<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/NCT02238743</url>
  </required_header>
  <id_info>
    <org_study_id>Project ADOPT- UM</org_study_id>
    <nct_id>NCT02238743</nct_id>
  </id_info>
  <brief_title>Assuring and Defining Outcomes Through Procedural Training Using a Proctorship Model That Collects Patient Outcomes A Single-Arm, Case-Series to Determine the Feasibility of Safe Skills Transfer for Laparoscopic Ventral Hernia Repair Utilizing a Hands-On Proctorship Model.</brief_title>
  <acronym>ADOPT</acronym>
  <official_title>A Single-Arm, Case-Series to Determine the Feasibility of Safe Skills Transfer for Laparoscopic Ventral Hernia Repair Utilizing a Hands-On Proctorship Model.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medtronic - MITG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medtronic - MITG</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the Project ADOPT- Ventral Hernia case-series is to collect clinical outcome&#xD;
      data following the completion of a hands-on proctorship training model in laparoscopic&#xD;
      ventral hernia repair.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The ADOPT- Ventral Hernia project is designed as a prospective, single arm, case series. The&#xD;
      proctor will select a limited number of licensed surgeon trainees (up to 5) as agreed upon by&#xD;
      Covidien and the proctor. The proctor will then train through clinical immersions, hands on&#xD;
      proctorship and video training for proper technique on minimally invasive surgical (MIS)&#xD;
      repair of ventral hernia. After the training, the data will be collected on the trainee's&#xD;
      next 10 MIS ventral hernia repair cases, pending subject consent to collect data. Procedural&#xD;
      and Post-Operative details will be captured for each of these subjects who have undergone the&#xD;
      laparoscopic ventral hernia repair.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of complications during independent cases post proctorship</measure>
    <time_frame>up to 30 days</time_frame>
    <description>collect clinical outcome data following the completion of a hands-on proctorship training model in laparoscopic ventral hernia repair</description>
  </primary_outcome>
  <enrollment type="Actual">10</enrollment>
  <condition>Hernia</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Determined by surgeon&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Determined by surgeon's standard of care&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Determined by surgeon's standard of care&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jonathan Pearl</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Maryland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Maryland</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>August 21, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>July 25, 2016</last_update_submitted>
  <last_update_submitted_qc>July 25, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 26, 2016</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>
  </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/NCT02238743
org study id: Project ADOPT- UM
nct id: NCT02238743
lead sponsor: 
has dmc: No
The objective of the Project ADOPT- Ventral Hernia case-series is to collect clinical outcome
      data following the completion of a hands-on proctorship training model in laparoscopic
      ventral hernia repair.
The ADOPT- Ventral Hernia project is designed as a prospective, single arm, case series. The
      proctor will select a limited number of licensed surgeon trainees (up to 5) as agreed upon by
      Covidien and the proctor. The proctor will then train through clinical immersions, hands on
      proctorship and video training for proper technique on minimally invasive surgical (MIS)
      repair of ventral hernia. After the training, the data will be collected on the trainee's
      next 10 MIS ventral hernia repair cases, pending subject consent to collect data. Procedural
      and Post-Operative details will be captured for each of these subjects who have undergone the
      laparoscopic ventral hernia repair.
observational model: Case-Only
time perspective: Prospective
measure: Number of complications during independent cases post proctorship
time frame: up to 30 days
description: collect clinical outcome data following the completion of a hands-on proctorship training model in laparoscopic ventral hernia repair
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Jonathan Pearl
role: Principal Investigator
affiliation: University of Maryland
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hernia
mesh term: Hernia, Ventral