<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/NCT02262884</url>
  </required_header>
  <id_info>
    <org_study_id>PRT DD112313</org_study_id>
    <nct_id>NCT02262884</nct_id>
  </id_info>
  <brief_title>SurgiQuest AirSeal in Robotic Partial Nephrectomy - (TARPAN Study)</brief_title>
  <acronym>TARPAN</acronym>
  <official_title>A Physician Preference Study of the Use of SurgiQuest AirSeal vs. Conventional Insufflation Systems for the Management of Pneumoperitoneum in Robotic Partial Nephrectomy .</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SurgiQuest, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>SurgiQuest, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A MULTI-CENTER, PROSPECTIVE, RANDOMIZED, CONTROLLED STUDY TO EVALUATE PHYSICIAN PREFERENCE&#xD;
      RELATED TO THE USE OF THE SURGIQUEST AIRSEAL INSUFFLATION SYSTEM (AIS) VS. CONVENTIONAL&#xD;
      INSUFFLATION SYSTEMS (CIS) FOR THE MANAGEMENT OF PNEUMOPERITONEUM DURING ROBOTIC PARTIAL&#xD;
      NEPHRECTOMY&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective, randomized, controlled multi-center clinical Study designed to evaluate&#xD;
      Physician Preference related to the use of the SurgiQuest AirSealTM Insufflation System (AIS)&#xD;
      vs. Conventional Insufflation Systems (CIS) for the Management of pneumoperitoneum during&#xD;
      Robotic Partial Nephrectomy. Subjects will be randomized in a 1:1:1 treatment device to&#xD;
      control ratio into one of three (3) different study arms: 1) AIS @ 12mmHg pressure, 2) AIS @&#xD;
      15mmHg pressure, and 3) CIS @ 15mmHg pressure. 189 randomized subjects distributed in three&#xD;
      arms of 63 patients. The three study sites are targeted to enroll 63 patients each, 21&#xD;
      patients in each of the three (3) study arms. It is expected that this will take up to 6&#xD;
      months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">March 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of insufflation device related subcutaneous emphysema (SCE) at 2 hours</measure>
    <time_frame>2 hours post procedure</time_frame>
    <description>Rate of insufflation device related subcutaneous emphysema(SCE)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of insufflation device related subcutaneous emphysema (SCE) at 4 hours</measure>
    <time_frame>4 hours post procedure</time_frame>
    <description>Rate of insufflation device related subcutaneous emphysema(SCE)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of insufflation device related subcutaneous emphysema (SCE) at 8 hours</measure>
    <time_frame>8 hours post procedure</time_frame>
    <description>Rate of insufflation device related subcutaneous emphysema(SCE)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of insufflation device related subcutaneous emphysema (SCE) at 12 hours</measure>
    <time_frame>12 hours post procedure</time_frame>
    <description>Rate of insufflation device related subcutaneous emphysema(SCE)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of insufflation device related subcutaneous emphysema (SCE) at 24 hours</measure>
    <time_frame>24 hours post procedure</time_frame>
    <description>Rate of insufflation device related subcutaneous emphysema(SCE)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) required pain medication, measured with Visual Analogue Scale (VAS)</measure>
    <time_frame>2, hours post procedure</time_frame>
    <description>Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) measured with Visual Analogue Scale (VAS), required pain medication</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) required pain medication, measured with Visual Analogue Scale (VAS)</measure>
    <time_frame>4 hours post procedure</time_frame>
    <description>Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) measured with Visual Analogue Scale (VAS), required pain medication</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) required pain medication, measured with Visual Analogue Scale (VAS)</measure>
    <time_frame>8 hours post procedure</time_frame>
    <description>Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) measured with Visual Analogue Scale (VAS), required pain medication</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) required pain medication, measured with Visual Analogue Scale (VAS)</measure>
    <time_frame>12 hours post procedure</time_frame>
    <description>Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) measured with Visual Analogue Scale (VAS), required pain medication</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) required pain medication, measured with Visual Analogue Scale (VAS)</measure>
    <time_frame>24 hours post procedure</time_frame>
    <description>Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) measured with Visual Analogue Scale (VAS), required pain medication</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">189</enrollment>
  <condition>Subcutaneous Emphysema</condition>
  <arm_group>
    <arm_group_label>AIS @ 12mmHg pressure</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>SurgiQuest AirSeal Insufflation System (AIS) set at 12mmHg pressure for the management of pneumoperitoneum during Robotic Partial Nephrectomy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AIS @ 15mmHg pressure</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>SurgiQuest AirSeal insufflation System (AIS) set at 15 mmHg pressure for the management of pneumoperitoneum during Robotic Partial Nephrectomy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CIS @ 15mmHg pressure</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Conventional Insufflation System (CIS) set at 15mmHg pressure for the management of pneumoperitoneum during Robotic Partial Nephectomy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SurgiQuest AirSeal Insufflation System (AIS)</intervention_name>
    <description>Comparison between Conventional Insufflation System (CIS) and the SurgiQuest AirSeal Insufflation System (AIS) at similar pressures (15mmHg) and the SurgiQuest AirSeal at 12mmHg.</description>
    <arm_group_label>AIS @ 12mmHg pressure</arm_group_label>
    <arm_group_label>AIS @ 15mmHg pressure</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Conventional Insufflation System (CIS)</intervention_name>
    <description>Comparison between Conventional Insufflation System (CIS) and the SurgiQuest AirSeal Insufflation System (AIS) at similar pressures (15mmHg) and the SurgiQuest AirSeal at 12mmHg.</description>
    <arm_group_label>CIS @ 15mmHg pressure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 18 to 80 years of age;&#xD;
&#xD;
          2. Capable and willing to give informed consent;&#xD;
&#xD;
          3. Acceptable candidate for an elective, non-emergent robotic partial nephrectomy;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subjects will be excluded from participating in this Study if they meet any of the&#xD;
        following criteria prior to initiation of the endoscopic procedure 1.Advanced refusal of&#xD;
        blood transfusion, if necessary; 2.Active systemic or cutaneous infection or inflammation;&#xD;
        3 Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids;&#xD;
        4.Uncontrolled diabetes mellitus 5.Known, significant history of bleeding diathesis,&#xD;
        coagulopathy, von Willebrand's disease or current platelet count &lt; 100,000 cells/mm3,&#xD;
        baseline INR ≥1.8, or fibrinogen level less than 150 mg/dl (if received a fibrinolytic&#xD;
        agent within prior 24 hours); 6.Severe co-existing morbidities having a life expectancy of&#xD;
        less than 30 days; 7.Currently involved in any other investigational clinical Studies;&#xD;
        8.Significant anemia with a hemoglobin level less than 10 g/dL or a hematocrit less than&#xD;
        30%; 9.Females who are pregnant, planning to become pregnant within 3 months of the&#xD;
        procedure, or lactating; 10.Extreme morbid obesity (BMI greater than 45 kg/m2) or&#xD;
        underweight (BMI less than 20 kg/m2); 11. Patients presenting with Ascites&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James Porter, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Swedish Medical Center, Seattle , WA</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>cynthia Harris, BS</last_name>
    <phone>775-392-2970</phone>
    <email>cindy@clinregconsult.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Michael Daniel, BS,MS,MBA</last_name>
    <phone>775-392-2970</phone>
    <email>MADaniel@clinregconsult.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aleksandra Klim, RN MHS CCRC</last_name>
      <phone>314-747-9781</phone>
      <email>klima@wudosis.wustl.edu</email>
    </contact>
    <investigator>
      <last_name>Robert Figenshau, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hackensack University Medical Center</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>cheryl Fittizzi</last_name>
      <phone>551-996-2255</phone>
      <email>CFittizzi@HackensackUMC.org</email>
    </contact>
    <investigator>
      <last_name>Michael Stifelman, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Swedish Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98122</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Heather Algren, RN</last_name>
      <phone>206-386-2820</phone>
      <email>heather.algren@swedish.org</email>
    </contact>
    <contact_backup>
      <last_name>Adel Islam</last_name>
      <phone>(206) 215-6532</phone>
      <email>adel.islam@swedish.org</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>September 30, 2014</study_first_submitted>
  <study_first_submitted_qc>October 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>June 2, 2016</last_update_submitted>
  <last_update_submitted_qc>June 2, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 6, 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>Emphysema</mesh_term>
    <mesh_term>Subcutaneous Emphysema</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/NCT02262884
org study id: PRT DD112313
nct id: NCT02262884
lead sponsor: 
has dmc: No
A MULTI-CENTER, PROSPECTIVE, RANDOMIZED, CONTROLLED STUDY TO EVALUATE PHYSICIAN PREFERENCE
      RELATED TO THE USE OF THE SURGIQUEST AIRSEAL INSUFFLATION SYSTEM (AIS) VS. CONVENTIONAL
      INSUFFLATION SYSTEMS (CIS) FOR THE MANAGEMENT OF PNEUMOPERITONEUM DURING ROBOTIC PARTIAL
      NEPHRECTOMY
A prospective, randomized, controlled multi-center clinical Study designed to evaluate
      Physician Preference related to the use of the SurgiQuest AirSealTM Insufflation System (AIS)
      vs. Conventional Insufflation Systems (CIS) for the Management of pneumoperitoneum during
      Robotic Partial Nephrectomy. Subjects will be randomized in a 1:1:1 treatment device to
      control ratio into one of three (3) different study arms: 1) AIS @ 12mmHg pressure, 2) AIS @
      15mmHg pressure, and 3) CIS @ 15mmHg pressure. 189 randomized subjects distributed in three
      arms of 63 patients. The three study sites are targeted to enroll 63 patients each, 21
      patients in each of the three (3) study arms. It is expected that this will take up to 6
      months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Rate of insufflation device related subcutaneous emphysema (SCE) at 2 hours
time frame: 2 hours post procedure
description: Rate of insufflation device related subcutaneous emphysema(SCE)
measure: Rate of insufflation device related subcutaneous emphysema (SCE) at 4 hours
time frame: 4 hours post procedure
description: Rate of insufflation device related subcutaneous emphysema(SCE)
measure: Rate of insufflation device related subcutaneous emphysema (SCE) at 8 hours
time frame: 8 hours post procedure
description: Rate of insufflation device related subcutaneous emphysema(SCE)
measure: Rate of insufflation device related subcutaneous emphysema (SCE) at 12 hours
time frame: 12 hours post procedure
description: Rate of insufflation device related subcutaneous emphysema(SCE)
measure: Rate of insufflation device related subcutaneous emphysema (SCE) at 24 hours
time frame: 24 hours post procedure
description: Rate of insufflation device related subcutaneous emphysema(SCE)
measure: Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) required pain medication, measured with Visual Analogue Scale (VAS)
time frame: 2, hours post procedure
description: Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) measured with Visual Analogue Scale (VAS), required pain medication
measure: Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) required pain medication, measured with Visual Analogue Scale (VAS)
time frame: 4 hours post procedure
description: Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) measured with Visual Analogue Scale (VAS), required pain medication
measure: Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) required pain medication, measured with Visual Analogue Scale (VAS)
time frame: 8 hours post procedure
description: Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) measured with Visual Analogue Scale (VAS), required pain medication
measure: Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) required pain medication, measured with Visual Analogue Scale (VAS)
time frame: 12 hours post procedure
description: Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) measured with Visual Analogue Scale (VAS), required pain medication
measure: Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) required pain medication, measured with Visual Analogue Scale (VAS)
time frame: 24 hours post procedure
description: Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) measured with Visual Analogue Scale (VAS), required pain medication
arm group label: AIS @ 12mmHg pressure
arm group type: Active Comparator
description: SurgiQuest AirSeal Insufflation System (AIS) set at 12mmHg pressure for the management of pneumoperitoneum during Robotic Partial Nephrectomy.
arm group label: AIS @ 15mmHg pressure
arm group type: Active Comparator
description: SurgiQuest AirSeal insufflation System (AIS) set at 15 mmHg pressure for the management of pneumoperitoneum during Robotic Partial Nephrectomy.
arm group label: CIS @ 15mmHg pressure
arm group type: Active Comparator
description: Conventional Insufflation System (CIS) set at 15mmHg pressure for the management of pneumoperitoneum during Robotic Partial Nephectomy.
intervention type: Device
intervention name: SurgiQuest AirSeal Insufflation System (AIS)
description: Comparison between Conventional Insufflation System (CIS) and the SurgiQuest AirSeal Insufflation System (AIS) at similar pressures (15mmHg) and the SurgiQuest AirSeal at 12mmHg.
arm group label: AIS @ 12mmHg pressure
arm group label: AIS @ 15mmHg pressure
intervention type: Device
intervention name: Conventional Insufflation System (CIS)
description: Comparison between Conventional Insufflation System (CIS) and the SurgiQuest AirSeal Insufflation System (AIS) at similar pressures (15mmHg) and the SurgiQuest AirSeal at 12mmHg.
arm group label: CIS @ 15mmHg pressure
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: James Porter, MD
role: Principal Investigator
affiliation: Swedish Medical Center, Seattle , WA
last name: cynthia Harris, BS
phone: 775-392-2970
email: cindy@clinregconsult.com
last name: Michael Daniel, BS,MS,MBA
phone: 775-392-2970
email: MADaniel@clinregconsult.com
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Sponsor
mesh term: Emphysema
mesh term: Subcutaneous Emphysema