<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/NCT03234855</url>
  </required_header>
  <id_info>
    <org_study_id>LMD-1</org_study_id>
    <nct_id>NCT03234855</nct_id>
  </id_info>
  <brief_title>Laparoscopic Measuring Device Study</brief_title>
  <acronym>LMD-1</acronym>
  <official_title>Laparoscopic Measuring Device Usability Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Labs LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Labs LLC</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>
      This study is gathering opinions from surgeons on the usability of our laparoscopic measuring&#xD;
      device.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In June of 2016, SAGES (Society of American Gastrointestinal and Endoscopic Surgeons) issued&#xD;
      a recommendation stating that:&#xD;
&#xD;
      &quot;Surgeons should measure and document the size of the hernia defect they are repairing. The&#xD;
      total area encompassing all the defects should be measured, and surgeons should be familiar&#xD;
      with internal and external measurement techniques for all hernia locations, as well as how to&#xD;
      avoid common measurement errors.&quot;&#xD;
&#xD;
      An incorrect mesh size can have detrimental consequences to the effectiveness of the mesh.&#xD;
      According to the SAGES recommendation:&#xD;
&#xD;
      &quot;Overestimating the defect size will result in the choice of a larger prosthetic size, which&#xD;
      may be more difficult to handle and may have more laxity, allowing it to bulge into the&#xD;
      defect more than if it was placed taut. The difficulty in prosthetic handling may also lead&#xD;
      to errors in fixation, and the prosthetic can more easily sway between fixation points, due&#xD;
      to the larger dimensions.&quot;&#xD;
&#xD;
      While a smaller mesh size can also be problematic:&#xD;
&#xD;
      &quot;Underestimating the defect size may lead to choosing a prosthetic that is too small, thus&#xD;
      increasing the risk of hernia recurrence.&quot; In order to aid surgeons in more accurately&#xD;
      measuring hernia defects, Boehringer Labs LLC has developed a laparoscopic surgical measuring&#xD;
      device. This study aims to obtain feedback from surgeons on the usefulness and design of the&#xD;
      device.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 15, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2017</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Physician Feedback</measure>
    <time_frame>6 months</time_frame>
    <description>Physician forms opinion on usefulness and design of LMD</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Physician Feedback</condition>
  <arm_group>
    <arm_group_label>LMD</arm_group_label>
    <description>Physician uses LMD during procedure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>LMD</intervention_name>
    <description>Physician uses LMD to measure defect during procedure.</description>
    <arm_group_label>LMD</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients whose physician has already decided that laparoscopic hernia repair surgery is the&#xD;
        best route of treatment for a hernia defect.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients with hernia defect that requires laparoscopic measurement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Minors&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Allen A Orr, BS</last_name>
    <phone>484-931-2314</phone>
    <email>aorr@boehringerlabs.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kevin Klocek</last_name>
    <email>kklocek@boehringerlabs.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Bryn Mawr Hospital</name>
      <address>
        <city>Bryn Mawr</city>
        <state>Pennsylvania</state>
        <zip>19010</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Jennifer Denne, MD</last_name>
      <phone>610-527-1185</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Temple University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19140</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Tatyan Clarke, MD</last_name>
      <phone>215-707-2000</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19140</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Ian Soriano, MD</last_name>
      <phone>215-707-8269</phone>
    </contact>
    <contact_backup>
      <last_name>David Wernsing, MD</last_name>
      <phone>215-829-8455</phone>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2017</study_first_posted>
  <last_update_submitted>July 27, 2017</last_update_submitted>
  <last_update_submitted_qc>July 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No patient data will be collected</ipd_description>
  </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/NCT03234855
org study id: LMD-1
nct id: NCT03234855
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This study is gathering opinions from surgeons on the usability of our laparoscopic measuring
      device.
In June of 2016, SAGES (Society of American Gastrointestinal and Endoscopic Surgeons) issued
      a recommendation stating that:

      "Surgeons should measure and document the size of the hernia defect they are repairing. The
      total area encompassing all the defects should be measured, and surgeons should be familiar
      with internal and external measurement techniques for all hernia locations, as well as how to
      avoid common measurement errors."

      An incorrect mesh size can have detrimental consequences to the effectiveness of the mesh.
      According to the SAGES recommendation:

      "Overestimating the defect size will result in the choice of a larger prosthetic size, which
      may be more difficult to handle and may have more laxity, allowing it to bulge into the
      defect more than if it was placed taut. The difficulty in prosthetic handling may also lead
      to errors in fixation, and the prosthetic can more easily sway between fixation points, due
      to the larger dimensions."

      While a smaller mesh size can also be problematic:

      "Underestimating the defect size may lead to choosing a prosthetic that is too small, thus
      increasing the risk of hernia recurrence." In order to aid surgeons in more accurately
      measuring hernia defects, Boehringer Labs LLC has developed a laparoscopic surgical measuring
      device. This study aims to obtain feedback from surgeons on the usefulness and design of the
      device.
observational model: Other
time perspective: Prospective
measure: Physician Feedback
time frame: 6 months
description: Physician forms opinion on usefulness and design of LMD
arm group label: LMD
description: Physician uses LMD during procedure.
intervention type: Device
intervention name: LMD
description: Physician uses LMD to measure defect during procedure.
arm group label: LMD
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Allen A Orr, BS
phone: 484-931-2314
email: aorr@boehringerlabs.com
last name: Kevin Klocek
email: kklocek@boehringerlabs.com
facility: 
contact: 
facility: 
contact: 
facility: 
contact: 
contact backup: 
country: United States
responsible party type: Sponsor
sharing ipd: No
ipd description: No patient data will be collected