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/NCT06034652</url>
    </required_header>
    <id_info>
      <org_study_id>T-GENVIH-003</org_study_id>
      <nct_id>NCT06034652</nct_id>
    </id_info>
    <brief_title>T-GENVIH-003 LTFU (Long Term Follow Up) Study</brief_title>
    <official_title>A Prospective Analysis of the Use of Gentrix® Surgical Matrix for Soft Tissue Reinforcement in Ventral Hernia Repair as Long Term Follow Up to T-GENVIH-002 Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Integra LifeSciences Corporation</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Integra LifeSciences 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>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The T-GENVIH-003 study will collect additional, longer term performance data of Gentrix®&#xD;
        Surgical Matrix used for reinforcement of ventral hernia repairs from a subset population&#xD;
        (i.e., the twenty-one minimally invasive surgical approach cases) from the prior T-GENVIH-002&#xD;
        study.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The purpose of this study is to collect additional safety data and demonstrate the&#xD;
        performance of Integra Gentrix® Surgical Matrix for reinforcement of ventral hernia repairs&#xD;
        from a sub-population of twenty-one participants from the previous T-GENVIH-002 study,&#xD;
        specifically those with laparoscopic or robotic repair. Prospective data will be collected&#xD;
        via a one-off study follow-up visit and assessed for later post-operative surgical site&#xD;
        events and complications in the post-operative period from the last timepoint of data&#xD;
        collection in T-GENVIH-002 to present.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 12, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</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>Clinically Confirmed Recurrence</measure>
      <time_frame>1 year to present</time_frame>
      <description>1. Incidence of clinically confirmed recurrence of the primary hernia to date, including not previously reported in T-GENVIH-002 study.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Self-Reported Recurrence</measure>
      <time_frame>1 year to present</time_frame>
      <description>Incidence of self-reported recurrence (i.e., bulge) of the primary hernia to date, including not previously reported in T-GENVIH-002 study.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of Surgical Site Occurrences requiring Procedural Intervention (SSOPI)</measure>
      <time_frame>1 year to present</time_frame>
      <description>Incidence of Surgical Site Occurrences requiring Procedural Intervention (SSOPI) of the primary hernia repair to date, including not previously reported in T-GENVIH-002.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of Surgical Site Occurrences (SSOs)</measure>
      <time_frame>1 year to present</time_frame>
      <description>Incidence of Surgical Site Occurrences (SSOs) of the primary hernia repair to date (seroma, abscess, dehiscence, hematoma, wound necrosis, ileus, fistula, delayed wound healing), including not previously reported in T-GENVIH-002 study.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of Surgical Site Infections (SSIs)</measure>
      <time_frame>1 year to present</time_frame>
      <description>Incidence of Surgical Site Infections (SSIs) post primary hernia repair to date, including not previously reported in T-GENVIH-002 study.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">21</enrollment>
    <condition>Hernia</condition>
    <condition>Hernia, Ventral</condition>
    <condition>Pathological Conditions, Anatomical</condition>
    <condition>Hernia, Abdominal</condition>
    <arm_group>
      <arm_group_label>Prospective Analysis of Minimally Invasive Surgical Approach (i.e., laparoscopic or robotic)</arm_group_label>
      <description>Collection of performance data for twenty-one subjects having prior minimally invasive surgical approach for ventral hernia repair (i.e., laparoscopic or robotic) from the previous T-GENVIH-002 study last data collection time-point (1-yr post-op) to present (prospective analysis), not previously reported.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Integra® Gentrix® Surgical Matrix</intervention_name>
      <description>Integra® Gentrix® Surgical Matrix is intended for implantation to reinforce soft tissue where weakness exists in patients requiring gastroenterological or plastic &amp; reconstructive surgery.</description>
      <arm_group_label>Prospective Analysis of Minimally Invasive Surgical Approach (i.e., laparoscopic or robotic)</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Subjects from the sub-population of minimally invasive surgical approach (e.g.,&#xD;
          laparoscopic or robotic) ventral hernia repair of the prior T-GENVIH-002 study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient was a subject in the T-GENVIH-002 study and underwent minimally invasive&#xD;
               (i.e., laparoscopic or robotic) abdominal wall reconstruction for a primary hernia&#xD;
               using Integra® Gentrix® Surgical Matrix.&#xD;
  &#xD;
            -  Subject has participated in the informed consent process and signed a study-specific&#xD;
               informed consent document.&#xD;
  &#xD;
            -  Subject is fluent in US English or US Spanish language.&#xD;
  &#xD;
            -  Subject is willing to complete an e-consent and phone or in-office visit.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Not applicable.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>22 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Adam Young, PhD PMP</last_name>
      <role>Study Director</role>
      <affiliation>Integra LifeSciences Corporation</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Karen Bartku</last_name>
      <phone>727.899.0990</phone>
      <email>karen.bartku@integralife.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Andrew Tummon</last_name>
      <phone>609.936.5490</phone>
      <email>andrew.tummon@integralife.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Surgical Healing Arts</name>
        <address>
          <city>Fort Myers</city>
          <state>Florida</state>
          <zip>33912</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Alfredo Mier y Leon</last_name>
        <phone>239-344-9876</phone>
        <email>alfredo@surgicalhealingarts.com</email>
      </contact>
      <contact_backup>
        <last_name>Kelsey Vest</last_name>
        <phone>239.344.9786</phone>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 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>
      <mesh_term>Hernia, Ventral</mesh_term>
      <mesh_term>Pathological Conditions, Anatomical</mesh_term>
      <mesh_term>Hernia, Abdominal</mesh_term>
      <mesh_term>Internal 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/NCT06034652
  org study id: T-GENVIH-003
  nct id: NCT06034652
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  The T-GENVIH-003 study will collect additional, longer term performance data of Gentrix®
        Surgical Matrix used for reinforcement of ventral hernia repairs from a subset population
        (i.e., the twenty-one minimally invasive surgical approach cases) from the prior T-GENVIH-002
        study.
  The purpose of this study is to collect additional safety data and demonstrate the
        performance of Integra Gentrix® Surgical Matrix for reinforcement of ventral hernia repairs
        from a sub-population of twenty-one participants from the previous T-GENVIH-002 study,
        specifically those with laparoscopic or robotic repair. Prospective data will be collected
        via a one-off study follow-up visit and assessed for later post-operative surgical site
        events and complications in the post-operative period from the last timepoint of data
        collection in T-GENVIH-002 to present.
  observational model: Cohort
  time perspective: Prospective
  measure: Clinically Confirmed Recurrence
  time frame: 1 year to present
  description: 1. Incidence of clinically confirmed recurrence of the primary hernia to date, including not previously reported in T-GENVIH-002 study.
  measure: Self-Reported Recurrence
  time frame: 1 year to present
  description: Incidence of self-reported recurrence (i.e., bulge) of the primary hernia to date, including not previously reported in T-GENVIH-002 study.
  measure: Incidence of Surgical Site Occurrences requiring Procedural Intervention (SSOPI)
  time frame: 1 year to present
  description: Incidence of Surgical Site Occurrences requiring Procedural Intervention (SSOPI) of the primary hernia repair to date, including not previously reported in T-GENVIH-002.
  measure: Incidence of Surgical Site Occurrences (SSOs)
  time frame: 1 year to present
  description: Incidence of Surgical Site Occurrences (SSOs) of the primary hernia repair to date (seroma, abscess, dehiscence, hematoma, wound necrosis, ileus, fistula, delayed wound healing), including not previously reported in T-GENVIH-002 study.
  measure: Incidence of Surgical Site Infections (SSIs)
  time frame: 1 year to present
  description: Incidence of Surgical Site Infections (SSIs) post primary hernia repair to date, including not previously reported in T-GENVIH-002 study.
  arm group label: Prospective Analysis of Minimally Invasive Surgical Approach (i.e., laparoscopic or robotic)
  description: Collection of performance data for twenty-one subjects having prior minimally invasive surgical approach for ventral hernia repair (i.e., laparoscopic or robotic) from the previous T-GENVIH-002 study last data collection time-point (1-yr post-op) to present (prospective analysis), not previously reported.
  intervention type: Device
  intervention name: Integra® Gentrix® Surgical Matrix
  description: Integra® Gentrix® Surgical Matrix is intended for implantation to reinforce soft tissue where weakness exists in patients requiring gastroenterological or plastic & reconstructive surgery.
  arm group label: Prospective Analysis of Minimally Invasive Surgical Approach (i.e., laparoscopic or robotic)
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 22 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Adam Young, PhD PMP
  role: Study Director
  affiliation: Integra LifeSciences Corporation
  last name: Karen Bartku
  phone: 727.899.0990
  email: karen.bartku@integralife.com
  last name: Andrew Tummon
  phone: 609.936.5490
  email: andrew.tummon@integralife.com
  facility: 
  contact: 
  contact backup: 
  country: United States
  responsible party type: Sponsor
  mesh term: Hernia
  mesh term: Hernia, Ventral
  mesh term: Pathological Conditions, Anatomical
  mesh term: Hernia, Abdominal
  mesh term: Internal Hernia
  sharing ipd: No