xml: <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/NCT06042205</url>
    </required_header>
    <id_info>
      <org_study_id>PF00006-CLPR-002</org_study_id>
      <nct_id>NCT06042205</nct_id>
    </id_info>
    <brief_title>TISSIUM™ Adhesive Hernia Repair System (TAHRS) Pilot Study</brief_title>
    <official_title>ALPHA: A Pilot Study to Evaluate the Initial Safety and Performance of the TISSIUM™ Adhesive Hernia Repair System (TAHRS) for Atraumatic Laparoscopic Hernia Repair</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tissium</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tissium</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>
        The purpose of this study is to capture preliminary clinical safety and performance on the&#xD;
        TAHRS&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 4, 2023</start_date>
    <completion_date type="Anticipated">December 27, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 27, 2024</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>Serious Adverse Device Effect (SADEs)</measure>
      <time_frame>through 12 months post-surgery</time_frame>
      <description>Cumulative incidence of complications (CIC) related to the TAHRS including:&#xD;
  Infection, Chronic pain, Recurrence of hernia, Impaired/delayed healing at the surgical site(s), Allergic reaction/hypersensitivity reaction,</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Rate of hernia recurrence through 12 months post- surgery</measure>
      <time_frame>through 12 months post-surgery</time_frame>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">12</enrollment>
    <condition>Hernia</condition>
    <arm_group>
      <arm_group_label>Hernia repair</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>There is no comparator for this study. All patients are in the treatment allocated group for hernia repair with TISSIUM™ Adhesive Hernia Repair System (TAHRS)</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>TISSIUM™ Adhesive Hernia Repair System (TAHRS)</intervention_name>
      <description>The TAHRS is intended for fixation of prosthetic material to soft tissue</description>
      <arm_group_label>Hernia repair</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Key Inclusion Criteria:&#xD;
  &#xD;
            1. Subject is 18 years old or older;&#xD;
  &#xD;
            2. Patient willing and able to provide a signed Patient Informed Consent Form;&#xD;
  &#xD;
            3. Has a midline primary ventral, umbilical or incisional hernia;&#xD;
  &#xD;
            4. Scheduled for a laparoscopic IPOM hernia repair;&#xD;
  &#xD;
            5. Hernia can be successfully repaired with at least a 5 cm overlap of the mesh on all&#xD;
               sides of the defect&#xD;
  &#xD;
          Key Exclusion Criteria:&#xD;
  &#xD;
            1. Patient has a known or suspected hypersensitivity to the constituent polymer of the&#xD;
               investigational device, mesh, or other surgical products (e.g., sutures);&#xD;
  &#xD;
            2. BMI &gt; 35;&#xD;
  &#xD;
            3. Patient is a current smoker, defined as self-reporting smoking more than 1 cigarette&#xD;
               per day;&#xD;
  &#xD;
            4. Patient is taking systemic immunosuppressive medications, systemic steroids, or&#xD;
               chemotherapy at the time of informed consent;&#xD;
  &#xD;
            5. Patient is pregnant, plans to become pregnant during the study period, or is&#xD;
               breastfeeding;&#xD;
  &#xD;
            6. Patient with Type 1 or uncontrolled Type 2 Diabetes Mellitus;&#xD;
  &#xD;
            7. Patient has more than one hernia defect (to be confirmed intraoperatively);&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Sr. Manager, Clinical Affairs</last_name>
      <phone>+1 603-630-2241</phone>
      <email>ntrinward@tissium.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Imelda Hospital</name>
        <address>
          <city>Bonheiden</city>
          <country>Belgium</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Tollens</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>AZ Sint-Jan</name>
        <address>
          <city>Ruddershove</city>
          <country>Belgium</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Cauwenberge</last_name>
      </contact>
      <investigator>
        <last_name>Van Cauwenberge</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Belgium</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</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>Hernia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06042205
  org study id: PF00006-CLPR-002
  nct id: NCT06042205
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The purpose of this study is to capture preliminary clinical safety and performance on the
        TAHRS
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Serious Adverse Device Effect (SADEs)
  time frame: through 12 months post-surgery
  description: Cumulative incidence of complications (CIC) related to the TAHRS including:
  Infection, Chronic pain, Recurrence of hernia, Impaired/delayed healing at the surgical site(s), Allergic reaction/hypersensitivity reaction,
  measure: Rate of hernia recurrence through 12 months post- surgery
  time frame: through 12 months post-surgery
  arm group label: Hernia repair
  arm group type: Experimental
  description: There is no comparator for this study. All patients are in the treatment allocated group for hernia repair with TISSIUM™ Adhesive Hernia Repair System (TAHRS)
  intervention type: Device
  intervention name: TISSIUM™ Adhesive Hernia Repair System (TAHRS)
  description: The TAHRS is intended for fixation of prosthetic material to soft tissue
  arm group label: Hernia repair
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Sr. Manager, Clinical Affairs
  phone: +1 603-630-2241
  email: ntrinward@tissium.com
  facility: 
  status: Recruiting
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Belgium
  responsible party type: Sponsor
  mesh term: Hernia
  sharing ipd: No