatment. 
 
2.8 Post Treatment Procedures 
 Adverse events will be documented after treatment. 
 Photographs may be taken post treatment.  
 Post treatment instructions will be reviewed with the subject. 

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 A diary will be handed to the subject to complete to track adverse events and when they were 
able to return to normal activities. They will need to bring this diary to all of their post 
procedure visits.  
 
  
 
2.8 Follow Up 
 Subjects will receive a phone call 1 week (1-10 days) after the procedure to record side effects. 
 Subjects will return for follow up visits at 30 and 90 days after the procedure. 
 Photographs will be taken and adverse events, and subject assessment (Subject Global 
Aesthetic Improvement Scale), and satisfaction will be documented. 
 Any subject affected by COVID-19 that is not able to attend their follow up visits to complete 
the study will be asked to return to the site for a final follow up visit within 1 year of last 
treatment. 
 
Some subjects may have an incomplete response or no response by the end of the study. At the end 
of the study, treatments/procedures using an FDA approved/cleared treatment method may be 
discussed with the subject and obtained at the cost of the subject. 
 
2.10 Unscheduled Visits 
An unscheduled visit may be performed at any time during the study at the subject’s request or as 
deemed necessary by the site Investigator. The date and reason for the unscheduled visit will be 
recorded in the source documentation. 
 
2.11 Replacement of Subjects 
Replacement of subjects who have withdrawn or been withdrawn from the study will be allowed to 
be replaced with prior approval from the sponsor and/or IRB. 
 
2.12 Schedule of Visits and Procedures 
 
Visit #1* 
Visit #2 
Call 
Visit #3 
Visit #4 
Procedure 
Screening and 
Pre-treatment 
Procedures 
Device Use 
 
Phone Call  
1 Week 
Post Device Use
(1-10 Days) 
Follow Up 
30 Days 
Post Device Use
(+/- 1 Week) 
Follow Up 
90 Days 
Post Device Use
(+/- 1 Week) 
Medical History 
X 
 
 
 
 
Pregnancy Verification
X
X
Informed Consent
X
Photographs (2D and/or 3D) 
X 
X 
 
X 
X 
MyEllevate Procedure 
 
X 
 
 
 
Parameters 
 
X 
 
 
 
Treatment Discomfort/ 
Pain Evaluation
 
X 
 
 
 
Subject Diary 
 
X 
 
X 
X 
Subject Satisfaction 
Questionnaire
 
 
 
X 
X 
PGAIS 
 
 
 
X 
X 

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SGAIS 
 
 
 
X 
X 
Adverse Events Assessment 
X 
X 
X 
X 
X 
 
*Screening and Pre-treatment Procedures may occur at the same time as the Device Use visit. 
 
2.13 Evaluation Methods 
Photographs: 
Photographs (2D and/or 3D) will be taken at baseline and at the 30 and 90 day follow up visit to 
assess the efficacy and safety of treatment. 2D photography may be taken at any time during the 
procedure to document performance and/or adverse events. 
 
Treatment Discomfort/Pain Evaluation: 
Subjects will be asked to report the general level of treatment discomfort on a scale of 0 (none) to 
10 (maximum intolerable pain) using the universal pain assessment tool (Appendix B) 
 
Physician and Subject Questionnaire:  
The Global Aesthetic Improvement Scale (GAIS) ranging from “worse” to “very much improved” 
will be used to judge the improvement as seen by the subject and Investigator. 
 
 
 
 
 
 
 
 
 
 
 
Subject Questionnaire:  
The subject will be asked their level of satisfaction using a 6-point Likert scale that ranges from 
“extremely satisfied” to “extremely unsatisfied.” 
 
Subject Satisfaction 
Rating 
Description 
6
Extremely Satisfied
5 
Satisfied 
4 
Slightly Satisfied 
3 
Slightly Unsatisfied 
2 
Dissatisfied 
1 
Extremely Unsatisfied 
 
Blinded Evaluation: 
Three blinded independent reviewers will perform a photographic evaluation in which they will be 
asked to identify pre-treatment images when compared to post treatment images. The reviewers 
Global Aesthetic Improvement Scale Assessment 
Rating
Description
1
Very Much Improved- Optimal cosmetic result in this subject 
2 
Much Improved- Marked improvement in appearance form the initial 
condition, but not completely optimal for this subject.   
3 
Improved- Obvious improvement in appearance from initial condition, but a 
re-treatment is indicated. 
4
No Change- The appearance is essentially the same as the original condition. 
5
Worse- The appearance is worse than the original condition. 

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will be Board Certified Dermatologist, Surgeons, and/or trained professionals and will be chosen 
based on availability and have relevant clinical experience. They will attend a training session 
prior to grading.   
  
2.14 Adverse Event Recording 
All data captured must be supported by the Investigator’s timely assessment and documentation of 
the adverse event in the case report forms or source documents.  All documented adverse events 
will be reviewed by the Sponsor or designee to determine whether the adverse event meets 
regulatory reporting requirements and to ensure timely adverse event reporting to meet local and 
global regulatory requirements. All adverse events must be followed until their resolution. 
 
Adverse Events Pertaining to the MyEllevate® Procedure: 
Mild discomfort during treatment may be experienced by the subject. Anticipated side effects 
include pain, edema (swelling) and erythema (redness), bleeding, bruising, and limitations in 
opening mouth. 
 
Other possible side effects may include; dimpling, infection, poor wound healing, facial asymmetry, 
hematoma (fluid accumulation), numbness or other changes in skin sensation, temporary or 
permanent hair loss along incisions, scarring, burns (up to 3rd degree), tissue hardness, weakness of 
the lower lip, skin irregularities, skin discoloration, suture surfacing, deep venous thrombosis with 
cardiac or pulmonary sequelae, facial nerve paresis of the mandibular bands.  
 
Adverse Events Pertaining to Anesthetic: 
Pain and numbness may be experienced at the site of the injection. Other side effects may include 
redness, blanching, swelling, application site reaction, rash, infection, skin damage or nerve damage 
at the site of the injection. Temporary loss of sensation and muscle function at the site of injection, 
although uncommon, may also be experienced. 
 
1% lidocaine (Lidocaine) with Epinephrine Injection 
Lidocaine with epinephrine contains the preservative sodium metabisulfite which may cause 
allergic-type reactions including anaphylactic symptoms such as itching, hives, swollen areas of the 
body, and/or trouble breathing and life-threatening or less severe asthmatic episodes in certain 
susceptible people. If the subject has a reaction, medical attention may be provided or they may need 
to seek emergency care. 
 
Adverse Events Pertaining to the Surgical Marker: 
Using surgical marker has minimal risks and may produce effects on the body such as redness or a 
rash. Markings may remain visible for a few days or may be removed with alcohol. 
 
Other Cautions: 
Incomplete response or no response may occur since some subjects may not respond to treatment. 
 
2.15 Statistical Analysis 
 
2.15.1 Hypothesis 

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For this study to be considered a success, the side effect profile is acceptable to the Physician as it 
relates to this type of treatment. 
 
For the additional assessments to be considered a success, the following must be true: 
 
Subject satisfaction will be ≥80% 
 
In cases where the subject’s improvement is being graded on a scale, such as the GAIS 
scale, we will test the statistical significance of our results against a hypothetical population 
that would have no change (average score of 4). 
 
Correct identification of pre-treatment images when compared to post treatment (90 day) 
images will be ≥80%. 
 
Subject diaries are collected. 
 
2.15.2 Sample Size Rationale 
Based on the need for data collected from this study, it was determined that a total of 10 subjects 
will be required, including departures. 
  
2.15.3 Patient Populations 
Interim results may be collected and reported.  All data will be analyzed at the end of the study.  
The primary analysis will be performed by the intention-to-treat approach. Everyone who begins 
the treatment is part of the study whether he or she completes the study or not. The most 
appropriate method of handling missing values will be chosen based on the individual trial goals, 
endpoints and context. 
 
The analysis of demographic, medical history, and efficacy variables will be based on all patients 
who are randomized and receive at least one treatment. The analysis of safety data will be based on 
all patients who receive at least one treatment, and have at least some safety data.  
  
2.15.4 Analysis of Demographic and Medical History Variables 
Summaries will be prepared for all important demographic and medical history variables. For 
quantitative variables summaries will include the sample size, mean, median, standard deviation, 
minimum, and maximum.  For these variables the treatment groups will be compared using either a 
t-test or a Wilcoxon Rank Sum test, as appropriate.  For categorical variables the summaries will 
include the sample size and the number and percent of patients for each outcome.  For these 
variables the treatment groups will be compared using Fisher’s Exact test.  Statistical significance 
will be declared if the two-sided p-value is < 0.05.  
  
2.15.5 Analysis of Efficacy Variables 
Additional efficacy variable is the change from baseline to Visit 4 (90 day follow up visit). 
Baseline is defined as the last assessment prior to the first treatment. The change from baseline to 
visits 3 and 4 will be analyzed using a Mixed Model Repeated Measures Analysis of Variance.  A 
pairwise treatment group comparison at visit 4 will be performed using the results of this analysis.  
If a patient has no post-baseline assessment of the primary efficacy variable it will be assumed that 
the change from baseline to visit 4 is zero.  The changes to visits 3 and 4 will be left as missing.  
Statistical significance with respect to the treatment group comparison at visit 4 will be declared if 
the two-sided p-value is < 0.05.  For each treatment group, summaries will be prepared for both the 
observed assessment and the change from baseline.  The summaries will include the sample size, 

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mean, median, standard deviation, minimum, and maximum.  The statistical significance of the 
mean change from baseline for each treatment group will be determined using a paired t-test. 
 
2.15.6 Analysis of Safety Variables 
Safety will be assessed through the degree of pain/discomfort related to the procedure (universal 
pain scale) and the collection of Adverse Events throughout the course of the study.  For each 
treatment group these variables will be summarized.  The summaries will include the number and 
percent of patients for each outcome.  No statistical comparisons will be performed for any of 
these variables. 
 
3.0 
 RISK ANALYSIS AND MANAGEMENT  
3.1 Risk Determination 
This device study used in this study does not meet the FDA definition for a Significant Risk 
Device study per 21 CFR 812.3(m).  Therefore, the sponsor determines that this is a non-
significant risk device study. 
 
Significant risk device means an investigational device that: 
(1) Is intended as an implant and presents a potential for serious risk to the health, safety, or 
welfare of a subject; 
(2) Is purported or represented to be for a use in supporting or sustaining human life and presents a 
potential for serious risk to the health, safety, or welfare of a subject; 
(3) Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or 
otherwise preventing impairment of human health and presents a potential for serious risk to the 
health, safety, or welfare of a subject; or 
(4) Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject. 
 
3.2 Risk Management  
The Investigator in this clinical trial has been invited to participate based on his/her previous 
experience with the use of the system and/or similar systems and industry experience.  Experience 
with treatments is the most critical element in managing subject risk in this trial. 
 
In addition, as with any study, there is a risk of bias. Objective evaluation methods may be used in 
conjunction with subjective evaluation methods when feasible.  The value of the compensation to 
the clinical investigator for conducting the study is not influenced by the study outcome.  If 
photographic results are listed as the primary objective, they are to be evaluated by blinded 
evaluators who did not partake in the study.  If information concerning investigator assessment of 
improvement or investigator satisfaction is collected, then it is not listed as an objective for the study. 
 
All other known risks will be disclosed to the subject via the informed consent process. Since this 
is an elective procedure and the subjects are volunteers, it can be assumed that their signature on 
the informed consent is indicative of their agreement to accept the risks involved. 
 
The risks to the subjects who participate in this study are the same as those for the subject 
undergoing similar non-ablative radiofrequency treatment. It is possible to have an adverse 
reaction to the MyEllevate® procedure. There may be some side effects that we don’t know about 
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3.3 Risk Analysis 
 
CONTEXT OF THE PROPOSED INVESTIGATION: 
Aging of the neck is characterized by a loss of skin elasticity, and is often accompanied by 
increased submental fat, ptosis of the neck, and a weakening of the platysma muscle. As a result, 
the inferior border of the mandible often loses definition, prompting patients to seek surgical 
correction. Various surgical and nonsurgical techniques have been described to lift the neck, 
including laser skin resurfacing, submental liposuction, skin tightening procedures, skin excision 
procedures, platysmaplasty, suspension sutures, and modification of the digastric muscle. More 
invasive procedures carry increased risks of complications. Therefore, minimally-invasive 
procedures of the neck represent a safer approach to address the aging process of the neck and 
deliver the desired result of restoration. 
 
ASSESSMENT OF RISKS OF THE PROPOSED INVESTIGATION: 
The risk identified with the overall clinical investigation is the integrity of the data collected. There 
are multiple clinical mitigation strategies for the risks identified. Proper training on the device and 
protocol will be performed. Data from prior investigations will be utilized to minimize side effects 
and optimize treatment outcomes. Monitoring of the study will be implemented to minimize 
subject and data risks. 
 
ASSESSMENT OF BENEFITS OF THE PROPOSED INVESTIGATION:   
The subject may or may not have improvement for the indication treated. 
 
CONSIDERATION OF PATIENT PREFERENCE INFORMATION: 
Many physicians support the use of minimally invasive cosmetic treatments in response to high 
patient satisfaction of cosmetic results with the currently available procedures and device. 
However, there is still a level of interest in novel technologies that could reduce the risk of 
complications and the need for future treatments.  
 
ASSESSMENT OF UNCERTAINTY: 
There is uncertainty of the safety profile and efficacy results with the MyEllevate® procedure. 
 
CONCLUSION: 
This device is determined to be a non-significant risk study and will be using a device cleared for use 
by the FDA.  
 
Patient population to be enrolled in this clinical study:  
Total anticipated population: 10 Subjects 
Age Range: 18 – 65 years of age 
Gender: Male or Female 
Condition: Visible platysma bands, glands and/or sagging in the submentum, jawline and/or neck. 
 
4.0  
DEVICE DESCRIPTION AND SPECIFICATIONS 
 
 
 

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Device Name 
Date of 510(k) 
Indication(s): 
ICLED Surgical 
Suture System 
09 October 2009 
K091061 
Indicated for soft tissue 
approximation and elevation 
of sub dermis and underlying 
muscle of the submentum & 
jawline 
 
 
The ImplicitCare ICLED Surgical Suture System provides a minimally invasive means of 
performing reconstructive, plastic and cosmetic surgery procedures by eliminating the need for 
extensive subdermal undermining through a large incision. Rather, the suture is guided 
subcutaneously using rigid rods like blunt-tipped needles. The ICLED Surgical Suture System, is a 
sterile, single use device kit consisting of five (5) device components: 
1.) 
Marking Tape: Intended to locate the marking sites of suture insertion. The backing of the 
tape is a medical acrylic adhesive 
2.) 
Lancet: Intended to puncture the skin at the site of suture insertion. The Lancet creates a 
perforation just large enough to pass the Suturod™ and suture. 
3.) 
Clearing Device: Intended to sweep away any dermal attachments for a 360° radius around 
the skin puncture made by the Lancet.This helps prevent “dermal tethering” as the suture is passed. 
4.) 
Suturod™: Stainless steel, connected at the midpoint by a 100” (254 cm) length of USP 4-0 
(1.5 Metric) TEVDEK® II braided nonabsorbable polyester Suture. The suture, acquired directly 
from Teleflex, is coated with polytetrafluoroethylene (PTFE) for improved handling characteristics 
and to reduce “tissue drag,” and is green in color. 
5.) 
Light Tool (Handle): Contains an LED light source supplied by three (3) 1.55V silver oxide 
batteries, and which connects to the Suturod™ When connected, the light created by the LED 
passed through the fiber optic light pipe within the Suturod™ and Illuminates the distal tip. This 
permits visual verifications—through the dermis—of both the path and depth of the Suturod™ as 
it passed through the subdermal tissue. 
 
Device Description  
Device Image 
Lancet: consists of a 400 seties 
stanless steel blade in a 
polycarbonate handle. 
 

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Device Description  
Device Image 
Clearing Device: right angled 
300 series stainless steel rod 
0.078” in diameter extending 
from the distal end of a 
polycarbonate handpiece. 
 
Suturod™ Rod: The Suturod™ 
is 0.078” in diameter, 8.5” long, 
is composed of 300 series 
stainless steel, and is hollow, 
with a fiber optic light pipe 
running the length of the 
Suturod™ internally. 
 
Light Handle: Consists of a 
polycarbonate handle into which 
the end of a Suturod™ may be 
connected. Simple mechanical 
switch internal to the Light 
Handle illuminates the LED as 
the Suturod™ is connected. The 
LED is a 5mm white LED rated 
at 25mA maximum at 3.6V. The 
LED is powered by three (3) 
silver oxide “button cell” 
batteries within the Light Tool, 
each of which produces 
approximately 1.2V. 
 
 

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The device manufacturer is: 
IMPLICITCARE, LLC 
830 Challenger St, Suite 120 Brea, CA 
92821 USA 
 
 
5.0 
MONITORING PROCEDURES  
The Sponsor Standard Operating Procedure (SOP) for monitoring the investigative site will be 
followed. The sponsor will train the site following sponsor SOP’s and may be present at initiation 
of treatment.  The sponsor will also monitor the site periodically. The Investigator/Institution will 
permit trial-related monitoring, audits, IRB/IEC review, and regulatory inspections by providing 
direct access to source documents.  The sponsor may request intermediate data following each visit 
to evaluate treatment progress. Case Report Forms will be reviewed for current data and 
Regulatory Binders will also be reviewed for correct documents. The sponsor will collect data at 
the end of the follow up period. The sponsor will list the study on clinicaltrials.gov when required 
by FDA regulations.  
 
The monitoring plan for this study is outlined in the Cynosure Monitoring Plan.  
 
ASSIGNED CLINICAL RESEARCH MONITOR: 
Monitor #1 
Name: Kristy Luis 
Institution: Cynosure, LLC 
Address: 5 Carlisle Rd. Westford, Ma  
 
6.0  
LABELING  
Sample labeling will follow FDA regulations and the sponsor standard operating procedure.  
If applicable, the MyEllevate® device label will include, (in accordance with 801.1):   
 
Statement: "CAUTION--Investigational device. Limited by Federal (or United States) law to 
investigational use."  
 
Additionally, the label or other labeling will describe all relevant contraindications, hazards, 
adverse effects, interfering substances or devices, warnings, and precautions. 
 
Directions for use are contained in the MyEllevate® IFU.  
 
7.0  
CONSENT MATERIALS 
Forms and informational materials which are provided to the subject during the informed consent 
process are listed below: 
 
Form/Informational Material 
Description 
Post Treatment Instructions 

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Informed Consent Form 
 
 
8.0  
INSTITUTIONAL REVIEW BOARD INFORMATION 
This protocol, informed consent forms, and any amendments to the protocol will be reviewed by 
the appropriate Institutional Review Board prior to initiation.  The study will not be initiated 
without the approval from the Institutional Review Board.  
 
IRB Contact Information: 
IRB Name: Allendale Investigational Review Board 
IRB Chairperson: Robert Staab 
IRB Address: 30 Neck Rd. Old Lyme, CT 06371 
Phone: 860-434-5872 
Fax: 860-434-5892 
Email: Rta1ali1@aol.com 
 
 
9.0  
OTHER INSTITUTIONS  
If a part of the study is conducted by an institution that has not previously been identified within 
the Investigational plan each institution’s contact information will be documented below; 
 
No other institutions will be part of this study. 
 
 
10.0  ADDITIONAL RECORDS AND REPORTS  
If this is an IDE study, additional records and reports will be maintained on the investigation in 
addition to those prescribed in 21 CFR 812 sub-part G. If this is a non-IDE study, the study 
summary will be maintained on the investigation and may include those prescribed in 21 CFR 812 
sub-part G.   
 
Additional Records and Reports: 
Report    
Submit To   
Description/Constraints 
N/A 
N/A 
This is a non-IDE study; no additional records or 
reports will be maintained. 
 
 
11.0  PREGNANCY 
Females may not participate in this study if they are pregnant, breastfeeding, were pregnant within 
the last three months or are planning a pregnancy during the study.   
 

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If the subject thinks they have become pregnant during the study, it is important that they inform the 
Investigator immediately. If she becomes pregnant or thinks that she may be pregnant, she will be 
removed from the study and will be asked to perform a final evaluation similar to the final follow-
up visit.  The Investigator may request to track the pregnancy and will report the pregnancy to the 
Sponsor. 
 
12.0      SUBJECT WITHDRAWAL  
The subject is free to withdraw from this study at any time. The subject must inform the Investigator 
immediately if they intend to withdraw. To terminate the subject’s participation in this study, they 
must contact the Investigator at the contact information listed on page one of the informed consent 
form. They will be asked to come to the study clinic or Investigators office to complete a final follow 
up visit and may be asked to perform end of study procedures.  Their decision to participate in this 
study or to withdraw from this study will not influence the availability of their future medical care and 
will involve no penalty or loss of benefits to which they are otherwise entitled. 
 
The Investigator in charge of the study can remove the subject from this study without their consent 
for any reason, including, but not limited to: 
a) His/her judgment that any condition or circumstance may jeopardize their welfare or the integrity 
of the study. 
b) Their failure to follow the instructions of the Investigator(s). 
c) If the study is stopped by the sponsor and/or Investigators participating in the study prior to 
completion. 
 
Data collected prior to withdrawal will be used in data analysis but after withdrawal no further data 
will be collected.  
 
13.0  PHOTOGRAPHY 
Standardized photographs will be taken of the treatment area. The subject will be asked to remove 
jewelry, make-up, and lotions prior to each photo session. Photographs will be taken with an 
appropriate high-resolution digital camera. Camera settings (lighting, distance, background, 
polarization, etc.) will be reproduced at each visit, so that photographs are suitable for comparison.  
Photographs will be taken of the treatment area for study purposes.  If the subject does not wish to 
have their photographs taken, they cannot be in the study.  
 
14.0  ADVERSE REACTIONS DEFINITIONS AND REPORTING REQUIREMENTS 
All adverse events that occur, starting from the time of the first treatment, will be recorded in the 
source documents and Case Report Forms (CRF). 
Adverse Events (AE) occurring will be captured and followed until the condition resolves, 
stabilizes, is otherwise explained, or the subject is lost to follow-up. Subjects will be instructed that 
they may contact the Investigator at any time throughout the course of the study. 
The Investigator and/or designated study staff will review each event and assess its relationship to 
the study device (not related, unlikely, possible, probable, and highly probable). The following 
definitions will be used for rating relationship to the MyEllevate® procedure:  

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 Not related – The event is clearly related to other factors such as the subject’s clinical state, 
therapeutic interventions, or concomitant medications administered to the subject. 
 Unlikely – The event was most likely produced by other factors such as the subject’s clinical 
state, therapeutic interventions, or a concomitant medication administered to the subject; and 
does not follow a known response pattern to the investigational product. 
 Possible – The event follows a reasonable temporal sequence from the time of investigational 
product administration; and/or follows a known response pattern to the study sampling 
sessions; but could have been produced by other factors such as the subject’s clinical state, 
therapeutic interventions, or concomitant medications administered to the subject. 
 Probable – The event follows a reasonable temporal sequence from the time of investigational 
product administration; and follows a known response pattern to the investigational product; 
and cannot be reasonably explained by other factors such as the subject’s clinical state, 
therapeutic interventions, or concomitant medications administered to the subject. 
 Highly Probable – The event follows a reasonable temporal sequence from the time of 
investigational product administration; and follows a known response pattern to the 
investigational product; and cannot be reasonably explained by other factors such as the 
subject’s clinical state, therapeutic interventions, or concomitant medications administered to 
the subject; and either occurs immediately following investigational product administration, or 
improves on stopping the investigational product, or reappears on repeat exposure, or there is a 
positive reaction at the application site. 
 
Each adverse event reported will be graded on a 3-point severity. Using the following 
definitions for rating severity will be used: 
 Mild – easily tolerated, causing minimal discomfort, and not interfering with normal everyday 
activities. 
 Moderate – sufficiently discomforting and may interfere with normal everyday activities. 
 Severe – incapacitating and/or preventing normal everyday activities. 
 
A Serious Adverse Event (SAE) is any adverse device experience that results in any of the 
following outcomes:  death, a life-threatening adverse device experience, in-patient hospitalization 
or prolongation of hospitalization, a persistent or significant disability/incapacity, or a congenital 
anomaly/birth defect. Important medical events that may or may not result in death, be life-
threatening, or require hospitalization may be considered a serious adverse device experience 
when, based upon appropriate medical judgment, they may jeopardize the subject or subject may 
require medical or surgical intervention to prevent one of the outcomes listed in this definition 
 
If any of the above adverse events are serious as defined by the FDA Code of Federal Regulations 
(CFR), Title 21, special procedures will be followed.  All serious adverse events will be reported 
within 24 hours of acknowledgment to the Sponsor whether or not the serious events are deemed 
sampling session-related.  All serious event reporting will adhere to 21 CFR part 812 and the IRB 
will be notified accordingly.  
 
  
The SAE information will be entered into the database and a desk copy of the complete SAE report 
will be submitted to the study file.  
 

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Adverse events, whether serious or non-serious, will be followed until the condition is resolved, 
stabilized, otherwise explained or the subject is lost to follow-up.  Adverse events will be captured 
throughout the study and where appropriate, medical tests and examinations will be performed to 
document the resolution of event(s). Outcomes may be classified as resolved, improved, 
unchanged, worse, fatal, unknown or lost to follow-up.  Following the resolution of any study-
associated adverse events there will be no further adverse event reports for that subject. 
 
Reporting Adverse Events: 
Report    
Submit To   
Description/Constraints 
Adverse 
Events, 
Unanticipated 
Adverse 
Device 
Effect
 
IRB 
and 
Sponsor 
If an unforeseen complication is determined to be 
an unanticipated adverse device effect, the 
investigator’s report must be submitted within 10 
working days after the investigator first learns of 
the effect. 
Serious 
Adverse 
Events 
IRB 
and 
Sponsor 
The sponsor must be notified within 24 hours of 
serious adverse events. The IRB must be notified 
within 1 working day of serious adverse events as 
defined by FDA guidelines.  
 
15.0  PROTOCOL DEVIATIONS 
All requests for protocol deviations by the Investigator must be communicated to the sponsor in 
writing and if accepted by the Sponsor must be approved by the IRB.  If a deviation occurs, the 
Investigator must inform the Sponsor as soon as possible.  The Sponsor will notify the IRB in 
accordance with IRB specific policies. 
 
 
16.0  CONFIDENTIALITY AND DISCLOSURE OF MEDICAL INFORMATION 
As part of this study the Investigator and the team at the research facility will keep records of subject 
participation in the study.  These study records will include personal information that the subjects 
provide including age, sex, etc., the results of the study, information about response to treatments, 
photographs taken during the study and other medical information relating to participation in the 
study.   
 
Under federal law the study records cannot be used or disclosed by the Investigator for research 
purposes unless subjects sign the informed consent authorization. 
 
Some or all of the test results, photographs and other information will be reported to Cynosure, LLC, 
the manufacturer of the test device (Sponsor), and consultants that are helping conduct the study.  
The Sponsor and its consultants will analyze and evaluate these results and information and may 
report them to the U.S. Food Administration and the FDA, Institutional Review Board or other 
regulatory agencies in the United States and/or foreign countries.  The subject’s study records will 
be assigned a code number by the study team and they will ordinarily not be identified by name in 

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the study records that are sent to the Sponsor and its consultants.  However, The Sponsor, the 
Institutional Review Board and its consultants will have the right to see the complete study records, 
including the subject’s name, and might choose to do so.  If reports or articles are written about the 
study, the subject will not be identified by name in them however your study information and 
photographs may be used. 
 
The research facility will review and use the study records only for purposes of this study.  They 
will keep the subject’s identity confidential and, except for the disclosures described above, will not 
disclose the study records to other parties unless disclosure is required by law.  Once the research 
facility discloses information in the study records, photographs or medical records to the Sponsor or 
its consultants, the information will no longer be protected by federal law.  Because of the need to 
release information to these parties, absolute confidentiality cannot be guaranteed.  However, the 
Sponsor and its consultants will only use information for purposes of the study and will not disclose 
your study records to parties other than; the FDA or other regulatory agencies in the United States 
and/or foreign countries, unless disclosure is required by law.  If reports or articles are written about 
the study, subjects will not be identified by name in them however, subject study information and 
photographs may be used. 
 
Study records will be kept at the research facility according to applicable regulations and policies 
and may be kept indefinitely following the completion of the study. Subjects will not have the right 
to review their records while the research is in progress.  However, they will be able to review their 
records after the research has been completed. 
 
17.0  CLINICAL RESEARCH CONDUCT 
The study will be conducted in accordance with the protocol, International Conference on 
Harmonization (ICH) GCP guidelines, applicable regulations and guidelines governing clinical 
study conduct and ethical principles that have their origin in the Declaration of Helsinki.  The 
investigator must ensure that the study is conducted in accordance with the provisions as stated in 
the FDA regulations and complies with the applicable local or regional regulatory requirements. 
 
18.0  REPORTING FOR THE STUDY 
A study summary report will be generated.  It will include a description of the clinical conduct of 
the study and results. 
 
Study Summary Reporting:                     
 
Report 
Submit To 
Description/Constraints 
Deviation 
from 
Investigational 
Plan 
IRB 
and 
Sponsor 
A deviation performed in an emergency to protect 
the life or physical well-being of a patient 
necessitates notification of the IRB and sponsor. 
The Investigator’s report must be submitted within 
5 working days after the emergency occurred. 
Deviations in a non-emergency situation require 
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Failure to 
Obtain 
Informed 
Consent 
 
IRB 
and 
Sponsor 
 
 
The Investigator must make notification within 5 
working days after device use, using the Protocol 
Deviation CRF. The report must include a brief 
description of the circumstances justifying the 
failure to obtain informed consent. 
Final Report 
IRB 
and 
Sponsor
The Investigator must submit a final report within 3 
months after termination or completion of the 
investigation.
Withdrawal of 
IRB approval 
Sponsor 
 
The Investigator must report a withdrawal of the 
reviewing IRB approval within 5 working days. 
Progress 
Report 
IRB, Monitor 
and 
Sponsor
The Investigator must submit progress reports at 
regular intervals, and as required by the IRB, but in 
no event less than annually.
 
 
19.0  DISCLOSURE 
The Principal Investigator and Cynosure employees and consultants have signed confidentiality 
agreements with the sponsor.  This confidentiality agreement ensures that all information provided 
to the Investigator or Data Management and Statistics group dealing with the study and information 
obtained during the study will be regarded as confidential. 
 
20.0  RESPONSIBILITY OF THE INVESTIGATOR 
The Investigator is responsible for ensuring that the clinical study is performed in accordance with 
the International Conference on Harmonization (ICH), Good Clinical Practice (GCP) guidance E6, 
FDA Good Clinical Practice Regulations, Declaration of Helsinki (DoH) and the Health Human 
Service (HHS) Belmont Study. Investigators will supply information to the sponsor such that the 
sponsor can comply with the Financial Disclosure Rules. 
 
21.0  PROCEDURE FOR AMMENDMENTS TO PROTOCOL 
No deviations from this protocol will be permitted, except in a medical emergency, without the 
approval of the Sponsor.  Any amendment to this study will be discussed by the Investigator and the 
Sponsor.  If agreement is reached concerning the need for modification, this will be made in a formal 
amendment to the protocol. 
 
All revisions and/or amendments to the protocol must be approved in writing by the appropriate 
Institutional Review Board. 
 
22.0  TERMINATION OF STUDY 
The Sponsor reserves the right to discontinue this study for administrative reasons at any time.  The 
Investigator reserves the right to discontinue the study for safety reasons at any time in collaboration 
with the Sponsor. 
 
23.0  DATA SECURITY 

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To ensure the privacy and confidentiality of data for this protocol, the data will be stored on a 
restricted access location on a company server. Access to the project directory containing the data 
will be limited to the Investigators and research staff.  Information about data security awareness is 
promoted through user training and education, supplemented by policies and procedures. Password 
protection will be used for all transactions that allow viewing, editing, and analysis of data, or that 
provide access to data fields derived from the original source documents. 
 
24.0  REPORT OF PRIOR INVESTIGATIONS 
 
The report of prior investigations or predicates are: 
 
Device 
Determination 
510(k) 
Featherlift Extended 
Length Aptos 
Threads (Contour 
Threads) 
 
Meets the criteria for exemption from 
IDE regulations, non-significant risk 
K041593 
FaceTite™  
Meets the criteria for exemption from 
IDE regulations, non-significant risk 
K151793 
 
Protocol 
Device 
IRB Name 
Determination 
Initial IRB 
Approval Date 
7053-RETRO-2022 
MyEllevate
® 
AIRB 
Meets the criteria for 
exemption from IDE 
regulations, non-significant 
risk 
3/3/2022 
 
 
 
APPENDIX A: 
Protocol Revisions Tracker 
 
Version 
Date 
Editor 
Description 
June 5, 2022 
Kristy Luis 
IRB Submission 
June 14, 2022 
Kristy Luis 
IRB Response 
 
 
 
 
 
 

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APPENDIX B: 
 
 

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REFERENCES 
 
i Sherber, N. S., MD FAAD. (2018). The Millennial Mindset. Journal of Drugs in Dermatology, 17(12), 
1340-1342. 
ii American Society of Plastic Surgeons. (2020) Plastic Surgery Statics Report. Available at 
https://www.plasticsurgery.org/documents/News/Statistics/2020/plastic-surgery-statistics-full-report-
2020.pdf 
iii American Society of Plastic Surgeons. (2020) American Society of Plastic Surgeons Unveils COVID-
19's Impact and Pent-Up Patient Demand Fueling the Industry's Current Post-Pandemic Boom. Available 
at https://www.plasticsurgery.org/news/press-releases/american-society-of-plastic-surgeons-unveils-
covid19s-impact-and-pent-up-patient-demand-fueling-the-industrys-current-post-pandemic-boom 
iv Gregory P. Mueller, Norman Leaf, Sherrell J. Aston, Corbett W. Stone, The Percutaneous Trampoline 
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