<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/NCT03279705</url>
  </required_header>
  <id_info>
    <org_study_id>DalinTCGH</org_study_id>
    <nct_id>NCT03279705</nct_id>
  </id_info>
  <brief_title>The efﬁcacy of the Integrated Water Jet Channel Colonoscopy in Water Exchange Method</brief_title>
  <official_title>Division of Gastroenterology, Department of Internal Medicine, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Chiayi, Taiwan</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chih-wei Tseng</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dalin Tzu Chi General Hospital</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>
      This prospective randomized controlled trial compared integrated water jet channel&#xD;
      colonoscopy with traditional accessory channel colonoscopy in cecal insertion time among&#xD;
      patients undergoing WE method colonoscopy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      When the WE method colonoscopy were done with the accessory channel for both infusing and&#xD;
      suctioning of water. The water had to be suctioned or infused alternatively and increaed the&#xD;
      insertion time.&#xD;
&#xD;
      With the new designed endoscopy that integrated a separate water jet channel for infusing&#xD;
      water, infusing and suctioning of water can be done at the same time. Besides, water jet&#xD;
      pumping system could provide a powerful jet to help us open the collapse lumen and keep an&#xD;
      appropriate distance between the mucosa and the lens, thus preventing loss of visualization.&#xD;
      It will help the colonoscopist to find the way during insertion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Actual">October 1, 2019</completion_date>
  <primary_completion_date type="Actual">April 1, 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>
    <intervention_model_description>A total of 120 patients were allocated into one of two groups by computerized randomization. In group A (Two-channel group), clear water was infused through the water jet channel and dirty water was sucked form the accessy channel. In group B (One-channel group), water exchange was done by using the accessory channel for both infusing and suctioning of water.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>These codes were contained in pre-arranged opaque envelopes, which were opened immediately before insertion of the colonoscope.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>cecal insertion time</measure>
    <time_frame>2 hours</time_frame>
    <description>Cecal insertion time was defined as the time from insertion into the rectum to the time when the colonoscope tip passed to a point proximal to the ileocecal valve so that the base of cecum was visible.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Colonoscopy</condition>
  <condition>Colon Disease</condition>
  <arm_group>
    <arm_group_label>Two-channel group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The colonoscopy was done with the new designed colonoscopy that integrated a separate water jet channel for infusing water. The dirty water was removed through other accessory channel.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>One-channel group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The colonoscopy was done with the traditional colonoscopy. Water exchange was done by using the accessory channel for both infusing and suctioning of water.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Water jet channel</intervention_name>
    <description>The separate water jet channel was used for infusing water.</description>
    <arm_group_label>Two-channel group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Accessory channel</intervention_name>
    <description>The accessory channel was used for infusing and/or suctioning water</description>
    <arm_group_label>One-channel group</arm_group_label>
    <arm_group_label>Two-channel group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Underwent fully sedative colonoscopy with WE method in the outpatient department&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 years old or &gt; 80 years old&#xD;
&#xD;
          -  Without standard colon preparation&#xD;
&#xD;
          -  Allergy to meperidine or propofol&#xD;
&#xD;
          -  With a history of partial colectomy&#xD;
&#xD;
          -  Refusal to provide written informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yu-Hsi Hsieh</last_name>
    <role>Study Director</role>
    <affiliation>Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation</name>
      <address>
        <city>Taipei</city>
        <zip>62247</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>September 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>October 25, 2019</last_update_submitted>
  <last_update_submitted_qc>October 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Dalin Tzu Chi General Hospital</investigator_affiliation>
    <investigator_full_name>Chih-wei Tseng</investigator_full_name>
    <investigator_title>Division of Gastroenterology, Department of Internal Medicine</investigator_title>
  </responsible_party>
  <keyword>water exchange</keyword>
  <keyword>water jet channel colonoscopy</keyword>
  <keyword>colonoscopy</keyword>
  <keyword>cecal insertion time</keyword>
  <keyword>adenoma detection rate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colonic 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/NCT03279705
org study id: DalinTCGH
nct id: NCT03279705
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This prospective randomized controlled trial compared integrated water jet channel
      colonoscopy with traditional accessory channel colonoscopy in cecal insertion time among
      patients undergoing WE method colonoscopy.
When the WE method colonoscopy were done with the accessory channel for both infusing and
      suctioning of water. The water had to be suctioned or infused alternatively and increaed the
      insertion time.

      With the new designed endoscopy that integrated a separate water jet channel for infusing
      water, infusing and suctioning of water can be done at the same time. Besides, water jet
      pumping system could provide a powerful jet to help us open the collapse lumen and keep an
      appropriate distance between the mucosa and the lens, thus preventing loss of visualization.
      It will help the colonoscopist to find the way during insertion.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A total of 120 patients were allocated into one of two groups by computerized randomization. In group A (Two-channel group), clear water was infused through the water jet channel and dirty water was sucked form the accessy channel. In group B (One-channel group), water exchange was done by using the accessory channel for both infusing and suctioning of water.
primary purpose: Diagnostic
masking: None (Open Label)
masking description: These codes were contained in pre-arranged opaque envelopes, which were opened immediately before insertion of the colonoscope.
measure: cecal insertion time
time frame: 2 hours
description: Cecal insertion time was defined as the time from insertion into the rectum to the time when the colonoscope tip passed to a point proximal to the ileocecal valve so that the base of cecum was visible.
arm group label: Two-channel group
arm group type: Experimental
description: The colonoscopy was done with the new designed colonoscopy that integrated a separate water jet channel for infusing water. The dirty water was removed through other accessory channel.
arm group label: One-channel group
arm group type: Active Comparator
description: The colonoscopy was done with the traditional colonoscopy. Water exchange was done by using the accessory channel for both infusing and suctioning of water.
intervention type: Device
intervention name: Water jet channel
description: The separate water jet channel was used for infusing water.
arm group label: Two-channel group
intervention type: Device
intervention name: Accessory channel
description: The accessory channel was used for infusing and/or suctioning water
arm group label: One-channel group
arm group label: Two-channel group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Yu-Hsi Hsieh
role: Study Director
affiliation: Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
facility: 
country: Taiwan
responsible party type: Sponsor-Investigator
investigator affiliation: Dalin Tzu Chi General Hospital
investigator full name: Chih-wei Tseng
investigator title: Division of Gastroenterology, Department of Internal Medicine
mesh term: Colonic Diseases
sharing ipd: No