Post Market Clinical Follow Up Study to Collect Additional Data and Imaging
Phase: NA
Conditions: Connective Tissue Defect
Sponsor: Cynosure, Inc.

PROTOCOL #: SW-MCPM-2021 
 
 
 
   
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Post-Market Clinical Follow Up Study to Collect Additional Data and Imaging 
NCT04880070 
Document Date: April 7, 2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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INVESTIGATIONAL PLAN 
 
PROTOCOL #: SW-MCPM-2021 
 
POST MARKET CLINICAL FOLLOW UP STUDY TO COLLECT ADDITIONAL DATA 
AND IMAGING 
 
 
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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POST MARKET CLINICAL FOLLOW UP STUDY TO COLLECT ADDITIONAL DATA AND IMAGING 
 
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: 
Sean Doherty, M.D. 
5 Carlisle Rd 
Westford, MA 01886 
Phone: 617-735-8735 
Email: info@seandohertymd.com 
 
SITE #2 CONTACT INFORMATION:  
Principal Investigator Information: 
David H. McDaniel, M.D., F.A.A.D. 
McDaniel Institute of Anti-Aging Research 
125 Market Street 
Virginia Beach, VA 23462 
Phone: 757-437-8900 
Email: dhm@miaar.com 
 
SPONSOR CONTACT INFORMATION: 
Jennifer Civiok 
Director, Clinical Development  
5 Carlisle Road 
Westford, MA 01886 
Phone: 978-399-4343 
Email: Jennifer.Civiok@cynosure.com 
 
 
Alexander Denis 
Clinical Research Supervisor,  
Clinical Development  
5 Carlisle Road 
Westford, MA 01886 
Phone: 978-895-9206 
Email: Alexander.Denis@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 
Optional Biopsy Portion 
2.11 
Unscheduled Visits  
2.12 
Replacement of Subjects 
2.13 
Schedule of Visits and Procedures  
2.14 
Evaluation Methods 
2.15 
Adverse Event Recording  
2.16 
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. 
OrthoGold Instructions for Use Part 1 
II. 
OW100 Instructions for Use Part 2 
III. 
SoftWave Protocol Manual 
IV. 
Informed Consent Form  
V. 
Post Treatment Instructions 
VI. 
510(k) Clearance(s) 

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1.0       PURPOSE 
1.1 Name and Intended Use  
The device used in this study is called the SoftWave device. 
 
The intended use of the SoftWave device used in this study is to assess the usability and tissue 
response to shock wave treatment and to support additional marketing claims. 
 
1.2 Objectives   
1. Primary Objective:  
 Collection of Treatment Discomfort/Pain Evaluation 
2. Additional Objectives: 
 Evaluation of tissue response through Biopsies at multiple timepoints up to 30 days 
post treatment (optional): 
o Sample staining as appropriate, such as H&E 
o Nano-string for Gene Expression 
 Device comparison treatment with similar low-intensity shockwave device 
(optional). 
 Photographic evaluation with Vivosight imaging at the 30 and/or 90 day follow up 
compared to baseline (optional). 
 Photographic evaluation with 2D and/or 3D imaging at the 30 and/or 90 day follow 
up compared to baseline (optional). 
 Subject treatment assessment through questionnaires (optional): 
o Subject treatment experience questionnaire  
o Subject follow up questionnaire 
o Subject satisfaction questionnaire 
 Clinician treatment assessment through questionnaires (optional): 
o Clinician treatment questionnaire 
o Clinician satisfaction questionnaire 
3. Safety Objectives: 
 
Collection of Adverse Events 
 
 
1.3 Duration of the Investigation 
The sponsor anticipates that all subjects can be enrolled within 6 months.  If subject participates in 
all required visits, then the subject’s participation in this study may last up to 6 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 15 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 18 – 65 years 
of age. Up to 50 subjects will be enrolled at 2 study centers. Subjects will attend a 
screening/pretreatment visit which may be performed on the same day as the treatment visit. 
Subjects may receive up to 5 treatments with the study device. Subjects may also receive treatment 

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with a similar shockwave device. Subjects may be consented to have biopsies collected at a 
specific time after their final treatment, which will occur up to 30 days post treatment.  Follow up 
visits may occur 30 and 90 days post last treatment visit.  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. 
 
 
Analysis: 
Upcoming generations are proving to have an interest in non-ablative aesthetic treatments and will 
drive demand for innovated products, procedures, and practice design.1 Due to this shift in patient 
base, practices need to evolve to adapt to the newer generational ideologies. This device will be 
using the SoftWave device to collect additional data and imaging. Although this device is cleared 
for use by the U.S. Food and Drug Administration, there is a need to collect additional data, 
images, and tissue response to expand marketing claims. 
 
Relevance: 
There is an increasing demand for new methods and additional cleared indications for non-
invasive treatments using shockwave therapy. Another device currently on the market cleared for 
use is, but are not limited to, the dermaPACE®System. 
 
Testability: 
The SoftWave device, had been previously cleared for the activation of connective tissue (FDA 
510(k) K182682), the treatment of chronic, full thickness diabetic foot ulcers (FDA 510(k) 
K191961), and the treatment of superficial partial thickness second degree burns in adults (FDA 
510(k) K200926). This study will utilize the collection of data and imaging to support additional 
marketing claims. 
 
Compatibility: 
Although shock wave technology is a well-known and widely use technique for non-invasive 
treatments, there is still a need to collect additional data and images, and expand marketing claims 
and device use.  
 
Predictive power: 
Assuming there is an acceptable side effect profile, it would be appropriate to expect results for 
other marketable indications. 
 
2.2 Protocol Study Design 
This is a prospective, open label, multi-center clinical study to collect additional data and imaging 
for the SoftWave device. 
 
2.3 Subject Selection Criteria 
 
Subjects will meet the criteria described below: 
 
Inclusion Criteria: 
 A healthy male or female 18 – 65 years of age. 
 Willing to undergo treatments with the SoftWave device. 

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 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. 
 The subject has a pacemaker or implantable defibrillator. 
 The subject has a severe coagulation disorder. 
 The subject has open epiphyseal plates.  
 The subject has recently had a steroid injection. 
 The subject 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 to entering this study.  
 The subject has any condition or is in a situation which, in the Investigator’s opinion, may 
put the subject at significant risk, may confound study results or may interfere significantly 
with the subject’s participation. 
 
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 use 
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, 
specifically pain killers, may be discussed and post treatment instruction will be reviewed with the 
subject. Subjects will be informed of standard COVID-19 procedures that adhere to federal and 
state guidelines. 
 
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 

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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. They must also review the site’s COVID-19 
procedures and agree to follow protocols put in place at the site relating to COVID-19. 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 with subject:  
o You can return to a normal lifestyle immediately after treatment including light athletic 
workouts but avoid extreme exercise or activities that may reinjure the damaged area 
through overuse. The inflammation may have eliminated pain but it takes time to heal. 
o You can continue previously prescribed therapies, such as stretching. 
o Avoid ice and anti-inflammatory medicine (i.e. NSAIDs, such as Ibuprofen) for several 
days after therapy as this may reduce outcomes. 
o Drink lots of water. 
o You may feel tired after a SoftWave treatment. 
o You may experience a tingling sensation in the treatment area for several days after 
therapy. This is good. 
o You may experience mild soreness or stiffness during the next 48 hours. This is normal. 
 
2.6 Pre-Treatment Procedures 
If the subject is of childbearing potential (i.e. females not post-menopausal or not surgically 
sterile), they will be asked if they are pregnant, the date of their last menstrual cycle, and perform a 
urine pregnancy test. At each subsequent treatment, subjects will be asked the date of their last 
menstrual cycle for pregnancy verification purposes. A urine pregnancy test may also be 
conducted at the Investigator’s discretion at any time during the study. If a urine pregnancy test is 
conducted, then a negative result must be obtained within 24 hours prior to the treatment. 
 
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 first treatment and may be taken prior to each 
subsequent treatment.  
 

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2.7 Treatment Procedures 
 Procedures for the shock wave treatment: 
o The defined study area will be identified and will be cleansed thoroughly using a facial 
cleanser or mild soap and water. The treatment area may be marked with a marker. 
o The device may be used in accordance with the Protocol Manual and Instructions for 
Use. 
o Test spots may be performed prior to treatment in an area, such as on the hand, or in or 
close to the treatment area or so the subject can get used to the sensation. 
o Ultrasound gel will be applied to the area to be treated. 
o The applicator will be placed on the skin and slowly moved over the identified 
treatment area administering pulses of acoustic pressure shockwaves.  
o Parameters may be adjusted throughout the treatment to increase subject comfort. 
o Subjects will be asked to report the general level of treatment discomfort/pain on a 
scale of 0 (none) to 10 (maximum intolerable pain). 
o Parameters and tissue response will be continuously monitored and recorded during 
treatment.  
 The additional treatments will follow the same procedure. 
 Subjects and Clinicians may be asked to complete treatment questionnaires. 
 Subjects may receive up to 5 treatments. Treatments will be performed every 3 – 14 days.  
 
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.  
 
2.9 Follow Up 
 Subjects will return for follow up visits at 30 and 90 days post last treatment. 
 Photographs will be taken and adverse events will be documented and each follow up visit. 
 Clinician and subject questionnaires may be performed at each follow up visits.  
 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 using an FDA approved/cleared treatment method may be 
discussed with the subject and obtained at the cost of the subject. 
 
2.10 Biopsy Portion of the Study  
 Subjects may enroll in the biopsy portion of this study. If the subject has signed the biopsy 
consent form and enrolled, the following will also be performed: 
o Biopsies may be taken from a treated area the day of treatment and/or may be taken 1, 3, 7 
(+/- 1 day), 14 (+/- 2 days),  21 (+/- 2 days), and.or 30 days (+/- 3 days) post last treatment. 
A control will also be taken on the contralateral side of the treatment area.  
o Biopsy subjects may receive up to 6 biopsies. 
o A local anesthetic, such as lidocaine, may be injected to the area prior to biopsy. 

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o A 2 mm or 3mm punch biopsy (based on Physician assessment) will be taken from the 
treatment area. 
o Sutures may be uses to close the incision site. 
o The subject may be asked to attend a 1 week (7-14 days) post each biopsy visit to remove 
the sutures and assess side effects.    
 The following post biopsy treatment instructions will be reviewed: 
o Slight redness, initial tenderness to the wound site is normal; however, if you experience 
more redness, swelling, pain, pus, or drainage contact the study site immediately. 
o If the biopsy site begins to bleed, apply direct pressure for 10-20 minutes. If it continues to 
bleed, call the study site immediately. 
o Keep the wound dry today and remove bandage in 24 hours and leave off. 
o Avoid hot tubs, pools, and ocean until sutures are removed.  Avoid soaking in water until 
14 days after your biopsy. 
o When showering, wash carefully and do not scrub or traumatize the treated skin, or allow 
spray of shower to strike the skin directly.  If the skin is treated harshly, this can increase 
the risk of scarring. 
o After showering, lightly pat dry the wound or let it air dry, then cover the biopsy site with 
an application of Vaseline (or petroleum jelly) at least 1-2 times daily.  Keeping the wound 
moist reduces infection, minimizes scarring, and prevents crust formation over the wound.  
o Band-Aids (or any generic Adhesive Bandages) may be used for sleeping or in daily 
routines where the area may be rubbed/irritated.   Whenever possible, keep Band-Aid (or 
generic Adhesive Bandage) off of the area and keep the area moist with Vaseline (or 
petroleum jelly) as previously described but do not allow drying out and forming a hard 
scab.  
o For any wound discomfort, you may take Tylenol as needed, or use cold compresses for up 
to 20 minutes hourly as needed.  If using ice, it should be wrapped in a plastic and then a 
cloth to avoid burning your skin and wetting your bandage. 
o Avoid picking at the wound site, which increases risk of infection and scarring. 
o In order for the wound to heal properly and not leave bumpy scars, be careful not to 
overstretch the wound site area.  As a wound heals, it will be weaker than the surrounding 
skin and can even "pop open" the sutures (stitches) if stretched too much.  Sport or 
strenuous exercises that can pull at the wound site are best avoided for at least the next 3 
days and up to one week. 
o Return for suture removal within 7 - 14 days as instructed per study protocol. If applied, 
Steri-strips must be kept dry as they are more likely to separate when wet. Steri-strips will 
usually fall off by themselves or you may be advised by the study doctor to remove them 
when the wound healed. 
o ONCE SUTURES ARE OUT: To minimize sore formation and to improve the final 
appearance of your skin, it is very important to keep the wound site area covered with the 
Vaseline for the next few days, until there is no more crust forming and the skin has 
completely healed.  
o Temporary discoloration at the wound site is normal and should gradually fade over the 
next few months.  Please protect newly healed biopsied area with SPF and avoid sunburn. 
 
 
2.11 Unscheduled Visits 

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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. 
 
2.12 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 
 
2.13 Schedule of Visits and Procedures 
 
 
Visit #1* 
Visit #2-6 
Visit #7 
Visit #8 
Visit #9 
Procedure 
Screening and 
Pre-treatment 
Procedures 
Treatment 
Visit(s) 1-5 
(3-14 days Apart) 
Follow up and 
Biopsy 
0, 1, 3, 7, 24, 21 or 
30 days 
 Post Last Tx 
(Optional)
Follow Up 
1 Month 
Post Last Tx 
(+/- 1 Week) 
(Optional) 
Follow Up 
3 Months 
Post Last Tx 
(+/- 1 Week) 
(Optional 
Medical History 
X 
 
 
 
 
Pregnancy 
Verification
X 
X 
 
 
 
Informed Consent
X
Treatment 
 
X 
 
 
 
Parameters 
 
X 
X 
 
 
Treatment 
Discomfort/ 
Pain Evaluation
 
X 
 
 
 
Subject Treatment 
Experience 
Questionnaire
 
X 
 
 
 
Clinician 
Treatment 
Questionnaire
 
X 
 
 
 
Biopsies 
 
 
X 
 
 
Photographs 
(Vivosight)
X 
 
X 
X 
X 
Photographs  
(2D, 3D)
X 
 
X 
X 
X 
Subject Follow Up 
Questionnaire
 
 
 
X 
X 
Subject 
Satisfaction 
Questionnaire
 
 
 
X 
X 
Clinician 
Satisfaction 
Questionnaire 
 
 
 
X 
X 
Adverse Event 
Assessment
X 
X 
X 
X 
X 
*Screening and Pre-treatment Procedures may occur at the same time as the Treatment Visit #1. 
 
 
 

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2.13 Evaluation Methods 
Photographs: 
Photographs will be taken at all visits and will be used to assess efficacy and safety of treatment. 
 
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) 
 
Subject and Clinician Satisfaction 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 
will be Board Certified Dermatologist and/or Surgeons and 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 SoftWave Device: 
 
Potential adverse effects associated with shock wave treatments include those listed below: 
 Transient moderate increase in pain 
 Redness and swelling 
 Hematoma and petechial hemorrhage 
 Headaches and fainting during extracorporeal shock wave treatments 
 Short-term hypoesthesia 
 Nausea during therapy 
 Tingling during therapy 
 
 
 

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Adverse Events Pertaining to the Marker: 
Using a marker has minimal risks and may produce effects on the body such as redness or a rash. 
 
Adverse Events Pertaining to Ultrasound Gel: 
The gel is a water-based gel that may be placed on the skin during treatment. No known adverse 
events are documented. However, an allergic reaction is always possible when placing a topical gel 
onto the skin. Allergic reaction may include a mild reaction such as skin redness, irritation, or hives. 
 
Biopsies 
Complication with biopsies can include pain, redness, swelling, infection, bleeding, scarring and 
skin texture irregularities. 
 
Lidocaine 
You may experience pain and numbness at the site of the injection. You may also experience 
redness, rash, infection, skin damage or nerve damage at the site of the injection. You may 
experience temporary loss of sensation and muscle function at the site of injection. 
 
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. 
 
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 
For this study to be considered a success, the average pain score is acceptable to the Physician as it 
relates to the type of treatment. 
 
For additional objectives to be considered a success, the following criteria must be met: 
 The side effect profile (adverse events) is acceptable to the Physician as it relates to the type of 
treatment. 
 The subject satisfaction rates at the follow up visit will be ≥80% (optional). 
 Correct identification of pre-treatment images when compared to post treatment (30 and/or 90 
day) images will be ≥80% (optional). 
 Successful collection of biopsies (optional). 
 Successful collection of treatment assessment questionnaires (optional). 
 
2.15.2 Sample Size Rationale 
Based on the need for data collected from this study, it was determined that a total of 50 subjects 
will be required, including departures. 
  
2.15.3 Patient Populations 

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Interim results may be collected and reported.  All data will be analyzed at the end of the study on 
a per device basis as well as overall.  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.  Additional per-protocol analysis may also be performed on subjects 
who complete the entire clinical trial according to the protocol.  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 are randomized, 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.  
  
2.15.6 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  

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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 shockwave treatment. It is possible to have an adverse reaction to 
the SoftWave device. There may be some side effects that we don’t know about yet. 
 
3.3 Risk Analysis 
 
CONTEXT OF THE PROPOSED INVESTIGATION: 
Shockwave is an effective approach to healing the human body using acoustic waves to stimulate 
the body's natural processes for self-repair. This technology is not new and although it has been in 
the marketplace for over 14 years in Europe, it just recently received FDA clearance in the US. 
 
Shockwaves are created through the use of an electrode contained within a soft latex dome filled 
with water. When charged with electricity, the electrode creates a spark under the water. This 
spark creates a hot bubble of gas that expands into the surrounding water and produces the 
shockwave that travels out of the applicator and into the affected area being treated. These high 
energy acoustic waves penetrate deep into damaged tissue causing cellular walls to become 
permeable allowing exosomes to escape into the interstitial tissue mimicking cellular injury which 
triggers the migration of your body’s own stem cells to the area for sustained long-term healing.  
 
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 risk identified. Proper training on the protocol will 
be performed. 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 shockwave devices for non-invasive treatments due to current 
patient satisfaction with their results with the currently available devices. However, there is still a 
level of interest in expanding indications and marketing claims for shockwave devices. 

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ASSESSMENT OF UNCERTAINTY: 
There is uncertainty of efficacy results for expanding marketing claims while using the SoftWave 
device in this study.  
 
CONCLUSION: 
This study is determined to be a non-significant risk study and the risks posed to the subjects and 
integrity of data are acceptable.  
 
Patient population to be enrolled in this clinical study:  
Total anticipated population: 50 Subjects 
Age Range: 18 – 65 years of age 
Gender: Male or Female 
Condition: Conditions that may be treated with the activation of connective tissue. 
 
4.0  
DEVICE DESCRIPTION AND SPECIFICATIONS 
The SoftWave device used in this study is cleared for use by the U.S. Food and Drug 
Administration (the FDA) for the following indications: 
K200926: 
The OrthoGold 100 is indicated to provide acoustic pressure shockwaves in the treatment of 
superficial partial thickness second degree burns in adults (22 years and older). The OrthoGold  
100 is indicated for use in conjunction with standard of care burn treatment(s). 
 
K191961: 
The OrthoGold 100™ is indicated to provide acoustic pressure shockwaves in the treatment of 
chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm2, 
which extend through the epidermis, dermis, tendon , or capsule , but without bone exposure. The 
OrthoGold 100 is indicated for adult (22 years and older), diabetic patients presenting with diabetic 
foot ulcers greater than 30 days in duration and is indicated for use in conjunction with standard 
diabetic ulcer care 
 
K182682: 
The OrthoGold 100 is intended for the activation of connective tissue. 
 
The device used in this study is considered investigational because it may not be used in 
accordance with the currently cleared instructions for use and may use the data collected for 
additional marketing claims and indication. 
 
SoftWave Technical Data: 
Water System 
 
Closed system 
 
Content of the water 
cartridge: 450 ml Water 
(15.22 fl oz) 
 
Adjustable water flow 
 
Fill time of the reflector: 
Approx. 25 seconds 
Shock wave generator 
 
The coupling to the treatment 

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area happens via water 
membrane. 
 
Principle: electro hydraulic, 
spark gap under water caused 
by discharge of high voltage 
condensers. 
 
Shock wave release frequency: 
0.5 to 8 Hz. 
Operation- and display 
elements 
 
Operation monitor and touch 
wheel at the front side of the 
device 
 
Power on / off, displayed by 
control lamp in switch 
 
Footswitch to release shock 
waves 
Supply 
 
Voltage supply: AC 100- 240 V, 
± 10 %, 50/60 Hz 
 
Single phase 
 
Class I equipment 
 
Type B 
 
Power consumption: 
100V/200VA 240V/200VA 
 
Changes to the SoftWave device are not anticipated during the investigation.  
 
The comparison device that may be used is called the Eclipse Evive shockwave device. This is an 
FDA Class 1 device that falls under FDA code Sec. 890.5660 for marketing. You can find 
additional information on the device’s website here: https://www.eclipsemed.com/evive/. 
 
 
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  
 

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6.0  
LABELING  
Sample labeling will follow FDA regulations and the sponsor standard operating procedure.  
If applicable, the SoftWave 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 SoftWave Instructions for Use  
 
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 
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  

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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.   
 
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 and IRB. 
 
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 
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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 SoftWave treatments:  
 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. 
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 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.  
 
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 

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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 
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 
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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 
notification to sponsor prior to implementation
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, 

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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 
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) 
OrthoGold 100 Meets the criteria for exemption from 
IDE regulations, non-significant risk 
K182682 
OrthoGold 100 Meets the criteria for exemption from 
IDE regulations, non-significant risk 
K191961 
OrthoGold 100 Meets the criteria for exemption from 
IDE regulations, non-significant risk 
K200926 
 
 
 
 

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APPENDIX A: 
Protocol Revisions Tracker 
 
Version 
Date 
Editor 
Description 
February 25, 2021 
Kristy Luis 
IRB Submission 
March 10, 2021 
Kristy Luis 
IRB Response 
March 11, 2021 
Kristy Luis 
Increased number of subjects to 50 
April 7, 2021 
Kristy Luis 
Added use of comparison device. Added a control and 
14 day biopsy.  
 
 
 
 

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APPENDIX B: 
 
 

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REFERENCES 
 
1 Sherber, N. S., MD FAAD. (2018). The Millennial Mindset. Journal of Drugs in Dermatology, 17(12), 
1340-1342.