<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/NCT03239405</url>
  </required_header>
  <id_info>
    <org_study_id>VIS-1</org_study_id>
    <nct_id>NCT03239405</nct_id>
  </id_info>
  <brief_title>Comparing the Cost Savings Potential of Orogastric Tubes in Laparoscopic Sleeve Gastrectomy</brief_title>
  <acronym>VS1</acronym>
  <official_title>Comparing the Cost Savings Potential of Orogastric Tubes in Laparoscopic Sleeve Gastrectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Labs LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Rochester General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </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>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Comparing the operation times and staple loads used between the use of multiple tubes and a&#xD;
      bougie versus a one-step suction callibrated system in laparoscopic sleeve gastrectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study we are comparing the cost/savings of using a bougie with a one-step suction&#xD;
      callibrated system in laparoscopic sleeve gastrectomy. We will be looking at OR time and&#xD;
      staple usage. This study is not affecting the treatment of the patients in any way. The&#xD;
      surgeons would be using the devices regardless of the study. We are simply looking at&#xD;
      procedure information after the fact.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">April 1, 2017</start_date>
  <completion_date type="Anticipated">December 1, 2017</completion_date>
  <primary_completion_date type="Anticipated">December 1, 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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Staples Used</measure>
    <time_frame>4 hours for the end of surgery</time_frame>
    <description>Number of staple loads needed to close stomach</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Operation time</measure>
    <time_frame>4 hours for the end of surgery</time_frame>
    <description>Total operation time</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Surgical Procedure, Unspecified</condition>
  <arm_group>
    <arm_group_label>SCS</arm_group_label>
    <description>Treated via suction callibrated system</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bougie</arm_group_label>
    <description>Treated with multiple tubes &amp; bougie</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Suction callibrated system</intervention_name>
    <description>One-step suction callibrated SG system</description>
    <arm_group_label>SCS</arm_group_label>
    <other_name>Visigi 3D</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Individuals already receiving a laparoscopic sleeve gastrectomy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient and surgeon have both agreed that a sleeve gastrectomy is a procedure that&#xD;
             they want performed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Rochester General</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14621</zip>
        <country>United States</country>
      </address>
    </facility>
  </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>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2017</study_first_posted>
  <last_update_submitted>August 1, 2017</last_update_submitted>
  <last_update_submitted_qc>August 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>laparoscopic</keyword>
  <keyword>sleeve</keyword>
  <keyword>gastrectomy</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Results will be published</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/NCT03239405
org study id: VIS-1
nct id: NCT03239405
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Comparing the operation times and staple loads used between the use of multiple tubes and a
      bougie versus a one-step suction callibrated system in laparoscopic sleeve gastrectomy.
In this study we are comparing the cost/savings of using a bougie with a one-step suction
      callibrated system in laparoscopic sleeve gastrectomy. We will be looking at OR time and
      staple usage. This study is not affecting the treatment of the patients in any way. The
      surgeons would be using the devices regardless of the study. We are simply looking at
      procedure information after the fact.
observational model: Other
time perspective: Other
measure: Staples Used
time frame: 4 hours for the end of surgery
description: Number of staple loads needed to close stomach
measure: Operation time
time frame: 4 hours for the end of surgery
description: Total operation time
arm group label: SCS
description: Treated via suction callibrated system
arm group label: Bougie
description: Treated with multiple tubes & bougie
intervention type: Device
intervention name: Suction callibrated system
description: One-step suction callibrated SG system
arm group label: SCS
other name: Visigi 3D
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No
ipd description: Results will be published