<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/NCT03767166</url>
  </required_header>
  <id_info>
    <org_study_id>2275</org_study_id>
    <nct_id>NCT03767166</nct_id>
  </id_info>
  <brief_title>The Archimedes Biodegradable Biliary and Pancreatic Stents</brief_title>
  <acronym>ARCHIMEDES</acronym>
  <official_title>A Prospective, Single Arm Study to Evaluate the Feasibility of the Archimedes Biodegradable Biliary and Pancreatic Stents Placement</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, phase II, single-centre, non-randomised, single-arm study, enrolling&#xD;
      patients with benign and malignant bilio-pancreatic diseases with an indication to biliary or&#xD;
      pancreatic plastic stent positioning during ERCP.&#xD;
&#xD;
      On procedure day, the study team will confirm that the patient meets all the inclusion&#xD;
      criteria and none of the exclusion criteria.&#xD;
&#xD;
      The patient will undergo the ABS insertion and monitored and follow-up accordingly to&#xD;
      biodegration variant.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Biodegradation time</measure>
    <time_frame>24 Months</time_frame>
  </primary_outcome>
  <enrollment type="Actual">30</enrollment>
  <condition>Pancreatic Diseases</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Biodegradable biliary and pancreatic stents placement</intervention_name>
    <description>Biodegradable biliary and pancreatic stents placement</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with benign and malignant bilio-pancreatic diseases with an indication to biliary&#xD;
        or pancreatic plastic stent positioning during ERCP.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with an indication to position one ore more biliary plastic stents during&#xD;
             ERCP&#xD;
&#xD;
          -  Patients with an indication to position a pancreatic plastic stent during ERCP&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 y&#xD;
&#xD;
          -  Life expectancy &lt; 1 m,&#xD;
&#xD;
          -  Inability to pass a guidewire through stricture&#xD;
&#xD;
          -  Contra-indication for endoscopy or interventional radiology&#xD;
&#xD;
          -  Presence of partial gastric resection&#xD;
&#xD;
          -  Unsigned informing consent form, ICF&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Pseudo Klatskin tumors (metastases in the liver hilum) and gallbladder carcinoma&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Endoscopy Unit, 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>March 2021</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>March 17, 2021</last_update_submitted>
  <last_update_submitted_qc>March 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 2021</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>Pancreatic Diseases</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/NCT03767166
org study id: 2275
nct id: NCT03767166
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This is a prospective, phase II, single-centre, non-randomised, single-arm study, enrolling
      patients with benign and malignant bilio-pancreatic diseases with an indication to biliary or
      pancreatic plastic stent positioning during ERCP.

      On procedure day, the study team will confirm that the patient meets all the inclusion
      criteria and none of the exclusion criteria.

      The patient will undergo the ABS insertion and monitored and follow-up accordingly to
      biodegration variant.
observational model: Cohort
time perspective: Prospective
measure: Biodegradation time
time frame: 24 Months
intervention type: Device
intervention name: Biodegradable biliary and pancreatic stents placement
description: Biodegradable biliary and pancreatic stents placement
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
facility: 
country: Italy
responsible party type: Sponsor
mesh term: Pancreatic Diseases
sharing ipd: No