<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/NCT03776825</url>
  </required_header>
  <id_info>
    <org_study_id>2134</org_study_id>
    <nct_id>NCT03776825</nct_id>
  </id_info>
  <brief_title>Permacol Paste in Perianal Crohn's Disease</brief_title>
  <acronym>UPpCro</acronym>
  <official_title>Use of Permacol Paste in Perianal Crohn's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istituto Clinico Humanitas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medtronic</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </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>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to collect data about the efficacy of Permacol Paste treatment&#xD;
      in perianal Crohn's Disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an observational prospective cohort study aimed to assess the efficacy of Permacol&#xD;
      Paste treatment in perianal Crohn's Disease, by evaluating the healing rate and quality of&#xD;
      life of 20 patients prospectively indicated to Permacol Paste treatment during one year.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 7, 2019</start_date>
  <completion_date type="Anticipated">October 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2021</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>Perianal fistula closure rate</measure>
    <time_frame>12 months</time_frame>
    <description>Complete fistula closure will be defined as absence of spontaneous suppuration or suppuration on applying gentle pressure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patients quality of life</measure>
    <time_frame>12 months</time_frame>
    <description>Quality of life will be assessed using the Inflammatory Bowel Disease Quality of Life (IBDQ). IBDQ is a disease-specific questionnaire included 32 questions. The questions consisted of 4 domains as follows: Bowel symptoms (10 questions), systemic symptoms (5 questions), emotional functioning (12 questions), and social functioning (5 questions). Every question score ranged from 1 to 7 which 7 corresponded to the highest level of functioning. Total score ranged from 32 to 224. Higher score showed higher quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients continence</measure>
    <time_frame>12 months</time_frame>
    <description>Continence will be assessed by means of the Cleveland Clinic Incontinence Score (CCIS, or Wexner scale). This scoring system cross-tabulates frequencies and different anal incontinence presentations (Gas/Liquid/Solid/Pad use/Need for lifestyle alterations) and sums the returned score to a total of 0-20 (where 0 = perfect continence and 20 = complete incontinence).</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Crohn Disease</condition>
  <condition>Perianal Fistula</condition>
  <arm_group>
    <arm_group_label>Perianal Crohn's Disease</arm_group_label>
    <description>Permacol Paste injection</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Permacol Paste</intervention_name>
    <description>Permacol Paste Injection</description>
    <arm_group_label>Perianal Crohn's Disease</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Perianal Crohn's Disease Patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18, any sex&#xD;
&#xD;
          -  Diagnosis of CD at least 6 months earlier in accordance with clinical, endoscopic,&#xD;
             histological an/or radiological criteria&#xD;
&#xD;
          -  Presence of perianal fistulas with maximum 3 external openings and a maximum of 2&#xD;
             internal openings, assessed by physical examination and MRI&#xD;
&#xD;
          -  Non-active or mildly active luminal CD defined by a CDAI &lt; 220&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  CDAI &gt; 220&#xD;
&#xD;
          -  Dominant luminal active CD requiring immediate surgical or medical therapy&#xD;
&#xD;
          -  Fistula with &gt; 3 external openings and &gt; 2 internal openings&#xD;
&#xD;
          -  Severe active proctitis and/or rectal stenosis&#xD;
&#xD;
          -  Abscess or pelvic collection &gt; 2 cm diameter&#xD;
&#xD;
          -  Concomitant rectovaginal fistulas&#xD;
&#xD;
          -  Concomitant steroid treatment or treated with steroids in the last 4 weeks&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Antonino Spinelli, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Istituto Clinico Humanitas</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Francesca Di Candido, MD</last_name>
    <phone>+390282247776</phone>
    <email>francesca.di_candido@humanitas.it</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Annalisa Maroli, PhD</last_name>
    <phone>+390282247776</phone>
    <email>annalisa.maroli@humanitas.it</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Istituto Clinico Humanitas</name>
      <address>
        <city>Rozzano</city>
        <state>MI</state>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Francesca Di Candido, MD</last_name>
      <phone>0282247776</phone>
      <email>francesca.di_candido@humanitas.it</email>
    </contact>
    <contact_backup>
      <last_name>Annalisa Maroli, PhD</last_name>
      <phone>+390282247776</phone>
      <email>annalisa.maroli@humanitas.it</email>
    </contact_backup>
    <investigator>
      <last_name>Antonino Spinelli, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>June 8, 2018</study_first_submitted>
  <study_first_submitted_qc>December 14, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>February 2, 2021</last_update_submitted>
  <last_update_submitted_qc>February 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 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>Crohn Disease</mesh_term>
    <mesh_term>Fistula</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/NCT03776825
org study id: 2134
nct id: NCT03776825
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of this study is to collect data about the efficacy of Permacol Paste treatment
      in perianal Crohn's Disease.
This is an observational prospective cohort study aimed to assess the efficacy of Permacol
      Paste treatment in perianal Crohn's Disease, by evaluating the healing rate and quality of
      life of 20 patients prospectively indicated to Permacol Paste treatment during one year.
observational model: Cohort
time perspective: Prospective
measure: Perianal fistula closure rate
time frame: 12 months
description: Complete fistula closure will be defined as absence of spontaneous suppuration or suppuration on applying gentle pressure
measure: Patients quality of life
time frame: 12 months
description: Quality of life will be assessed using the Inflammatory Bowel Disease Quality of Life (IBDQ). IBDQ is a disease-specific questionnaire included 32 questions. The questions consisted of 4 domains as follows: Bowel symptoms (10 questions), systemic symptoms (5 questions), emotional functioning (12 questions), and social functioning (5 questions). Every question score ranged from 1 to 7 which 7 corresponded to the highest level of functioning. Total score ranged from 32 to 224. Higher score showed higher quality of life.
measure: Patients continence
time frame: 12 months
description: Continence will be assessed by means of the Cleveland Clinic Incontinence Score (CCIS, or Wexner scale). This scoring system cross-tabulates frequencies and different anal incontinence presentations (Gas/Liquid/Solid/Pad use/Need for lifestyle alterations) and sums the returned score to a total of 0-20 (where 0 = perfect continence and 20 = complete incontinence).
arm group label: Perianal Crohn's Disease
description: Permacol Paste injection
intervention type: Device
intervention name: Permacol Paste
description: Permacol Paste Injection
arm group label: Perianal Crohn's Disease
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Antonino Spinelli, MD, PhD
role: Principal Investigator
affiliation: Istituto Clinico Humanitas
last name: Francesca Di Candido, MD
phone: +390282247776
email: francesca.di_candido@humanitas.it
last name: Annalisa Maroli, PhD
phone: +390282247776
email: annalisa.maroli@humanitas.it
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Italy
responsible party type: Sponsor
mesh term: Crohn Disease
mesh term: Fistula
sharing ipd: No