<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/NCT04472741</url>
  </required_header>
  <id_info>
    <org_study_id>GastroBaWe</org_study_id>
    <nct_id>NCT04472741</nct_id>
  </id_info>
  <brief_title>Comparison of Newer Colonoscopy Devices With Standard Forward Viewing (SFV) Colonoscopes in Daily Practice</brief_title>
  <official_title>Comparison of Newer Colonoscopy Devices With Standard Forward Viewing (SFV) High Definition Colonoscopes in Daily Practice</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gastroenterologie Baden-Wettingen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gastroenterologie Baden-Wettingen</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>
      Retrospective data analysis of comparsion of 3 types of colonoscopes in daily practice (FUSE&#xD;
      Full spectrum colonoscopy with 330° angle of view vs Pentax standard HD-colonoscopes and&#xD;
      Pentax plus Endocuff): medical device of the category IIb (CE-marked device used within its&#xD;
      intended purpose)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      From March 2015 through February 2017 (phase A) patients referred for ambulant colonoscopy in&#xD;
      a private Swiss gastroenterologist's practice were alternatingly allocated to one of the two&#xD;
      endoscopy theatres. One equipped with a FUSE® endoscopy system from Endochoice (later: Boston&#xD;
      Scientific, nA/FUSE®=1044 examinations), the other with an EPKi Processor and Pentax i10&#xD;
      colonoscopes (nA/Pentax=934 examinations). In March 2017 a second doctor joined the practice,&#xD;
      but did not contribute to the study. These organizational changes required randomization to&#xD;
      be switched from per-patient alternation to per-day alternation in phase B from March 2018&#xD;
      through September 2019. In phase B the FUSE® system was unchanged (nB/FUSE®=1386&#xD;
      examinations), while the Pentax i10 colonoscopes were additionally equipped with Endocuff®&#xD;
      (nB/Endocuff®=750 examinations). Patients with contraindica-tion against Endocuff® (known or&#xD;
      found diverticular stenosis) were excluded from the study (nB/removed=127). Patients were&#xD;
      given their appointments to any free slot throughout the week without stratification. The&#xD;
      study and data analysis was consented by the ethical committee EKNZ Ethikkom-mission&#xD;
      Nordwest- und Zentralschweiz (Project-ID 2019-01643).&#xD;
&#xD;
      All procedures were performed by one experienced endoscopist (board certified 2004) under&#xD;
      nurse assisted propofol sedation (NAPS).&#xD;
&#xD;
      Baseline characteristics, age, sex, BMI, smoking habits, diabetes as well as quality of bowel&#xD;
      prepara-tion (measured by BBPS score) and indication for colonoscopy (screening,&#xD;
      surveillance, diagnostic, such as diarrhea, bleeding, persistent abdominal pain) were&#xD;
      assessed. Amount of sedatives, other medications given during endoscopy (e.g. Buscopan®) and&#xD;
      time for the endoscopy e.g. time to ile-um, retraction time (pullback time minus intervention&#xD;
      time) and time for intervention were measured by the assistant with a stopwatch. These&#xD;
      parameters, polyp counts, size and their localisation (entered in a table and to an&#xD;
      anatomical scheme), and satisfaction for all parts of the examination (bowel prep and overall&#xD;
      satisfaction) were realtime entered to the database by a tablet computer. The data entry was&#xD;
      done coded. Only the main investigator could subdue each single patient.&#xD;
&#xD;
      Statistics were done with a professional statistics, the co-author Dr. Leiner&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2015</start_date>
  <completion_date type="Actual">September 25, 2019</completion_date>
  <primary_completion_date type="Actual">September 25, 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>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adenoma detection rate</measure>
    <time_frame>within 45 minutes of examination</time_frame>
    <description>adenoma counts</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>time for endoscopy (time to ileum, withdrawal and intervention time). Medication, Satisfaction on VAS</measure>
    <time_frame>within 45 minutes of examination</time_frame>
    <description>different endoscopy characteristics</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">4114</enrollment>
  <condition>Adenoma Detection Rate</condition>
  <arm_group>
    <arm_group_label>FUSE</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>wide angle colonoscope</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HD Pentax i10 colonoscopes</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>SFV instrument</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Endocuff</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Cuff on SFV</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>difference between colonoscopes</intervention_name>
    <description>patients have been randomly assigned for colonoscopy with FUSE or HD SFV endoscopes with or without Endocuff</description>
    <arm_group_label>Endocuff</arm_group_label>
    <arm_group_label>FUSE</arm_group_label>
    <arm_group_label>HD Pentax i10 colonoscopes</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all patient fit for ambulatory colonoscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  for Endocuff stricturing divertculosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>July 11, 2020</study_first_submitted>
  <study_first_submitted_qc>July 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>February 8, 2021</last_update_submitted>
  <last_update_submitted_qc>February 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Gastroenterologie Baden-Wettingen</investigator_affiliation>
    <investigator_full_name>Geyer Martin</investigator_full_name>
    <investigator_title>Geyer Martin, Director and Principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenoma</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/NCT04472741
org study id: GastroBaWe
nct id: NCT04472741
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Retrospective data analysis of comparsion of 3 types of colonoscopes in daily practice (FUSE
      Full spectrum colonoscopy with 330° angle of view vs Pentax standard HD-colonoscopes and
      Pentax plus Endocuff): medical device of the category IIb (CE-marked device used within its
      intended purpose)
From March 2015 through February 2017 (phase A) patients referred for ambulant colonoscopy in
      a private Swiss gastroenterologist's practice were alternatingly allocated to one of the two
      endoscopy theatres. One equipped with a FUSE® endoscopy system from Endochoice (later: Boston
      Scientific, nA/FUSE®=1044 examinations), the other with an EPKi Processor and Pentax i10
      colonoscopes (nA/Pentax=934 examinations). In March 2017 a second doctor joined the practice,
      but did not contribute to the study. These organizational changes required randomization to
      be switched from per-patient alternation to per-day alternation in phase B from March 2018
      through September 2019. In phase B the FUSE® system was unchanged (nB/FUSE®=1386
      examinations), while the Pentax i10 colonoscopes were additionally equipped with Endocuff®
      (nB/Endocuff®=750 examinations). Patients with contraindica-tion against Endocuff® (known or
      found diverticular stenosis) were excluded from the study (nB/removed=127). Patients were
      given their appointments to any free slot throughout the week without stratification. The
      study and data analysis was consented by the ethical committee EKNZ Ethikkom-mission
      Nordwest- und Zentralschweiz (Project-ID 2019-01643).

      All procedures were performed by one experienced endoscopist (board certified 2004) under
      nurse assisted propofol sedation (NAPS).

      Baseline characteristics, age, sex, BMI, smoking habits, diabetes as well as quality of bowel
      prepara-tion (measured by BBPS score) and indication for colonoscopy (screening,
      surveillance, diagnostic, such as diarrhea, bleeding, persistent abdominal pain) were
      assessed. Amount of sedatives, other medications given during endoscopy (e.g. Buscopan®) and
      time for the endoscopy e.g. time to ile-um, retraction time (pullback time minus intervention
      time) and time for intervention were measured by the assistant with a stopwatch. These
      parameters, polyp counts, size and their localisation (entered in a table and to an
      anatomical scheme), and satisfaction for all parts of the examination (bowel prep and overall
      satisfaction) were realtime entered to the database by a tablet computer. The data entry was
      done coded. Only the main investigator could subdue each single patient.

      Statistics were done with a professional statistics, the co-author Dr. Leiner
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Adenoma detection rate
time frame: within 45 minutes of examination
description: adenoma counts
measure: time for endoscopy (time to ileum, withdrawal and intervention time). Medication, Satisfaction on VAS
time frame: within 45 minutes of examination
description: different endoscopy characteristics
arm group label: FUSE
arm group type: Other
description: wide angle colonoscope
arm group label: HD Pentax i10 colonoscopes
arm group type: Other
description: SFV instrument
arm group label: Endocuff
arm group type: Other
description: Cuff on SFV
intervention type: Device
intervention name: difference between colonoscopes
description: patients have been randomly assigned for colonoscopy with FUSE or HD SFV endoscopes with or without Endocuff
arm group label: Endocuff
arm group label: FUSE
arm group label: HD Pentax i10 colonoscopes
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Gastroenterologie Baden-Wettingen
investigator full name: Geyer Martin
investigator title: Geyer Martin, Director and Principal investigator
mesh term: Adenoma
sharing ipd: No