<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/NCT04506190</url>
  </required_header>
  <id_info>
    <org_study_id>ISI-dVBR-002</org_study_id>
    <nct_id>NCT04506190</nct_id>
  </id_info>
  <brief_title>Prospective Robotic-assisted Revisional Bariatric Study</brief_title>
  <official_title>A Prospective Multicenter Study to Evaluate the Perioperative Outcomes of Robotic-assisted Revisional Bariatric Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Intuitive Surgical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Intuitive Surgical</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Very few studies have compared robotic-assisted (RRBS) versus laparoscopic revisional&#xD;
      bariatric surgeries (LRBS). To date, there has not been a prospective study comparing the&#xD;
      perioperative outcomes of patients undergoing robotic-assisted and laparoscopic revisional&#xD;
      bariatric surgery. This study aims to enroll patients undergoing RRBS and LRBS and evaluate&#xD;
      the outcomes through 45 days, including the perioperative period. We hypothesize that RRBS&#xD;
      may be associated with lower rates of perioperative outcomes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 1, 2020</start_date>
  <completion_date type="Anticipated">March 1, 2023</completion_date>
  <primary_completion_date type="Actual">March 15, 2022</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>Rate of conversions</measure>
    <time_frame>During the surgical procedure</time_frame>
    <description>Conversions is defined as RRBS to LRBS or open revisional bariatric surgery, and LRBS to open revisional bariatric surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative rate of anastomotic leak</measure>
    <time_frame>45 days after date of procedure</time_frame>
    <description>Anastomotic leak is defined as a leak of luminal contents from a surgical join</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Bariatric Surgery Candidate</condition>
  <arm_group>
    <arm_group_label>Robotic-assisted revisional bariatric surgery</arm_group_label>
    <description>Subjects who undergo robotic-assisted revisional bariatric surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Revisional bariatric surgery</intervention_name>
    <description>Subjects who undergo revisional bariatric surgery</description>
    <arm_group_label>Robotic-assisted revisional bariatric surgery</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects who have had one previous bariatric surgery, are undergoing a revisional bariatric&#xD;
        surgery applicable to this study, and who are deemed qualified by study inclusion and&#xD;
        exclusion criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject is 18 years or older at the time of consent&#xD;
&#xD;
          2. Subject has a history of prior bariatric surgery&#xD;
&#xD;
          3. Subject's revisional procedure will be either laparoscopic revisional bariatric&#xD;
             surgery (LRBS) or robotic-assisted revisional bariatric surgery (RRBS)&#xD;
&#xD;
          4. Subject undergoes revisional bariatric surgery that is applicable to study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject is undergoing a primary bariatric procedure&#xD;
&#xD;
          2. Subject has undergone more than one previous bariatric procedure&#xD;
&#xD;
          3. Subject's revisional bariatric procedure is an emergent procedure&#xD;
&#xD;
          4. Subject is contraindicated for general anesthesia or surgery&#xD;
&#xD;
          5. Subject is unable to comply with the follow-up visit schedule&#xD;
&#xD;
          6. Subject is pregnant or suspects pregnancy&#xD;
&#xD;
          7. Subject is mentally handicapped or has a psychological disorder or severe systemic&#xD;
             illness that would preclude compliance with study requirements or ability to provide&#xD;
             informed consent&#xD;
&#xD;
          8. Subject belonging to other vulnerable population, e.g, prisoner or ward of the state&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Orlando Health</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>August 5, 2020</study_first_submitted>
  <study_first_submitted_qc>August 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>March 25, 2022</last_update_submitted>
  <last_update_submitted_qc>March 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>All individual participant data that underlie results in a publication</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/NCT04506190
org study id: ISI-dVBR-002
nct id: NCT04506190
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Very few studies have compared robotic-assisted (RRBS) versus laparoscopic revisional
      bariatric surgeries (LRBS). To date, there has not been a prospective study comparing the
      perioperative outcomes of patients undergoing robotic-assisted and laparoscopic revisional
      bariatric surgery. This study aims to enroll patients undergoing RRBS and LRBS and evaluate
      the outcomes through 45 days, including the perioperative period. We hypothesize that RRBS
      may be associated with lower rates of perioperative outcomes.
observational model: Other
time perspective: Prospective
measure: Rate of conversions
time frame: During the surgical procedure
description: Conversions is defined as RRBS to LRBS or open revisional bariatric surgery, and LRBS to open revisional bariatric surgery
measure: Postoperative rate of anastomotic leak
time frame: 45 days after date of procedure
description: Anastomotic leak is defined as a leak of luminal contents from a surgical join
arm group label: Robotic-assisted revisional bariatric surgery
description: Subjects who undergo robotic-assisted revisional bariatric surgery
intervention type: Procedure
intervention name: Revisional bariatric surgery
description: Subjects who undergo revisional bariatric surgery
arm group label: Robotic-assisted revisional bariatric surgery
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: Undecided
ipd description: All individual participant data that underlie results in a publication