<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/NCT03756636</url>
  </required_header>
  <id_info>
    <org_study_id>2046</org_study_id>
    <nct_id>NCT03756636</nct_id>
  </id_info>
  <brief_title>&quot;Underwater&quot; Technique With Submucosal Solution of Viscose Solution -SIC 8000 (EleviewTM) - For Endoscopic Resection of Cole-rectal Polyps With Signs of Fibrosis.</brief_title>
  <acronym>UEMREleview</acronym>
  <official_title>&quot;Underwater&quot; Technique With Submucosal Solution of Viscose Solution -SIC 8000 (EleviewTM) - For Endoscopic Resection of Cole-rectal Polyps With Signs of Fibrosis. Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istituto Clinico Humanitas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istituto Clinico Humanitas</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>
      All procedures are performed in the investigator's outpatient gastroenterology and digestive&#xD;
      endoscopy unit by experienced endoscopists in conventional mucosectomies of the lower&#xD;
      intestinal tract.&#xD;
&#xD;
      Before the procedure each patient, a normal endoscopic procedure. At the site of the lesion&#xD;
      the lumen will be completely decompressed with aspiration of the gas, and then again relaxed&#xD;
      with the instillation of only water. The EleviewTM will be injected into the submucosa in&#xD;
      such quantities as to obtain a satisfactory lift of the lesion. The lesion will then be&#xD;
      removed with a diathermic loop, preferably en-bloc, and in any case up to macroscopic&#xD;
      evidence of complete resection. All the removed material will be stored and sent to&#xD;
      histological analysis. Tolerability score will be recorded during the procedure.&#xD;
&#xD;
      Any &quot;bleeding&quot; (both intra- and post-procedural), perforation, post-polypectomy syndrome,&#xD;
      stenosis or death in the 6 months following the procedure will be born &quot;complication&quot;.&#xD;
&#xD;
      A surveillance colonoscopy including biopsy sampling of the research site scheduled 6 months&#xD;
      after the procedure&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2018</start_date>
  <completion_date type="Actual">November 26, 2018</completion_date>
  <primary_completion_date type="Actual">November 26, 2018</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>Macroscopically complete resection rate</measure>
    <time_frame>6 Months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>6-month recurrence rate;</measure>
    <time_frame>6 Months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of adverse events (according to the lexiconA ASGE).</measure>
    <time_frame>6 Months</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Colo-rectal Polyps</condition>
  <arm_group>
    <arm_group_label>&quot;Underwater&quot; mucosectomy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>&quot;Underwater&quot; mucosectomy with submucosal injection of viscous solution -SIC 8000 (EleviewTM)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>&quot;Underwater&quot; mucosectomy with submucosal injection of viscous solution -SIC 8000 (EleviewTM)</intervention_name>
    <description>&quot;Underwater&quot; mucosectomy with submucosal injection of viscous solution -SIC 8000 (EleviewTM)</description>
    <arm_group_label>&quot;Underwater&quot; mucosectomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age&gt; 18 years.&#xD;
&#xD;
          -  Signing of informed consent.&#xD;
&#xD;
          -  Possibility of being subjected to the diagnostic and therapeutic procedures of the&#xD;
             study.&#xD;
&#xD;
          -  Presence of colo-rectal polypoid lesions ≥ 15mm presenting macroscopic aspects of&#xD;
             fibrosis as a consequence of previous incomplete treatments or biopsies or relapses&#xD;
             after previous removal.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Highly indicative morphological characteristics of carcinoma with submucosal invasion&#xD;
             (Ulceration, Pit Pattern Vn according to Kudo et al.18)&#xD;
&#xD;
          -  Pregnancy or breastfeeding&#xD;
&#xD;
          -  ASA&gt; 3&#xD;
&#xD;
          -  Unstable personality or unable to adhere to the protocol procedures.&#xD;
&#xD;
          -  Inability to provide informed consent.&#xD;
&#xD;
          -  Injury not reachable endoscopically.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Endoscopy Unit, Gastroenterology Department, Humanitas Research Hospital</name>
      <address>
        <city>Rozzano</city>
        <state>Milano</state>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>January 10, 2020</last_update_submitted>
  <last_update_submitted_qc>January 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rectal Neoplasms</mesh_term>
    <mesh_term>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/NCT03756636
org study id: 2046
nct id: NCT03756636
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
All procedures are performed in the investigator's outpatient gastroenterology and digestive
      endoscopy unit by experienced endoscopists in conventional mucosectomies of the lower
      intestinal tract.

      Before the procedure each patient, a normal endoscopic procedure. At the site of the lesion
      the lumen will be completely decompressed with aspiration of the gas, and then again relaxed
      with the instillation of only water. The EleviewTM will be injected into the submucosa in
      such quantities as to obtain a satisfactory lift of the lesion. The lesion will then be
      removed with a diathermic loop, preferably en-bloc, and in any case up to macroscopic
      evidence of complete resection. All the removed material will be stored and sent to
      histological analysis. Tolerability score will be recorded during the procedure.

      Any "bleeding" (both intra- and post-procedural), perforation, post-polypectomy syndrome,
      stenosis or death in the 6 months following the procedure will be born "complication".

      A surveillance colonoscopy including biopsy sampling of the research site scheduled 6 months
      after the procedure
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Macroscopically complete resection rate
time frame: 6 Months
measure: 6-month recurrence rate;
time frame: 6 Months
measure: Rate of adverse events (according to the lexiconA ASGE).
time frame: 6 Months
arm group label: "Underwater" mucosectomy
arm group type: Other
description: "Underwater" mucosectomy with submucosal injection of viscous solution -SIC 8000 (EleviewTM)
intervention type: Procedure
intervention name: "Underwater" mucosectomy with submucosal injection of viscous solution -SIC 8000 (EleviewTM)
description: "Underwater" mucosectomy with submucosal injection of viscous solution -SIC 8000 (EleviewTM)
arm group label: "Underwater" mucosectomy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Italy
responsible party type: Sponsor
mesh term: Rectal Neoplasms
mesh term: Polyps