<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/NCT03286764</url>
  </required_header>
  <id_info>
    <org_study_id>14-006242</org_study_id>
    <nct_id>NCT03286764</nct_id>
  </id_info>
  <brief_title>Use of Peppermint Oil During Screening Colonoscopy to Improve Visibility</brief_title>
  <official_title>Use of Peppermint Oil During Screening Colonoscopy to Improve Visibility</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</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 investigators hypothesize that spraying peppermint oil containing L-menthol onto the&#xD;
      colonic mucosa during colonoscopy will relax smooth muscle allowing better colonic&#xD;
      visualization.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">September 10, 2019</completion_date>
  <primary_completion_date type="Actual">September 10, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Determination of Adenoma Detection Rate during Colonoscopy Procedure</measure>
    <time_frame>2 hours</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Enhancement of the ADR During Colonoscopy</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Distilled water spray as a placebo during Colonoscopy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Peppermint Oil</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Peppermint Oil spray during Colonoscopy</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Peppermint Oil</intervention_name>
    <arm_group_label>Peppermint Oil</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Distilled water</intervention_name>
    <description>Distilled water spray as a placebo during Colonoscopy</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Screening colonoscopy&#xD;
&#xD;
          -  Age 50 years and older&#xD;
&#xD;
          -  Able to give consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No consent obtained or adult lacking capacity to consent&#xD;
&#xD;
          -  Do not reach cecum on colonoscopy&#xD;
&#xD;
          -  Renal impairment (defined as CrCl &lt;30 ml/min)&#xD;
&#xD;
          -  Allergy to study peppermint oil solution&#xD;
&#xD;
          -  History of colon resection&#xD;
&#xD;
          -  Inflammatory bowel disease&#xD;
&#xD;
          -  Known colorectal neoplasia&#xD;
&#xD;
          -  Non-correctable coagulopathy&#xD;
&#xD;
          -  Pregnancy or lactating&#xD;
&#xD;
          -  Prisoners&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kevin C Ruff</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Arizona</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85259</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>April 2, 2020</last_update_submitted>
  <last_update_submitted_qc>April 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Kevin C. Ruff, M.D.</investigator_full_name>
    <investigator_title>PI</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peppermint oil</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03286764
org study id: 14-006242
nct id: NCT03286764
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators hypothesize that spraying peppermint oil containing L-menthol onto the
      colonic mucosa during colonoscopy will relax smooth muscle allowing better colonic
      visualization.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Triple (Participant, Care Provider, Investigator)
measure: Determination of Adenoma Detection Rate during Colonoscopy Procedure
time frame: 2 hours
arm group label: Placebo
arm group type: Placebo Comparator
description: Distilled water spray as a placebo during Colonoscopy
arm group label: Peppermint Oil
arm group type: Experimental
description: Peppermint Oil spray during Colonoscopy
intervention type: Other
intervention name: Peppermint Oil
arm group label: Peppermint Oil
intervention type: Other
intervention name: Distilled water
description: Distilled water spray as a placebo during Colonoscopy
arm group label: Placebo
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kevin C Ruff
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Kevin C. Ruff, M.D.
investigator title: PI
mesh term: Peppermint oil