<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/NCT03246282</url>
  </required_header>
  <id_info>
    <org_study_id>UVL_P001</org_study_id>
    <nct_id>NCT03246282</nct_id>
  </id_info>
  <brief_title>Feasibility of Polychromatic Light Emitting Diode System to Reduce Pain</brief_title>
  <official_title>A Polychromatic Light Emitting Diode System to Deliver Low Dose Light Directly Into a Peripheral Intravascular Catheter: A Pain Reduction Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>John W. Reeves, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>White Clover Research Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>White Clover Wellness and Research Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>White Clover Research Foundation</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study uses a prospective non-randomized, non-controlled design. One Hundred Fifty (150)&#xD;
      subjects presenting with pain will be enrolled into a single treatment group The purpose of&#xD;
      the study is to evaluate the feasibility of PLEDS for PIV catheter light delivery for pain&#xD;
      reduction, through change between baseline average pain and final average VAS score. The&#xD;
      absence of a control group is based on the following reason: The purpose of this&#xD;
      investigation is to further the understanding of the feasibility of PLEDS for PIV catheter&#xD;
      light delivery for pain management. Further, the results of this investigation will be used&#xD;
      (internally only) to determine if subject-perceived reductions in pain warrant proceeding&#xD;
      with more controlled, targeted and possibly randomized studies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study uses a prospective non-randomized, non-controlled design. One Hundred Fifty (150)&#xD;
      subjects presenting with pain will be enrolled into a single treatment group The purpose of&#xD;
      the study is to evaluate the feasibility of Polychromatic Light Emitting Diode System (PLEDS)&#xD;
      for Peripheral Intravenous (PIV) catheter light delivery for pain reduction, through change&#xD;
      between baseline average pain and final average VAS score. The absence of a control group is&#xD;
      based on the following reason: The purpose of this investigation is to further the&#xD;
      understanding of the feasibility of PLEDS for PIV catheter light delivery for pain&#xD;
      management. Further, the results of this investigation will be used (internally only) to&#xD;
      determine if subject-perceived reductions in pain warrant proceeding with more controlled,&#xD;
      targeted and possibly randomized studies.&#xD;
&#xD;
      PIV therapy has been used for decades as an effective therapy to maintain proper hydration&#xD;
      and electrolyte levels. Additionally, PIV therapy can be infused with various agents,&#xD;
      including supplements and pharmacological agents. Low-energy light therapy has been&#xD;
      established as an alternative treatment for a myriad of medical conditions including&#xD;
      reduction of pain. The concurrent administration of low-light therapy and PIV therapy may&#xD;
      serve as a viable therapy for the treatment of pain associated with various medical&#xD;
      conditions. Accordingly, this study is designed to assess the feasibility of low light&#xD;
      therapy via PLEDS integrated into a standard PIV catheter for the purposes of reduction of&#xD;
      pain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Lack of Funding&#xD;
  </why_stopped>
  <start_date type="Actual">February 8, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2018</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2018</primary_completion_date>
  <phase>Early Phase 1</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The use of polychromatic light therapy delivered through an intravascular catheter to assess the change in self-reported VAS pain score.</measure>
    <time_frame>2 weeks</time_frame>
    <description>To evaluate the feasibility of PLEDS for PIV catheter light delivery for the purposes of pain reduction, through assessing the change between baseline average pain (via &quot;Brief Pain Inventory - Short Form&quot;) and final average VAS score (via the &quot;Per Treatment VAS Score Form&quot;) following treatment administration.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Subject Satisfaction</measure>
    <time_frame>2 weeks</time_frame>
    <description>Self-reported overall treatment satisfaction based on perceived response from treatment</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Treatment Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Polychromatic light emitting diode system is a non-significant risk device that administers low-dose light generated by light emitting diode(s). A small adapter attaches directly to a standard 20-guage catheter that threads a small fiber optic through the distal end of the catheter. The optic terminates at the proximal end of the catheter. Polychromatic light is emitted to illuminate the catheter near the site of catheter entrance. Concurrently, normal saline flows through the optic adapter, into and through the 20-gauge catheter.&#xD;
Device: UVL1000 Treatment Station Drug: Normal Saline 0.9% Infusion Solution Bag Device: Peripheral Catheterization</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>UVL1000 Treatment Station</intervention_name>
    <description>Non-coherent light source administered 365 nm, 630 nm, and 530 nm at an output intensity of 0.1 mW directly into an existing intravascular 20 gauge 1.0&quot; catheter</description>
    <arm_group_label>Treatment Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal Saline 0.9% Infusion Solution Bag</intervention_name>
    <description>250 ml of 0.9% Sodium Chloride Solution</description>
    <arm_group_label>Treatment Group</arm_group_label>
    <other_name>Normal Saline</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Peripheral Catheterization</intervention_name>
    <description>20-gauge 1.0&quot; catheter</description>
    <arm_group_label>Treatment Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Voluntarily signed informed consent form (see Informed Consent Forms)&#xD;
&#xD;
          -  Ages 18-70&#xD;
&#xD;
          -  Non-Pregnant Female Participants&#xD;
&#xD;
          -  Self-reported perceived pain score via &quot;Brief Pain Inventory - Short Form&quot; score of 2&#xD;
             or more.&#xD;
&#xD;
          -  No breastfeeding for 1 week prior to enrollment&#xD;
&#xD;
          -  Birth control measures to be used throughout the duration of the study for women of&#xD;
             child bearing potential&#xD;
&#xD;
          -  Powerful antioxidants (e.g. oral antioxidants, Vitamin C and E, glutathione or Myer's&#xD;
             cocktail IV infusion therapy) will not be used on treatment days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active infection along potential intravenous catheter sites&#xD;
&#xD;
          -  Use of anti-inflammatory medications on day of treatment and no more than 400mg per&#xD;
             day for over 30 days&#xD;
&#xD;
          -  Suffering from blood clotting disorders (hypercoagulable condition, thrombocytosis,&#xD;
             etc.)&#xD;
&#xD;
          -  Participated in a clinical study in the last 14 days&#xD;
&#xD;
          -  Breastfeeding&#xD;
&#xD;
          -  Currently taking photosensitizing agents&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John W Reeves, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>White Clover Wellness and Research Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>White Clover Wellness and Research Center</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
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  <verification_date>November 2017</verification_date>
  <study_first_submitted>August 6, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>November 9, 2017</last_update_submitted>
  <last_update_submitted_qc>November 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>White Clover Research Foundation</investigator_affiliation>
    <investigator_full_name>John W. Reeves, MD</investigator_full_name>
    <investigator_title>John W. Reeves, MD</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03246282
org study id: UVL_P001
nct id: NCT03246282
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This study uses a prospective non-randomized, non-controlled design. One Hundred Fifty (150)
      subjects presenting with pain will be enrolled into a single treatment group The purpose of
      the study is to evaluate the feasibility of PLEDS for PIV catheter light delivery for pain
      reduction, through change between baseline average pain and final average VAS score. The
      absence of a control group is based on the following reason: The purpose of this
      investigation is to further the understanding of the feasibility of PLEDS for PIV catheter
      light delivery for pain management. Further, the results of this investigation will be used
      (internally only) to determine if subject-perceived reductions in pain warrant proceeding
      with more controlled, targeted and possibly randomized studies.
This study uses a prospective non-randomized, non-controlled design. One Hundred Fifty (150)
      subjects presenting with pain will be enrolled into a single treatment group The purpose of
      the study is to evaluate the feasibility of Polychromatic Light Emitting Diode System (PLEDS)
      for Peripheral Intravenous (PIV) catheter light delivery for pain reduction, through change
      between baseline average pain and final average VAS score. The absence of a control group is
      based on the following reason: The purpose of this investigation is to further the
      understanding of the feasibility of PLEDS for PIV catheter light delivery for pain
      management. Further, the results of this investigation will be used (internally only) to
      determine if subject-perceived reductions in pain warrant proceeding with more controlled,
      targeted and possibly randomized studies.

      PIV therapy has been used for decades as an effective therapy to maintain proper hydration
      and electrolyte levels. Additionally, PIV therapy can be infused with various agents,
      including supplements and pharmacological agents. Low-energy light therapy has been
      established as an alternative treatment for a myriad of medical conditions including
      reduction of pain. The concurrent administration of low-light therapy and PIV therapy may
      serve as a viable therapy for the treatment of pain associated with various medical
      conditions. Accordingly, this study is designed to assess the feasibility of low light
      therapy via PLEDS integrated into a standard PIV catheter for the purposes of reduction of
      pain.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: The use of polychromatic light therapy delivered through an intravascular catheter to assess the change in self-reported VAS pain score.
time frame: 2 weeks
description: To evaluate the feasibility of PLEDS for PIV catheter light delivery for the purposes of pain reduction, through assessing the change between baseline average pain (via "Brief Pain Inventory - Short Form") and final average VAS score (via the "Per Treatment VAS Score Form") following treatment administration.
measure: Subject Satisfaction
time frame: 2 weeks
description: Self-reported overall treatment satisfaction based on perceived response from treatment
arm group label: Treatment Group
arm group type: Experimental
description: Polychromatic light emitting diode system is a non-significant risk device that administers low-dose light generated by light emitting diode(s). A small adapter attaches directly to a standard 20-guage catheter that threads a small fiber optic through the distal end of the catheter. The optic terminates at the proximal end of the catheter. Polychromatic light is emitted to illuminate the catheter near the site of catheter entrance. Concurrently, normal saline flows through the optic adapter, into and through the 20-gauge catheter.
Device: UVL1000 Treatment Station Drug: Normal Saline 0.9% Infusion Solution Bag Device: Peripheral Catheterization
intervention type: Device
intervention name: UVL1000 Treatment Station
description: Non-coherent light source administered 365 nm, 630 nm, and 530 nm at an output intensity of 0.1 mW directly into an existing intravascular 20 gauge 1.0" catheter
arm group label: Treatment Group
intervention type: Drug
intervention name: Normal Saline 0.9% Infusion Solution Bag
description: 250 ml of 0.9% Sodium Chloride Solution
arm group label: Treatment Group
other name: Normal Saline
intervention type: Device
intervention name: Peripheral Catheterization
description: 20-gauge 1.0" catheter
arm group label: Treatment Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: John W Reeves, MD
role: Principal Investigator
affiliation: White Clover Wellness and Research Center
facility: 
country: United States
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responsible party type: Sponsor-Investigator
investigator affiliation: White Clover Research Foundation
investigator full name: John W. Reeves, MD
investigator title: John W. Reeves, MD
sharing ipd: No