<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/NCT02245854</url>
  </required_header>
  <id_info>
    <org_study_id>E-Scope</org_study_id>
    <nct_id>NCT02245854</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of a New Polypectomy Snare for Cold-polypectomy for Small Colorectal Polyps</brief_title>
  <official_title>Efficacy and Safety of a New Polypectomy Snare for Cold-polypectomy for Subcentimetric Colorectal Polyps: the E-scope (Efficacy and Safety of COld PolypEctomy) Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istituto Clinico Humanitas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>San Gerardo Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Azienda Ospedaliero Universitaria Maggiore della Carita</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Istituto Clinico Humanitas</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Colorectal cancer is a major cause of morbidity and mortality in Western countries.&#xD;
      Scientific studies have shown that endoscopic polypectomy is efficacious in preventing CRC&#xD;
      incidence and mortality.&#xD;
&#xD;
      Endoscopic polypectomy carries a risk of major complications, such as bleeding or bowel&#xD;
      perforation, so that a careful balance between efficacy and safety appears to be clinically&#xD;
      relevant.&#xD;
&#xD;
      Most of the polypectomies are performed for diminutive (&lt;5 mm) or small (6-9 mm) lesions,&#xD;
      which represent over 90% of all the polyps.&#xD;
&#xD;
      To minimize the risk of complications when removing &lt;10 mm polyps, cold-polypectomy&#xD;
      techniques - i.e. without electric current - by means of biopsy forceps or snare, have been&#xD;
      proposed.&#xD;
&#xD;
      Although the risk of perforation is virtually excluded by cold-polypectomy, the lack of&#xD;
      electrocautery may result in an increased risk of bleeding. The safety of cold-snare&#xD;
      polypectomy has however been recently shown in controlled trials.&#xD;
&#xD;
      Regarding the efficacy of cold-polypectomy for subcentimetric polyps, very few studies have&#xD;
      assessed the post-polypectomy completeness of the removal of polyp tissue (i.e. residual&#xD;
      disease), and no studies have compared it to conventional polypectomy.&#xD;
&#xD;
      The investigators perform this study to assess both the efficacy and safety of a novel snare&#xD;
      (Exacto™) for polyp removal.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2013</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">April 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of complete polyp removal</measure>
    <time_frame>One year</time_frame>
    <description>Clinical success, defined as absence of polyp tissue, either hyperplastic or adenomatous, on the margins of the polypectomy area after cold-polypectomy of subcentimetric polyps. Such assessment is performed on two biopsies performed on the polypectomy scar. The investigators will calculate the percentage (%) of complete and incomplete polypectomies with the new device.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical success according to size</measure>
    <time_frame>One year</time_frame>
    <description>Clinical success (as defined in the primary end-point) according to the size class: diminutive (&lt;5 mm) and small (6-9 mm) polyps.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-polypectomy bleeding rates</measure>
    <time_frame>One year</time_frame>
    <description>Post-polypectomy bleeding defined as any bleeding requiring immediate therapeutic endoscopic procedure (i.e. clipping, electrocautery) or delayed treatment, such as hospitalization or new endoscopic procedure.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">250</enrollment>
  <condition>Polyp of Large Intestine</condition>
  <condition>Colonic Polyps</condition>
  <condition>Colon Nos Polypectomy Tubular Adenoma</condition>
  <condition>Complications</condition>
  <condition>Bleeding</condition>
  <arm_group>
    <arm_group_label>Colonic polyps</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Exacto™</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Exacto™</intervention_name>
    <description>Cold snare polypectomy</description>
    <arm_group_label>Colonic polyps</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All consecutive patients undergoing colonoscopy, with at least one and no more than 5&#xD;
             polyps &lt;10 mm.&#xD;
&#xD;
          -  The patient is at satisfactory risk to undergo abdominal surgery.&#xD;
&#xD;
          -  The patient must understand and provide written consent for the procedure.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with inflammatory bowel disease.&#xD;
&#xD;
          -  Patients undergoing standard snare resection (with cautery) of polyps larger than 10&#xD;
             mm.&#xD;
&#xD;
          -  Patients with a personal history of polyposis syndrome.&#xD;
&#xD;
          -  Patients with suspected chronic stricture potentially precluding complete colonoscopy.&#xD;
&#xD;
          -  Patients with diverticulitis or toxic megacolon.&#xD;
&#xD;
          -  Patients with a history of radiation therapy to abdomen or pelvis.&#xD;
&#xD;
          -  Patients with a history of severe cardiovascular, pulmonary, liver or renal disease.&#xD;
&#xD;
          -  Personal history of coagulation disorders or use of&#xD;
             anticoagulants/clopidogrel/aspirin/ticlopidine.&#xD;
&#xD;
          -  Patients who are currently enrolled in another clinical investigation in which the&#xD;
             intervention might compromise the safety of the patient's participation in this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alessandro Repici, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Istituto Clinico Humanitas</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>San Gerardo Hospital</name>
      <address>
        <city>Monza</city>
        <zip>20052</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera &quot;Maggiore della Carità&quot;</name>
      <address>
        <city>Novara</city>
        <zip>28100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoscopy Unit, Gastroenterology Department, Humanitas Research Hospital</name>
      <address>
        <city>Rozzano, Milan</city>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Repici A, Hassan C, Vitetta E, Ferrara E, Manes G, Gullotti G, Princiotta A, Dulbecco P, Gaffuri N, Bettoni E, Pagano N, Rando G, Strangio G, Carlino A, Romeo F, de Paula Pessoa Ferreira D, Zullo A, Ridola L, Malesci A. Safety of cold polypectomy for &lt;10mm polyps at colonoscopy: a prospective multicenter study. Endoscopy. 2012 Jan;44(1):27-31. doi: 10.1055/s-0031-1291387. Epub 2011 Nov 28.</citation>
    <PMID>22125197</PMID>
  </reference>
  <reference>
    <citation>Ichise Y, Horiuchi A, Nakayama Y, Tanaka N. Prospective randomized comparison of cold snare polypectomy and conventional polypectomy for small colorectal polyps. Digestion. 2011;84(1):78-81. doi: 10.1159/000323959. Epub 2011 Apr 14.</citation>
    <PMID>21494037</PMID>
  </reference>
  <reference>
    <citation>Horiuchi A, Nakayama Y, Kajiyama M, Tanaka N, Sano K, Graham DY. Removal of small colorectal polyps in anticoagulated patients: a prospective randomized comparison of cold snare and conventional polypectomy. Gastrointest Endosc. 2014 Mar;79(3):417-23. doi: 10.1016/j.gie.2013.08.040. Epub 2013 Oct 11.</citation>
    <PMID>24125514</PMID>
  </reference>
  <reference>
    <citation>Paspatis GA, Tribonias G, Konstantinidis K, Theodoropoulou A, Vardas E, Voudoukis E, Manolaraki MM, Chainaki I, Chlouverakis G. A prospective randomized comparison of cold vs hot snare polypectomy in the occurrence of postpolypectomy bleeding in small colonic polyps. Colorectal Dis. 2011 Oct;13(10):e345-8. doi: 10.1111/j.1463-1318.2011.02696.x.</citation>
    <PMID>21689363</PMID>
  </reference>
  <reference>
    <citation>Lieberman D, Moravec M, Holub J, Michaels L, Eisen G. Polyp size and advanced histology in patients undergoing colonoscopy screening: implications for CT colonography. Gastroenterology. 2008 Oct;135(4):1100-5. doi: 10.1053/j.gastro.2008.06.083. Epub 2008 Jul 3.</citation>
    <PMID>18691580</PMID>
  </reference>
  <reference>
    <citation>Heldwein W, Dollhopf M, Rosch T, Meining A, Schmidtsdorff G, Hasford J, Hermanek P, Burlefinger R, Birkner B, Schmitt W; Munich Gastroenterology Group. The Munich Polypectomy Study (MUPS): prospective analysis of complications and risk factors in 4000 colonic snare polypectomies. Endoscopy. 2005 Nov;37(11):1116-22. doi: 10.1055/s-2005-870512.</citation>
    <PMID>16281142</PMID>
  </reference>
  <reference>
    <citation>Panteris V, Haringsma J, Kuipers EJ. Colonoscopy perforation rate, mechanisms and outcome: from diagnostic to therapeutic colonoscopy. Endoscopy. 2009 Nov;41(11):941-51. doi: 10.1055/s-0029-1215179. Epub 2009 Oct 28.</citation>
    <PMID>19866393</PMID>
  </reference>
  <reference>
    <citation>Atkin WS, Edwards R, Kralj-Hans I, Wooldrage K, Hart AR, Northover JM, Parkin DM, Wardle J, Duffy SW, Cuzick J; UK Flexible Sigmoidoscopy Trial Investigators. Once-only flexible sigmoidoscopy screening in prevention of colorectal cancer: a multicentre randomised controlled trial. Lancet. 2010 May 8;375(9726):1624-33. doi: 10.1016/S0140-6736(10)60551-X. Epub 2010 Apr 27.</citation>
    <PMID>20430429</PMID>
  </reference>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 1, 2014</study_first_submitted>
  <study_first_submitted_qc>September 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 22, 2014</study_first_posted>
  <last_update_submitted>September 19, 2014</last_update_submitted>
  <last_update_submitted_qc>September 19, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 22, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istituto Clinico Humanitas</investigator_affiliation>
    <investigator_full_name>Michele Tedeschi</investigator_full_name>
    <investigator_title>Responsible of the Clinical Research Project</investigator_title>
  </responsible_party>
  <keyword>diminutive polyps</keyword>
  <keyword>small polyps</keyword>
  <keyword>cold snare polypectomy</keyword>
  <keyword>complications</keyword>
  <keyword>bleeding</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenoma</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
    <mesh_term>Polyps</mesh_term>
    <mesh_term>Colonic Polyps</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/NCT02245854
org study id: E-Scope
nct id: NCT02245854
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
Colorectal cancer is a major cause of morbidity and mortality in Western countries.
      Scientific studies have shown that endoscopic polypectomy is efficacious in preventing CRC
      incidence and mortality.

      Endoscopic polypectomy carries a risk of major complications, such as bleeding or bowel
      perforation, so that a careful balance between efficacy and safety appears to be clinically
      relevant.

      Most of the polypectomies are performed for diminutive (<5 mm) or small (6-9 mm) lesions,
      which represent over 90% of all the polyps.

      To minimize the risk of complications when removing <10 mm polyps, cold-polypectomy
      techniques - i.e. without electric current - by means of biopsy forceps or snare, have been
      proposed.

      Although the risk of perforation is virtually excluded by cold-polypectomy, the lack of
      electrocautery may result in an increased risk of bleeding. The safety of cold-snare
      polypectomy has however been recently shown in controlled trials.

      Regarding the efficacy of cold-polypectomy for subcentimetric polyps, very few studies have
      assessed the post-polypectomy completeness of the removal of polyp tissue (i.e. residual
      disease), and no studies have compared it to conventional polypectomy.

      The investigators perform this study to assess both the efficacy and safety of a novel snare
      (Exacto™) for polyp removal.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of complete polyp removal
time frame: One year
description: Clinical success, defined as absence of polyp tissue, either hyperplastic or adenomatous, on the margins of the polypectomy area after cold-polypectomy of subcentimetric polyps. Such assessment is performed on two biopsies performed on the polypectomy scar. The investigators will calculate the percentage (%) of complete and incomplete polypectomies with the new device.
measure: Clinical success according to size
time frame: One year
description: Clinical success (as defined in the primary end-point) according to the size class: diminutive (<5 mm) and small (6-9 mm) polyps.
measure: Post-polypectomy bleeding rates
time frame: One year
description: Post-polypectomy bleeding defined as any bleeding requiring immediate therapeutic endoscopic procedure (i.e. clipping, electrocautery) or delayed treatment, such as hospitalization or new endoscopic procedure.
arm group label: Colonic polyps
arm group type: Experimental
description: Exacto™
intervention type: Device
intervention name: Exacto™
description: Cold snare polypectomy
arm group label: Colonic polyps
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alessandro Repici, MD
role: Principal Investigator
affiliation: Istituto Clinico Humanitas
facility: 
facility: 
facility: 
country: Italy
citation: Repici A, Hassan C, Vitetta E, Ferrara E, Manes G, Gullotti G, Princiotta A, Dulbecco P, Gaffuri N, Bettoni E, Pagano N, Rando G, Strangio G, Carlino A, Romeo F, de Paula Pessoa Ferreira D, Zullo A, Ridola L, Malesci A. Safety of cold polypectomy for <10mm polyps at colonoscopy: a prospective multicenter study. Endoscopy. 2012 Jan;44(1):27-31. doi: 10.1055/s-0031-1291387. Epub 2011 Nov 28.
PMID: 22125197
citation: Ichise Y, Horiuchi A, Nakayama Y, Tanaka N. Prospective randomized comparison of cold snare polypectomy and conventional polypectomy for small colorectal polyps. Digestion. 2011;84(1):78-81. doi: 10.1159/000323959. Epub 2011 Apr 14.
PMID: 21494037
citation: Horiuchi A, Nakayama Y, Kajiyama M, Tanaka N, Sano K, Graham DY. Removal of small colorectal polyps in anticoagulated patients: a prospective randomized comparison of cold snare and conventional polypectomy. Gastrointest Endosc. 2014 Mar;79(3):417-23. doi: 10.1016/j.gie.2013.08.040. Epub 2013 Oct 11.
PMID: 24125514
citation: Paspatis GA, Tribonias G, Konstantinidis K, Theodoropoulou A, Vardas E, Voudoukis E, Manolaraki MM, Chainaki I, Chlouverakis G. A prospective randomized comparison of cold vs hot snare polypectomy in the occurrence of postpolypectomy bleeding in small colonic polyps. Colorectal Dis. 2011 Oct;13(10):e345-8. doi: 10.1111/j.1463-1318.2011.02696.x.
PMID: 21689363
citation: Lieberman D, Moravec M, Holub J, Michaels L, Eisen G. Polyp size and advanced histology in patients undergoing colonoscopy screening: implications for CT colonography. Gastroenterology. 2008 Oct;135(4):1100-5. doi: 10.1053/j.gastro.2008.06.083. Epub 2008 Jul 3.
PMID: 18691580
citation: Heldwein W, Dollhopf M, Rosch T, Meining A, Schmidtsdorff G, Hasford J, Hermanek P, Burlefinger R, Birkner B, Schmitt W; Munich Gastroenterology Group. The Munich Polypectomy Study (MUPS): prospective analysis of complications and risk factors in 4000 colonic snare polypectomies. Endoscopy. 2005 Nov;37(11):1116-22. doi: 10.1055/s-2005-870512.
PMID: 16281142
citation: Panteris V, Haringsma J, Kuipers EJ. Colonoscopy perforation rate, mechanisms and outcome: from diagnostic to therapeutic colonoscopy. Endoscopy. 2009 Nov;41(11):941-51. doi: 10.1055/s-0029-1215179. Epub 2009 Oct 28.
PMID: 19866393
citation: Atkin WS, Edwards R, Kralj-Hans I, Wooldrage K, Hart AR, Northover JM, Parkin DM, Wardle J, Duffy SW, Cuzick J; UK Flexible Sigmoidoscopy Trial Investigators. Once-only flexible sigmoidoscopy screening in prevention of colorectal cancer: a multicentre randomised controlled trial. Lancet. 2010 May 8;375(9726):1624-33. doi: 10.1016/S0140-6736(10)60551-X. Epub 2010 Apr 27.
PMID: 20430429
responsible party type: Principal Investigator
investigator affiliation: Istituto Clinico Humanitas
investigator full name: Michele Tedeschi
investigator title: Responsible of the Clinical Research Project
mesh term: Adenoma
mesh term: Hemorrhage
mesh term: Polyps
mesh term: Colonic Polyps