<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/NCT03259295</url>
  </required_header>
  <id_info>
    <org_study_id>20171314 - WIRB</org_study_id>
    <secondary_id>PRO00002692</secondary_id>
    <nct_id>NCT03259295</nct_id>
  </id_info>
  <brief_title>Study to Evaluate the Efficacy of Removing Skin Tags With Digiclamp</brief_title>
  <official_title>Research on Current Prototypes of the Digiclamp. Short Term and Long Term Outcomes of Treating Adults With Achrocordons (Skin Tags)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>XDG Technologies, LLC</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Florida</source>
  <oversight_info>
    <has_dmc>No</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>
      The objective of this study is to assess the efficacy of using the Digiclamp device to remove&#xD;
      achrocordons (skin tags). The hypothesis is that utilizing the device will result in low&#xD;
      rates of re-occurrence, scars, scar tissue and discoloration at the site of removal.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Achrocorodons, or skin tags, are superficial cutaneous lesions that occur most commonly among&#xD;
      middle aged adults, obese persons and those who suffer from Type 2 Diabetes. In most cases,&#xD;
      the tags are not bothersome but there are instances when they can become infected or&#xD;
      irritated. There are several skin tag removal options available, including suture ligature,&#xD;
      freezing, cautery or excision. These procedures are often done in a dermatology office and&#xD;
      are an out-of-pocket cost.&#xD;
&#xD;
      The Digiclamp device was invented to make skin tag removal procedures more accessible. The&#xD;
      Digiclamp represents a new option that when placed in the hands of primary care clinicians,&#xD;
      it will allow them to remove skin tags without having to purchase expensive devices or to&#xD;
      refer them to a Dermatologist. The device is disposable, and relatively painless when used&#xD;
      correctly, and requires minimal training.&#xD;
&#xD;
      The investigator is planning to enroll 100 subjects, who will have skin tags removed using&#xD;
      the Digiclamp device. Subjects will return for follow up at 2-3 months after skin tag&#xD;
      removal.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2017</start_date>
  <completion_date type="Actual">June 15, 2019</completion_date>
  <primary_completion_date type="Actual">June 15, 2019</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>Re-occurrence Rate of Skin Tags</measure>
    <time_frame>3 months</time_frame>
    <description>Percentage of subjects who experience a re-occurrence of the skin tag at the removal site.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Permanent Scars Among Lesion Sites</measure>
    <time_frame>3 months</time_frame>
    <description>Percentage of subjects who develop a scar at the removal site</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Scar Tissue Formation Among Lesion Sites</measure>
    <time_frame>3 months</time_frame>
    <description>Percentage of subjects who develop scar tissue or keloid at the site of removal</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Discoloration Among Subjects</measure>
    <time_frame>3 months</time_frame>
    <description>Percentage of subjects who develop discoloration at the site of removal</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Pain/Numbness Where Skin Tag Was Removed</measure>
    <time_frame>3 months</time_frame>
    <description>Percentage of subjects who develop pain/numbness at the site of removal</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction With Pain Post Procedure</measure>
    <time_frame>2 months post procedure</time_frame>
    <description>All study participants were asked three questions in a post procedure satisfaction survey.&#xD;
1. How satisfied are you with the amount of pain you experienced while having your skin tag removed? Study participants responded whether they were &quot;very satisfied&quot;, &quot;somewhat satisfied&quot;, &quot;neither satisfied nor dissatisfied&quot;, &quot;somewhat dissatisfied&quot;, &quot;very dissatisfied&quot;. Subjects were counted in each category and reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction With What the Area Looked Like Post Procedure</measure>
    <time_frame>2 months post procedure</time_frame>
    <description>All study participants were given a satisfaction survey 2 months post procedure. Subjects had to choose if they were &quot;very satisfied:, &quot;somewhat satisfied&quot;, &quot;neither satisfied nor dissatisfied&quot;, &quot;somewhat dissatisfied&quot;, &quot;very dissatisfied&quot; with how the area looks where the skin tag used to be. Subjects in each category were counted and reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>How Likely to Recommend the Procedure to Friends and Family</measure>
    <time_frame>2 months post procedure</time_frame>
    <description>All study participants were asked a satisfaction survey post procedure and whether they would recommend the procedure to friends and family. Categories for response were: &quot;very likely&quot;, &quot;somewhat likely&quot;, &quot;neither likely nor unlikely&quot;, &quot;somewhat unlikely&quot;, &quot;very unlikely&quot;. Subjects in each category were counted and reported.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Achrochordon</condition>
  <arm_group>
    <arm_group_label>Skin tag removal initial visit plus follow-up</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Removal of skin tags 1 cm or less using Digiclamp and follow-up 2-3 months after skin tag removal to assess functionality and effectiveness of the device.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Digiclamp (Skin tag removal initial plus follow-up)</intervention_name>
    <description>Skin tag will be assessed for size, location, and overall appearance. After assessment and confirmation that the skin tag is not infected or possibly malignant, the site will be photographed, prepped with an antimicrobial solution, anesthetized, and removed using the Digiclamp. A bandaid will be applied to the site. Site of skin tag removal will be photographed to document lesion recurrence and presence of scar tissue or hyperpigmentation. Subjects will be asked to complete a brief survey about their satisfaction with the use of Digiclamp.</description>
    <arm_group_label>Skin tag removal initial visit plus follow-up</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects with simple skin tag(s) measuring up to 1 centimeter width at the base of the&#xD;
             skin tag&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with skin tags measuring greater than 1 centimeter width at the base&#xD;
&#xD;
          -  Subjects whose skin tags appear infected or may need to be evaluated by pathology&#xD;
&#xD;
          -  Subjects whose skin tags are located in genital areas or eyelids&#xD;
&#xD;
          -  Pregnant subjects&#xD;
&#xD;
          -  Subjects with bleeding disorders.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Juan C Roig, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Office of Raymond Marquette, MD</name>
      <address>
        <city>Ocala</city>
        <state>Florida</state>
        <zip>34471</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Watson BT, Hennrikus WL. Postaxial type-B polydactyly. Prevalence and treatment. J Bone Joint Surg Am. 1997 Jan;79(1):65-8. doi: 10.2106/00004623-199701000-00007.</citation>
    <PMID>9010187</PMID>
  </reference>
  <reference>
    <citation>Schmook T, Stockfleth E. Current treatment patterns in non-melanoma skin cancer across Europe. J Dermatolog Treat. 2003;14 Suppl 3:3-10. doi: 10.1080/jdt.14.s3.3.10.</citation>
    <PMID>14522635</PMID>
  </reference>
  <reference>
    <citation>Kahana M, Grossman E, Feinstein A, Ronnen M, Cohen M, Millet MS. Skin tags: a cutaneous marker for diabetes mellitus. Acta Derm Venereol. 1987;67(2):175-7.</citation>
    <PMID>2438887</PMID>
  </reference>
  <reference>
    <citation>Banik R, Lubach D. Skin tags: localization and frequencies according to sex and age. Dermatologica. 1987;174(4):180-3. doi: 10.1159/000249169.</citation>
    <PMID>3582706</PMID>
  </reference>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <results_first_submitted>December 6, 2021</results_first_submitted>
  <results_first_submitted_qc>February 13, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">February 15, 2023</results_first_posted>
  <last_update_submitted>February 13, 2023</last_update_submitted>
  <last_update_submitted_qc>February 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>skin tag</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 17, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/95/NCT03259295/Prot_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Skin Tag Removal Initial Visit Plus Follow-up</title>
          <description>Removal of skin tags 1 cm or less using Digiclamp and follow-up 2-3 months after skin tag removal to assess functionality and effectiveness of the device.&#xD;
Digiclamp (Skin tag removal initial plus follow-up): Skin tag will be assessed for size, location, and overall appearance. After assessment and confirmation that the skin tag is not infected or possibly malignant, the site will be photographed, prepped with an antimicrobial solution, anesthetized, and removed using the Digiclamp. A bandaid will be applied to the site. Site of skin tag removal will be photographed to document lesion recurrence and presence of scar tissue or hyperpigmentation. Subjects will be asked to complete a brief survey about their satisfaction with the use of Digiclamp.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Skin Tag Removal Initial Visit Plus Follow-up</title>
          <description>Removal of skin tags 1 cm or less using Digiclamp and follow-up 2-3 months after skin tag removal to assess functionality and effectiveness of the device.&#xD;
Digiclamp (Skin tag removal initial plus follow-up): Skin tag will be assessed for size, location, and overall appearance. After assessment and confirmation that the skin tag is not infected or possibly malignant, the site will be photographed, prepped with an antimicrobial solution, anesthetized, and removed using the Digiclamp. A bandaid will be applied to the site. Site of skin tag removal will be photographed to document lesion recurrence and presence of scar tissue or hyperpigmentation. Subjects will be asked to complete a brief survey about their satisfaction with the use of Digiclamp.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="20"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45.8" spread="9.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>pounds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="182" spread="43.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>inches</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="66.4" spread="3.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of lesions</title>
          <units>lesions</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.5" spread="1.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Location of lesions</title>
          <units>lesions</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>neck</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>maxilla</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>axilla</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>back</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>areola</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>thigh</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>rib cage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>buttock</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>mandible</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>shoulder</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>abdomen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>chest</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>width of lesion</title>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.404" spread="0.276"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>height of lesion</title>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.376" spread="0.252"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Re-occurrence Rate of Skin Tags</title>
        <description>Percentage of subjects who experience a re-occurrence of the skin tag at the removal site.</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Skin Tag Removal Initial Visit Plus Follow-up</title>
            <description>Removal of skin tags 1 cm or less using Digiclamp and follow-up 2-3 months after skin tag removal to assess functionality and effectiveness of the device.&#xD;
Digiclamp (Skin tag removal initial plus follow-up): Skin tag will be assessed for size, location, and overall appearance. After assessment and confirmation that the skin tag is not infected or possibly malignant, the site will be photographed, prepped with an antimicrobial solution, anesthetized, and removed using the Digiclamp. A bandaid will be applied to the site. Site of skin tag removal will be photographed to document lesion recurrence and presence of scar tissue or hyperpigmentation. Subjects will be asked to complete a brief survey about their satisfaction with the use of Digiclamp.</description>
          </group>
        </group_list>
        <measure>
          <title>Re-occurrence Rate of Skin Tags</title>
          <description>Percentage of subjects who experience a re-occurrence of the skin tag at the removal site.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Permanent Scars Among Lesion Sites</title>
        <description>Percentage of subjects who develop a scar at the removal site</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Skin Tag Removal Initial Visit Plus Follow-up</title>
            <description>Removal of skin tags 1 cm or less using Digiclamp and follow-up 2-3 months after skin tag removal to assess functionality and effectiveness of the device.&#xD;
Digiclamp (Skin tag removal initial plus follow-up): Skin tag will be assessed for size, location, and overall appearance. After assessment and confirmation that the skin tag is not infected or possibly malignant, the site will be photographed, prepped with an antimicrobial solution, anesthetized, and removed using the Digiclamp. A bandaid will be applied to the site. Site of skin tag removal will be photographed to document lesion recurrence and presence of scar tissue or hyperpigmentation. Subjects will be asked to complete a brief survey about their satisfaction with the use of Digiclamp.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Permanent Scars Among Lesion Sites</title>
          <description>Percentage of subjects who develop a scar at the removal site</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Scar Tissue Formation Among Lesion Sites</title>
        <description>Percentage of subjects who develop scar tissue or keloid at the site of removal</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Skin Tag Removal Initial Visit Plus Follow-up</title>
            <description>Removal of skin tags 1 cm or less using Digiclamp and follow-up 2-3 months after skin tag removal to assess functionality and effectiveness of the device.&#xD;
Digiclamp (Skin tag removal initial plus follow-up): Skin tag will be assessed for size, location, and overall appearance. After assessment and confirmation that the skin tag is not infected or possibly malignant, the site will be photographed, prepped with an antimicrobial solution, anesthetized, and removed using the Digiclamp. A bandaid will be applied to the site. Site of skin tag removal will be photographed to document lesion recurrence and presence of scar tissue or hyperpigmentation. Subjects will be asked to complete a brief survey about their satisfaction with the use of Digiclamp.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Scar Tissue Formation Among Lesion Sites</title>
          <description>Percentage of subjects who develop scar tissue or keloid at the site of removal</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Discoloration Among Subjects</title>
        <description>Percentage of subjects who develop discoloration at the site of removal</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Skin Tag Removal Initial Visit Plus Follow-up</title>
            <description>Removal of skin tags 1 cm or less using Digiclamp and follow-up 2-3 months after skin tag removal to assess functionality and effectiveness of the device.&#xD;
Digiclamp (Skin tag removal initial plus follow-up): Skin tag will be assessed for size, location, and overall appearance. After assessment and confirmation that the skin tag is not infected or possibly malignant, the site will be photographed, prepped with an antimicrobial solution, anesthetized, and removed using the Digiclamp. A bandaid will be applied to the site. Site of skin tag removal will be photographed to document lesion recurrence and presence of scar tissue or hyperpigmentation. Subjects will be asked to complete a brief survey about their satisfaction with the use of Digiclamp.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Discoloration Among Subjects</title>
          <description>Percentage of subjects who develop discoloration at the site of removal</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Pain/Numbness Where Skin Tag Was Removed</title>
        <description>Percentage of subjects who develop pain/numbness at the site of removal</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Skin Tag Removal Initial Visit Plus Follow-up</title>
            <description>Removal of skin tags 1 cm or less using Digiclamp and follow-up 2-3 months after skin tag removal to assess functionality and effectiveness of the device.&#xD;
Digiclamp (Skin tag removal initial plus follow-up): Skin tag will be assessed for size, location, and overall appearance. After assessment and confirmation that the skin tag is not infected or possibly malignant, the site will be photographed, prepped with an antimicrobial solution, anesthetized, and removed using the Digiclamp. A bandaid will be applied to the site. Site of skin tag removal will be photographed to document lesion recurrence and presence of scar tissue or hyperpigmentation. Subjects will be asked to complete a brief survey about their satisfaction with the use of Digiclamp.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Pain/Numbness Where Skin Tag Was Removed</title>
          <description>Percentage of subjects who develop pain/numbness at the site of removal</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Satisfaction With Pain Post Procedure</title>
        <description>All study participants were asked three questions in a post procedure satisfaction survey.&#xD;
1. How satisfied are you with the amount of pain you experienced while having your skin tag removed? Study participants responded whether they were &quot;very satisfied&quot;, &quot;somewhat satisfied&quot;, &quot;neither satisfied nor dissatisfied&quot;, &quot;somewhat dissatisfied&quot;, &quot;very dissatisfied&quot;. Subjects were counted in each category and reported.</description>
        <time_frame>2 months post procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Skin Tag Removal Initial Visit Plus Follow-up</title>
            <description>Removal of skin tags 1 cm or less using Digiclamp and follow-up 2-3 months after skin tag removal to assess functionality and effectiveness of the device.&#xD;
Digiclamp (Skin tag removal initial plus follow-up): Skin tag will be assessed for size, location, and overall appearance. After assessment and confirmation that the skin tag is not infected or possibly malignant, the site will be photographed, prepped with an antimicrobial solution, anesthetized, and removed using the Digiclamp. A bandaid will be applied to the site. Site of skin tag removal will be photographed to document lesion recurrence and presence of scar tissue or hyperpigmentation. Subjects will be asked to complete a brief survey about their satisfaction with the use of Digiclamp.</description>
          </group>
        </group_list>
        <measure>
          <title>Satisfaction With Pain Post Procedure</title>
          <description>All study participants were asked three questions in a post procedure satisfaction survey.&#xD;
1. How satisfied are you with the amount of pain you experienced while having your skin tag removed? Study participants responded whether they were &quot;very satisfied&quot;, &quot;somewhat satisfied&quot;, &quot;neither satisfied nor dissatisfied&quot;, &quot;somewhat dissatisfied&quot;, &quot;very dissatisfied&quot;. Subjects were counted in each category and reported.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Very satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Somewhat satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Neither satisfied nor dissatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Somewhat dissatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Very dissatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Satisfaction With What the Area Looked Like Post Procedure</title>
        <description>All study participants were given a satisfaction survey 2 months post procedure. Subjects had to choose if they were &quot;very satisfied:, &quot;somewhat satisfied&quot;, &quot;neither satisfied nor dissatisfied&quot;, &quot;somewhat dissatisfied&quot;, &quot;very dissatisfied&quot; with how the area looks where the skin tag used to be. Subjects in each category were counted and reported.</description>
        <time_frame>2 months post procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Skin Tag Removal Initial Visit Plus Follow-up</title>
            <description>Removal of skin tags 1 cm or less using Digiclamp and follow-up 2-3 months after skin tag removal to assess functionality and effectiveness of the device.&#xD;
Digiclamp (Skin tag removal initial plus follow-up): Skin tag will be assessed for size, location, and overall appearance. After assessment and confirmation that the skin tag is not infected or possibly malignant, the site will be photographed, prepped with an antimicrobial solution, anesthetized, and removed using the Digiclamp. A bandaid will be applied to the site. Site of skin tag removal will be photographed to document lesion recurrence and presence of scar tissue or hyperpigmentation. Subjects will be asked to complete a brief survey about their satisfaction with the use of Digiclamp.</description>
          </group>
        </group_list>
        <measure>
          <title>Satisfaction With What the Area Looked Like Post Procedure</title>
          <description>All study participants were given a satisfaction survey 2 months post procedure. Subjects had to choose if they were &quot;very satisfied:, &quot;somewhat satisfied&quot;, &quot;neither satisfied nor dissatisfied&quot;, &quot;somewhat dissatisfied&quot;, &quot;very dissatisfied&quot; with how the area looks where the skin tag used to be. Subjects in each category were counted and reported.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Very satisfied with how the area looked like where the skin tag used to be</title>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Somewhat satisfied with what the area looked like</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Neither satisfied nor dissatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Somewhat dissatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Very dissatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>How Likely to Recommend the Procedure to Friends and Family</title>
        <description>All study participants were asked a satisfaction survey post procedure and whether they would recommend the procedure to friends and family. Categories for response were: &quot;very likely&quot;, &quot;somewhat likely&quot;, &quot;neither likely nor unlikely&quot;, &quot;somewhat unlikely&quot;, &quot;very unlikely&quot;. Subjects in each category were counted and reported.</description>
        <time_frame>2 months post procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Skin Tag Removal Initial Visit Plus Follow-up</title>
            <description>Removal of skin tags 1 cm or less using Digiclamp and follow-up 2-3 months after skin tag removal to assess functionality and effectiveness of the device.&#xD;
Digiclamp (Skin tag removal initial plus follow-up): Skin tag will be assessed for size, location, and overall appearance. After assessment and confirmation that the skin tag is not infected or possibly malignant, the site will be photographed, prepped with an antimicrobial solution, anesthetized, and removed using the Digiclamp. A bandaid will be applied to the site. Site of skin tag removal will be photographed to document lesion recurrence and presence of scar tissue or hyperpigmentation. Subjects will be asked to complete a brief survey about their satisfaction with the use of Digiclamp.</description>
          </group>
        </group_list>
        <measure>
          <title>How Likely to Recommend the Procedure to Friends and Family</title>
          <description>All study participants were asked a satisfaction survey post procedure and whether they would recommend the procedure to friends and family. Categories for response were: &quot;very likely&quot;, &quot;somewhat likely&quot;, &quot;neither likely nor unlikely&quot;, &quot;somewhat unlikely&quot;, &quot;very unlikely&quot;. Subjects in each category were counted and reported.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Very likely to recommend the procedure to friends and family</title>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Somewhat likely</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Neither likely nor unlikely</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Somewhat unlikely</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Very unlikely</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Skin Tag Removal Initial Visit Plus Follow-up</title>
          <description>Removal of skin tags 1 cm or less using Digiclamp and follow-up 2-3 months after skin tag removal to assess functionality and effectiveness of the device.&#xD;
Digiclamp (Skin tag removal initial plus follow-up): Skin tag will be assessed for size, location, and overall appearance. After assessment and confirmation that the skin tag is not infected or possibly malignant, the site will be photographed, prepped with an antimicrobial solution, anesthetized, and removed using the Digiclamp. A bandaid will be applied to the site. Site of skin tag removal will be photographed to document lesion recurrence and presence of scar tissue or hyperpigmentation. Subjects will be asked to complete a brief survey about their satisfaction with the use of Digiclamp.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Juan Carlos Roig</name_or_title>
      <organization>University of Florida</organization>
      <phone>352-273-8985</phone>
      <email>roigjc@peds.ufl.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03259295
org study id: 20171314 - WIRB
secondary id: PRO00002692
nct id: NCT03259295
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The objective of this study is to assess the efficacy of using the Digiclamp device to remove
      achrocordons (skin tags). The hypothesis is that utilizing the device will result in low
      rates of re-occurrence, scars, scar tissue and discoloration at the site of removal.
Achrocorodons, or skin tags, are superficial cutaneous lesions that occur most commonly among
      middle aged adults, obese persons and those who suffer from Type 2 Diabetes. In most cases,
      the tags are not bothersome but there are instances when they can become infected or
      irritated. There are several skin tag removal options available, including suture ligature,
      freezing, cautery or excision. These procedures are often done in a dermatology office and
      are an out-of-pocket cost.

      The Digiclamp device was invented to make skin tag removal procedures more accessible. The
      Digiclamp represents a new option that when placed in the hands of primary care clinicians,
      it will allow them to remove skin tags without having to purchase expensive devices or to
      refer them to a Dermatologist. The device is disposable, and relatively painless when used
      correctly, and requires minimal training.

      The investigator is planning to enroll 100 subjects, who will have skin tags removed using
      the Digiclamp device. Subjects will return for follow up at 2-3 months after skin tag
      removal.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Re-occurrence Rate of Skin Tags
time frame: 3 months
description: Percentage of subjects who experience a re-occurrence of the skin tag at the removal site.
measure: Percentage of Permanent Scars Among Lesion Sites
time frame: 3 months
description: Percentage of subjects who develop a scar at the removal site
measure: Percentage of Scar Tissue Formation Among Lesion Sites
time frame: 3 months
description: Percentage of subjects who develop scar tissue or keloid at the site of removal
measure: Percentage of Discoloration Among Subjects
time frame: 3 months
description: Percentage of subjects who develop discoloration at the site of removal
measure: Percentage of Pain/Numbness Where Skin Tag Was Removed
time frame: 3 months
description: Percentage of subjects who develop pain/numbness at the site of removal
measure: Satisfaction With Pain Post Procedure
time frame: 2 months post procedure
description: All study participants were asked three questions in a post procedure satisfaction survey.
1. How satisfied are you with the amount of pain you experienced while having your skin tag removed? Study participants responded whether they were "very satisfied", "somewhat satisfied", "neither satisfied nor dissatisfied", "somewhat dissatisfied", "very dissatisfied". Subjects were counted in each category and reported.
measure: Satisfaction With What the Area Looked Like Post Procedure
time frame: 2 months post procedure
description: All study participants were given a satisfaction survey 2 months post procedure. Subjects had to choose if they were "very satisfied:, "somewhat satisfied", "neither satisfied nor dissatisfied", "somewhat dissatisfied", "very dissatisfied" with how the area looks where the skin tag used to be. Subjects in each category were counted and reported.
measure: How Likely to Recommend the Procedure to Friends and Family
time frame: 2 months post procedure
description: All study participants were asked a satisfaction survey post procedure and whether they would recommend the procedure to friends and family. Categories for response were: "very likely", "somewhat likely", "neither likely nor unlikely", "somewhat unlikely", "very unlikely". Subjects in each category were counted and reported.
arm group label: Skin tag removal initial visit plus follow-up
arm group type: Experimental
description: Removal of skin tags 1 cm or less using Digiclamp and follow-up 2-3 months after skin tag removal to assess functionality and effectiveness of the device.
intervention type: Device
intervention name: Digiclamp (Skin tag removal initial plus follow-up)
description: Skin tag will be assessed for size, location, and overall appearance. After assessment and confirmation that the skin tag is not infected or possibly malignant, the site will be photographed, prepped with an antimicrobial solution, anesthetized, and removed using the Digiclamp. A bandaid will be applied to the site. Site of skin tag removal will be photographed to document lesion recurrence and presence of scar tissue or hyperpigmentation. Subjects will be asked to complete a brief survey about their satisfaction with the use of Digiclamp.
arm group label: Skin tag removal initial visit plus follow-up
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Juan C Roig, MD
role: Principal Investigator
affiliation: University of Florida
facility: 
country: United States
citation: Watson BT, Hennrikus WL. Postaxial type-B polydactyly. Prevalence and treatment. J Bone Joint Surg Am. 1997 Jan;79(1):65-8. doi: 10.2106/00004623-199701000-00007.
PMID: 9010187
citation: Schmook T, Stockfleth E. Current treatment patterns in non-melanoma skin cancer across Europe. J Dermatolog Treat. 2003;14 Suppl 3:3-10. doi: 10.1080/jdt.14.s3.3.10.
PMID: 14522635
citation: Kahana M, Grossman E, Feinstein A, Ronnen M, Cohen M, Millet MS. Skin tags: a cutaneous marker for diabetes mellitus. Acta Derm Venereol. 1987;67(2):175-7.
PMID: 2438887
citation: Banik R, Lubach D. Skin tags: localization and frequencies according to sex and age. Dermatologica. 1987;174(4):180-3. doi: 10.1159/000249169.
PMID: 3582706
responsible party type: Sponsor
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 