<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/NCT02991794</url>
  </required_header>
  <id_info>
    <org_study_id>AAG-O-H-1607</org_study_id>
    <nct_id>NCT02991794</nct_id>
  </id_info>
  <brief_title>Prostatectomies Using Einstein Vision® 3D</brief_title>
  <acronym>PROSTEVIS</acronym>
  <official_title>Prospective, Multi-centre, Non-interventional Trial on Laparoscopic Radical PROSTatectomies Using EinsteinVISion® 3D Visualization System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aesculap AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aesculap AG</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is collecting clinical data on the learning curve of different surgeons&#xD;
      using the EinsteinVision® 3D visualization system in laparoscopic radical prostatectomies.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 19, 2017</start_date>
  <completion_date type="Actual">November 6, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 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>Time needed to perform the vesicourethral anastomosis using EinsteinVision® in a group of different surgeons [min. sec.]</measure>
    <time_frame>Intraoperatively</time_frame>
    <description>learning curve of different surgeons with diverse level of experience using EinsteinVision® 3D visualization system</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intraoperative blood loss [ml]</measure>
    <time_frame>Intraoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraoperative blood transfusions [quantity]</measure>
    <time_frame>Intraoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative blood transfusions [quantity]</measure>
    <time_frame>Postoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraoperative incidence of complications [percentage]</measure>
    <time_frame>Intraoperatively</time_frame>
    <description>(e.g. bleedings, Trauma of ureter)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative incidence of complications [percentage]</measure>
    <time_frame>During stay in Hospital (5-12 days postoperatively)</time_frame>
    <description>(e.g. Ileus, venous thrombo-embolic events, wound infection, bleedings)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgeon's experience with different operation methods and application systems</measure>
    <time_frame>After first intervention for each hospital and after study completion, an average of 1 year later</time_frame>
    <description>using a questionnaire at the beginning (First Patient In) and the end of the study (Last Patient In)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's quality of life</measure>
    <time_frame>Preoperatively, 5-12 days postoperatively, 3 months, 6 months, 12 months postoperatively</time_frame>
    <description>Pre- and postoperative patient's quality of life using the questionnaire EQ-5D-5L&#xD;
The following dimensions are assessed:&#xD;
Mobility&#xD;
Self-care&#xD;
Usual activities&#xD;
Pain / discomfort&#xD;
Anxiety / depression&#xD;
Health</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operation time [min.]</measure>
    <time_frame>Intraoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraoperative usability of the device</measure>
    <time_frame>Intraoperatively</time_frame>
    <description>using a questionnaire containing different dimensions and a 5-point assessment level (Likert Scale: 1 = excellent, 5 = unacceptable).&#xD;
The following dimensions are assessed:&#xD;
Control&#xD;
Expenditure of energy&#xD;
Image quality&#xD;
Overall satisfaction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incontinence after catheterization [percentage]</measure>
    <time_frame>During stay in Hospital (5-12 days postoperatively)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative hospital stay [days]</measure>
    <time_frame>During stay in Hospital (5-12 days postoperatively)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Return to erectile function [percentage]</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Return to continence function [percentage]</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incontinence pads/pants per day [quantity]</measure>
    <time_frame>5-12 days postoperatively, 3 months, 6 months, 12 months postoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative patient satisfaction</measure>
    <time_frame>5-12 days postoperatively, 3 months, 6 months, 12 months postoperatively</time_frame>
    <description>using a 10-point assessment level (1 = completely dissatisfied, 10 = completely satisfied)</description>
  </secondary_outcome>
  <enrollment type="Actual">156</enrollment>
  <condition>Prostate Carcinoma</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>EinsteinVision 3D visualization system</intervention_name>
    <description>Elective laparoscopic radical prostatectomy due to histologically proven prostate cancer using EinsteinVision® 3D visualization system.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        adult patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing planned radical prostatectomy prostatectomy because of&#xD;
             histologically proven prostate cancer using EinsteinVision®&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous TURP (= transurethral resection of the prostate)&#xD;
&#xD;
          -  Previous operations on the sigmoid colon or rectum (e.g. because of carcinoma,&#xD;
             perforation, diverticulum)&#xD;
&#xD;
          -  BMI &gt; 35 kg/m²&#xD;
&#xD;
          -  Participation in another clinical study&#xD;
&#xD;
          -  Representation by a legal guardian or under involuntary commitment&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Sana Klinikum Offenbach</name>
      <address>
        <city>Offenbach</city>
        <zip>63069</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>medius Klinik Ostfildern-Ruit</name>
      <address>
        <city>Ostfildern</city>
        <zip>73760</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>January 12, 2021</last_update_submitted>
  <last_update_submitted_qc>January 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>prostatectomy</keyword>
  <keyword>laparoscopy</keyword>
  <keyword>3D visualization</keyword>
  <keyword>learning curve</keyword>
  <keyword>anastomosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic 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/NCT02991794
org study id: AAG-O-H-1607
nct id: NCT02991794
lead sponsor: 
has dmc: No
The aim of the study is collecting clinical data on the learning curve of different surgeons
      using the EinsteinVision® 3D visualization system in laparoscopic radical prostatectomies.
observational model: Cohort
time perspective: Prospective
measure: Time needed to perform the vesicourethral anastomosis using EinsteinVision® in a group of different surgeons [min. sec.]
time frame: Intraoperatively
description: learning curve of different surgeons with diverse level of experience using EinsteinVision® 3D visualization system
measure: Intraoperative blood loss [ml]
time frame: Intraoperatively
measure: Intraoperative blood transfusions [quantity]
time frame: Intraoperatively
measure: Postoperative blood transfusions [quantity]
time frame: Postoperatively
measure: Intraoperative incidence of complications [percentage]
time frame: Intraoperatively
description: (e.g. bleedings, Trauma of ureter)
measure: Postoperative incidence of complications [percentage]
time frame: During stay in Hospital (5-12 days postoperatively)
description: (e.g. Ileus, venous thrombo-embolic events, wound infection, bleedings)
measure: Surgeon's experience with different operation methods and application systems
time frame: After first intervention for each hospital and after study completion, an average of 1 year later
description: using a questionnaire at the beginning (First Patient In) and the end of the study (Last Patient In)
measure: Patient's quality of life
time frame: Preoperatively, 5-12 days postoperatively, 3 months, 6 months, 12 months postoperatively
description: Pre- and postoperative patient's quality of life using the questionnaire EQ-5D-5L
The following dimensions are assessed:
Mobility
Self-care
Usual activities
Pain / discomfort
Anxiety / depression
Health
measure: Operation time [min.]
time frame: Intraoperatively
measure: Intraoperative usability of the device
time frame: Intraoperatively
description: using a questionnaire containing different dimensions and a 5-point assessment level (Likert Scale: 1 = excellent, 5 = unacceptable).
The following dimensions are assessed:
Control
Expenditure of energy
Image quality
Overall satisfaction
measure: Incontinence after catheterization [percentage]
time frame: During stay in Hospital (5-12 days postoperatively)
measure: Postoperative hospital stay [days]
time frame: During stay in Hospital (5-12 days postoperatively)
measure: Return to erectile function [percentage]
time frame: 12 months
measure: Return to continence function [percentage]
time frame: 12 months
measure: Incontinence pads/pants per day [quantity]
time frame: 5-12 days postoperatively, 3 months, 6 months, 12 months postoperatively
measure: Postoperative patient satisfaction
time frame: 5-12 days postoperatively, 3 months, 6 months, 12 months postoperatively
description: using a 10-point assessment level (1 = completely dissatisfied, 10 = completely satisfied)
intervention type: Device
intervention name: EinsteinVision 3D visualization system
description: Elective laparoscopic radical prostatectomy due to histologically proven prostate cancer using EinsteinVision® 3D visualization system.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
sharing ipd: No