A Prospective Non-Randomized Unblinded Study Evaluating the Treatment of Knee Osteoarthritis With the Cryo-Touch III Device
Phase: NA
Conditions: Osteoarthritis of the Knee
Sponsor: Pacira Pharmaceuticals, Inc

 
 
A PROSPECTIVE NON-RANDOMIZED UNBLINDED STUDY EVALUATING 
THE TREATMENT OF KNEE OSTEOARTHRITIS WITH THE CRYO-
TOUCH III DEVICE 
MYO-0601 REV 04 
 
 
 
 
 
Author: Sally Hallas 
Revision History: 
Revision 
Description 
Justification  
DCO# 
Release Date 
01 
Initial Release. 
Initial Release 
N/A 
10/15/2012 
02 
Updated the Schedule of 
Events in Appendix B 
Schedule of Events 
for Visit 5 did not 
originally reflect the 
requirement for 
completion of Subject 
Post-Treatment 
Questionnaire as 
required by protocol 
N/A 
11/27/2012 
03 
Increase enrollment 
 Enrollment based on 
number of subjects rather 
than number of 
“treatments 
Remove “lidocaine with 
epinephrine” and replace 
with “Local anesthesia” 
 
Spelling and grammar 
edits 
Allow for additional 
enrollment 
Provide clarification  
 
Allow investigators to 
use local anesthetic of 
choice to achieve 
complete cutaneous 
anesthesia 
Provide clarification 
N/A 
12/19/2012 
04 
Define end of study 
 
 
Remove secondary 
endpoint: Analgesic Use 
Provide end date of 
Day 84 for any 
subject who has 
treatment effect at or 
beyond Day 56 
Data not collected for 
this secondary 
endpoint 
1740 
6/25/2013 
 
 

 
CONFIDENTIAL & PROPRIETARY 
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MYO-0601 REV 04: A Prospective Non-Randomized, Unblinded Study Evaluating the Treatment of Knee 
Osteoarthritis with the Cryo-Touch III Device  
A PROSPECTIVE NON-RANDOMIZED UNBLINDED STUDY EVALUATING THE 
TREATMENT OF KNEE OSTEOARTHRITIS WITH THE CRYO-TOUCH III DEVICE 
 
 
 
Protocol Number: 
MYO-0601/04 
Protocol Date: 
6/25/2013 
Sponsor & Address (Pre-
September 1, 2012): 
myoscience, Inc. 
525 Chesapeake Drive  
Redwood City, CA 94063 
Sponsor & Address (Post-
September 1, 2012): 
myoscience, Inc. 
 
1600 Seaport Blvd. Suite 450 
Redwood City, CA 94063 
Sponsor Representative(s): 
John Allison 
Vice President, Research and Development 
myoscience, Inc.  
650-474-2600 (office) 
650-474-2900 (fax) 
 
Tracey Henry 
Vice President, QA, RA, Operations 
myoscience, Inc. 
650-474-2600 (office) 
650-474-2900 (fax) 
 
 
 
 

 
CONFIDENTIAL & PROPRIETARY 
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MYO-0601 REV 04: A Prospective Non-Randomized, Unblinded Study Evaluating the Treatment of Knee 
Osteoarthritis with the Cryo-Touch III Device  
Protocol Synopsis 
 
Title 
A Prospective Non-Randomized Unblinded Study Evaluating the Treatment 
of Knee Osteoarthritis with the Cryo-Touch III Device  
Study Device 
Cryo-Touch III (a.k.a. PCP 1.0) 
Study Objective 
A proof of concept study to evaluate the feasibility of safe and effective 
treatment through optimization of the Cryo-Touch III device for temporary 
relief of pain.  
Treatment Groups 
Multiple  
Duration of Study 
Enrollment and follow-up is expected to take approximately 4 months.  A 
subject will participate for approximately 10 weeks. 
Study Population 
Healthy subjects, male or female, ages 18 and older with chronic knee pain 
related to a diagnosis of osteoarthritis of the knee.  
Total Number of 
Subjects 
Up to 50 subjects will be enrolled.  
Number of Sites 
1-2 
Inclusion Criteria 
Eligible subjects must meet the following criteria:  
 
1. Male or female, 18 years of age and older. 
2. Trial participants must meet American College of Rheumatology 
(ACR) criteria for osteoarthritis of the knee (unilateral or bilateral).  
3. Any medications must be maintained on a stable schedule for at 
least two weeks prior to treatment. No washout period is allowed. 
4. Must have an average VFRUHIRUSDLQRIVisual Analog Scale 
(VAS) over the last 30 days. 
5. Subject is willing and able to give written informed consent. 
6. Subject is willing and able to comply with study instructions and 
commit to all follow-up visits for the duration of the study. 
7. Subject is in good general health and free of any systemic disease 
state or physical condition that might impair evaluation or which in 
the investigator’s opinion, exposes the subject to an unacceptable 
risk by study participation. 
Exclusion Criteria 
A subject is ineligible if one or more of the following criteria applies:  
 
1. A partial or full knee replacement (in the treated knee). 
2. Any use of systemic injections (in any area) within the last 6 
months. 
3. Current enrollment in an investigational drug or a device study that 
specifically targets pain treatment. 
4. Any additional diagnosis that in the opinion of the investigator 
directly contributes to knee pain.  

 
CONFIDENTIAL & PROPRIETARY 
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MYO-0601 REV 04: A Prospective Non-Randomized, Unblinded Study Evaluating the Treatment of Knee 
Osteoarthritis with the Cryo-Touch III Device  
5. Any concomitant inflammatory disease or other condition that 
affects the joints (e.g. rheumatoid arthritis, metabolic bones 
disease, gout, active infection, etc.) 
6. Any clotting disorder and/or has used an anticoagulant (e.g., 
warfarin, clopidogrel, etc.) within seven (7) days prior to 
administration of the device. 
7. Allergy or intolerance to local anesthetic. 
8. Any local skin condition at the treatment site that in the 
investigator’s opinion would adversely affect treatment or 
outcomes. 
9. Any chronic medical condition that in the investigator’s opinion 
would prevent adequate participation. 
10. Any chronic medication use (prescription, over-the-counter, etc.) 
that in the investigator’s opinion would affect study participation or 
subject safety.  
11. For any reason, in the opinion of the investigator, the subject may 
not be a suitable candidate for study participation (i.e., history of 
noncompliance, drug dependency, any related knee injury due to a 
worker’s compensation claim, etc.). 
 
Study Visit Schedule 
1. 
Visit 1/Screening (-30 Days to Day 0) 
2. 
Visit 2/Treatment (Day 0)  
3. 
Visit 3/ Maintenance (Day 7) 
4. 
Visit 4/ Maintenance (Day 30)  
5. 
Visit 5/Study Exit (Day 56) – Telephone Follow-Up 
Primary Outcome 
An improvement in the Visual Analog Scale (VAS) for pain at Day 7. 
Secondary Outcomes 
1. Improvement (pain, stiffness, and functionality) as determined by the 
Western Ontario and McMaster Osteoarthritis Index (WOMAC) Scale 
at Day 7. A significant difference is observed as -points.  
2. Duration of Treatment Effect 
 
 
 

 
CONFIDENTIAL & PROPRIETARY 
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MYO-0601 REV 04: A Prospective Non-Randomized, Unblinded Study Evaluating the Treatment of Knee 
Osteoarthritis with the Cryo-Touch III Device  
Table of Contents 
 
Protocol Synopsis ........................................................................................................................... 2 
Declaration of Investigator ............................................................................................................ 6 
1. Introduction ................................................................................................................................ 7 
1.1. 
Background ................................................................................................................................... 7 
1.2. 
Device Description ........................................................................................................................ 7 
1.3. 
Regulatory Status ......................................................................................................................... 9 
2. Study Protocol ......................................................................................................................... 9 
2.1. 
Design ............................................................................................................................................ 9 
2.2. 
Study Duration ............................................................................................................................. 9 
2.3. 
Sample Size ................................................................................................................................... 9 
2.4. 
Subject Inclusionary Criteria ...................................................................................................... 9 
2.5. 
Subject Exlusionary Criteria ..................................................................................................... 10 
2.6. 
Schedule of Events ...................................................................................................................... 10 
2.6.1. 
Visit 1/Screening (Day -30 to Day 0) ................................................................................................... 10 
2.6.2. 
Visit 2/Treatment (Day 0) .................................................................................................................... 11 
2.6.2.1. 
Pre-Treatment/Evaluation Preparation ......................................................................................... 11 
2.6.2.2. 
Treatment ...................................................................................................................................... 12 
2.6.2.3. 
Post-Treatment ............................................................................................................................. 12 
2.6.3. 
Visit 3/ Maintenance (Day 7) & Visit 4/Maintenance (Day 30) ........................................................... 13 
2.6.4. 
Visit 5/Study Exit (Day 56) – Telephone Follow-Up ........................................................................... 13 
3. Outcome Measures and Assessments ................................................................................... 14 
3.1.1. 
Primary Outcome Measure ................................................................................................................... 14 
3.1.2. 
Secondary Outcome Measures ............................................................................................................. 14 
3.1.2.1. 
Improvement (pain, stiffness, and functionality) as determined by the Western Ontario and 
McMaster Osteoarthritis Index (WOMAC) Scale at Day 7. A VLJQLILFDQWGLIIHUHQFHLVREVHUYHGDV-
points. See Appendix. .................................................................................................................................... 14 
3.1.2.2. 
Duration of Treatment Effect/No Effect [Data Collection Tool] .................................................. 14 
3.1.3. 
Ancillary Measures (Potential measures not part of analysis) .............................................................. 14 
3.1.3.1. 
Subject Post-Treatment Questionnaire (See Appendix) ............................................................... 14 
3.1.4. 
Anticipated Observations (AO) [Data Collection Tool] ....................................................................... 14 
3.1.5. 
Safety Measures [Data Collection] ....................................................................................................... 15 
3.2. 
Adverse Event Reporting ........................................................................................................... 15 
3.2.1. 
Serious Adverse Event (SAE)/Unanticipated Adverse Device Effect (UADE) ................................... 16 
3.3. 
Statistical Analysis Plan ............................................................................................................. 17 
4. Risk/Benefit Analysis ............................................................................................................ 17 
4.1. 
Benefits ........................................................................................................................................ 17 
4.2. 
Risks ............................................................................................................................................ 18 

 
CONFIDENTIAL & PROPRIETARY 
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MYO-0601 REV 04: A Prospective Non-Randomized, Unblinded Study Evaluating the Treatment of Knee 
Osteoarthritis with the Cryo-Touch III Device  
5. Study Management and Quality Control ............................................................................. 18 
5.1. 
Data Collection ........................................................................................................................... 18 
5.2. 
Investigator Responsibilities ...................................................................................................... 18 
5.2.1. 
Compliance with Good Clinical Research Practice .............................................................................. 18 
5.2.2. 
Institutional Review Board (IRB) ........................................................................................................ 19 
5.2.3. 
Device Accountability .......................................................................................................................... 19 
5.2.4. 
Confidentiality ...................................................................................................................................... 20 
5.2.5. 
Record Retention .................................................................................................................................. 20 
5.3. 
Sponsor Responsibilities ............................................................................................................ 20 
5.3.1. 
Study Monitoring ................................................................................................................................. 20 
5.3.2. 
Protocol Revisions ................................................................................................................................ 21 
5.3.3. 
Trial Registration .................................................................................................................................. 21 
6. Data Ownership..................................................................................................................... 21 
7. Publication Policy ................................................................................................................. 21 
 
Appendix A: Abbreviations .......................................................................................................... 23 
Appendix B: Schedule of Events ................................................................................................. 24 
Appendix C: Pain Visual Analog Scale ...................................................................................... 25 
Appendix D: WOMAC ................................................................................................................. 26 
Appendix E: Subject Post-Treatment Questionnaire ................................................................. 27 
 
 
 
 

 
CONFIDENTIAL & PROPRIETARY 
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MYO-0601 REV 04: A Prospective Non-Randomized, Unblinded Study Evaluating the Treatment of Knee 
Osteoarthritis with the Cryo-Touch III Device  
Declaration of Investigator 
 
I confirm that I understand the protocol and agree to conduct the study as detailed herein. 
I will not make changes in the protocol without approval from 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 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 inform any subjects, or any persons in the study, that the investigational 
product(s) are being used for investigational purposes and I will ensure that the requirements 
relating to obtaining informed consent in 21 CFR Part 50 and institutional review board (IRB) 
review and approval in 21 CFR Part 56 are met. 
 
I agree to report to the sponsor adverse experiences that occur in the course of the 
investigation(s) in accordance with 21 CFR 812.150(a)(1). I have read and understand the 
information in the product description, including any potential risks and side effects of the 
product. 
 
I agree to maintain adequate and accurate records in accordance with 21 CFR 812.140 
and to make those records available for inspection in accordance with 21 CFR 812.140. 
 
I will ensure the IRB complies with the requirements of 21 CFR Part 56 and will be 
responsible for the initial and continuing review and approval of the clinical investigation. I also 
agree to promptly report to the IRB and Sponsor 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 Sponsor and 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 and all other pertinent requirements in 21 CFR Part 812.110 and 812.150. I also 
agree to adhere to the internationally recognized Declaration of Helsinki, International 
Conference on Harmonisation (ICH) guidelines, and Good Clinical Practices (GCP). 
 
Signature: ________________________________________ Date: ____________________ 
 
Printed Name: _____________________________________ 
 
 
 
 

 
CONFIDENTIAL & PROPRIETARY 
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MYO-0601 REV 04: A Prospective Non-Randomized, Unblinded Study Evaluating the Treatment of Knee 
Osteoarthritis with the Cryo-Touch III Device  
1. Introduction 
1.1. 
Background 
Over 100 million patients in the United States suffer from chronic pain. Chronic 
pain conditions are often debilitating, taking a toll on a patient’s physical and 
mental welfare. Though a variety of pain management techniques currently exist, 
the most common nonsurgical options provide slow-acting and/or short-term 
relief. Medication, often in the form of non-steroidal anti-inflammatory drugs 
(NSAIDs) and opioids, comes with an array of side effects such as nausea and 
vomiting. Medication also presents the possibility of more serious effects such as 
increased risk of heart attack and stroke, and tolerance or dependency issues. 
Surgical strategies tend to be reserved for more severe cases and are limited by 
the risks and complications typically associated with surgery including bleeding, 
bruising, scarring, and infection.  A nonsurgical, minimally invasive, long-lasting 
approach to chronic pain management is desirable. 
 
Myoscience, Inc. (Redwood City, CA) has developed a pain management device 
– the Cryo-Touch III – for a novel, minimally invasive procedure using focused 
cold therapy to target sensory nerve tissue and offer long-lasting pain relief 
through cryoanalgesia. The device operates on the well-established cryobiology 
principle that localized exposure to controlled moderately low temperature 
conditions can alter tissue function.  The therapy treats nerves with low 
temperatures via a cold probe in the form of an assembly of small diameter 
needles, creating a highly localized treatment zone around the probe.  This 
focused cold therapy creates a conduction block that prevents nerve signaling. 
Prior studies of Cryo-Touch, Cryo-Touch II, Cryo-Touch III (a.k.a. PCP 1.0) have 
provided preliminary evidence of effectiveness on motor nerves and have been 
shown to be safe with no serious device-related adverse events.   
 
Though studies have proven efficacious in targeting motor nerves, the device’s 
effect on sensory nerves has yet to have been investigated in the clinical setting. 
The goal of the study described herein is to evaluate the degree and duration of 
effect of the Cryo-Touch III in reducing chronic pain by targeting sensory nerves.   
1.2. 
Device Description 
The Cryo-Touch III device (a.k.a. PCP 1.0) (Figure 1) is a minimally invasive 
needle-based device. The device consists of a re-usable portable Control Unit, 
Handpiece, single use Cryoprobes (Figure 2) and Cryogen Cartridges. The 
Control Unit and Handpiece are powered by the Control Unit utilizing connection 
to a standard power outlet and is microprocessor controlled. Its functionality is 
driven by an operator controlled on/off switch. The unit displays indicator lights 
to guide the operator. The system produces the desired effects through initiation 

 
CONFIDENTIAL & PROPRIETARY 
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MYO-0601 REV 04: A Prospective Non-Randomized, Unblinded Study Evaluating the Treatment of Knee 
Osteoarthritis with the Cryo-Touch III Device  
of a cooling cycle. Each cooling cycle is initiated by subcutaneous insertion of the 
Cryoprobe into the selected site and activation of the cryogen flow. A freezing 
zone forms around the tip of the Cryoprobe and the adjacent tissue. The Cryogen 
Cartridges are provided in individually sealed pouches. Each cartridge contains a 
nitrous oxide cylinder encased with a safety cap and filtering. The Cryoprobes are 
supplied in sterile packaging and are single-patient use. The Cyroprobe tips are 
closed, no cryogen enters the insertion site. A skin warmer provides warming at 
the base of the Cryoprobe tips to keep the surface above freezing temperatures.  
 
 
 
Figure 1.  Picture of Cryo-Touch III device.  
 
 
 
 
 
Figure 2. Picture of the Cryoprobe. 
 
A. Control Unit 
B. Handpiece 
C. Cryoprobe 
D. Cryogen Cartridge 
C 
B 
D 
A. Skin Warmer 
B. Cryoprobe Tips 
B 
A 
A 

 
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MYO-0601 REV 04: A Prospective Non-Randomized, Unblinded Study Evaluating the Treatment of Knee 
Osteoarthritis with the Cryo-Touch III Device  
1.3. 
Regulatory Status 
The myoscience Cryo-Touch III device has been cleared by the U.S. FDA as a 
class II medical device, K120415. Approved indications include general tissue 
destruction during surgical procedures and cryo-treatment of nerves to block pain.  
Additionally, myoscience and an independent review board has determined that 
the Cryo-Touch III device is a non-significant risk device under 21 CFR 
§812.2(b) as described for use within this protocol.  
Therefore, an approved Investigational Device Exemption (IDE) from FDA is not 
required to legally perform the study described herein in the US. 
 
2. 
Study Protocol 
2.1. 
Design 
This is a prospective non-randomized unblinded study. 
2.2. 
Study Duration  
Enrollment and follow-up is expected to take approximately 4 months. 
2.3. 
Sample Size 
Up to 50 subjects will be enrolled. 
2.4. 
 Subject Inclusionary Criteria 
1. Male or female, 18 years of age and older. 
2. Participants must meet American College of Rheumatology (ACR) criteria for 
osteoarthritis of the knee (unilateral or bilateral). Clinical criteria includes 
knee pain and at least three of the following 6 criteria: 50 years of age or 
older, stiffness lasting less than 30 minutes, crepitus, bony tenderness, bony 
enlargement, and/or no warmth to the touch.  
3. Any medications (prescription and/or over-the counter) must be maintained on 
a stable schedule for  weeks prior to treatment. No washout period is 
allowed.  
4. An average Visual Analog Scale (VAS) for pain RYHUWKHODVWGD\V  
5. Subject is willing and able to give written informed consent. 
6. Subject is willing and able to comply with study instructions and commit to 
all follow-up visits for the duration of the study. 

 
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MYO-0601 REV 04: A Prospective Non-Randomized, Unblinded Study Evaluating the Treatment of Knee 
Osteoarthritis with the Cryo-Touch III Device  
7. Subject is in good general health and free of any systemic disease state or 
physical condition that might impair evaluation or which in the investigator’s 
opinion, exposes the subject to an unacceptable risk by study participation. 
 
2.5. 
Subject Exlusionary Criteria 
1. A partial or full knee replacement (in the treated knee). 
2. Any use of systemic injections (in any area) within the last 6 months. 
3. Current enrollment in an investigational drug or a device study that 
specifically targets pain treatment. 
4. Any additional diagnosis that in the opinion of the investigator may directly 
contribute to knee pain.   
5. Any concomitant inflammatory disease or other condition that affects the 
joints (e.g. rheumatoid arthritis, metabolic bones disease, gout, active 
infection, etc.).  
6. Any clotting disorder and/or has used an anticoagulant (e.g., warfarin, 
clopidogrel, etc.) within seven (7) days prior to administration of the device. 
7. Allergy or intolerance to local anesthetic. 
8. Any local skin condition at the treatment site that in the investigator’s opinion 
would adversely affect treatment or outcomes. 
9. Any chronic medical condition that in the investigator’s opinion would 
prevent adequate participation. 
10. Any chronic medication use (prescription, over-the-counter, etc.) that in the 
investigator’s opinion would affect study participation or subject safety.  
11. For any reason, in the opinion of the investigator, the subject may not be a 
suitable candidate for study participation (i.e., history of noncompliance, drug 
dependency, any related knee injury due to a worker’s compensation claim, 
etc.). 
 
2.6. 
Schedule of Events 
See Appendix B. 
2.6.1. 
Visit 1/Screening (Day -30 to Day 0) 
Subjects will be informed of all study activities and requirements. After the 
subject has had ample opportunity to ask and have questions answered an 
informed consent form will be signed and a copy provided to the subject. 
 
The investigator, or designee, will document the subject’s medical history, 
demographic information, concomitant medications/concurrent procedures, 
and any other required data points to determine subject eligibility.  
 

 
CONFIDENTIAL & PROPRIETARY 
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MYO-0601 REV 04: A Prospective Non-Randomized, Unblinded Study Evaluating the Treatment of Knee 
Osteoarthritis with the Cryo-Touch III Device  
Once the subject is determined to be eligible, the subject will be scheduled 
for the next visit.  The Screening Visit 1 and Treatment Visit 2 may occur on 
the same day. Every effort will be made to reduce the time between 
Screening and Treatment Visits if possible. 
 
2.6.2. 
Visit 2/Treatment (Day 0)  
2.6.2.1. Pre-Treatment/Evaluation Preparation 
 
No special preparation by the subject is required prior to the treatment. 
The investigator will reaffirm eligibility criteria and the subject’s 
willingness to continue participation in the trial. Any changes in 
concomitant medications/concurrent procedures will be recorded.  Any 
adverse events that may have occurred prior to treatment will be 
documented as a change in medical history.  
 
Non-invasive ultrasound imaging of the treatment area may be captured. 
Nerve stimulation may be used to assess location of nerves via a 
percutaneous nerve stimulator or a transcutaneous nerve stimulator.  
The Cryo-Touch III device will be used on awake subjects who are 
prepared with dermal anesthesia only. The skin in the treatment area will 
be cleansed with alcohol.  Local anesthetic will be injected into target sites 
with the goal of complete cutaneous anesthesia at the target treatment 
areas prior to the treatment.   
The target of treatment is the infrapatellar branch of the saphenous nerve. 
The nerve will be accessed by locating adjacent landmarks and treating in 
a linear fashion to capture the nerve as it travels inferiorly (see Figure 3).  
Subjects with a bilateral indication will receive treatment in both knees. 
 
 
 
 
 
 
 
 
 

 
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MYO-0601 REV 04: A Prospective Non-Randomized, Unblinded Study Evaluating the Treatment of Knee 
Osteoarthritis with the Cryo-Touch III Device  
 
 
 
 
 
 
 
 
 
 
 
Figure 3: Nerve map of intended treatment. 
 
2.6.2.2. Treatment 
The Cryo-Touch III device will have been prepared by the trained 
investigator (or Sponsor designee) according to the Instructions for Use 
(IFU) as provided by myoscience (see supplementary material). 
Representatives of myoscience may be present at the treatment. 
Photography of the treatment area may be taken. Videography may also be 
captured during the treatment.  
Varying treatment algorithms will be pre-determined by the sponsor and 
placed into cohorts as appropriate for anyalysis. This is intended to 
determine the most effective method of treatment and device optimization. 
Algorithms may include the following parameters: temperature, length of 
treatment, number of treatment cycles, probe tip design, and probe length. 
If at any time the device does not perform as expected the investigator (or 
designee) we follow procedures as outlined in the IFU.  
2.6.2.3. Post-Treatment 
Upon completion of treatment, the treatment area will be cleansed and the 
skin will be left undressed. Pressure to the treatment area with gauze 5-10 
minutes may be applied to minimize bleeding.  The subject will be 
instructed in post-treatment care.   
The subject will be instructed to report any adverse events or treatment 
side effects (e.g., excessive redness, swelling, bruising, soreness, altered 
sensation, etc.) to the investigator between and at follow-up visits. Non-
invasive ultrasound may be used to assess the volume and location of the 

 
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MYO-0601 REV 04: A Prospective Non-Randomized, Unblinded Study Evaluating the Treatment of Knee 
Osteoarthritis with the Cryo-Touch III Device  
soft tissue treated below the dermis.  Photography and videography of the 
treatment area may be obtained.  
The subject will be scheduled and instructed for their follow-up visits and 
discharged from the clinic. 
2.6.3. 
Visit 3/ Maintenance (Day 7) & Visit 4/Maintenance (Day 30)  
Subject will be evaluated and data collected per the schedule of events. Any 
changes in concomitant medications/concurrent procedures will be assessed. 
Any anticipated observations, adverse events, and/or SAE/UADE of the 
previous treatment site(s) will be assessed and documented. Non-invasive 
ultrasound imaging of the treatment area may be captured. Photography may 
be taken of the treatment area.  
2.6.4. 
Visit 5/Study Exit (Day 56) – Telephone Follow-Up 
Subject will be contacted via telephone and data collected since their last visit 
per 
the 
schedule 
of 
events. 
Any 
changes 
in 
concomitant 
medications/concurrent procedures will be assessed. Any anticipated 
observations, adverse events, and/or SAE/UADE of the previous treatment 
site(s) will be documented.  
If the treatment effect remains at Day 56 the subject will be followed every 
four (4) weeks via telephone until Day 84. Any clinically significant adverse 
event will be followed until resolution. The subject will exit the study after 
Day 56 once there is no longer a treatment effect or the Day 84 follow-up is 
completed and no ongoing clinically significant events.  
Study exit data will be collected and the subject reminded to contact the 
investigator if any new previously unreported event occurs as it related to the 
treatment. 
A subject is considered to have exited (a completer) the study after 
completing all scheduled visits. In the event that a subject does not attend a 
scheduled visit every effort will be made to reschedule and those efforts will 
be documented. In the event of a subject lost to follow-up a study exit will be 
completed.  
 
If a subject decides to withdraw participation early, the subject will be 
requested to complete a final study visit and exit the study. The investigator 
or sponsor may at any time during the study remove a subject if there is any 
potential safety issue or extreme non-compliance. In all cases every attempt 
will be made to complete a final study visit. 
 

 
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MYO-0601 REV 04: A Prospective Non-Randomized, Unblinded Study Evaluating the Treatment of Knee 
Osteoarthritis with the Cryo-Touch III Device  
3. 
Outcome Measures and Assessments 
Outcome measures will be assessed around multiple endpoints. These measures will be: 
pain, function, range of motion, anticipated observations, duration of improvement, and 
safety. Additional assessments may also be taken but not part of  analysis (i.e. subject 
post-treatment questionnaire). The specific assessment tools, collection method and time 
points are listed herein.   
3.1.1. 
Primary Outcome Measure 
Improvement of knee pain as measured on the Visual Analog Scale (VAS) 
for pain at Day 7 as compared to baseline (Day 0). See Appendix. 
3.1.2. 
Secondary Outcome Measures 
3.1.2.1. Improvement (pain, stiffness, and functionality) as determined by the 
Western Ontario and McMaster Osteoarthritis Index (WOMAC) Scale at 
Day 7. A significant difference is observed as -points. See Appendix. 
3.1.2.2. Duration of Treatment Effect/No Effect [Data Collection Tool] 
3.1.3. 
Ancillary Measures (Potential measures not part of analysis) 
3.1.3.1. Subject Post-Treatment Questionnaire (See Appendix) 
3.1.4. 
Anticipated Observations (AO) [Data Collection Tool] 
During each visit, the area to be treated will be assessed by the investigator 
(observation and subject query) for the following anticipated observations 
(AO’s). These AO’s will be collected independent of adverse events.  
x Bruising (ecchymosis)/Soreness 
x Tingling/altered sensation (transient 
paresthesia/dysesthesia/anesthesia) 
x Redness/inflammation (erythema) 
x Swelling  
x Itching (pruritus) 
x Local pain/tenderness 
x Erosion/ulceration 
x Eschar/crusting 
x Dimpling/depression 
x Hyperpigmentation 
x Hypopigmentation 

 
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MYO-0601 REV 04: A Prospective Non-Randomized, Unblinded Study Evaluating the Treatment of Knee 
Osteoarthritis with the Cryo-Touch III Device  
3.1.5. 
Safety Measures [Data Collection] 
Adverse events and SAEs/UADEs will be assessed at all visits.  Incidence of 
serious adverse events (SAEs) and unanticipated adverse device effects 
(UADEs) will be recorded. A serious adverse event is one that meets the ISO 
definition of SAE (see section 4.2.1). 
3.2. 
Adverse Event Reporting 
 
Adverse events (AEs) will be assessed continuously from initiation of study treatment 
through study exit. An AE can be any unfavorable and unintended sign (e.g., an abnormal 
laboratory finding), symptom, or disease temporally associated with the use of a device, 
without any judgment about causality.  An AE can arise from any use of the device (e.g., 
off-label use, use in combination with any drug) and from any route of administration 
including an overdose. 
Timely and complete reporting of all AEs assists the Sponsor in identifying any untoward 
medical occurrence, thereby allowing:  
1) 
protection of the safety of study subjects;  
2) 
a greater understanding of the overall safety profile of the device;  
3) 
recognition of device-related toxicity or ill effects; 
4) 
appropriate modification of study protocols;  
5) 
improvements in study design or procedures; and  
6) 
adherence to worldwide regulatory requirements.   
AEs may be either spontaneously reported or elicited during questioning and examination 
of a subject.  All AEs must be completely recorded within subject’s source 
documentation.  If known, the investigator should report the diagnosis of the underlying 
illness or disorder, rather than its individual symptoms.  Subjects experiencing AEs that 
cause interruption or discontinuation of participation, or those experiencing AEs that are 
present at the end of their participation in the study should receive follow-up as 
appropriate.  If possible, report the outcome of any AE that caused permanent 
discontinuation or that was present at the end of the study particularly if the AE was 
considered by the investigator to be definitely, probably, or possibly related to the study 
device.  
The investigator will instruct the subject to report any adverse events that may occur 
during the study.  At each visit, the investigator should ask the subject, in non-directive 
fashion, about any change in the subject’s overall condition since the previous visit. 

 
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3.2.1. 
Serious Adverse Event (SAE)/Unanticipated Adverse Device Effect 
(UADE) 
A device-related SAE is an AE that meets the ISO definition for SAE and is rated by the 
investigator to be related to the study device.  No device-related SAEs have been reported 
in prior studies of Cryo-Touch II. 
Per ISO14155, an international clinical trial standard, an SAE is an AE that: 
1 led to a death, 
2 led to a serious deterioration in the health of the subject that 
a. resulted in a life-threatening illness or injury, 
b. resulted in a permanent impairment of a body structure or a body 
function, 
c. required in-patient hospitalization or prolongation of existing 
hospitalization, 
d. resulted in medical or surgical intervention to prevent permanent 
impairment to body structure or a body function. 
3 led to fetal distress, fetal death or a congenital abnormality or birth defect 
 
An event that is serious must be recorded on the AE worksheet and requires expeditious 
handling to comply with regulatory requirements. 
Events NOT considered to be serious adverse events are: 
x Hospitalizations for the treatment, which was elective or pre-planned, of a 
pre-existing condition that did not worsen, and 
x Treatment on an emergency, outpatient basis for an event not fulfilling any of 
the definitions of “serious” given above and not resulting in hospital 
admission. 
An unanticipated adverse device effect (UADE) is any of the following events that is 
caused by, or associated with, a device, if that effect, problem, or death was not 
previously identified in nature, severity, or degree of incidence in the investigational plan 
or application (including a supplementary plan or application): 
x Any serious adverse effect on health or safety. 
x Any life-threatening problem. 
x Death. 
x Any other unanticipated serious problem associated with a device that relates 
to the rights, safety, or welfare of subjects. 

 
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Report of any UADEs shall be submitted to Sponsor within 24 hours of knowledge of the 
event. 
UADEs and AEs that are classified as “serious” by the investigator or the Sponsor require 
expeditious handling and reporting to the Sponsor.  All SAEs, whether related or 
unrelated to the study device, must be immediately (within 24 hours of becoming aware 
of the SAE) reported to the sponsor by telephone or confirmed facsimile transmission: 
Tracey Henry, John Allison, and/or Study Manager  
myoscience, Inc. 
650-474-2600 (office) 
650-474-2900 (fax) 
 
In addition, such information should also be provided to the site’s respective IRB per 
their governing guidelines for SAE/UADE reporting.  If only limited information is 
initially available, follow-up reports are required.  Should the investigator become aware 
of an SAE (regardless of its relationship to the device) that occurs within 30 days after 
completion of the study, the SAE must be reported in accordance with procedures 
specified in this protocol.  In the event of death, if an autopsy is performed, a copy of the 
report should be sent to the Sponsor, if available. 
As required, the Sponsor will notify all investigators of any UADE within 10 working 
days of the Sponsor’s receipt of the effect.   
Upon receiving such notices, the investigator must review and retain the notice and 
immediately submit a copy of this information to the responsible IRB according to local 
regulations.  The investigator and IRB will determine if the informed consent requires 
revision.  The investigator should also comply with the IRB procedures for reporting any 
other safety information.  Where required, submission of Safety Updates by the 
investigator to Health Authorities should be handled according to local regulations. 
3.3. 
Statistical Analysis Plan 
Not Applicable.   
 
4. 
Risk/Benefit Analysis 
4.1. 
Benefits 
Subjects may experience an improvement in pain post-treatment or may 
experience no improvement at all.  

 
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4.2. 
Risks  
The Cryo-Touch III device involves percutaneous access to subcutaneous tissue 
using a needle and use of dermal anesthesia.  Passage of a needle into the skin and 
delivery of local anesthesia are known and may be documented as anticipated 
observations (AO). See list in section 3.1.4.  
 
These reactions do not typically require medical intervention on the part of the 
investigator and are usually transient.  Self-care with compression or oral non-
narcotic analgesics usually suffices. 
In the event that an AO exceeds the expected response to the treatment, either in 
severity or in duration by the investigator’s assessment, they will be reported as 
AEs per Section 3.2. 
Additional adverse events which have occurred but are considered to be rare 
include: 
x 
Infection/Fever 
x 
Weakness which could result in difficulty ambulating 
x 
Limitations in range of motion of joint  
x 
Vasovagal reaction to needle insertion 
x 
Burns, blistering, or scarring due to heat or cold injury 
 
5. 
Study Management and Quality Control 
5.1. 
Data Collection 
Incoming data will be reviewed by the Sponsor or designee to identify 
inconsistent or missing data and to ensure compliance with the study protocol.    
Investigators will be responsible for the accurate and timely completion of all 
source documents, case report forms, and any other required study data (i.e., 
worksheets, questionnaires, etc.) during the trial.   
5.2. 
Investigator Responsibilities 
Investigators are responsible for ensuring the investigation is conducted according 
to all signed agreements, the study protocol, and applicable regulatory agency 
regulations. This section describes these responsibilities. 
5.2.1. 
Compliance with Good Clinical Research Practice 
This study will be conducted in compliance with the principles of the 
Declaration of Helsinki, with the current Good Clinical Practice (GCP) 
guidelines and with other applicable regulations.  The investigator and all 

 
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study staff will conduct the study in compliance with this protocol.  The 
protocol, informed consent documents, recruitment advertisements and any 
amendments to these items will have IRB approval prior to study initiation.  
Every subject prior to the initiation of any study-related procedures will give 
voluntary informed consent.  The rights, safety and welfare of the study 
subjects are the most important considerations and prevail over the interests 
of science and society.  All personnel involved in the conduct of this study 
must be qualified by education, training and experience to perform their 
assigned responsibilities. 
5.2.2. 
Institutional Review Board (IRB) 
Before study initiation, the investigator must have written and dated approval 
from the IRB for the protocol, consent form, subject recruitment 
materials/process (e.g., advertisements), and any other written information to 
be provided to subjects. The investigator will submit documentation of the 
IRB approval to the Sponsor or designee.  
The IRB approved consent form must include all elements required by FDA, 
state, and local regulations, and may include appropriate additional elements. 
The investigator/designee will explain the study to each potential subject and 
the subject must indicate voluntary consent by signing and dating the 
approved informed consent form.  The investigator/designee must provide 
the subject with a copy of the consent form, in a language the subject 
understands.   
The investigator/designee will maintain documentation that informed consent 
was obtained prior to the initiation of any study-specific procedures. 
Withdrawal of IRB approval of the investigator’s part in the investigation 
shall be reported to the Sponsor within 5 working days. 
5.2.3. 
Device Accountability 
The investigator is responsible for providing a secure storage location for the 
devices, supervising device use, as well as the disposal of the device or return 
of the device as instructed by the Sponsor or designee.  In addition, 
investigators will maintain records of receipt, use or disposition of all 
devices.  The Sponsor or designee will maintain records of all shipments and 
disposition of the investigational devices and will routinely inspect for device 
accountability at the clinical sites participating in this trial. 
All used units and probes shall be stored and upon request returned to the 
Sponsor or designee for analysis unless otherwise directed.  If a Sponsor 
representative or designee is present at the time of use, he/she may directly 

 
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take possession of used device(s).  All devices will be returned to the 
Sponsor after the study is complete.   
5.2.4. 
Confidentiality 
The investigator is responsible for ensuring the confidentiality of subjects 
throughout the trial.  A unique identification code will be assigned to each 
subject participating in this trial.  Any data that may be published in 
abstracts, scientific journals, or presented at medical meetings will reference 
a unique subject code and will not reveal the subject’s identity.  
5.2.5. 
Record Retention 
The investigator must maintain all study records (including device 
disposition, informed consents, case report forms/worksheets, source 
documents, correspondence, regulatory documents, contracts etc.) for the 
maximum period required by the Sponsor or the institution where the study is 
conducted, whichever is longer. 
The investigator must contact the Sponsor prior to destroying any records 
associated with this study. 
If the investigator withdraws from the study, the records shall be transferred 
to a mutually agreed upon designee.   
5.3. 
Sponsor Responsibilities 
Myoscience or designee’s responsibilities in the study include: 
x Completing IRB approvals and reporting. 
x Ensuring device availability.  
x Providing site training on all study aspects and procedures. 
x Managing the data: data collection, verification, records storage, etc. 
x Analyzing results and assisting with presentation(s) and/or publication(s). 
x Retaining custodianship of the multi-center clinical data generated.  
5.3.1. 
Study Monitoring  
Representatives of the Sponsor or designee must be allowed to visit all study 
sites, to review study records and to directly compare them with source 
documents (including, but not limited to patient and hospital records), to 
discuss the study conduct with the investigator and study staff and to verify 

 
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that the investigator, study staff, and facilities remain acceptable for the 
conduct of the study. 
Representatives of government regulatory authorities may also evaluate the 
study records, source documents, investigator, study staff, and facilities. 
The investigator should immediately notify the Sponsor or designee of any 
audits of this study by any regulatory agency, and must promptly provide 
copies of any audit reports. 
5.3.2. 
Protocol Revisions 
The Sponsor or designee must prepare all protocol revisions.  All protocol 
amendments must receive IRB approval prior to implementation.  All 
administrative letters must be submitted to the IRB for their information.  All 
correspondence with the IRB regarding this study must be maintained in the 
site regulatory file and made available to the Sponsor or designee. 
The most recent IRB approved version of the informed consent form (ICF) 
must be administered to all subjects upon enrollment. In some cases, due to 
new information or protocol amendments, an ICF may be updated. Subjects 
only need to be re-consented using the latest approved version if directed so 
by the IRB and/or Sponsor. 
5.3.3. 
Trial Registration  
The trial will be registered on a publicly accessible study database such as 
clinicaltrials.gov. 
 
6. 
Data Ownership 
Myoscience, Inc., the study Sponsor, retains ownership of all data generated in this study, 
and controls the use of the data for purposes of regulatory submissions to the United 
States and/or other governments.  Investigator(s) and institution(s) (which shall include 
their employees, agents, and representatives) may not issue or disseminate any press 
release or statement, nor initiate any communication of information regarding this study 
(written or oral) to the communications media or third parties without the prior written 
consent of myoscience.  
 
7. 
Publication Policy 
Participating investigators and/or Institutions may publish information or data collected 
or produced as a result of participation in appropriate scientific conference or journals or 
other professional publications subject to written permission from myoscience, provided 

 
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that drafts of the material are provided to myoscience for purposes of review and 
comment at least sixty (60) days prior to the first submission for publication or public 
release.  Investigators may not publish information regarding site-specific data until a 
multicenter study report has been published.  
 

 
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Appendix A: Abbreviations 
 
ACR 
AE 
AO 
American College of Rheumatology 
Adverse Event 
Anticipated Observations 
ASR 
CFR 
Anticipated Site Reaction 
Code of Federal Regulations 
US FDA 
EOS 
United States Food and Drug Administration 
End of Study 
GCP 
Good Clinical Practice 
HIV 
ICH 
ICF 
Human Immunodeficiency Virus 
International Conference on Harmonisation 
Informed Consent Form 
IDE 
Investigational Device Exemption 
IFU 
Instructions for Use 
IRB 
Institutional Review Board/Independent Review Board 
ISO 
International Organization for Standardization 
NSAID 
Non-Steroidal Anti-Inflammatory Drug 
SAE 
Serious Adverse Event 
UADE 
VAS 
Unanticipated Adverse Device Effect 
Visual Analog Scale 
 
 

 
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Appendix B: Schedule of Events   
 
 
 * A variance of +/- 3 days is allowed.   
Study Activity 
V1 
Screening 
V2 
Treatment 
V3 
V4 
 
V5 
Phone 
Follow-
up/EOS 
Day -30 to 
Day 0 
Day 0 
Day 7* 
Day 30* 
Day 56* 
Obtain Informed Consent 
X 
 
 
 
 
Review eligibility criteria 
X 
X 
 
 
 
Physical examination 
X 
 
 
 
 
Medical history 
X 
 
 
 
 
Concomitant medications/procedures 
X 
X 
X 
X 
X 
WOMAC  
 
X 
X 
 
 
Visual Analog Scale (VAS) for pain 
X 
X 
X 
X 
 
Treatment 
 
X 
 
 
 
AO Assessment 
X 
 
X 
X 
X 
Subject Post-Treatment Questionnaire 
 
X 
X 
X 
X 
Adverse events/procedures review 
 
X 
X 
X 
X 
Duration of Treatment Effect/No Effect 
 
 
X 
X 
X 

 
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Appendix C: Pain Visual Analog Scale 
 
Instructions: Adults may have difficulty using a number scale and may be assisted with the use 
of the six facial expressions suggesting various pain intensities. Ask the subject to choose the 
face that best describes how they feel. The far left face indicates ‘No hurt’ and the far right face 
indicates ‘Hurts worst’. Document number below the face chosen. 
 
 
Faces rating scale (FRS) 
 
 
 

 
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Appendix D: WOMAC 
 
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a widely used, 
proprietary set of standardized questionnaires used by health professionals to evaluate the 
condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and 
physical functioning of the joints. The WOMAC has also been used to assess back 
pain, rheumatoid arthritis, juvenile rheumatoid arthritis, systemic lupus erythematosus, and 
fibromyalgia. It can be self-administered and was developed at Western 
Ontario and McMaster Universities in 1982. [1] 
 
The WOMAC measures five items for pain (score range 0–20), two for stiffness (score range 0–
8), and 17 for functional limitation (score range 0–68). [2]. Physical functioning questions cover 
everyday activities such as stair use, standing up from a sitting or lying position, standing, 
bending, walking, getting in and out of a car, shopping, putting on or taking off socks, lying in 
bed, getting in or out of a bath, sitting, and heavy and light household duties. [3] 
 
A WOMAC test takes about 12 minutes, but is also available in a short form, (although this has 
not been as extensively tested as the full version). Versions of the WOMAC have also been 
developed that can be used in telephone or online surveys. [3] 
 
The WOMAC is among the most widely used assessments in arthritis research. For example, it 
appears as a search keyword in more than 1500 papers cataloged in PubMed, as of June 2012. It 
has been translated into more than 65 languages. [1] 
 
The American College of Rheumatology notes that the test-retest reliability of the WOMAC 
varies for the pain, stiffness, and function subscales. The ACR says the pain subscale "has been 
variable across studies but generally meets the minimum standard." Reliability for the physical 
function scale "has been more consistent and stronger... but the stiffness subscale has shown low 
test-retest reliability."[3] When used in clinical studies, the WOMAC pain and function 
subscales perform comparably or better than other tests in being responsive to change from 
experimental interventions, but this varies for the different subscales and types of intervention. 
 
An example of a intended WOMAC index is attached for reference. 
 
 
 
1. 
^ a b "WOMAC Osteoarthritis Index". Retrieved 6 June 2012. 
2. 
^ Quintana, Jose; Escobar, Arostegui, Bilbao (January 2006). "Health-Related Quality of Life and Appropriateness of Knee or Hip 
Joint Replacement". Archives of Internal Medicine 166: 220–226. 
3. 
^ a b c American College of Rheumatology. "Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)--General 
Description". ACR. Retrieved 6 June 2012. 

 
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 Appendix E: Subject Post-Treatment Questionnaire 
  
Instructions: To better help the sponsor understand the dynamics of the treatment the 
following questions have been compiled. The investigator, or designee, will request a response 
from the subject at the designated time and complete the source document as appropriate. If no 
response or not applicable check the appropriate box.  
 
Day 0/Visit 2/Post-Treatment 
 
1. How nervous were you during the procedure?  On a scale from 1-5, 1 being extremely 
nervous and 5 being completely relaxed.  
2. Prior to your treatment today, how effective or helpful was the information provided 
beforehand (information pamphlet, informed consent, etc.)? On a scale from 1-5, 1 being 
not at all effective/helpful to 5 being very effective/helpful.  
3. Was the treatment painful? On a scale from 1-5, 1 being not at all painful to 5 being very 
painful.  
 
Visit 3/Day 7 and Visit 4/Day 30 
 
1. If you any had anticipated observations (AO) from your treatment (i.e., bruising, 
swelling), how much did they/it impact your daily routine? On a scale from 1-5, 1 being 
the AO had a very negative impact to 5 being no impact at all. 
2. Would you recommend this treatment to a friend or family member? Yes or No.  
3. Would you have the treatment again if available? Yes or No.  
4. Is there any pain present from the treatment? On a scale from 1-5, 1 being not at all 
painful to 5 being very painful.