<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/NCT04403022</url>
  </required_header>
  <id_info>
    <org_study_id>dV SP - CR-01</org_study_id>
    <nct_id>NCT04403022</nct_id>
  </id_info>
  <brief_title>da Vinci SP® Investigational Device Exemption Study in Colorectal Procedures</brief_title>
  <official_title>A Prospective, Multi-Center Investigation of the da Vinci SP® Surgical System in Colorectal Procedures for Benign and Malignant Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Intuitive Surgical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Intuitive Surgical</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      To confirm the safety and performance of the da Vinci SP Surgical System, Instruments and&#xD;
      Accessories in a complex colorectal procedure such as low anterior resections or right&#xD;
      colectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary Performance:&#xD;
&#xD;
        -  The primary performance endpoint will be assessed as the ability to complete the planned&#xD;
           da Vinci SP-assisted colorectal procedure without conversion to an alternate approach.&#xD;
           Conversion* to an alternate approach comprises conversion to open, multiport&#xD;
           laparoscopic**, multiport robotic or hand-assisted§ approach requiring undocking of the&#xD;
           da Vinci SP Surgical System in order to complete the planned procedure using the&#xD;
           alternate approach.&#xD;
&#xD;
             -  Performing an extracorporeal anastomosis is not considered a conversion ** Use of&#xD;
                additional assistant laparoscopic port(s) is not considered a conversion §&#xD;
                Laparoscopic or robotic with hand assistance&#xD;
&#xD;
      Primary Safety:&#xD;
&#xD;
      • The primary safety endpoint will be assessed as the incidence of all intraoperative and&#xD;
      post-operative adverse events that occur through the 42-day follow-up period&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 3, 2021</start_date>
  <completion_date type="Anticipated">November 30, 2028</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Performance</measure>
    <time_frame>IntraOperative period</time_frame>
    <description>Performance defined as ability to complete the planned da Vinci SP-assisted colorectal procedure without conversion to an alternate approach.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adverse Events Rates</measure>
    <time_frame>Intraoperative through the 42-day postoperative period</time_frame>
    <description>Safety defined as the incidence of all intraoperative and post-operative adverse events that occur through the 42-day follow-up period</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Colorectal Cancer</condition>
  <condition>Benign or Malignant Rectal or Colon Tumors</condition>
  <arm_group>
    <arm_group_label>Single arm</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Colorectal procedure will be performed by da Vinci SP® Surgical System</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Robotic Assisted Surgery</intervention_name>
    <description>da Vinci SP Surgical System, instruments, and accessories in complex colorectal procedures such as low anterior resection procedure or right colectomy with or without total mesorectal excision</description>
    <arm_group_label>Single arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  BMI ≤ 35&#xD;
&#xD;
          -  Candidate for single-port robotic-assisted surgery for low anterior resection with or&#xD;
             without total mesorectal excision or right colectomy procedures&#xD;
&#xD;
          -  ASA ≤ 3&#xD;
&#xD;
          -  Willing and able to provide a written informed consent document&#xD;
&#xD;
          -  Willing and able to comply with the study protocol requirements including&#xD;
             perioperative follow-up examinations at 14 days, 42 days post operatively, and&#xD;
             post-market long-term follow-up on an annual basis through 5 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinical or radiological evidence of metastatic disease&#xD;
&#xD;
          -  Life expectancy less than 6 months&#xD;
&#xD;
          -  Cancer of the anal canal requiring an abdominoperineal resection&#xD;
&#xD;
          -  Subjects with threatened mesorectal margins (≤1 mm) on MRI or ultrasound (for LAR&#xD;
             ONLY)&#xD;
&#xD;
          -  Subjects with planned major concomitant procedures (eg. hepatectomaies, other&#xD;
             intestinal resections) or emergent case&#xD;
&#xD;
          -  Subjects undergoing both LAR/TME and right colectomy during the same operation&#xD;
&#xD;
          -  Preoperative colonoscopy demonstrating synchronous colorectal cancer&#xD;
&#xD;
          -  History of inflammatory bowel disease&#xD;
&#xD;
          -  Subject has a known bleeding or clotting disorder&#xD;
&#xD;
          -  Uncontrolled illness including, but not limited to ongoing or active infection,&#xD;
             symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or&#xD;
             psychiatric illness/social situations that would limit compliance with study&#xD;
             requirements&#xD;
&#xD;
          -  Subject is contraindicated for general anesthesia or surgery&#xD;
&#xD;
          -  Subject had prior incisional hernia with mesh repair&#xD;
&#xD;
          -  Subject belongs to vulnerable population&#xD;
&#xD;
          -  Subject is pregnant or suspected to be pregnant&#xD;
&#xD;
        Intraoperative Exclusion Criteria:&#xD;
&#xD;
        • Subject presents with adhesions or scarring in the pelvis which in the opinion of the&#xD;
        investigator limits the ability to perform the minimally invasive procedure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kathryn Wine</last_name>
    <role>Study Director</role>
    <affiliation>Medical Affairs Director</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Adventist Health System/Sunbelt</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MountianView Hospital</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allegheny General Hospital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Houston Methodist Research Institute</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MultiCare - Tacoma</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ulsan University Hospital</name>
      <address>
        <city>Ulsan</city>
        <state>Dong-gu</state>
        <zip>25 Daehakbyeongwon-ro</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ewha Womans University College of Medicine</name>
      <address>
        <city>Seoul</city>
        <state>Gangseo-gu</state>
        <zip>Gonghang-daero</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>May 14, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>July 14, 2023</last_update_submitted>
  <last_update_submitted_qc>July 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 18, 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>Colonic Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04403022
org study id: dV SP - CR-01
nct id: NCT04403022
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
To confirm the safety and performance of the da Vinci SP Surgical System, Instruments and
      Accessories in a complex colorectal procedure such as low anterior resections or right
      colectomy.
Primary Performance:

        -  The primary performance endpoint will be assessed as the ability to complete the planned
           da Vinci SP-assisted colorectal procedure without conversion to an alternate approach.
           Conversion* to an alternate approach comprises conversion to open, multiport
           laparoscopic**, multiport robotic or hand-assisted§ approach requiring undocking of the
           da Vinci SP Surgical System in order to complete the planned procedure using the
           alternate approach.

             -  Performing an extracorporeal anastomosis is not considered a conversion ** Use of
                additional assistant laparoscopic port(s) is not considered a conversion §
                Laparoscopic or robotic with hand assistance

      Primary Safety:

      • The primary safety endpoint will be assessed as the incidence of all intraoperative and
      post-operative adverse events that occur through the 42-day follow-up period
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Performance
time frame: IntraOperative period
description: Performance defined as ability to complete the planned da Vinci SP-assisted colorectal procedure without conversion to an alternate approach.
measure: Adverse Events Rates
time frame: Intraoperative through the 42-day postoperative period
description: Safety defined as the incidence of all intraoperative and post-operative adverse events that occur through the 42-day follow-up period
arm group label: Single arm
arm group type: Other
description: Colorectal procedure will be performed by da Vinci SP® Surgical System
intervention type: Device
intervention name: Robotic Assisted Surgery
description: da Vinci SP Surgical System, instruments, and accessories in complex colorectal procedures such as low anterior resection procedure or right colectomy with or without total mesorectal excision
arm group label: Single arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kathryn Wine
role: Study Director
affiliation: Medical Affairs Director
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Korea, Republic of
country: United States
responsible party type: Sponsor
mesh term: Colonic Neoplasms
sharing ipd: No