<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/NCT04403997</url>
  </required_header>
  <id_info>
    <org_study_id>NBICromo</org_study_id>
    <nct_id>NCT04403997</nct_id>
  </id_info>
  <brief_title>Virtual Chromoendoscopy With Second Generation NBI (HQ190) vs Chromoendoscopy in Inflammatory Bowel Disease</brief_title>
  <official_title>Virtual Chromoendoscopy With Second Generation NBI (HQ190) vs Chromoendoscopy in Inflammatory Bowel Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Universitario La Paz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Universitario La Paz</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study to compare the detection of neoplastic lesions between chromoendoscopy and NBI&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Single-blind (patient) randomized study to compare detection of neoplastic lesions between&#xD;
      chromoendoscopy and NBI.&#xD;
&#xD;
      Patients with Inflammatory Bowel Disease who are to undergo chromoendoscopy according to&#xD;
      usual clinical criteria will be included. The endoscopic procedure is similar to the one&#xD;
      usually performed. All patients will undergo colonoscopy according to the usual procedure,&#xD;
      with Olympus HQ190 series endoscopes, with the same bowel preparation. During intubation, the&#xD;
      faecal remains will be thoroughly washed.&#xD;
&#xD;
      Patients will be randomly assigned to one of the two techniques: Chromoendoscopy with 0.1%&#xD;
      methylene blue or New generation NBI with Near focus.&#xD;
&#xD;
      Biopsies will be taken of all those lesions detected, instead of random biopsies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 1, 2019</start_date>
  <completion_date type="Anticipated">February 25, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2021</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Lesions detected</measure>
    <time_frame>Baseline</time_frame>
    <description>Total number of IBD dysplastic lesions detected by the use of NBI virtual chromoendoscopy versus conventional chromoendoscopy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Detection rate of dysplastic lesions</measure>
    <time_frame>Baseline</time_frame>
    <description>Number of patients with at least one dysplastic lesion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-dysplastic lesions</measure>
    <time_frame>Baseline</time_frame>
    <description>Assess the number of non-dysplastic lesions detected with both methods</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ratio of neoplastic lesions/total lesions</measure>
    <time_frame>Baseline</time_frame>
    <description>Compare the ratio of neoplastic lesions/total lesions between both groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total endoscopy time</measure>
    <time_frame>Baseline</time_frame>
    <description>The total endoscopy time is counted from the introduction of the endoscope in the patient until its complete removal</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Removal time</measure>
    <time_frame>Baseline</time_frame>
    <description>Withdrawal time is counted from the time the cecum is reached to the completion of the test, including time spent on staining, biopsy or polypectomy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Near Focus ability</measure>
    <time_frame>Baseline</time_frame>
    <description>Assess Near Focus ability to optically differentiate dysplastic from non-dysplastic lesions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of biopsies</measure>
    <time_frame>Baseline</time_frame>
    <description>Number of biopsies taken in the different groups</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">175</enrollment>
  <condition>Chromoendoscopy</condition>
  <arm_group>
    <arm_group_label>Chromoendoscopy with methylene blue 0.1%</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Once the cecum is reached, a spray catheter is introduced through the working channel and the dye, a 0.1% methylene blue solution, is applied.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Virtual Chromoendoscopy with NBI with HQ190 endoscopes</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intubation is done with normal white light. Once the cecum is reached, the removal will be done in NBI mode</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Chromoendoscopy</intervention_name>
    <description>Chromoendoscopy is an endoscopic technique used in the follow-up of inflammatory bowel disease of long evolution. Chromoendoscopy, through the application of specific dyes used directly on the intestinal mucosa, promotes the visualization of mucosal lesions.</description>
    <arm_group_label>Chromoendoscopy with methylene blue 0.1%</arm_group_label>
    <arm_group_label>Virtual Chromoendoscopy with NBI with HQ190 endoscopes</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with an established diagnosis of Inflammatory Bowel Disease with indication&#xD;
             to undergo chromoendoscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are not trained to understand the nature of the study, the procedures to&#xD;
             be followed or are not able to sign an informed consent&#xD;
&#xD;
          -  Known allergy or intolerance to methylene blue&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Personal history of colorectal cancer&#xD;
&#xD;
          -  Ulcerative colitis active more than 20 cm from the anal verge&#xD;
&#xD;
          -  Patients with known G6PD deficiency&#xD;
&#xD;
          -  Severe kidney failure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eduardo Martín Arranz, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Universitario La Paz</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Eduardo Martín Arranz, PhD</last_name>
    <phone>+34912071350</phone>
    <email>emarranz@salud.madrid.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hospital Universitario La Paz</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eduardo Martín Arranz, PhD</last_name>
      <phone>+34912071350</phone>
      <email>emarranz@salud.madrid.org</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>July 22, 2021</last_update_submitted>
  <last_update_submitted_qc>July 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Universitario La Paz</investigator_affiliation>
    <investigator_full_name>María Dolores Martín Arranz, PhD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Inflammatory Bowel Diseases</mesh_term>
  </condition_browse>
  <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/NCT04403997
org study id: NBICromo
nct id: NCT04403997
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Study to compare the detection of neoplastic lesions between chromoendoscopy and NBI
Single-blind (patient) randomized study to compare detection of neoplastic lesions between
      chromoendoscopy and NBI.

      Patients with Inflammatory Bowel Disease who are to undergo chromoendoscopy according to
      usual clinical criteria will be included. The endoscopic procedure is similar to the one
      usually performed. All patients will undergo colonoscopy according to the usual procedure,
      with Olympus HQ190 series endoscopes, with the same bowel preparation. During intubation, the
      faecal remains will be thoroughly washed.

      Patients will be randomly assigned to one of the two techniques: Chromoendoscopy with 0.1%
      methylene blue or New generation NBI with Near focus.

      Biopsies will be taken of all those lesions detected, instead of random biopsies.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Participant)
measure: Lesions detected
time frame: Baseline
description: Total number of IBD dysplastic lesions detected by the use of NBI virtual chromoendoscopy versus conventional chromoendoscopy
measure: Detection rate of dysplastic lesions
time frame: Baseline
description: Number of patients with at least one dysplastic lesion
measure: Non-dysplastic lesions
time frame: Baseline
description: Assess the number of non-dysplastic lesions detected with both methods
measure: Ratio of neoplastic lesions/total lesions
time frame: Baseline
description: Compare the ratio of neoplastic lesions/total lesions between both groups
measure: Total endoscopy time
time frame: Baseline
description: The total endoscopy time is counted from the introduction of the endoscope in the patient until its complete removal
measure: Removal time
time frame: Baseline
description: Withdrawal time is counted from the time the cecum is reached to the completion of the test, including time spent on staining, biopsy or polypectomy
measure: Near Focus ability
time frame: Baseline
description: Assess Near Focus ability to optically differentiate dysplastic from non-dysplastic lesions
measure: Number of biopsies
time frame: Baseline
description: Number of biopsies taken in the different groups
arm group label: Chromoendoscopy with methylene blue 0.1%
arm group type: Active Comparator
description: Once the cecum is reached, a spray catheter is introduced through the working channel and the dye, a 0.1% methylene blue solution, is applied.
arm group label: Virtual Chromoendoscopy with NBI with HQ190 endoscopes
arm group type: Experimental
description: Intubation is done with normal white light. Once the cecum is reached, the removal will be done in NBI mode
intervention type: Procedure
intervention name: Chromoendoscopy
description: Chromoendoscopy is an endoscopic technique used in the follow-up of inflammatory bowel disease of long evolution. Chromoendoscopy, through the application of specific dyes used directly on the intestinal mucosa, promotes the visualization of mucosal lesions.
arm group label: Chromoendoscopy with methylene blue 0.1%
arm group label: Virtual Chromoendoscopy with NBI with HQ190 endoscopes
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Eduardo Martín Arranz, PhD
role: Principal Investigator
affiliation: Hospital Universitario La Paz
last name: Eduardo Martín Arranz, PhD
phone: +34912071350
email: emarranz@salud.madrid.org
facility: 
status: Recruiting
contact: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Hospital Universitario La Paz
investigator full name: María Dolores Martín Arranz, PhD
investigator title: Principal Investigator
mesh term: Inflammatory Bowel Diseases
sharing ipd: No