<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/NCT04456218</url>
  </required_header>
  <id_info>
    <org_study_id>A-BR-108-097</org_study_id>
    <nct_id>NCT04456218</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of a Custom-made and Disposable Endoscope System for Biliary Tract</brief_title>
  <official_title>Clinical Evaluation of a Custom-made and Disposable Endoscope System for Biliary Tract</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cheng-Kung University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Cheng-Kung University Hospital</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>
      A disposable endoscopy system (NCKU-scope-01) was developed for the evaluation of bile duct&#xD;
      stone or neoplasm. This system consists of a camera, light sources, a working channel, and a&#xD;
      water injection channel. The endoscope could be inserted into the common bile duct via the&#xD;
      working channel of a commercial duodenoscope. This study aims to test the feasibility and&#xD;
      safety of this system. The efficacy of stone and neoplasm diagnosis will also be analyzed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">June 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>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>A complete common bile duct accessing rate</measure>
    <time_frame>1 day</time_frame>
    <description>To test the device's feasibility</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Image quality evaluation: the light brightness and the imaging sharpness in Likert scale</measure>
    <time_frame>1 day</time_frame>
    <description>To test the device's feasibility. About Likert scale, it range from 1 to 5 (1 is worse and 5 is better).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of complications (ablation, bleeding, perforation in percentage) or system malfunction</measure>
    <time_frame>1 day</time_frame>
    <description>To test the device's safety</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In biliary stone arm: The biggest residual stone size (in cm).</measure>
    <time_frame>1 day</time_frame>
    <description>The ability for residual stones diagnosis after initial ERCP stone extraction, compared with standard x-ray imaging)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In biliary stricture arm: Number of the lesions with or without presenting of the specific features for DDx of the benign or malignant stricture</measure>
    <time_frame>1 day</time_frame>
    <description>The ability for differential diagnosis of benign or malignant stricture. The specific features include increased vascularity, irregular mucosa/nodularity, luminal narrowing, tumor vessel, mucosal lesion.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Biliary Tract</condition>
  <condition>Neoplasms</condition>
  <condition>Stone - Biliary</condition>
  <arm_group>
    <arm_group_label>Biliary stone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who meet the criteria of biliary stone enrollment and are willing to join in this study will be applied to the custom-made endoscope system for biliary disease diagnosis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Biliary stricture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who meet the criteria of biliary neoplasm enrollment and are willing to join in this study will be applied to the custom-made endoscope system for biliary disease diagnosis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NCKU-scope-01 (a custom-made biliary endoscope system)</intervention_name>
    <description>The NCKU-scope-01 is a custom-made endoscope system for this study and it will be applied to help biliary disorders diagnosis</description>
    <arm_group_label>Biliary stone</arm_group_label>
    <arm_group_label>Biliary stricture</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with complicated bile duct stone (stone size &gt; 1.5 cm or number of stone &gt; 3&#xD;
             )&#xD;
&#xD;
          -  Patients with indeterminate biliary stricture or obstruction&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant woman;&#xD;
&#xD;
          -  Patients who are not suitable for ERCP (e.g. behavior disorder, major&#xD;
             cognitive-perceptual deficit, etc.).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>National Cheng Kung University Hospital</name>
      <address>
        <city>Tainan</city>
        <zip>704</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>June 14, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>July 29, 2022</last_update_submitted>
  <last_update_submitted_qc>July 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Cheng-Kung University Hospital</investigator_affiliation>
    <investigator_full_name>Chiao-Hsiung Chuang</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholelithiasis</mesh_term>
    <mesh_term>Cholecystolithiasis</mesh_term>
    <mesh_term>Gallstones</mesh_term>
  </condition_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/NCT04456218
org study id: A-BR-108-097
nct id: NCT04456218
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A disposable endoscopy system (NCKU-scope-01) was developed for the evaluation of bile duct
      stone or neoplasm. This system consists of a camera, light sources, a working channel, and a
      water injection channel. The endoscope could be inserted into the common bile duct via the
      working channel of a commercial duodenoscope. This study aims to test the feasibility and
      safety of this system. The efficacy of stone and neoplasm diagnosis will also be analyzed.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: A complete common bile duct accessing rate
time frame: 1 day
description: To test the device's feasibility
measure: Image quality evaluation: the light brightness and the imaging sharpness in Likert scale
time frame: 1 day
description: To test the device's feasibility. About Likert scale, it range from 1 to 5 (1 is worse and 5 is better).
measure: Number of complications (ablation, bleeding, perforation in percentage) or system malfunction
time frame: 1 day
description: To test the device's safety
measure: In biliary stone arm: The biggest residual stone size (in cm).
time frame: 1 day
description: The ability for residual stones diagnosis after initial ERCP stone extraction, compared with standard x-ray imaging)
measure: In biliary stricture arm: Number of the lesions with or without presenting of the specific features for DDx of the benign or malignant stricture
time frame: 1 day
description: The ability for differential diagnosis of benign or malignant stricture. The specific features include increased vascularity, irregular mucosa/nodularity, luminal narrowing, tumor vessel, mucosal lesion.
arm group label: Biliary stone
arm group type: Experimental
description: Participants who meet the criteria of biliary stone enrollment and are willing to join in this study will be applied to the custom-made endoscope system for biliary disease diagnosis.
arm group label: Biliary stricture
arm group type: Experimental
description: Participants who meet the criteria of biliary neoplasm enrollment and are willing to join in this study will be applied to the custom-made endoscope system for biliary disease diagnosis.
intervention type: Device
intervention name: NCKU-scope-01 (a custom-made biliary endoscope system)
description: The NCKU-scope-01 is a custom-made endoscope system for this study and it will be applied to help biliary disorders diagnosis
arm group label: Biliary stone
arm group label: Biliary stricture
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: National Cheng-Kung University Hospital
investigator full name: Chiao-Hsiung Chuang
investigator title: Associate Professor
mesh term: Cholelithiasis
mesh term: Cholecystolithiasis
mesh term: Gallstones