<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/NCT04464837</url>
  </required_header>
  <id_info>
    <org_study_id>COLDSNAP-1</org_study_id>
    <nct_id>NCT04464837</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Cold Snare Polypectomy (CSP) of Intermediate Sized Colorectal Polyps 10-15 mm</brief_title>
  <acronym>COLDSNAP-1</acronym>
  <official_title>Efficacy and Safety of Cold Snare Polypectomy (CSP) of Intermediate Sized Colorectal Polyps 10-15 mm With a Newly Designed Polypectomy Snare - A Feasibility Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Technical University of Munich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Technical University of Munich</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>
      Colorectal cancer (CRC) has become the third most common malignant tumor and is the second&#xD;
      leading cause of cancer related deaths worldwide. Adenomatous polyps of the colon are&#xD;
      possible precursor lesions for CRC. Screening for CRC has been shown effective in preventing&#xD;
      CRC and related deaths, especially colonoscopy and resection of adenomatous polyps.&#xD;
      Currently, for intermediate sized polyps 5 - 20 mm hot snare polypectomy (HSP) with the use&#xD;
      of electrocautery is conventionally used, causing relevant adverse events including&#xD;
      haemorrhage and postpolypectomy coagulation syndrome, but is safe regarding complete&#xD;
      resection of the polyp due to burning effect on residual tissue. On the other hand, cold&#xD;
      snare polypectomy (CSP) has grown popularity. Absence of electrocautery makes it technically&#xD;
      easier and most important reduces adverse events. CSP is recommended as the preferred&#xD;
      technique for polyps &lt;5 mm by the European Society of Gastrointestinal Endoscopy (ESGE)&#xD;
      guidelines. In literature, there is one multicenter trial from Japan recommending CSP for&#xD;
      polyps 4-9 mm (average polyp size 5,4 mm) and only a few case studies for polyps 10-15 mm&#xD;
      with inconsistent results, especially regarding the complete resection and pathological&#xD;
      evaluation of the specimen.&#xD;
&#xD;
      In this feasibility trial, the investigators try to find out if CSP with a new designed&#xD;
      polypectomy snare is efficient and safe in terms of complete resection (R0), pathological&#xD;
      evaluation and adverse events.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 1, 2020</start_date>
  <completion_date type="Anticipated">June 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Proof-Of-Concept</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Complete Resection Rate (R0-resection)</measure>
    <time_frame>6 month</time_frame>
    <description>Complete resection rate of polyps resected by cold snare polypectomy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Required additional attempts for complete resection during surgery</measure>
    <time_frame>during surgery</time_frame>
    <description>Where there more than one attempts for complete resection of the polyp during surgery?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of immediate and delayed bleeding.</measure>
    <time_frame>3 weeks</time_frame>
    <description>Immediate bleeding: Bleeding &gt;30 seconds after snaring. Delayed bleeding: Bleeding during the next 3 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Technical Impossibility of CSP during surgery</measure>
    <time_frame>during surgery</time_frame>
    <description>Necessity of changing to HSP, if CSP is technically not possible</description>
  </secondary_outcome>
  <enrollment type="Anticipated">35</enrollment>
  <condition>Colorectal Polyp</condition>
  <condition>Colorectal Adenoma</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cold Snare Polypectomy of intermediate sized polyps (10-15 mm)</intervention_name>
    <description>If an eligible polyp (10-15mm) is found, cold snare polypectomy is performed with the Olympus SnareMaster® Plus Snare</description>
    <other_name>Olympus SnareMaster® Plus</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  indication for colonoscopy&#xD;
&#xD;
          -  signed informed consent&#xD;
&#xD;
          -  at least one polyp of the size 10-15mm&#xD;
&#xD;
          -  American Society of Anesthesiologists-classification (ASA) I-III&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists-classification (ASA) IV-VI&#xD;
&#xD;
          -  Inflammatory bowel disease (IBD)&#xD;
&#xD;
          -  known/suspected invasive colorectal cancer&#xD;
&#xD;
          -  contraindications for polypectomy&#xD;
&#xD;
          -  emergency indication for colonoscopy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>2nd Medical Department, Klinikum rechts der Isar</name>
      <address>
        <city>Munich</city>
        <zip>81675</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>July 6, 2020</last_update_submitted>
  <last_update_submitted_qc>July 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Technical University of Munich</investigator_affiliation>
    <investigator_full_name>Monther Bajbouj</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>coldsnare polypectomy</keyword>
  <keyword>hotsnare polypectomy</keyword>
  <keyword>intermediate sized polyps</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenoma</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/NCT04464837
org study id: COLDSNAP-1
nct id: NCT04464837
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Colorectal cancer (CRC) has become the third most common malignant tumor and is the second
      leading cause of cancer related deaths worldwide. Adenomatous polyps of the colon are
      possible precursor lesions for CRC. Screening for CRC has been shown effective in preventing
      CRC and related deaths, especially colonoscopy and resection of adenomatous polyps.
      Currently, for intermediate sized polyps 5 - 20 mm hot snare polypectomy (HSP) with the use
      of electrocautery is conventionally used, causing relevant adverse events including
      haemorrhage and postpolypectomy coagulation syndrome, but is safe regarding complete
      resection of the polyp due to burning effect on residual tissue. On the other hand, cold
      snare polypectomy (CSP) has grown popularity. Absence of electrocautery makes it technically
      easier and most important reduces adverse events. CSP is recommended as the preferred
      technique for polyps <5 mm by the European Society of Gastrointestinal Endoscopy (ESGE)
      guidelines. In literature, there is one multicenter trial from Japan recommending CSP for
      polyps 4-9 mm (average polyp size 5,4 mm) and only a few case studies for polyps 10-15 mm
      with inconsistent results, especially regarding the complete resection and pathological
      evaluation of the specimen.

      In this feasibility trial, the investigators try to find out if CSP with a new designed
      polypectomy snare is efficient and safe in terms of complete resection (R0), pathological
      evaluation and adverse events.
allocation: Non-Randomized
intervention model: Single Group Assignment
intervention model description: Proof-Of-Concept
primary purpose: Treatment
masking: None (Open Label)
measure: Complete Resection Rate (R0-resection)
time frame: 6 month
description: Complete resection rate of polyps resected by cold snare polypectomy
measure: Required additional attempts for complete resection during surgery
time frame: during surgery
description: Where there more than one attempts for complete resection of the polyp during surgery?
measure: Incidence of immediate and delayed bleeding.
time frame: 3 weeks
description: Immediate bleeding: Bleeding >30 seconds after snaring. Delayed bleeding: Bleeding during the next 3 weeks.
measure: Technical Impossibility of CSP during surgery
time frame: during surgery
description: Necessity of changing to HSP, if CSP is technically not possible
intervention type: Device
intervention name: Cold Snare Polypectomy of intermediate sized polyps (10-15 mm)
description: If an eligible polyp (10-15mm) is found, cold snare polypectomy is performed with the Olympus SnareMaster® Plus Snare
other name: Olympus SnareMaster® Plus
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Technical University of Munich
investigator full name: Monther Bajbouj
investigator title: Principal Investigator
mesh term: Adenoma
mesh term: Polyps
sharing ipd: No