<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/NCT04407884</url>
  </required_header>
  <id_info>
    <org_study_id>Soovu 001-20</org_study_id>
    <nct_id>NCT04407884</nct_id>
  </id_info>
  <brief_title>Long Term Use of a High Energy Pulsed Heating Device in the Management of Chronic Pain</brief_title>
  <official_title>Long Term Use of a High Energy Pulsed Heating Device in the Management of Chronic Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Soovu Labs Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Soovu Labs Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the Soovu Labs pain Relief System in a group of&#xD;
      users that represent people most likely to purchase and use the units. This study is called&#xD;
      an In Home Users Trial (IHUT). The device is called Soovu and was determined by the FDA to be&#xD;
      Class II 510(k) except (C190061 November 2019). Relevant endpoints include ease of use, pain&#xD;
      relief, quality of life, and long-term effectiveness.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Soovu device description:&#xD;
&#xD;
      From the FDA document (C190061) &quot;The system is indicated to provide topical heating for the&#xD;
      purpose of elevating tissue temperature for the temporary relief of minor muscle and joint&#xD;
      pain and stiffness; the temporary relief of joint pain associated with arthritis; the&#xD;
      temporary relief of muscle spasms, minor sprains and strains, and minor muscular back pain;&#xD;
      the temporary relief of menstrual discomfort; the relaxation of muscles; and the temporary&#xD;
      increase of local circulation where applied.&quot; The devices are constructed following&#xD;
      documented ANSI/AAMI ES60601-1, ANSI/AAMI HA60601-1-11, IEC 60601-1-2, IEC 60529, ISO&#xD;
      10993-5, and 10993-10 safety standards.&#xD;
&#xD;
      The device consists of two separate heating units pods that are attached to the body via a&#xD;
      ring coated with medical grade adhesive. The units are easily removed from the body. The&#xD;
      units are controlled by a phone app that the user downloads to his or her phone and pairs&#xD;
      with the units via Bluetooth. The app contains instructional material on how to use the&#xD;
      device and general information related to pain management. The user may start and end heat&#xD;
      cycles via the app, may adjust the temperature of the unit, and select from one of three&#xD;
      heating profiles. The maximum temperature of the unit is 113° F well within accepted safety&#xD;
      limits. The three heating algorithms are:&#xD;
&#xD;
        1. Waves of heat up 113F that occur about 2 times per minute for up to 30 minutes&#xD;
&#xD;
        2. Waves of heat up 113F that occur about 4 times per minute for up to 30 minutes&#xD;
&#xD;
        3. Waves of heat up 113 F that occur about 2-3 times per minute for up to 30 minutes. These&#xD;
           waves of heat are synchronized with instructions in the app that guide users through&#xD;
           relaxed breathing exercises sometimes called box breathing. This option lasts up to 30&#xD;
           minutes.&#xD;
&#xD;
      The user can freely select any of the options, can end the session before the 30 minute time&#xD;
      out, and can reduce the maximum temperature of the heat wave from 113° F all via the app.&#xD;
&#xD;
      Objective(s) To assess the consumer experience of Soovu Labs wearable thermal pulsed-heat&#xD;
      device with Blue-tooth connected app among patients with recurring lower back. Assessment&#xD;
      will include a) whether the device is perceived to work in managing their pain, b) if the&#xD;
      device is comfortable to wear and use, c) if the app is easy to use, and d) if patients would&#xD;
      purchase the product and replacement adhesive.&#xD;
&#xD;
      Design Single arm. home-use study&#xD;
&#xD;
      Treatment Participants will be provided with a Soovu Labs device. Back pain sufferers will&#xD;
      apply the product to their pain site as needed following label instructions during an&#xD;
      approximate 60 day usage period. Participants will download the app to their personal mobile&#xD;
      phone.&#xD;
&#xD;
      Number of Patients A total of 40 participants will be recruited for the study.&#xD;
&#xD;
      Rationale Pain is an unpleasant sensory and emotional experience that is associated with&#xD;
      actual or potential tissue damage or is described associated with such damage. It causes&#xD;
      significant disability and dramatically decreases the patients' quality of life especially if&#xD;
      it lasts for a long time and becomes chronic. Many key opinion leaders and experts in&#xD;
      orthopedics and rheumatology accept that the pain is considered chronic if it lasts more than&#xD;
      six months. Chronic neck, back, and shoulder pain are among the most common and disabling&#xD;
      conditions accompanying different musculoskeletal disorders. As many other chronic painful&#xD;
      conditions, they are very disabling and lead to considerable stress on healthcare systems.&#xD;
      Several treatment modalities and their combinations have been proposed with different success&#xD;
      rates, including exercises, physical therapy, oral medication, injections and even surgery.&#xD;
      However, many products have low satisfaction rates given poor design, poor aesthetics, and&#xD;
      limited effectiveness.&#xD;
&#xD;
      The present study suggests a new therapeutic option (pulsed heat) for patients with recurring&#xD;
      lower back or cervical pain. The new wearable device delivers pulsed heat that automatically&#xD;
      raises and lowers the heat intensity over wear time may provide a better patient experience.&#xD;
      This study will assess opinions of likely users about the device.&#xD;
&#xD;
      Study Procedures The IHUT study will be run by Soovu Labs Inc. Seattle, WA.&#xD;
&#xD;
      Subjects may be recruited via an internal database of those who have participated in previous&#xD;
      studies and focus groups as well as new recruits. Subjects will be given the device for home&#xD;
      use for up to 60 days. Prior to entering the study all subjects will be screened for&#xD;
      inclusion/exclusion criteria (Attachment 1). If subjects are eligible and wish to enter the&#xD;
      study, they will complete an intake form (Attachment 2).&#xD;
&#xD;
      Subjects will be mailed the devices, adhesive rings (three different types), charger and&#xD;
      instructional materials including Owner's Manual with appropriate indications, warnings and&#xD;
      cautions, and Quick Start Guide to unbox at home. The attachment rings contain adhesives that&#xD;
      are commercially available, are biocompatible, and approved for human use. Questions related&#xD;
      to the unboxing are listed in attachment 3.&#xD;
&#xD;
      Once entered into the study users will be free to use the Soovu device as needed, with a&#xD;
      recommendation to use daily. The phone app that controls the device automatically tracks the&#xD;
      use of the device. Specifically, location of pain, which treatment profile (1-3) the subject&#xD;
      used, relief post use, the time and number of uses per day, duration of each treatment, and&#xD;
      whether the user viewed any of the supportive instructions contained on the app.&#xD;
&#xD;
      Subjects will periodically be contacted via telephone or internet and asked a set of&#xD;
      questions and opinions . At the conclusion of the study subjects will be contacted via&#xD;
      telephone or internet and asked a set of exit questions as well as to return the study&#xD;
      device.&#xD;
&#xD;
      In addition, a social media site with participation limited to study participants will be&#xD;
      made available for participants to share comments amongst themselves, and for the company to&#xD;
      provide clarifications on product usage as needed.&#xD;
&#xD;
      Criteria for Evaluation of Safety Any adverse event related or unrelated to the tested&#xD;
      products will be documented and reported as required (occurrence date, site, outcome and&#xD;
      assessment of causality and severity etc.) following approved operating procedures. All&#xD;
      adverse events will be recorded in the final study report. Adverse event instructions will be&#xD;
      included in the participant's Informed Consent Statement and in the study materials.&#xD;
&#xD;
      Statistical Methods Data will be analyzed using analysis of variance with pain site, past&#xD;
      treatments, and gender as discrete factors, and age as a covariate. Purchase interested will&#xD;
      be assessed using frequency analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 15, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 20, 2020</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>
    <intervention_model_description>Single group with longitudinal follow-up</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>pain level via numeric pain scale</measure>
    <time_frame>After week 8 of treatment</time_frame>
    <description>11 point Numeric pain scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mood levels</measure>
    <time_frame>After week 8 of treatment</time_frame>
    <description>0-10 scale from Brief Pain Inventory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>stress level</measure>
    <time_frame>After week 8 of treatment</time_frame>
    <description>0-10 scale from Brief Pain Inventory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Enjoyment of life</measure>
    <time_frame>After week 8 of treatment</time_frame>
    <description>0-10 scale BPI short form</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of device</measure>
    <time_frame>After week 8 of treatment</time_frame>
    <description>Number of times per week device is used (0-70)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ease of use</measure>
    <time_frame>After week 8 of treatment</time_frame>
    <description>0-10 use scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>benefits scale</measure>
    <time_frame>After week 8 of treatment</time_frame>
    <description>0-10 scale from the Westendorp subscale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>activity level</measure>
    <time_frame>After week 8 of treatment</time_frame>
    <description>0-10 scale from short form Brief Pain Inventory</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Pain</condition>
  <condition>Pain, Chronic</condition>
  <condition>Pain, Back</condition>
  <arm_group>
    <arm_group_label>study arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive an active study device.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Soovu Labs Inc. Pain Relief System</intervention_name>
    <description>Longnitual follow-up</description>
    <arm_group_label>study arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ● A total of 40 males and females aged 21-70, with recurring lower back will be&#xD;
             recruited. Back pain sufferers must report pain at least 3 days/week for the past&#xD;
             month. This back pain must be present for at least 6 months. Otherwise, self-reporting&#xD;
             moderate good to excellent health;&#xD;
&#xD;
               -  Self-assessed pain intensity level 5 or greater on the 0-10 Numeric Pain scale.&#xD;
                  This corresponds to a mild to moderate pain intensity;&#xD;
&#xD;
               -  Having signed an Informed Consent Form (ICF), be able to read, comprehend, and&#xD;
                  sign the informed consent form;&#xD;
&#xD;
               -  Has Apple iPhone version 6 or later IOS operating system and willing to download&#xD;
                  device app&#xD;
&#xD;
               -  Available for the entire study duration;&#xD;
&#xD;
               -  Willing to comply with all study related requirements;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ● Has or had a history of clinically significant, severe, progressive, or uncontrolled&#xD;
             renal, hepatic, hematological, immunologic, gastrointestinal, endocrine, pulmonary,&#xD;
             cardiac, neurologic, cerebrovascular or psychiatric disease;&#xD;
&#xD;
               -  Has sciatica where the sciatic component of the pain is greater than the&#xD;
                  non-radiating pain located in the low back;&#xD;
&#xD;
               -  Skin diseases and disorders (e.g., psoriasis, eczema, scars, wounds and other&#xD;
                  dermatological lesions…), which may prevent the location of the device to the&#xD;
                  skin;&#xD;
&#xD;
               -  Taking dietary supplements or herbal remedies inconsistently (on and off) for the&#xD;
                  month prior to enrollment. If taking these supplements, subjects must stay on a&#xD;
                  regular daily dose of the product(s) for the duration of the study. If not&#xD;
                  currently taking these supplements, subjects cannot start taking them during&#xD;
                  their participation in the study;&#xD;
&#xD;
               -  Patients with neoplasms receiving treatment that may interfere with the study;&#xD;
&#xD;
               -  Subjects who are self-reported to be pregnant, lactating or planning to become&#xD;
                  pregnant;&#xD;
&#xD;
               -  Having a history of hypersensitivity to similar products;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>charles chabal, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Soovu Labs</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>charles chabal, md</last_name>
    <phone>2065794910</phone>
    <email>Chuck@Soovu.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jenny Hapgood</last_name>
    <email>jenny@Soovu.com</email>
  </overall_contact_backup>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 17, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>May 26, 2020</last_update_submitted>
  <last_update_submitted_qc>May 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Soovu Labs Inc.</investigator_affiliation>
    <investigator_full_name>charles chabal</investigator_full_name>
    <investigator_title>Chief Science officer</investigator_title>
  </responsible_party>
  <keyword>heat</keyword>
  <keyword>analgesia</keyword>
  <keyword>chronic pain</keyword>
  <keyword>thermal analgesia</keyword>
  <keyword>low back pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
    <mesh_term>Back Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>April 29, 2021</submitted>
    <returned>May 20, 2021</returned>
  </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/NCT04407884
org study id: Soovu 001-20
nct id: NCT04407884
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the Soovu Labs pain Relief System in a group of
      users that represent people most likely to purchase and use the units. This study is called
      an In Home Users Trial (IHUT). The device is called Soovu and was determined by the FDA to be
      Class II 510(k) except (C190061 November 2019). Relevant endpoints include ease of use, pain
      relief, quality of life, and long-term effectiveness.
Soovu device description:

      From the FDA document (C190061) "The system is indicated to provide topical heating for the
      purpose of elevating tissue temperature for the temporary relief of minor muscle and joint
      pain and stiffness; the temporary relief of joint pain associated with arthritis; the
      temporary relief of muscle spasms, minor sprains and strains, and minor muscular back pain;
      the temporary relief of menstrual discomfort; the relaxation of muscles; and the temporary
      increase of local circulation where applied." The devices are constructed following
      documented ANSI/AAMI ES60601-1, ANSI/AAMI HA60601-1-11, IEC 60601-1-2, IEC 60529, ISO
      10993-5, and 10993-10 safety standards.

      The device consists of two separate heating units pods that are attached to the body via a
      ring coated with medical grade adhesive. The units are easily removed from the body. The
      units are controlled by a phone app that the user downloads to his or her phone and pairs
      with the units via Bluetooth. The app contains instructional material on how to use the
      device and general information related to pain management. The user may start and end heat
      cycles via the app, may adjust the temperature of the unit, and select from one of three
      heating profiles. The maximum temperature of the unit is 113° F well within accepted safety
      limits. The three heating algorithms are:

        1. Waves of heat up 113F that occur about 2 times per minute for up to 30 minutes

        2. Waves of heat up 113F that occur about 4 times per minute for up to 30 minutes

        3. Waves of heat up 113 F that occur about 2-3 times per minute for up to 30 minutes. These
           waves of heat are synchronized with instructions in the app that guide users through
           relaxed breathing exercises sometimes called box breathing. This option lasts up to 30
           minutes.

      The user can freely select any of the options, can end the session before the 30 minute time
      out, and can reduce the maximum temperature of the heat wave from 113° F all via the app.

      Objective(s) To assess the consumer experience of Soovu Labs wearable thermal pulsed-heat
      device with Blue-tooth connected app among patients with recurring lower back. Assessment
      will include a) whether the device is perceived to work in managing their pain, b) if the
      device is comfortable to wear and use, c) if the app is easy to use, and d) if patients would
      purchase the product and replacement adhesive.

      Design Single arm. home-use study

      Treatment Participants will be provided with a Soovu Labs device. Back pain sufferers will
      apply the product to their pain site as needed following label instructions during an
      approximate 60 day usage period. Participants will download the app to their personal mobile
      phone.

      Number of Patients A total of 40 participants will be recruited for the study.

      Rationale Pain is an unpleasant sensory and emotional experience that is associated with
      actual or potential tissue damage or is described associated with such damage. It causes
      significant disability and dramatically decreases the patients' quality of life especially if
      it lasts for a long time and becomes chronic. Many key opinion leaders and experts in
      orthopedics and rheumatology accept that the pain is considered chronic if it lasts more than
      six months. Chronic neck, back, and shoulder pain are among the most common and disabling
      conditions accompanying different musculoskeletal disorders. As many other chronic painful
      conditions, they are very disabling and lead to considerable stress on healthcare systems.
      Several treatment modalities and their combinations have been proposed with different success
      rates, including exercises, physical therapy, oral medication, injections and even surgery.
      However, many products have low satisfaction rates given poor design, poor aesthetics, and
      limited effectiveness.

      The present study suggests a new therapeutic option (pulsed heat) for patients with recurring
      lower back or cervical pain. The new wearable device delivers pulsed heat that automatically
      raises and lowers the heat intensity over wear time may provide a better patient experience.
      This study will assess opinions of likely users about the device.

      Study Procedures The IHUT study will be run by Soovu Labs Inc. Seattle, WA.

      Subjects may be recruited via an internal database of those who have participated in previous
      studies and focus groups as well as new recruits. Subjects will be given the device for home
      use for up to 60 days. Prior to entering the study all subjects will be screened for
      inclusion/exclusion criteria (Attachment 1). If subjects are eligible and wish to enter the
      study, they will complete an intake form (Attachment 2).

      Subjects will be mailed the devices, adhesive rings (three different types), charger and
      instructional materials including Owner's Manual with appropriate indications, warnings and
      cautions, and Quick Start Guide to unbox at home. The attachment rings contain adhesives that
      are commercially available, are biocompatible, and approved for human use. Questions related
      to the unboxing are listed in attachment 3.

      Once entered into the study users will be free to use the Soovu device as needed, with a
      recommendation to use daily. The phone app that controls the device automatically tracks the
      use of the device. Specifically, location of pain, which treatment profile (1-3) the subject
      used, relief post use, the time and number of uses per day, duration of each treatment, and
      whether the user viewed any of the supportive instructions contained on the app.

      Subjects will periodically be contacted via telephone or internet and asked a set of
      questions and opinions . At the conclusion of the study subjects will be contacted via
      telephone or internet and asked a set of exit questions as well as to return the study
      device.

      In addition, a social media site with participation limited to study participants will be
      made available for participants to share comments amongst themselves, and for the company to
      provide clarifications on product usage as needed.

      Criteria for Evaluation of Safety Any adverse event related or unrelated to the tested
      products will be documented and reported as required (occurrence date, site, outcome and
      assessment of causality and severity etc.) following approved operating procedures. All
      adverse events will be recorded in the final study report. Adverse event instructions will be
      included in the participant's Informed Consent Statement and in the study materials.

      Statistical Methods Data will be analyzed using analysis of variance with pain site, past
      treatments, and gender as discrete factors, and age as a covariate. Purchase interested will
      be assessed using frequency analysis.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Single group with longitudinal follow-up
primary purpose: Treatment
masking: None (Open Label)
measure: pain level via numeric pain scale
time frame: After week 8 of treatment
description: 11 point Numeric pain scale
measure: Mood levels
time frame: After week 8 of treatment
description: 0-10 scale from Brief Pain Inventory
measure: stress level
time frame: After week 8 of treatment
description: 0-10 scale from Brief Pain Inventory
measure: Enjoyment of life
time frame: After week 8 of treatment
description: 0-10 scale BPI short form
measure: Use of device
time frame: After week 8 of treatment
description: Number of times per week device is used (0-70)
measure: ease of use
time frame: After week 8 of treatment
description: 0-10 use scale
measure: benefits scale
time frame: After week 8 of treatment
description: 0-10 scale from the Westendorp subscale
measure: activity level
time frame: After week 8 of treatment
description: 0-10 scale from short form Brief Pain Inventory
arm group label: study arm
arm group type: Experimental
description: Subjects will receive an active study device.
intervention type: Device
intervention name: Soovu Labs Inc. Pain Relief System
description: Longnitual follow-up
arm group label: study arm
criteria: 
gender: All
minimum age: 21 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: charles chabal, MD
role: Principal Investigator
affiliation: Soovu Labs
last name: charles chabal, md
phone: 2065794910
email: Chuck@Soovu.com
last name: Jenny Hapgood
email: jenny@Soovu.com
responsible party type: Principal Investigator
investigator affiliation: Soovu Labs Inc.
investigator full name: charles chabal
investigator title: Chief Science officer
mesh term: Chronic Pain
mesh term: Back Pain
sharing ipd: No
submitted: April 29, 2021
returned: May 20, 2021