<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/NCT03252470</url>
  </required_header>
  <id_info>
    <org_study_id>2015-SE-01</org_study_id>
    <nct_id>NCT03252470</nct_id>
  </id_info>
  <brief_title>The BlackBox Study</brief_title>
  <official_title>A Prospective, Post Market, Feasibility Study to Assess the Practical Utility of the OR BlackBox Platform When Used to Compare Surgical Technique During 2D Versus 3D Laparoscopic Bariatric Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Olympus Corporation of the Americas</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Unity Health Toronto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Olympus Corporation of the Americas</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a hypothesis generating pilot study to compare the impact of 2D versus 3D&#xD;
      visualization on surgical performance, as measured by the OR BlackBox platform, during&#xD;
      laparoscopic bariatric surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Data published in 2008 estimated the global number of surgical procedures performed annually&#xD;
      as 234 million with a rate of major perioperative complications reported between 3% and 17%&#xD;
      in industrialized countries. As a derivative of these figures, it is estimated that&#xD;
      approximately 7 to 40 million major complications occur worldwide each year. Studies have&#xD;
      shown that between 39.6% and 54.2% of surgical complications occur in the operating room&#xD;
      (OR); furthermore, it has been suggested that one third to half of all surgical errors are&#xD;
      potentially avoidable. These findings have brought considerable attention to quality&#xD;
      improvement in the technically demanding field of laparoscopic surgery wherein the risk of&#xD;
      intraoperative error is increased by the sociotechnical complexity of the operative&#xD;
      environment. In particular, there has been growing interest in evaluating surgical processes&#xD;
      from a human factors point of view, as human factors, such as fatigue and mental workload,&#xD;
      have become increasingly recognized as root causes of adverse surgical events and outcomes.&#xD;
&#xD;
      Among the most commonly reported errors in conventional laparoscopic surgery are technical&#xD;
      errors associated with impaired depth perception; laparoscopic surgeons rely on&#xD;
      two-dimensional (2D) video displays to guide their work in a three-dimensional (3D) space,&#xD;
      resulting in the loss of depth perception and spatial orientation, as well as the experience&#xD;
      of increased visual and cognitive load. Technical errors can be defined as manual errors of&#xD;
      the surgeon (e.g. damage to adjacent structures) and procedural errors due to a lack of&#xD;
      surgeon proficiency or experience. These errors are frequently described, especially when&#xD;
      evaluating closed malpractice cases. These factors have been extensively examined but still&#xD;
      remain controversial. A major limitation of error analyses of closed malpractice cases and&#xD;
      root cause analyses of complications is the hindsight bias introduced through the knowledge&#xD;
      of patient outcome.&#xD;
&#xD;
      Laparoscopic cameras with 3D display functionality were first developed in the early 1990s.&#xD;
      The poor image quality produced by early cameras resulted in pronounced physical side&#xD;
      effects, including dizziness, headache, and nausea; however, a significant technological&#xD;
      advancement in the field of 3D laparoscopy has dramatically improved the usability of these&#xD;
      systems. Despite these improvements and the potential for improved surgical safety, the use&#xD;
      of 3D laparoscopic equipment remains limited in modern surgical centers. Outdated and&#xD;
      conflicting research findings regarding the effectiveness of these systems and the physical&#xD;
      side effects associated with their use may be contributing to slow adoption into clinical&#xD;
      practice. Furthermore, investigations assessing the impact of 3D laparoscopy on surgical&#xD;
      performance in the clinical setting are notably lacking. Thus, robust comparative evaluations&#xD;
      of modern 2D and 3D laparoscopic surgical display systems in clinical settings are required&#xD;
      to clearly elucidate the impact of 3D laparoscopy on surgical performance and safety with an&#xD;
      aim to establish best practices in laparoscopic surgery.&#xD;
&#xD;
      The restoration of stereoscopic vision in laparoscopic surgery has the potential to mitigate&#xD;
      these challenges and, to this end, the introduction of 3D stereoscopic displays in&#xD;
      laparoscopic surgery may be beneficial to improving surgical safety. The purpose of this&#xD;
      study is to compare the impact of 2D versus 3D visualization on surgical performance, as&#xD;
      measured by the OR BlackBox Platform, during laparoscopic Roux-en-Y gastric bypass surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 6, 2018</start_date>
  <completion_date type="Actual">March 20, 2019</completion_date>
  <primary_completion_date type="Actual">March 11, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Quantify operative performance and intraoperative errors</measure>
    <time_frame>12 months</time_frame>
    <description>This pilot study will quantify operative performance and intraoperative errors after the introduction of the 2D and 3D technology using the following tools:&#xD;
Generic Error Rating Tool (GERT)&#xD;
Objective Structured Assessment of Technical Skill (OSATS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Significant adverse events</measure>
    <time_frame>one month</time_frame>
    <description>1. Clinically significant adverse events related to the device(s) and/or procedure</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Laparoscopic Roux-en-y Gastric Bypass</condition>
  <arm_group>
    <arm_group_label>2D laparoscopic surgeries</arm_group_label>
    <description>Two-Dimensional Laparascopic Surgical Video System</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3D laparoscopic surgeries</arm_group_label>
    <description>Three-Dimensional Laparascopic Surgical Video System</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparoscopic Roux-en-y Gastric Bypass Surgery</intervention_name>
    <description>Laparoscopic Roux-en-y Gastric Bypass Surgery</description>
    <arm_group_label>2D laparoscopic surgeries</arm_group_label>
    <arm_group_label>3D laparoscopic surgeries</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who meet all of the inclusion criteria and none of the exclusion criteria will be&#xD;
        considered for enrollment in this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. ≥ 18 years of age&#xD;
&#xD;
          2. Scheduled to undergo elective, primary roux-en-y gastric bypass surgery&#xD;
&#xD;
          3. BMI of 35 to 54.9&#xD;
&#xD;
          4. Willing and able to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous open abdominal surgery&#xD;
&#xD;
          2. Previous open or laparoscopic upper GI surgery&#xD;
&#xD;
          3. Contraindicated for laparoscopic bariatric surgery&#xD;
&#xD;
          4. Unable or unwilling to provide informed consent&#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>St. Michael's Hospital, Division of Surgery</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5B</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>August 11, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>August 12, 2019</last_update_submitted>
  <last_update_submitted_qc>August 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>2D laparoscopic surgery</keyword>
  <keyword>3D laparascopic surgery</keyword>
  <keyword>laparoscopic roux-en-y gastric bypass</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 18, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/70/NCT03252470/ICF_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 22, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/70/NCT03252470/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03252470
org study id: 2015-SE-01
nct id: NCT03252470
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a hypothesis generating pilot study to compare the impact of 2D versus 3D
      visualization on surgical performance, as measured by the OR BlackBox platform, during
      laparoscopic bariatric surgery.
Data published in 2008 estimated the global number of surgical procedures performed annually
      as 234 million with a rate of major perioperative complications reported between 3% and 17%
      in industrialized countries. As a derivative of these figures, it is estimated that
      approximately 7 to 40 million major complications occur worldwide each year. Studies have
      shown that between 39.6% and 54.2% of surgical complications occur in the operating room
      (OR); furthermore, it has been suggested that one third to half of all surgical errors are
      potentially avoidable. These findings have brought considerable attention to quality
      improvement in the technically demanding field of laparoscopic surgery wherein the risk of
      intraoperative error is increased by the sociotechnical complexity of the operative
      environment. In particular, there has been growing interest in evaluating surgical processes
      from a human factors point of view, as human factors, such as fatigue and mental workload,
      have become increasingly recognized as root causes of adverse surgical events and outcomes.

      Among the most commonly reported errors in conventional laparoscopic surgery are technical
      errors associated with impaired depth perception; laparoscopic surgeons rely on
      two-dimensional (2D) video displays to guide their work in a three-dimensional (3D) space,
      resulting in the loss of depth perception and spatial orientation, as well as the experience
      of increased visual and cognitive load. Technical errors can be defined as manual errors of
      the surgeon (e.g. damage to adjacent structures) and procedural errors due to a lack of
      surgeon proficiency or experience. These errors are frequently described, especially when
      evaluating closed malpractice cases. These factors have been extensively examined but still
      remain controversial. A major limitation of error analyses of closed malpractice cases and
      root cause analyses of complications is the hindsight bias introduced through the knowledge
      of patient outcome.

      Laparoscopic cameras with 3D display functionality were first developed in the early 1990s.
      The poor image quality produced by early cameras resulted in pronounced physical side
      effects, including dizziness, headache, and nausea; however, a significant technological
      advancement in the field of 3D laparoscopy has dramatically improved the usability of these
      systems. Despite these improvements and the potential for improved surgical safety, the use
      of 3D laparoscopic equipment remains limited in modern surgical centers. Outdated and
      conflicting research findings regarding the effectiveness of these systems and the physical
      side effects associated with their use may be contributing to slow adoption into clinical
      practice. Furthermore, investigations assessing the impact of 3D laparoscopy on surgical
      performance in the clinical setting are notably lacking. Thus, robust comparative evaluations
      of modern 2D and 3D laparoscopic surgical display systems in clinical settings are required
      to clearly elucidate the impact of 3D laparoscopy on surgical performance and safety with an
      aim to establish best practices in laparoscopic surgery.

      The restoration of stereoscopic vision in laparoscopic surgery has the potential to mitigate
      these challenges and, to this end, the introduction of 3D stereoscopic displays in
      laparoscopic surgery may be beneficial to improving surgical safety. The purpose of this
      study is to compare the impact of 2D versus 3D visualization on surgical performance, as
      measured by the OR BlackBox Platform, during laparoscopic Roux-en-Y gastric bypass surgery.
observational model: Cohort
time perspective: Prospective
measure: Quantify operative performance and intraoperative errors
time frame: 12 months
description: This pilot study will quantify operative performance and intraoperative errors after the introduction of the 2D and 3D technology using the following tools:
Generic Error Rating Tool (GERT)
Objective Structured Assessment of Technical Skill (OSATS)
measure: Significant adverse events
time frame: one month
description: 1. Clinically significant adverse events related to the device(s) and/or procedure
arm group label: 2D laparoscopic surgeries
description: Two-Dimensional Laparascopic Surgical Video System
arm group label: 3D laparoscopic surgeries
description: Three-Dimensional Laparascopic Surgical Video System
intervention type: Procedure
intervention name: Laparoscopic Roux-en-y Gastric Bypass Surgery
description: Laparoscopic Roux-en-y Gastric Bypass Surgery
arm group label: 2D laparoscopic surgeries
arm group label: 3D laparoscopic surgeries
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Canada
responsible party type: Sponsor
sharing ipd: Undecided
provided document: 
provided document: 