<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/NCT03814369</url>
  </required_header>
  <id_info>
    <org_study_id>amplifeye</org_study_id>
    <nct_id>NCT03814369</nct_id>
  </id_info>
  <brief_title>AmplifEYE Colonoscopy vs Standard Colonoscopy</brief_title>
  <official_title>Use of AmplifEYE-assisted Colonoscopy Compared to Standard Colonoscopy in Polyp and Adenoma Detection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Queen Elizabeth Hospital, Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Our Lady of Maryknoll Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Queen Elizabeth Hospital, Hong Kong</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Colonoscopy screening is proven to reduce mortality rates for colorectal cancer, which relies&#xD;
      on early detection and removal of colonic polyps. AmplifEYE is a FDA-approved device with a&#xD;
      row of flexible detection arms attached to the tip of colonoscope which can separate colonic&#xD;
      folds during scope withdrawal and is believed to improve polyp detection. Real-life clinical&#xD;
      data on this relatively new device is lacking and this study aims to compare the adenoma and&#xD;
      polyp detection rates in AmplifEYE-assisted colonoscopy versus standard colonoscopy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, randomized controlled study. Patients admitted to Queen Elizabeth&#xD;
      Hospital and Our Lady of Maryknoll Hospital for colonoscopy are randomly allocated 1:1 to&#xD;
      receive either colonoscopy equipped with AmplifEYE (AC) or standard colonoscopy (SC). All&#xD;
      study team members will have a prior run-in phase of performing at least 5 AmplifEYE&#xD;
      colonoscopies before starting the study. The colonic polyp detection rate (PDR), adenoma&#xD;
      detection rate (ADR), serrated polyp detection rate (SDR), caecal intubation time,&#xD;
      colonoscope withdrawal time, procedure pain and any adverse events were analyzed in each&#xD;
      group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Actual">November 30, 2018</completion_date>
  <primary_completion_date type="Actual">June 30, 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>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adenoma detection rate</measure>
    <time_frame>1 day</time_frame>
    <description>number of patients in whom at least one adenoma could be found</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Polyp detection rate</measure>
    <time_frame>1 day</time_frame>
    <description>number of patients in whom at least one polyp could be found</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serrated polyp detection rate</measure>
    <time_frame>1 day</time_frame>
    <description>number of patients in whom at least one serrated polyp could be found</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>caecal intubation rate</measure>
    <time_frame>1 day</time_frame>
    <description>number of patients in whom caecal intubation is acheived</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>caecal intubation time</measure>
    <time_frame>1 day</time_frame>
    <description>time beginning with the insertion of the colonoscope until reaching the caecum</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">355</enrollment>
  <condition>Colon Polyp</condition>
  <condition>Adenoma Colon</condition>
  <condition>Serrated Polyp</condition>
  <condition>Colonic Neoplasms</condition>
  <arm_group>
    <arm_group_label>AmplifEYE colonoscopy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Colonoscopy performed with AmplifEYE equipped</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard colonoscopy</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard colonoscopy performed</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>AmplifEYE</intervention_name>
    <description>AmplifEYE colonoscopy</description>
    <arm_group_label>AmplifEYE colonoscopy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged between 50 to 79 years old&#xD;
&#xD;
          -  Scheduled for screening, surveillance or diagnostic colonoscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Colonic strictures&#xD;
&#xD;
          -  History of bowel surgery&#xD;
&#xD;
          -  Per-rectal bleeding within six weeks&#xD;
&#xD;
          -  Inflammatory bowel disease&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shun Fung Sze, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Medicine, Queen Elizabeth Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Medicine, Queen Elizabeth Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <reference>
    <citation>Nishihara R, Wu K, Lochhead P, Morikawa T, Liao X, Qian ZR, Inamura K, Kim SA, Kuchiba A, Yamauchi M, Imamura Y, Willett WC, Rosner BA, Fuchs CS, Giovannucci E, Ogino S, Chan AT. Long-term colorectal-cancer incidence and mortality after lower endoscopy. N Engl J Med. 2013 Sep 19;369(12):1095-105. doi: 10.1056/NEJMoa1301969.</citation>
    <PMID>24047059</PMID>
  </reference>
  <reference>
    <citation>Rex DK, Cutler CS, Lemmel GT, Rahmani EY, Clark DW, Helper DJ, Lehman GA, Mark DG. Colonoscopic miss rates of adenomas determined by back-to-back colonoscopies. Gastroenterology. 1997 Jan;112(1):24-8. doi: 10.1016/s0016-5085(97)70214-2.</citation>
    <PMID>8978338</PMID>
  </reference>
  <reference>
    <citation>Corley DA, Jensen CD, Marks AR, Zhao WK, Lee JK, Doubeni CA, Zauber AG, de Boer J, Fireman BH, Schottinger JE, Quinn VP, Ghai NR, Levin TR, Quesenberry CP. Adenoma detection rate and risk of colorectal cancer and death. N Engl J Med. 2014 Apr 3;370(14):1298-306. doi: 10.1056/NEJMoa1309086.</citation>
    <PMID>24693890</PMID>
  </reference>
  <reference>
    <citation>Kaminski MF, Regula J, Kraszewska E, Polkowski M, Wojciechowska U, Didkowska J, Zwierko M, Rupinski M, Nowacki MP, Butruk E. Quality indicators for colonoscopy and the risk of interval cancer. N Engl J Med. 2010 May 13;362(19):1795-803. doi: 10.1056/NEJMoa0907667.</citation>
    <PMID>20463339</PMID>
  </reference>
  <reference>
    <citation>Floer M, Biecker E, Fitzlaff R, Roming H, Ameis D, Heinecke A, Kunsch S, Ellenrieder V, Strobel P, Schepke M, Meister T. Higher adenoma detection rates with endocuff-assisted colonoscopy - a randomized controlled multicenter trial. PLoS One. 2014 Dec 3;9(12):e114267. doi: 10.1371/journal.pone.0114267. eCollection 2014.</citation>
    <PMID>25470133</PMID>
  </reference>
  <reference>
    <citation>Sawatzki M, Meyenberger C, Marbet UA, Haarer J, Frei R. Prospective Swiss pilot study of Endocuff-assisted colonoscopy in a screening population. Endosc Int Open. 2015 Jun;3(3):E236-9. doi: 10.1055/s-0034-1391418. Epub 2015 Feb 27.</citation>
    <PMID>26171436</PMID>
  </reference>
  <reference>
    <citation>van Doorn SC, van der Vlugt M, Depla A, Wientjes CA, Mallant-Hent RC, Siersema PD, Tytgat K, Tuynman H, Kuiken SD, Houben G, Stokkers P, Moons L, Bossuyt P, Fockens P, Mundt MW, Dekker E. Adenoma detection with Endocuff colonoscopy versus conventional colonoscopy: a multicentre randomised controlled trial. Gut. 2017 Mar;66(3):438-445. doi: 10.1136/gutjnl-2015-310097. Epub 2015 Dec 16.</citation>
    <PMID>26674360</PMID>
  </reference>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>January 20, 2019</study_first_submitted>
  <study_first_submitted_qc>January 20, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>March 24, 2019</last_update_submitted>
  <last_update_submitted_qc>March 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Queen Elizabeth Hospital, Hong Kong</investigator_affiliation>
    <investigator_full_name>Sze Shun Fung</investigator_full_name>
    <investigator_title>Associate Consultant</investigator_title>
  </responsible_party>
  <keyword>colonoscopy</keyword>
  <keyword>adenoma detection rate</keyword>
  <keyword>colorectal cancer screening</keyword>
  <keyword>new technology</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenoma</mesh_term>
    <mesh_term>Colonic Neoplasms</mesh_term>
    <mesh_term>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/NCT03814369
org study id: amplifeye
nct id: NCT03814369
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Colonoscopy screening is proven to reduce mortality rates for colorectal cancer, which relies
      on early detection and removal of colonic polyps. AmplifEYE is a FDA-approved device with a
      row of flexible detection arms attached to the tip of colonoscope which can separate colonic
      folds during scope withdrawal and is believed to improve polyp detection. Real-life clinical
      data on this relatively new device is lacking and this study aims to compare the adenoma and
      polyp detection rates in AmplifEYE-assisted colonoscopy versus standard colonoscopy.
This is a prospective, randomized controlled study. Patients admitted to Queen Elizabeth
      Hospital and Our Lady of Maryknoll Hospital for colonoscopy are randomly allocated 1:1 to
      receive either colonoscopy equipped with AmplifEYE (AC) or standard colonoscopy (SC). All
      study team members will have a prior run-in phase of performing at least 5 AmplifEYE
      colonoscopies before starting the study. The colonic polyp detection rate (PDR), adenoma
      detection rate (ADR), serrated polyp detection rate (SDR), caecal intubation time,
      colonoscope withdrawal time, procedure pain and any adverse events were analyzed in each
      group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Adenoma detection rate
time frame: 1 day
description: number of patients in whom at least one adenoma could be found
measure: Polyp detection rate
time frame: 1 day
description: number of patients in whom at least one polyp could be found
measure: Serrated polyp detection rate
time frame: 1 day
description: number of patients in whom at least one serrated polyp could be found
measure: caecal intubation rate
time frame: 1 day
description: number of patients in whom caecal intubation is acheived
measure: caecal intubation time
time frame: 1 day
description: time beginning with the insertion of the colonoscope until reaching the caecum
arm group label: AmplifEYE colonoscopy
arm group type: Experimental
description: Colonoscopy performed with AmplifEYE equipped
arm group label: Standard colonoscopy
arm group type: No Intervention
description: Standard colonoscopy performed
intervention type: Device
intervention name: AmplifEYE
description: AmplifEYE colonoscopy
arm group label: AmplifEYE colonoscopy
criteria: 
gender: All
minimum age: 50 Years
maximum age: 79 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Shun Fung Sze, MBBS
role: Principal Investigator
affiliation: Department of Medicine, Queen Elizabeth Hospital
facility: 
country: Hong Kong
citation: Nishihara R, Wu K, Lochhead P, Morikawa T, Liao X, Qian ZR, Inamura K, Kim SA, Kuchiba A, Yamauchi M, Imamura Y, Willett WC, Rosner BA, Fuchs CS, Giovannucci E, Ogino S, Chan AT. Long-term colorectal-cancer incidence and mortality after lower endoscopy. N Engl J Med. 2013 Sep 19;369(12):1095-105. doi: 10.1056/NEJMoa1301969.
PMID: 24047059
citation: Rex DK, Cutler CS, Lemmel GT, Rahmani EY, Clark DW, Helper DJ, Lehman GA, Mark DG. Colonoscopic miss rates of adenomas determined by back-to-back colonoscopies. Gastroenterology. 1997 Jan;112(1):24-8. doi: 10.1016/s0016-5085(97)70214-2.
PMID: 8978338
citation: Corley DA, Jensen CD, Marks AR, Zhao WK, Lee JK, Doubeni CA, Zauber AG, de Boer J, Fireman BH, Schottinger JE, Quinn VP, Ghai NR, Levin TR, Quesenberry CP. Adenoma detection rate and risk of colorectal cancer and death. N Engl J Med. 2014 Apr 3;370(14):1298-306. doi: 10.1056/NEJMoa1309086.
PMID: 24693890
citation: Kaminski MF, Regula J, Kraszewska E, Polkowski M, Wojciechowska U, Didkowska J, Zwierko M, Rupinski M, Nowacki MP, Butruk E. Quality indicators for colonoscopy and the risk of interval cancer. N Engl J Med. 2010 May 13;362(19):1795-803. doi: 10.1056/NEJMoa0907667.
PMID: 20463339
citation: Floer M, Biecker E, Fitzlaff R, Roming H, Ameis D, Heinecke A, Kunsch S, Ellenrieder V, Strobel P, Schepke M, Meister T. Higher adenoma detection rates with endocuff-assisted colonoscopy - a randomized controlled multicenter trial. PLoS One. 2014 Dec 3;9(12):e114267. doi: 10.1371/journal.pone.0114267. eCollection 2014.
PMID: 25470133
citation: Sawatzki M, Meyenberger C, Marbet UA, Haarer J, Frei R. Prospective Swiss pilot study of Endocuff-assisted colonoscopy in a screening population. Endosc Int Open. 2015 Jun;3(3):E236-9. doi: 10.1055/s-0034-1391418. Epub 2015 Feb 27.
PMID: 26171436
citation: van Doorn SC, van der Vlugt M, Depla A, Wientjes CA, Mallant-Hent RC, Siersema PD, Tytgat K, Tuynman H, Kuiken SD, Houben G, Stokkers P, Moons L, Bossuyt P, Fockens P, Mundt MW, Dekker E. Adenoma detection with Endocuff colonoscopy versus conventional colonoscopy: a multicentre randomised controlled trial. Gut. 2017 Mar;66(3):438-445. doi: 10.1136/gutjnl-2015-310097. Epub 2015 Dec 16.
PMID: 26674360
responsible party type: Principal Investigator
investigator affiliation: Queen Elizabeth Hospital, Hong Kong
investigator full name: Sze Shun Fung
investigator title: Associate Consultant
mesh term: Adenoma
mesh term: Colonic Neoplasms
mesh term: Polyps
sharing ipd: No