<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/NCT03839277</url>
  </required_header>
  <id_info>
    <org_study_id>SINOCOLO2019A</org_study_id>
    <nct_id>NCT03839277</nct_id>
  </id_info>
  <brief_title>Adenoma Detection Rate Using Endocuff Vision in China</brief_title>
  <acronym>SinoEVADR</acronym>
  <official_title>Adenoma Detection Rate Using Endocuff Vision in China</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Changhai Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sixth Affiliated Hospital, Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai Zhongshan Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tianjin People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tianjin Nankai Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Changhai 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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary aim of this study is&#xD;
&#xD;
      - to explore the usefulness of Endocuff Vision in colonoscopy on adenoma detection rate&#xD;
      (ADR).&#xD;
&#xD;
      Other aims include to explore the data below when Endocuff Vision is used.&#xD;
&#xD;
      Mean adenomas detected per procedure, MAP Proximal Adenoma detection rate, pADR Polyp&#xD;
      detection rate, PDR Proximal polyp detection rate, pPDR Mean polyps detected per procedure,&#xD;
      MPP Withdrawal time, WT Cecal intubation rate, CIR Cecal intubation time, CIT&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Colorectal cancer is common in China. Most colorectal cancers happen when an adenoma becomes&#xD;
      cancerous. Doctors use colonoscopy to look inside the colon and rectum and find adenomas and&#xD;
      remove them. Removing adenomas is known to reduce the chances of a person developing&#xD;
      colorectal cancers. The ability of colonoscopists finding adenomas varies, and there is a lot&#xD;
      of researches into how to improve &quot;adenoma detection rates&quot;.&#xD;
&#xD;
      A new device, called the Endocuff Vision has been shown to improve the rate of polyp&#xD;
      detection at colonoscopy, and to make polyp removal easier. Previous studies have shown that&#xD;
      there is a significant improvement in detection of adenomas when an Endocuff Vision is used&#xD;
      (with the rate of detection of adenomas rising from 49% to 66%). Colonoscopists who have used&#xD;
      the Endocuff Vision before also feel that polyp removal is easier when it is on the&#xD;
      colonoscope. This study will randomise patients coming for colonoscopy to have their&#xD;
      procedure performed as usual or as an Endocuff Vision-assisted colonoscopy. The investigators&#xD;
      will record polyp and adenoma detection rates, duration of procedure, participant comfort&#xD;
      levels, and complications. All patients referred for colonoscopy will be invited in 5&#xD;
      centres, recruiting a total of 1200 participants.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    One investigator is out-of-service due to carrying out another task.&#xD;
  </why_stopped>
  <start_date type="Actual">June 12, 2019</start_date>
  <completion_date type="Anticipated">December 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2020</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>Endocuff Vision is a new device made of soft plastic material with a unique dynamic shape. It is manufactured by ARC Medical Design Limited and Diagmed in the United Kingdom. It has European Conformity in United Kingdom. The core is made of polypropylene and the 'finger like' projections are made of a thermoplastic elastomer. It comes in four colour coded sizes (purple, blue, green and orange) to fit a range of paediatric and adult colonoscopes. Endocuff Vision is the more updated version of device that has only one proximal row of more rounded finger-like projections. It is mounted at the tip of the colonoscope and held on by friction (pull-off force is a minimum of 10 Newtons).</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adenoma detection rate, ADR</measure>
    <time_frame>At the end of the procedure, up to 1 hour.</time_frame>
    <description>ADR refer to the rate of adenoma detection, calculated as the proportion of subjects with at least one adenoma.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Polyp detection rate, PDR</measure>
    <time_frame>At the end of the procedure, up to 1 hour.</time_frame>
    <description>PDR refer to the rate of polyp detection, calculated as the proportion of subjects with at least one polyp.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1200</enrollment>
  <condition>Colorectal Neoplasms</condition>
  <condition>Colonic Polyp</condition>
  <condition>Adenoma</condition>
  <arm_group>
    <arm_group_label>Endocuff Vision-assisted Colonoscopy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in this arm undergo Endocuff Vision-assisted colonoscopy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Colonoscopy</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in this arm undergo standard colonoscopy</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Endocuff Vision</intervention_name>
    <description>Endocuff Vision is attached to the tip of colonoscope before intubation.</description>
    <arm_group_label>Endocuff Vision-assisted Colonoscopy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients referred for screening, surveillance, or diagnostic colonoscopy&#xD;
&#xD;
          -  All patients must be able to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with any absolute contraindications to colonoscopy&#xD;
&#xD;
          -  Patients with established or suspicion of large bowel obstruction or&#xD;
             pseudo-obstruction&#xD;
&#xD;
          -  Patients with known colon cancer or polyposis syndromes&#xD;
&#xD;
          -  Patients with known colonic strictures&#xD;
&#xD;
          -  Patients with known severe diverticular segments (that is likely to impede colonoscope&#xD;
             passage)&#xD;
&#xD;
          -  Patients with active colitis (ulcerative colitis, Crohn's colitis, diverticulitis,&#xD;
             infective colitis)&#xD;
&#xD;
          -  Patients lacking capacity to give informed consent&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Patients who are on clopidogrel, warfarin, or other new generation anticoagulants who&#xD;
             have not stopped this for the procedure.&#xD;
&#xD;
          -  Patients who are attending for a therapeutic procedure or assessment of a known lesion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>En-Da YU</last_name>
    <role>Principal Investigator</role>
    <affiliation>Changhai Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sixth affiliated Hospital, Sun Yat-Sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510655</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai Zhongshan Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Changhai Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200433</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tianjin Nankai Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300100</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tianjin People's Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300121</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/29363535</url>
    <description>PubMed link</description>
  </link>
  <reference>
    <citation>Ngu WS, Bevan R, Tsiamoulos ZP, Bassett P, Hoare Z, Rutter MD, Clifford G, Totton N, Lee TJ, Ramadas A, Silcock JG, Painter J, Neilson LJ, Saunders BP, Rees CJ. Improved adenoma detection with Endocuff Vision: the ADENOMA randomised controlled trial. Gut. 2019 Feb;68(2):280-288. doi: 10.1136/gutjnl-2017-314889. Epub 2018 Jan 23.</citation>
    <PMID>29363535</PMID>
  </reference>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>February 11, 2019</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>September 24, 2020</last_update_submitted>
  <last_update_submitted_qc>September 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Changhai Hospital</investigator_affiliation>
    <investigator_full_name>En-Da Yu</investigator_full_name>
    <investigator_title>Director of Department of Colorectal Surgery and Vice Director of GI Endoscopy</investigator_title>
  </responsible_party>
  <keyword>adenoma detection rate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenoma</mesh_term>
    <mesh_term>Colorectal Neoplasms</mesh_term>
    <mesh_term>Colonic Polyps</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/NCT03839277
org study id: SINOCOLO2019A
nct id: NCT03839277
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The primary aim of this study is

      - to explore the usefulness of Endocuff Vision in colonoscopy on adenoma detection rate
      (ADR).

      Other aims include to explore the data below when Endocuff Vision is used.

      Mean adenomas detected per procedure, MAP Proximal Adenoma detection rate, pADR Polyp
      detection rate, PDR Proximal polyp detection rate, pPDR Mean polyps detected per procedure,
      MPP Withdrawal time, WT Cecal intubation rate, CIR Cecal intubation time, CIT
Colorectal cancer is common in China. Most colorectal cancers happen when an adenoma becomes
      cancerous. Doctors use colonoscopy to look inside the colon and rectum and find adenomas and
      remove them. Removing adenomas is known to reduce the chances of a person developing
      colorectal cancers. The ability of colonoscopists finding adenomas varies, and there is a lot
      of researches into how to improve "adenoma detection rates".

      A new device, called the Endocuff Vision has been shown to improve the rate of polyp
      detection at colonoscopy, and to make polyp removal easier. Previous studies have shown that
      there is a significant improvement in detection of adenomas when an Endocuff Vision is used
      (with the rate of detection of adenomas rising from 49% to 66%). Colonoscopists who have used
      the Endocuff Vision before also feel that polyp removal is easier when it is on the
      colonoscope. This study will randomise patients coming for colonoscopy to have their
      procedure performed as usual or as an Endocuff Vision-assisted colonoscopy. The investigators
      will record polyp and adenoma detection rates, duration of procedure, participant comfort
      levels, and complications. All patients referred for colonoscopy will be invited in 5
      centres, recruiting a total of 1200 participants.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Endocuff Vision is a new device made of soft plastic material with a unique dynamic shape. It is manufactured by ARC Medical Design Limited and Diagmed in the United Kingdom. It has European Conformity in United Kingdom. The core is made of polypropylene and the 'finger like' projections are made of a thermoplastic elastomer. It comes in four colour coded sizes (purple, blue, green and orange) to fit a range of paediatric and adult colonoscopes. Endocuff Vision is the more updated version of device that has only one proximal row of more rounded finger-like projections. It is mounted at the tip of the colonoscope and held on by friction (pull-off force is a minimum of 10 Newtons).
primary purpose: Diagnostic
masking: None (Open Label)
measure: Adenoma detection rate, ADR
time frame: At the end of the procedure, up to 1 hour.
description: ADR refer to the rate of adenoma detection, calculated as the proportion of subjects with at least one adenoma.
measure: Polyp detection rate, PDR
time frame: At the end of the procedure, up to 1 hour.
description: PDR refer to the rate of polyp detection, calculated as the proportion of subjects with at least one polyp.
arm group label: Endocuff Vision-assisted Colonoscopy
arm group type: Active Comparator
description: Participants in this arm undergo Endocuff Vision-assisted colonoscopy
arm group label: Standard Colonoscopy
arm group type: No Intervention
description: Participants in this arm undergo standard colonoscopy
intervention type: Device
intervention name: Endocuff Vision
description: Endocuff Vision is attached to the tip of colonoscope before intubation.
arm group label: Endocuff Vision-assisted Colonoscopy
criteria: 
gender: All
minimum age: 45 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: En-Da YU
role: Principal Investigator
affiliation: Changhai Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
country: China
url: http://www.ncbi.nlm.nih.gov/pubmed/29363535
description: PubMed link
citation: Ngu WS, Bevan R, Tsiamoulos ZP, Bassett P, Hoare Z, Rutter MD, Clifford G, Totton N, Lee TJ, Ramadas A, Silcock JG, Painter J, Neilson LJ, Saunders BP, Rees CJ. Improved adenoma detection with Endocuff Vision: the ADENOMA randomised controlled trial. Gut. 2019 Feb;68(2):280-288. doi: 10.1136/gutjnl-2017-314889. Epub 2018 Jan 23.
PMID: 29363535
responsible party type: Principal Investigator
investigator affiliation: Changhai Hospital
investigator full name: En-Da Yu
investigator title: Director of Department of Colorectal Surgery and Vice Director of GI Endoscopy
mesh term: Adenoma
mesh term: Colorectal Neoplasms
mesh term: Colonic Polyps
sharing ipd: No