<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01704157</url>
  </required_header>
  <id_info>
    <org_study_id>MYO-0601</org_study_id>
    <secondary_id>Pain-OA</secondary_id>
    <nct_id>NCT01704157</nct_id>
  </id_info>
  <brief_title>A Prospective Study Evaluating the Treatment of Knee Osteoarthritis With the Cryo-Touch III Device</brief_title>
  <official_title>A Prospective Non-Randomized Unblinded Study Evaluating the Treatment of Knee Osteoarthritis With the Cryo-Touch III Device</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pacira CryoTech, Inc., a wholly owned subsidiary of Pacira BioSciences, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pacira CryoTech, Inc., a wholly owned subsidiary of Pacira BioSciences, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A proof of concept study to evaluate the feasibility of safe and effective treatment through&#xD;
      optimization of the Cryo-Touch III device for temporary relief of pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Over 100 million patients in the United States suffer from chronic pain. Chronic pain&#xD;
      conditions are often debilitating, taking a toll on a patient's physical and mental welfare.&#xD;
      Though a variety of pain management techniques currently exist, the most common nonsurgical&#xD;
      options provide slow-acting and/or short-term relief. Medication, often in the form of&#xD;
      non-steroidal anti-inflammatory drugs (NSAIDs) and opioids, comes with an array of side&#xD;
      effects such as nausea and vomiting. Medication also presents the possibility of more serious&#xD;
      effects such as increased risk of heart attack and stroke, and tolerance or dependency&#xD;
      issues. Surgical strategies tend to be reserved for more severe cases and are limited by the&#xD;
      risks and complications typically associated with surgery including bleeding, bruising,&#xD;
      scarring, and infection. A nonsurgical, minimally invasive, long-lasting approach to chronic&#xD;
      pain management is desirable.&#xD;
&#xD;
      The Cryo-Touch III is a pain management device developed for a novel, minimally invasive&#xD;
      procedure using focused cold therapy to target sensory nerve tissue and offer long-lasting&#xD;
      pain relief through cryoanalgesia. The device operates on the well-established cryobiology&#xD;
      principle that localized exposure to controlled moderately low temperature conditions can&#xD;
      alter tissue function. The therapy treats nerves with low temperatures via a cold probe in&#xD;
      the form of an assembly of small diameter needles, creating a highly localized treatment zone&#xD;
      around the probe. This focused cold therapy creates a conduction block that prevents nerve&#xD;
      signaling.&#xD;
&#xD;
      Though studies have proven efficacious in targeting motor nerves, the device's effect on&#xD;
      sensory nerves has yet to have been investigated in the clinical setting. The goal of the&#xD;
      study described herein is to evaluate the degree and duration of effect of the Cryo-Touch III&#xD;
      in reducing chronic pain by targeting sensory nerves.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">July 2013</completion_date>
  <primary_completion_date type="Actual">April 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>An improvement in the Visual Analog Scale (VAS) for pain at Day 7</measure>
    <time_frame>Screening (Day -30 to Day 0), Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 30)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement (pain, stiffness, and functionality) as determined by WOMAC Scale at Day 7.</measure>
    <time_frame>Visit 2 (Day 0), Visit 3 (Day 7)</time_frame>
    <description>A significant difference is observed as &gt;/= 2-points</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Treatment Effect</measure>
    <time_frame>Visit 3 (Day 7), Visit 4 (Day 30), Visit 5 (Day 56)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analgesic Use</measure>
    <time_frame>Screening thru Visit 5 (Day 56)</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Osteoarthritis of the Knee</condition>
  <arm_group>
    <arm_group_label>Open Treatment</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Treatment with Cryo-Touch III Device</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cryo-Touch III</intervention_name>
    <description>Study treatment at Day 0.</description>
    <arm_group_label>Open Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female, 18 years of age and older.&#xD;
&#xD;
          -  Participants must meet American College of Rheumatology (ACR) criteria for&#xD;
             osteoarthritis of the knee (unilateral or bilateral). Clinical criteria includes knee&#xD;
             pain and at least three of the following 6 criteria: 50 years of age or older,&#xD;
             stiffness lasting less than 30 minutes, crepitus, bony tenderness, bony enlargement,&#xD;
             and/or no warmth to the touch.&#xD;
&#xD;
          -  Any medications (prescription and/or over-the counter) must be maintained on a stable&#xD;
             schedule for ≥ 2 weeks prior to treatment. No washout period is allowed.&#xD;
&#xD;
          -  An average Visual Analog Scale (VAS) for pain ≥ 4 over the last 30 days.&#xD;
&#xD;
          -  Subject is willing and able to give written informed consent.&#xD;
&#xD;
          -  Subject is willing and able to comply with study instructions and commit to all&#xD;
             follow-up visits for the duration of the study.&#xD;
&#xD;
          -  Subject is in good general health and free of any systemic disease state or physical&#xD;
             condition that might impair evaluation or which in the investigator's opinion, exposes&#xD;
             the subject to an unacceptable risk by study participation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A partial or full knee replacement (in the treated knee).&#xD;
&#xD;
          -  Any use of systemic injections (in any area) within the last 6 months.&#xD;
&#xD;
          -  Current enrollment in an investigational drug or a device study that specifically&#xD;
             targets pain treatment.&#xD;
&#xD;
          -  Any additional diagnosis that in the opinion of the investigator may directly&#xD;
             contribute to knee pain.&#xD;
&#xD;
          -  Any concomitant inflammatory disease or other condition that affects the joints (e.g.&#xD;
             rheumatoid arthritis, metabolic bones disease, gout, active infection, etc.).&#xD;
&#xD;
          -  Any clotting disorder and/or has used an anticoagulant (e.g., warfarin, clopidogrel,&#xD;
             etc.) within seven (7) days prior to administration of the device.&#xD;
&#xD;
          -  Allergy or intolerance to lidocaine.&#xD;
&#xD;
          -  Any local skin condition at the treatment site that in the investigator's opinion&#xD;
             would adversely affect treatment or outcomes.&#xD;
&#xD;
          -  Any chronic medical condition that in the investigator's opinion would prevent&#xD;
             adequate participation.&#xD;
&#xD;
          -  Any chronic medication use (prescription, over-the-counter, etc.) that in the&#xD;
             investigator's opinion would affect study participation or subject safety.&#xD;
&#xD;
          -  For any reason, in the opinion of the investigator, the subject may not be a suitable&#xD;
             candidate for study participation (i.e., history of noncompliance, drug dependency,&#xD;
             any related knee injury due to a worker's compensation claim, etc.).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Neurovations</name>
      <address>
        <city>Napa</city>
        <state>California</state>
        <zip>94557</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Injury Care Medical Center</name>
      <address>
        <city>Boise</city>
        <state>Idaho</state>
        <zip>83713</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2014</verification_date>
  <study_first_submitted>October 5, 2012</study_first_submitted>
  <study_first_submitted_qc>October 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 11, 2012</study_first_posted>
  <last_update_submitted>January 27, 2014</last_update_submitted>
  <last_update_submitted_qc>January 27, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 29, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Osteoarthritis</keyword>
  <keyword>knee</keyword>
  <keyword>chronic pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>May 2, 2023</submitted>
    <returned>May 24, 2023</returned>
    <submitted>May 31, 2023</submitted>
    <returned>June 22, 2023</returned>
    <submitted>July 17, 2023</submitted>
    <returned>August 3, 2023</returned>
    <submitted>August 11, 2023</submitted>
    <returned>September 1, 2023</returned>
    <submitted>September 6, 2023</submitted>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01704157
org study id: MYO-0601
secondary id: Pain-OA
nct id: NCT01704157
lead sponsor: 
has dmc: No
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.
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.

      The Cryo-Touch III is a pain management device developed 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.

      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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: An improvement in the Visual Analog Scale (VAS) for pain at Day 7
time frame: Screening (Day -30 to Day 0), Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 30)
measure: Improvement (pain, stiffness, and functionality) as determined by WOMAC Scale at Day 7.
time frame: Visit 2 (Day 0), Visit 3 (Day 7)
description: A significant difference is observed as >/= 2-points
measure: Duration of Treatment Effect
time frame: Visit 3 (Day 7), Visit 4 (Day 30), Visit 5 (Day 56)
measure: Analgesic Use
time frame: Screening thru Visit 5 (Day 56)
arm group label: Open Treatment
arm group type: Other
description: Treatment with Cryo-Touch III Device
intervention type: Device
intervention name: Cryo-Touch III
description: Study treatment at Day 0.
arm group label: Open Treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
submitted: May 2, 2023
returned: May 24, 2023
submitted: May 31, 2023
returned: June 22, 2023
submitted: July 17, 2023
returned: August 3, 2023
submitted: August 11, 2023
returned: September 1, 2023
submitted: September 6, 2023