<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/NCT03298776</url>
  </required_header>
  <id_info>
    <org_study_id>STH18011</org_study_id>
    <nct_id>NCT03298776</nct_id>
  </id_info>
  <brief_title>I-Scan a Novel Endoscopic Tool for the Macroscopic Identification of Mucosal Lesions</brief_title>
  <official_title>I-Scan a Novel Endoscopic Tool for the Macroscopic Identification of Mucosal Lesions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sheffield Teaching Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sheffield Teaching Hospitals NHS Foundation Trust</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 use of endoscopy for the diagnosis of gastrointestinal diseases has continued to increase&#xD;
      in recent years.&#xD;
&#xD;
      Endoscopy provides an advantage over other noninvasive or minimally invasive procedures in&#xD;
      that it allows both direct visualisation of the mucosa but direct and accurate sampling of&#xD;
      abnormalities for histological examination. However standard endoscopy does have some&#xD;
      limitations particularly with small lesions and pan mucosal changes. Some lesions may be&#xD;
      entirely benign and require no further intervention but as a result of difficulty with&#xD;
      accurate endoscopic characterization of lesions in many cases unnecessary biopsies or&#xD;
      polypectomies are undertaken. Therefore any technology that can augment the use of standard&#xD;
      endoscopy to minimise unnecessary intervention should be encouraged. IScan is a digital&#xD;
      enhancement technique available with Pentax endoscopes. There have been other novel&#xD;
      endoscopic advances for example, Narrow band imaging but these have not been adopted widely&#xD;
      for a number of reasons including technical difficulties or patient tolerability. The aim of&#xD;
      this study is to assess whether Pentax IScan technology is a reliable method of improving our&#xD;
      recognition of macroscopic mucosal lesions compared to standard white light endoscopy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All patients recruited will undergo standard endoscopy using current generation Pentax&#xD;
      endoscopes. These endoscopes are widely used for standard endoscopic procedures. All of the&#xD;
      endoscopes that will be used have the I-scan function which is controlled by the operator.&#xD;
      Therefore there will be no difference between the groups randomised to I-Scan or standard&#xD;
      endoscopy, other than a very slight difference in duration for I-scan, which the patient is&#xD;
      unlikely to detect. We have received no funding from Pentax for the use of their endoscopes.&#xD;
&#xD;
      Following recruitment patients will be randomly allocated to receive standard white light&#xD;
      endoscopy or standard white light endoscopy plus I-Scan using a random number generator at&#xD;
      www.random.org with possible values of 0 or 1. Those with a 0 will receive standard endoscopy&#xD;
      and those with a 1 will receive standard endoscopy plus I-Scan. Both arms will undergo&#xD;
      standard endoscopic evaluation including appropriate biopsies by fully trained experienced&#xD;
      endoscopists with Joint Advisory Group (JAG) accreditation for endoscopy. The investigators&#xD;
      will be initially blinded to the indication for endoscopy until the I-Scan has been utilised&#xD;
      at which point the indication will be revealed to ensure patient safety. Patients will have&#xD;
      biopsies only by the clinical indication. No extra biopsies that would not normally be&#xD;
      clinically justified will be taken. Following the procedure all patients will be asked to&#xD;
      evaluate the tolerability of their test using a validated 10 point likert scale. All&#xD;
      procedures will be recorded on an anonymised basis using a unique research identifier and&#xD;
      subsequently reviewed by other expert endoscopists within the department to allow us to&#xD;
      accurately assess the reliability and interobserver variability of the test. Each of the&#xD;
      endoscopists will be fully trained in standard endoscopy and will be blinded to the&#xD;
      indication for the procedure.&#xD;
&#xD;
      The study will be a randomised controlled trial. Given the nature of the study it is not&#xD;
      possible to blind the investigators to the procedure type. The investigator carrying out the&#xD;
      procedure will however be blinded to the indication for the procedure until the I-Scan has&#xD;
      been used as this could lead to bias. The endoscopists reviewing the images will be blinded&#xD;
      to all patient information and indications for the endoscopy throughout the study period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 26, 2013</start_date>
  <completion_date type="Actual">January 5, 2019</completion_date>
  <primary_completion_date type="Actual">August 6, 2018</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clarity of mucosal lesions found using I-Scan</measure>
    <time_frame>through study completion, on average one year</time_frame>
    <description>The endoscopic assessment of mucosal lesions using standard endoscopy and standard endoscopy plus I-Scan Will be compared to histological assessment where this is indicated. Interobserver variability of assessment of mucosal lesions will be compared between endoscopic techniques</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient reported tolerability of I-scan procedure</measure>
    <time_frame>through study completion, on average one year</time_frame>
    <description>The use of the I-scan results in a slight prolongation of the endoscopy procedure. A ten point likert patient reported questionnaire will assess patient tolerability of the I-scan</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">758</enrollment>
  <condition>Endoscopy</condition>
  <arm_group>
    <arm_group_label>standard white light endoscopy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will undergo the standard of care which is standard white light endoscopy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Endoscopy and I-Scan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will undergo standard of care endoscopy plus the I-Scan</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>I-Scan</intervention_name>
    <description>I-Scan is a digital enhancement technique. These endoscopes already have greater definition compared to many standard endoscopes but they also utilise a 'zoom' function and digital image enhancement.</description>
    <arm_group_label>Endoscopy and I-Scan</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Standard endoscopy</intervention_name>
    <description>Patients referred for standard endoscopy to receive standard of care only</description>
    <arm_group_label>standard white light endoscopy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients attending for a routine diagnostic endoscopic procedure where Pentax&#xD;
             endoscopes are in use at the endoscopy unit at the Royal Hallamshire Hospital.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients attending for a therapeutic endoscopic procedure.&#xD;
&#xD;
          -  Patients with a known endoscopic diagnosis&#xD;
&#xD;
          -  Patients with abnormal coagulation or any other contraindication to use of standard&#xD;
             biopsy or polypectomy techniques used in routine diagnostic endoscopic procedures&#xD;
&#xD;
          -  Patients who are unable to understand English or give informed consent&#xD;
&#xD;
          -  Patients under the age of 16&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Sanders</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sheffield Teaching Hospitals NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Royal Hallamshire Hospital</name>
      <address>
        <city>Sheffield</city>
        <state>South Yorkshire</state>
        <zip>S10 2JF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 2, 2017</study_first_posted>
  <last_update_submitted>February 28, 2019</last_update_submitted>
  <last_update_submitted_qc>February 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>no plan to share IPD</ipd_description>
  </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/NCT03298776
org study id: STH18011
nct id: NCT03298776
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The use of endoscopy for the diagnosis of gastrointestinal diseases has continued to increase
      in recent years.

      Endoscopy provides an advantage over other noninvasive or minimally invasive procedures in
      that it allows both direct visualisation of the mucosa but direct and accurate sampling of
      abnormalities for histological examination. However standard endoscopy does have some
      limitations particularly with small lesions and pan mucosal changes. Some lesions may be
      entirely benign and require no further intervention but as a result of difficulty with
      accurate endoscopic characterization of lesions in many cases unnecessary biopsies or
      polypectomies are undertaken. Therefore any technology that can augment the use of standard
      endoscopy to minimise unnecessary intervention should be encouraged. IScan is a digital
      enhancement technique available with Pentax endoscopes. There have been other novel
      endoscopic advances for example, Narrow band imaging but these have not been adopted widely
      for a number of reasons including technical difficulties or patient tolerability. The aim of
      this study is to assess whether Pentax IScan technology is a reliable method of improving our
      recognition of macroscopic mucosal lesions compared to standard white light endoscopy
All patients recruited will undergo standard endoscopy using current generation Pentax
      endoscopes. These endoscopes are widely used for standard endoscopic procedures. All of the
      endoscopes that will be used have the I-scan function which is controlled by the operator.
      Therefore there will be no difference between the groups randomised to I-Scan or standard
      endoscopy, other than a very slight difference in duration for I-scan, which the patient is
      unlikely to detect. We have received no funding from Pentax for the use of their endoscopes.

      Following recruitment patients will be randomly allocated to receive standard white light
      endoscopy or standard white light endoscopy plus I-Scan using a random number generator at
      www.random.org with possible values of 0 or 1. Those with a 0 will receive standard endoscopy
      and those with a 1 will receive standard endoscopy plus I-Scan. Both arms will undergo
      standard endoscopic evaluation including appropriate biopsies by fully trained experienced
      endoscopists with Joint Advisory Group (JAG) accreditation for endoscopy. The investigators
      will be initially blinded to the indication for endoscopy until the I-Scan has been utilised
      at which point the indication will be revealed to ensure patient safety. Patients will have
      biopsies only by the clinical indication. No extra biopsies that would not normally be
      clinically justified will be taken. Following the procedure all patients will be asked to
      evaluate the tolerability of their test using a validated 10 point likert scale. All
      procedures will be recorded on an anonymised basis using a unique research identifier and
      subsequently reviewed by other expert endoscopists within the department to allow us to
      accurately assess the reliability and interobserver variability of the test. Each of the
      endoscopists will be fully trained in standard endoscopy and will be blinded to the
      indication for the procedure.

      The study will be a randomised controlled trial. Given the nature of the study it is not
      possible to blind the investigators to the procedure type. The investigator carrying out the
      procedure will however be blinded to the indication for the procedure until the I-Scan has
      been used as this could lead to bias. The endoscopists reviewing the images will be blinded
      to all patient information and indications for the endoscopy throughout the study period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Clarity of mucosal lesions found using I-Scan
time frame: through study completion, on average one year
description: The endoscopic assessment of mucosal lesions using standard endoscopy and standard endoscopy plus I-Scan Will be compared to histological assessment where this is indicated. Interobserver variability of assessment of mucosal lesions will be compared between endoscopic techniques
measure: Patient reported tolerability of I-scan procedure
time frame: through study completion, on average one year
description: The use of the I-scan results in a slight prolongation of the endoscopy procedure. A ten point likert patient reported questionnaire will assess patient tolerability of the I-scan
arm group label: standard white light endoscopy
arm group type: Active Comparator
description: Patients will undergo the standard of care which is standard white light endoscopy
arm group label: Endoscopy and I-Scan
arm group type: Experimental
description: Patients will undergo standard of care endoscopy plus the I-Scan
intervention type: Device
intervention name: I-Scan
description: I-Scan is a digital enhancement technique. These endoscopes already have greater definition compared to many standard endoscopes but they also utilise a 'zoom' function and digital image enhancement.
arm group label: Endoscopy and I-Scan
intervention type: Diagnostic Test
intervention name: Standard endoscopy
description: Patients referred for standard endoscopy to receive standard of care only
arm group label: standard white light endoscopy
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: David Sanders
role: Principal Investigator
affiliation: Sheffield Teaching Hospitals NHS Foundation Trust
facility: 
country: United Kingdom
responsible party type: Sponsor
sharing ipd: No
ipd description: no plan to share IPD