<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/NCT01670760</url>
  </required_header>
  <id_info>
    <org_study_id>2012-DTT-BS-01</org_study_id>
    <nct_id>NCT01670760</nct_id>
  </id_info>
  <brief_title>Zero Heat Flux Thermometry System Comparison Trial</brief_title>
  <official_title>3M(TM)SpotOn(TM) Temperature Monitoring System Thermometry Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>3M</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>3M</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Nasopharyngeal and deep tissue temperatures will be measured simultaneously during surgery&#xD;
      and compared for agreement. The hypothesis of this trial is that deep tissue temperature as&#xD;
      measured by zero-heat-flux thermometry will agree with nasopharyngeal temperatures during&#xD;
      surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The core temperature of the body normally decreases in response to anesthesia. Deep tissue&#xD;
      temperature can be used to estimate of body core temperature. Deep tissue temperature of the&#xD;
      forehead will be measured using a new technology known as zero-heat-flux thermometry. The&#xD;
      usual way to measure internal body temperature is within the nasal cavity (nasopharyngeal&#xD;
      temperature). Nasopharyngeal and deep tissue temperatures will be measured simultaneously&#xD;
      during surgery and compared for agreement. The hypothesis of this trial is that deep tissue&#xD;
      temperature as measured by zero-heat-flux thermometry will agree with nasopharyngeal&#xD;
      temperatures during surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2013</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Body Temperature Difference in Degrees Celsius</measure>
    <time_frame>Every 5 to 10 minutes, or as clinically indicated, for the duration of the surgery from the time of incision to the time of closure. The average duration of surgery was 57 minutes.</time_frame>
    <description>Body temperature difference as defined by Agreement (bias - Zero heat flux thermometry minus nasopharyngeal) between simultaneously-acquired nasopharyngeal and forehead deep tissue temperatures as assessed by Bland and Altman repeated measures technique.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Body Temperature</condition>
  <condition>Thermosensing</condition>
  <condition>Temperature</condition>
  <arm_group>
    <arm_group_label>Zero-Heat-Flux</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This is a single arm study. All patients will have deep tissue temperature monitored from the nasopharyngeal and lateral forehead sites simultaneously.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Zero-heat-flux thermometry</intervention_name>
    <description>The zero-heat-flux thermometer will be placed on the subject's lateral forehead for the duration of the surgery to measure deep tissue temperature.</description>
    <arm_group_label>Zero-Heat-Flux</arm_group_label>
    <other_name>3M(TM) SpotOn(TM) temperature monitoring system</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Less than or equal to 17 years old&#xD;
&#xD;
          -  patients undergoing surgery during which core temperature is estimated&#xD;
&#xD;
          -  Willing to participate in trial&#xD;
&#xD;
          -  Able to provide consent&#xD;
&#xD;
          -  Adequate forehead surface area available for probe attachment&#xD;
&#xD;
          -  Urology, orthopedic, or general abdominal surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Skin lesions at thermometer target site&#xD;
&#xD;
          -  Infectious disease&#xD;
&#xD;
          -  Bleeding disorder&#xD;
&#xD;
          -  Prone intraoperative positioning anticipated&#xD;
&#xD;
          -  Head and neck procedures&#xD;
&#xD;
          -  Cardiothoracic procedures&#xD;
&#xD;
          -  Tonsillectomy, cosmetic, or other brief surgical or nonsurgical procedures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter J Davis, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospital of Pittsburg of the University of Pittsburgh Medical Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15241</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Langham GE, Maheshwari A, Contrera K, You J, Mascha E, Sessler DI. Noninvasive temperature monitoring in postanesthesia care units. Anesthesiology. 2009 Jul;111(1):90-6. doi: 10.1097/ALN.0b013e3181a864ca.</citation>
    <PMID>19512860</PMID>
  </reference>
  <reference>
    <citation>Teunissen LP, Klewer J, de Haan A, de Koning JJ, Daanen HA. Non-invasive continuous core temperature measurement by zero heat flux. Physiol Meas. 2011 May;32(5):559-70. doi: 10.1088/0967-3334/32/5/005. Epub 2011 Mar 28.</citation>
    <PMID>21444968</PMID>
  </reference>
  <reference>
    <citation>Fox RH, Solman AJ. A new technique for monitoring the deep body temperature in man from the intact skin surface. J Physiol. 1971 Jan;212(2):8P-10P. No abstract available.</citation>
    <PMID>5548025</PMID>
  </reference>
  <reference>
    <citation>Togwa T, Nemoto T, Yamazaki T, Kobayashi T. A modified internal temperature measurement device. Med Biol Eng. 1976 May;14(3):361-4. doi: 10.1007/BF02478138. No abstract available.</citation>
    <PMID>940402</PMID>
  </reference>
  <reference>
    <citation>Matsukawa T, Sessler DI, Ozaki M, Hanagata K, Iwashita H, Kumazawa T. Comparison of distal oesophageal temperature with &quot;deep&quot; and tracheal temperatures. Can J Anaesth. 1997 Apr;44(4):433-8. doi: 10.1007/BF03014466.</citation>
    <PMID>9104528</PMID>
  </reference>
  <reference>
    <citation>Harioka T, Matsukawa T, Ozaki M, Nomura K, Sone T, Kakuyama M, Toda H. &quot;Deep-forehead&quot; temperature correlates well with blood temperature. Can J Anaesth. 2000 Oct;47(10):980-3. doi: 10.1007/BF03024869.</citation>
    <PMID>11032273</PMID>
  </reference>
  <reference>
    <citation>Yamakage M, Namiki A. Deep temperature monitoring using a zero-heat-flow method. J Anesth. 2003;17(2):108-15. doi: 10.1007/s005400300026. No abstract available.</citation>
    <PMID>12903922</PMID>
  </reference>
  <reference>
    <citation>Jost U, Hanf K, Kohler CO, Just OH. [A new method for the transcutaneous measurement of deep body temperature during anaesthesia and intensive care (author's transl)]. Prakt Anaesth. 1978 Apr;13(2):144-9. German.</citation>
    <PMID>652707</PMID>
  </reference>
  <reference>
    <citation>Esamai F, Mining S, Forsberg P, Lewis DH. A comparison of brain, core and skin temperature in children with complicated and uncomplicated malaria. J Trop Pediatr. 2001 Jun;47(3):170-5. doi: 10.1093/tropej/47.3.170.</citation>
    <PMID>11419682</PMID>
  </reference>
  <reference>
    <citation>Akata T, Setoguchi H, Shirozu K, Yoshino J. Reliability of temperatures measured at standard monitoring sites as an index of brain temperature during deep hypothermic cardiopulmonary bypass conducted for thoracic aortic reconstruction. J Thorac Cardiovasc Surg. 2007 Jun;133(6):1559-65. doi: 10.1016/j.jtcvs.2006.11.031.</citation>
    <PMID>17532957</PMID>
  </reference>
  <reference>
    <citation>Yamakage M, Iwasaki S, Namiki A. Evaluation of a newly developed monitor of deep body temperature. J Anesth. 2002;16(4):354-7. doi: 10.1007/s005400200056. No abstract available.</citation>
    <PMID>14517632</PMID>
  </reference>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>August 16, 2012</study_first_submitted>
  <study_first_submitted_qc>August 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2012</study_first_posted>
  <results_first_submitted>August 12, 2019</results_first_submitted>
  <results_first_submitted_qc>August 11, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">August 21, 2020</results_first_posted>
  <last_update_submitted>September 1, 2020</last_update_submitted>
  <last_update_submitted_qc>September 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Deep Tissue Temperature</keyword>
  <keyword>Zero Heat Flux Thermometry</keyword>
  <keyword>Thermometry</keyword>
  <keyword>Core Temperature</keyword>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Zero-Heat-Flux</title>
          <description>This is a single arm study. All patients will have deep tissue temperature monitored from the nasopharyngeal and lateral forehead sites simultaneously.&#xD;
Zero-heat-flux thermometry: The zero-heat-flux thermometer will be placed on the subject's lateral forehead for the duration of the surgery to measure deep tissue temperature.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Zero-Heat-Flux</title>
          <description>This is a single arm study. All patients will have deep tissue temperature monitored from the nasopharyngeal and lateral forehead sites simultaneously.&#xD;
Zero-heat-flux thermometry: The zero-heat-flux thermometer will be placed on the subject's lateral forehead for the duration of the surgery to measure deep tissue temperature.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="20"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.1" spread="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Body Temperature Difference in Degrees Celsius</title>
        <description>Body temperature difference as defined by Agreement (bias - Zero heat flux thermometry minus nasopharyngeal) between simultaneously-acquired nasopharyngeal and forehead deep tissue temperatures as assessed by Bland and Altman repeated measures technique.</description>
        <time_frame>Every 5 to 10 minutes, or as clinically indicated, for the duration of the surgery from the time of incision to the time of closure. The average duration of surgery was 57 minutes.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Zero-Heat-Flux</title>
            <description>This is a single arm study. All patients will have deep tissue temperature monitored from the nasopharyngeal and lateral forehead sites simultaneously.&#xD;
Zero-heat-flux thermometry: The zero-heat-flux thermometer will be placed on the subject's lateral forehead for the duration of the surgery to measure deep tissue temperature.</description>
          </group>
        </group_list>
        <measure>
          <title>Body Temperature Difference in Degrees Celsius</title>
          <description>Body temperature difference as defined by Agreement (bias - Zero heat flux thermometry minus nasopharyngeal) between simultaneously-acquired nasopharyngeal and forehead deep tissue temperatures as assessed by Bland and Altman repeated measures technique.</description>
          <units>Degrees Celsius</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <units_analyzed>Observation</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Observation</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="247"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.28" spread="0.027"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.69</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.69</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>For the duration of the surgery from the time of incision to the time of closure. The average duration of surgery was 57 minutes.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Zero-Heat-Flux</title>
          <description>This is a single arm study. All patients will have deep tissue temperature monitored from the nasopharyngeal and lateral forehead sites simultaneously.&#xD;
Zero-heat-flux thermometry: The zero-heat-flux thermometer will be placed on the subject's lateral forehead for the duration of the surgery to measure deep tissue temperature.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Redness at attachment site</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Terri White</name_or_title>
      <organization>3M</organization>
      <phone>651-733-0228</phone>
      <email>twhite3@mmm.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01670760
org study id: 2012-DTT-BS-01
nct id: NCT01670760
lead sponsor: 
has dmc: No
Nasopharyngeal and deep tissue temperatures will be measured simultaneously during surgery
      and compared for agreement. The hypothesis of this trial is that deep tissue temperature as
      measured by zero-heat-flux thermometry will agree with nasopharyngeal temperatures during
      surgery.
The core temperature of the body normally decreases in response to anesthesia. Deep tissue
      temperature can be used to estimate of body core temperature. Deep tissue temperature of the
      forehead will be measured using a new technology known as zero-heat-flux thermometry. The
      usual way to measure internal body temperature is within the nasal cavity (nasopharyngeal
      temperature). Nasopharyngeal and deep tissue temperatures will be measured simultaneously
      during surgery and compared for agreement. The hypothesis of this trial is that deep tissue
      temperature as measured by zero-heat-flux thermometry will agree with nasopharyngeal
      temperatures during surgery.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Body Temperature Difference in Degrees Celsius
time frame: Every 5 to 10 minutes, or as clinically indicated, for the duration of the surgery from the time of incision to the time of closure. The average duration of surgery was 57 minutes.
description: Body temperature difference as defined by Agreement (bias - Zero heat flux thermometry minus nasopharyngeal) between simultaneously-acquired nasopharyngeal and forehead deep tissue temperatures as assessed by Bland and Altman repeated measures technique.
arm group label: Zero-Heat-Flux
arm group type: Experimental
description: This is a single arm study. All patients will have deep tissue temperature monitored from the nasopharyngeal and lateral forehead sites simultaneously.
intervention type: Device
intervention name: Zero-heat-flux thermometry
description: The zero-heat-flux thermometer will be placed on the subject's lateral forehead for the duration of the surgery to measure deep tissue temperature.
arm group label: Zero-Heat-Flux
other name: 3M(TM) SpotOn(TM) temperature monitoring system
criteria: 
gender: All
minimum age: N/A
maximum age: 17 Years
healthy volunteers: No
last name: Peter J Davis, MD
role: Principal Investigator
affiliation: University of Pittsburgh
facility: 
country: United States
citation: Langham GE, Maheshwari A, Contrera K, You J, Mascha E, Sessler DI. Noninvasive temperature monitoring in postanesthesia care units. Anesthesiology. 2009 Jul;111(1):90-6. doi: 10.1097/ALN.0b013e3181a864ca.
PMID: 19512860
citation: Teunissen LP, Klewer J, de Haan A, de Koning JJ, Daanen HA. Non-invasive continuous core temperature measurement by zero heat flux. Physiol Meas. 2011 May;32(5):559-70. doi: 10.1088/0967-3334/32/5/005. Epub 2011 Mar 28.
PMID: 21444968
citation: Fox RH, Solman AJ. A new technique for monitoring the deep body temperature in man from the intact skin surface. J Physiol. 1971 Jan;212(2):8P-10P. No abstract available.
PMID: 5548025
citation: Togwa T, Nemoto T, Yamazaki T, Kobayashi T. A modified internal temperature measurement device. Med Biol Eng. 1976 May;14(3):361-4. doi: 10.1007/BF02478138. No abstract available.
PMID: 940402
citation: Matsukawa T, Sessler DI, Ozaki M, Hanagata K, Iwashita H, Kumazawa T. Comparison of distal oesophageal temperature with "deep" and tracheal temperatures. Can J Anaesth. 1997 Apr;44(4):433-8. doi: 10.1007/BF03014466.
PMID: 9104528
citation: Harioka T, Matsukawa T, Ozaki M, Nomura K, Sone T, Kakuyama M, Toda H. "Deep-forehead" temperature correlates well with blood temperature. Can J Anaesth. 2000 Oct;47(10):980-3. doi: 10.1007/BF03024869.
PMID: 11032273
citation: Yamakage M, Namiki A. Deep temperature monitoring using a zero-heat-flow method. J Anesth. 2003;17(2):108-15. doi: 10.1007/s005400300026. No abstract available.
PMID: 12903922
citation: Jost U, Hanf K, Kohler CO, Just OH. [A new method for the transcutaneous measurement of deep body temperature during anaesthesia and intensive care (author's transl)]. Prakt Anaesth. 1978 Apr;13(2):144-9. German.
PMID: 652707
citation: Esamai F, Mining S, Forsberg P, Lewis DH. A comparison of brain, core and skin temperature in children with complicated and uncomplicated malaria. J Trop Pediatr. 2001 Jun;47(3):170-5. doi: 10.1093/tropej/47.3.170.
PMID: 11419682
citation: Akata T, Setoguchi H, Shirozu K, Yoshino J. Reliability of temperatures measured at standard monitoring sites as an index of brain temperature during deep hypothermic cardiopulmonary bypass conducted for thoracic aortic reconstruction. J Thorac Cardiovasc Surg. 2007 Jun;133(6):1559-65. doi: 10.1016/j.jtcvs.2006.11.031.
PMID: 17532957
citation: Yamakage M, Iwasaki S, Namiki A. Evaluation of a newly developed monitor of deep body temperature. J Anesth. 2002;16(4):354-7. doi: 10.1007/s005400200056. No abstract available.
PMID: 14517632
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 