<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/NCT03766035</url>
  </required_header>
  <id_info>
    <org_study_id>E7136</org_study_id>
    <nct_id>NCT03766035</nct_id>
  </id_info>
  <brief_title>Cholangioscopy in Primary Sclerosing Cholangitis (PSC)</brief_title>
  <official_title>Cholangioscopy in Primary Sclerosing Cholangitis (PSC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Scientific Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Scientific Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To demonstrate the clinical utility of the addition of per oral cholangioscopy (POCS) to&#xD;
      standard endoscopic retrograde cholangiopancreatography (ERCP) with brushing cytology for&#xD;
      diagnosis and early detection of cholangiocarcinoma in patients diagnosed with primary&#xD;
      sclerosing cholangitis (PSC).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of this study is to demonstrate the clinical utility of the addition of&#xD;
      per oral cholangioscopy (POCS) to standard ERCP with brushing cytology for diagnosis and&#xD;
      early detection of cholangiocarcinoma in patients diagnosed with primary sclerosing&#xD;
      cholangitis (PSC).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 6, 2018</start_date>
  <completion_date type="Actual">December 12, 2022</completion_date>
  <primary_completion_date type="Actual">December 12, 2022</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>Diagnostic Accuracy of POCS visualization for Early Detection of Cholangiocarcinoma</measure>
    <time_frame>12 months</time_frame>
    <description>Diagnostic accuracy of POCS visualization for cholangiocarcinoma evaluated clinically at 12 months after initial POCS procedure by clinical presentation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>POCS-guided Biopsy for Early Detection of Cholangiocarcinoma</measure>
    <time_frame>12 months</time_frame>
    <description>Diagnostic accuracy for POCS-guided Biopsy for cholangiocarcinoma evaluated on pathology at 12 months after initial POCS procedure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Technical Success - Ability to advance the scope.</measure>
    <time_frame>Baseline</time_frame>
    <description>Ability to advance the cholangioscope to the target stricture, ability to visualize the stricture and ability to obtain a tissue sample with Spy Bite where applicable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Adverse Events</measure>
    <time_frame>From index through study completion, an average of one year</time_frame>
    <description>Serious adverse events from initial POCS procedure until end of follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients identified for repeat procedure.</measure>
    <time_frame>During index procedure</time_frame>
    <description>Proportion of patients identified for repeat procedure considering the addition of Spy Glass DS visualization and Spy Bite biopsy at Index compared to the proportion identified for repeat procedure without consideration of Spy Glass DS visualization and Spy Bite biopsy at Index.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correspondence of Biopsies</measure>
    <time_frame>From index through study completion, an average of one year</time_frame>
    <description>Correlation between histopathology of Spy Bite biopsies collected during the initial POCS procedure and final diagnosis.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">43</enrollment>
  <condition>Primary Sclerosing Cholangitis (PSC)</condition>
  <arm_group>
    <arm_group_label>Consented, enrolled PSC patients undergoing ERCP + SpyGlass</arm_group_label>
    <description>Patients with PSC who have been consented and enrolled in the study will undergo ERCP with the addition of SpyGlass as indicated by their treating physician.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SpyGlass DS I - II</intervention_name>
    <description>The SpyScope™ DS Access and Delivery Catheter (SpyScope™ DS Catheter) is a sterile, single-use endoscope that enables access and delivery of accessories to targeted pancreaticobiliary anatomy and displays live video when connected to a Spy Glass DS Digital Controller.</description>
    <arm_group_label>Consented, enrolled PSC patients undergoing ERCP + SpyGlass</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum collection&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients diagnosed with PSC&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Confirmed diagnosis of PSC&#xD;
&#xD;
          2. Clinical indication for ERCP per local standard of practice, such as suspicion of&#xD;
             potential malignancy based on worsening cholestatic values or clinical presentation&#xD;
             (such as itching, cholangitis) or new biliary stricture on trans-abdominal imaging&#xD;
             (MRI/MRCP, US or CT) or suspicious cytology&#xD;
&#xD;
          3. Diameter of bile ducts deemed sufficient to accommodate the cholangioscopy system&#xD;
             based on imaging performed prior to scheduled ERCP&#xD;
&#xD;
          4. Written informed consent from patient to participate in the study, including&#xD;
             compliance with study procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Contraindication for an ERCP or POCS&#xD;
&#xD;
          2. History of liver transplantation&#xD;
&#xD;
          3. Mass/metastasis extrinsic to the bile duct identifiable on diagnostic imaging&#xD;
&#xD;
          4. History of iatrogenic bile duct trauma, including biliary surgery within 6 months of&#xD;
             enrollment&#xD;
&#xD;
          5. INR &gt; 1.5 or platelets count &lt; 50,000&#xD;
&#xD;
          6. Age &lt; 18 years&#xD;
&#xD;
          7. Pregnant women or women trying to become pregnant&#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>Johannes Eksteen, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aspen Woods Clinic</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Douglas Adler, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Utah Hospital and Clinic</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lars Aabakken, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rikshospitalet Oslo University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Cyriel Ponsioen, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sooraj Tejaswi, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sutter Davis Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Christopher Bowlus, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UC Davis Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sutter Davis Hospital</name>
      <address>
        <city>Davis</city>
        <state>California</state>
        <zip>95616</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UC Davis Health</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah Hospital and Clinic</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aspen Woods Clinic</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T3H 0V5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Academic Medical Center</name>
      <address>
        <city>Amsterdam-Zuidoost</city>
        <zip>1105 AZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rikshospitalet University Hospital</name>
      <address>
        <city>Oslo</city>
        <zip>0372</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Netherlands</country>
    <country>Norway</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Finland</country>
    <country>Sweden</country>
  </removed_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>November 8, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>January 20, 2023</last_update_submitted>
  <last_update_submitted_qc>January 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>per oral cholangioscopy</keyword>
  <keyword>PSC</keyword>
  <keyword>cholangiocarcinoma</keyword>
  <keyword>primary sclerosing cholangitis</keyword>
  <keyword>ERCP</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholangitis</mesh_term>
    <mesh_term>Cholangitis, Sclerosing</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/NCT03766035
org study id: E7136
nct id: NCT03766035
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
To demonstrate the clinical utility of the addition of per oral cholangioscopy (POCS) to
      standard endoscopic retrograde cholangiopancreatography (ERCP) with brushing cytology for
      diagnosis and early detection of cholangiocarcinoma in patients diagnosed with primary
      sclerosing cholangitis (PSC).
The primary objective of this study is to demonstrate the clinical utility of the addition of
      per oral cholangioscopy (POCS) to standard ERCP with brushing cytology for diagnosis and
      early detection of cholangiocarcinoma in patients diagnosed with primary sclerosing
      cholangitis (PSC).
observational model: Cohort
time perspective: Prospective
measure: Diagnostic Accuracy of POCS visualization for Early Detection of Cholangiocarcinoma
time frame: 12 months
description: Diagnostic accuracy of POCS visualization for cholangiocarcinoma evaluated clinically at 12 months after initial POCS procedure by clinical presentation.
measure: POCS-guided Biopsy for Early Detection of Cholangiocarcinoma
time frame: 12 months
description: Diagnostic accuracy for POCS-guided Biopsy for cholangiocarcinoma evaluated on pathology at 12 months after initial POCS procedure.
measure: Technical Success - Ability to advance the scope.
time frame: Baseline
description: Ability to advance the cholangioscope to the target stricture, ability to visualize the stricture and ability to obtain a tissue sample with Spy Bite where applicable.
measure: Rate of Adverse Events
time frame: From index through study completion, an average of one year
description: Serious adverse events from initial POCS procedure until end of follow-up.
measure: Proportion of patients identified for repeat procedure.
time frame: During index procedure
description: Proportion of patients identified for repeat procedure considering the addition of Spy Glass DS visualization and Spy Bite biopsy at Index compared to the proportion identified for repeat procedure without consideration of Spy Glass DS visualization and Spy Bite biopsy at Index.
measure: Correspondence of Biopsies
time frame: From index through study completion, an average of one year
description: Correlation between histopathology of Spy Bite biopsies collected during the initial POCS procedure and final diagnosis.
arm group label: Consented, enrolled PSC patients undergoing ERCP + SpyGlass
description: Patients with PSC who have been consented and enrolled in the study will undergo ERCP with the addition of SpyGlass as indicated by their treating physician.
intervention type: Device
intervention name: SpyGlass DS I - II
description: The SpyScope™ DS Access and Delivery Catheter (SpyScope™ DS Catheter) is a sterile, single-use endoscope that enables access and delivery of accessories to targeted pancreaticobiliary anatomy and displays live video when connected to a Spy Glass DS Digital Controller.
arm group label: Consented, enrolled PSC patients undergoing ERCP + SpyGlass
Serum collection
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Johannes Eksteen, MD, PhD
role: Principal Investigator
affiliation: Aspen Woods Clinic
last name: Douglas Adler, MD
role: Principal Investigator
affiliation: University of Utah Hospital and Clinic
last name: Lars Aabakken, MD, PhD
role: Principal Investigator
affiliation: Rikshospitalet Oslo University Hospital
last name: Cyriel Ponsioen, MD, PhD
role: Principal Investigator
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
last name: Sooraj Tejaswi, MD, PhD
role: Principal Investigator
affiliation: Sutter Davis Hospital
last name: Christopher Bowlus, MD, PhD
role: Principal Investigator
affiliation: UC Davis Health
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
country: Netherlands
country: Norway
country: United States
country: Finland
country: Sweden
responsible party type: Sponsor
mesh term: Cholangitis
mesh term: Cholangitis, Sclerosing