<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/NCT03812471</url>
  </required_header>
  <id_info>
    <org_study_id>ICBE-2-24301</org_study_id>
    <nct_id>NCT03812471</nct_id>
  </id_info>
  <brief_title>Optimization of Fetal Biometry With 3D Ultrasound and Image Recognition</brief_title>
  <acronym>EPICEA</acronym>
  <official_title>Optimization of Fetal Biometry With 3D Ultrasound and Image Recognition</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Philips Electronics Nederland B.V. acting through Philips CTO organization</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Philips Electronics Nederland B.V. acting through Philips CTO organization</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>
      In the proposed clinical investigation, the investigational device (BabySize3D) will provide&#xD;
      automated plane extraction and automated biometry measurements from 3D US volumes. The&#xD;
      results obtained from the investigational software&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 23, 2018</start_date>
  <completion_date type="Actual">March 17, 2023</completion_date>
  <primary_completion_date type="Actual">March 11, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bi-parietal diameter in mm.</measure>
    <time_frame>Day 1</time_frame>
    <description>The bi-parietal diameter in mm will be obtained with three methods: (1) fully automated 3D volume processing and caliper placement, (2) manual 3D volume processing and caliper placement, (3) manual selection of the 2D view plane and manual caliper placement on the screen of the ultrasound system (corresponding to standard of care measurements). The values obtained with the three methods and the differences between these values will be reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Head circumference in mm</measure>
    <time_frame>Day 1</time_frame>
    <description>The Head circumference in mm will be obtained with three methods: (1) fully automated 3D volume processing and caliper placement, (2) manual 3D volume processing and caliper placement, (3) manual selection of the 2D view plane and manual caliper placement on the screen of the ultrasound system (corresponding to standard of care measurements). The values obtained with the three methods and the differences between these values will be reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Abdominal circumference in mm</measure>
    <time_frame>Day 1</time_frame>
    <description>The Abdominal circumference in mm will be obtained with three methods: (1) fully automated 3D volume processing and caliper placement, (2) manual 3D volume processing and caliper placement, (3) manual selection of the 2D view plane and manual caliper placement on the screen of the ultrasound system (corresponding to standard of care measurements). The values obtained with the three methods and the differences between these values will be reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Femur length in mm</measure>
    <time_frame>Day 1</time_frame>
    <description>The Femur length in mm will be obtained with three methods: (1) fully automated 3D volume processing and caliper placement, (2) manual 3D volume processing and caliper placement, (3) manual selection of the 2D view plane and manual caliper placement on the screen of the ultrasound system (corresponding to standard of care measurements). The values obtained with the three methods and the differences between these values will be reported</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Failure rate of the automated measurements</measure>
    <time_frame>Day 1</time_frame>
    <description>Failure rate of the automated measurements</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exam and post-processing duration</measure>
    <time_frame>Day 1</time_frame>
    <description>Exam and post-processing duration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference of scores of the 2D standard cephalic plane and cephalic plane extracted from the 3D volume, based on six criteria listed in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40)</measure>
    <time_frame>Day 1</time_frame>
    <description>The cephalic plane extracted from the 3D volume and the 2D standard cephalic plane will be scored according to the six criteria described in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40). The scores and their difference will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference of scores of the 2D standard abdominal plane and abdominal plane extracted from the 3D volume, based on six criteria listed in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40)</measure>
    <time_frame>Day 1</time_frame>
    <description>The abdominal plane extracted from the 3D volume and the 2D standard abdominal plane will be scored according to the six criteria described in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40). The scores and their difference will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference of scores of the 2D standard femoral plane and femoral plane extracted from the 3D volume, based on four criteria listed in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40)</measure>
    <time_frame>Day 1</time_frame>
    <description>The femoral plane extracted from the 3D volume and the 2D standard femoral plane will be scored according to the four criteria described in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40). The scores and their difference will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference of scores of (i) the 2D standard cephalic plane and of (ii) the frames of a sequence of 2D images including the fetus head (cine-loop), based on six criteria listed in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40)</measure>
    <time_frame>Day 1</time_frame>
    <description>The 2D standard cephalic plane and the frames of a sequence of 2D images including the fetus head will be scored according to the six criteria described in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40). The scores and the score difference (standard view score - frame score) will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference of scores of (i) the 2D standard abdominal plane and of (ii) the frames of a sequence of 2D images including the fetus abdomen (cine-loop), based on six criteria listed in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40)</measure>
    <time_frame>Day 1</time_frame>
    <description>The 2D standard abdominal plane and the frames of a sequence of 2D images including the fetus abdomen will be scored according to the six criteria described in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40). The scores and the score difference (standard view score - frame score) will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference of scores of (i) the 2D standard femoral plane and of (ii) the frames of a sequence of 2D images including the fetus femur (cine-loop), based on four criteria listed in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40)</measure>
    <time_frame>Day 1</time_frame>
    <description>The 2D standard femoral plane and the frames of a sequence of 2D images including the fetus femur will be scored according to the four criteria described in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40). The scores and the score difference (standard view score - frame score) will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Title: Intraclass correlation coefficient of the bi-parietal diameter in mm (same operator)</measure>
    <time_frame>Day 1</time_frame>
    <description>The intraclass correlation coefficient of the bi-parietal diameter in mm measured from two different 3D volumetric acquisitions of the same patient performed by the same operator will be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bland-Altman representation of the bi-parietal diameter in mm (same operator)</measure>
    <time_frame>Day 1</time_frame>
    <description>A Bland-Altman representation of the the bi-parietal diameter in mm measured from two different 3D volumetric acquisitions of the same patient performed by the same operator will be built.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraclass correlation coefficient of the bi-parietal diameter in mm (different operators)</measure>
    <time_frame>Day 1</time_frame>
    <description>The intraclass correlation coefficient of the bi-parietal diameter in mm measured from the 3D volumetric acquisitions of the same patient performed by two different operators will be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bland-Altman representation of the bi-parietal diameter in mm (different operators)</measure>
    <time_frame>Day 1</time_frame>
    <description>A Bland-Altman representation of the bi-parietal diameter in mm measured from the 3D volumetric acquisitions of the same patient performed by two different operators will be built.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraclass correlation coefficient of the head circumference in mm (same operator)</measure>
    <time_frame>Day 1</time_frame>
    <description>the intraclass correlation coefficient of the head circumference in mm measured from two different 3D volumetric acquisitions of the same patient performed by the same operator will be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bland-Altman representation of the head circumference in mm (same operator)</measure>
    <time_frame>Day 1</time_frame>
    <description>A Bland-Altman representation of the head circumference in mm measured from two different 3D volumetric acquisitions of the same patient performed by the same operator will be built.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraclass correlation coefficient of the head circumference in mm (different operators)</measure>
    <time_frame>Day 1</time_frame>
    <description>The intraclass correlation coefficient of the head circumference in mm measured from the 3D volumetric acquisitions of the same patient performed by two different operators will be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bland-Altman representation of the head circumference in mm (different operators)</measure>
    <time_frame>Day 1</time_frame>
    <description>A Bland-Altman representation of the head circumference in mm measured from the 3D volumetric acquisitions of the same patient performed by two different operators will be built.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraclass correlation coefficient of the abdominal circumference in mm (same operator)</measure>
    <time_frame>Day 1</time_frame>
    <description>The intraclass correlation coefficient of the abdominal circumference in mm measured from two different 3D volumetric acquisitions of the same patient performed by the same operator will be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bland-Altman representation of the abdominal circumference in mm (same operator)</measure>
    <time_frame>Day 1</time_frame>
    <description>A Bland-Altman representation of the abdominal circumference in mm measured from two different 3D volumetric acquisitions of the same patient performed by the same operator will be built.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraclass correlation coefficient of the abdominal circumference in mm (different operators)</measure>
    <time_frame>Day 1</time_frame>
    <description>The intraclass correlation coefficient of the abdominal circumference in mm measured from the 3D volumetric acquisitions of the same patient performed by two different operators will be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bland-Altman representation of the abdominal circumference in mm (different operators)</measure>
    <time_frame>Day 1</time_frame>
    <description>A Bland-Altman representation of the abdominal circumference in mm measured from the 3D volumetric acquisitions of the same patient performed by two different operators built.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraclass correlation coefficient of the femoral length in mm (same operator)</measure>
    <time_frame>Day 1</time_frame>
    <description>The intraclass correlation coefficient of the femoral length in mm measured from two different 3D volumetric acquisitions of the same patient performed by the same operator will be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bland-Altman representation of the femoral length in mm (same operator)</measure>
    <time_frame>Day 1</time_frame>
    <description>A Bland-Altman representation of the femoral length in mm measured from two different 3D volumetric acquisitions of the same patient performed by the same operator will be built.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Title: Intraclass correlation coefficient of the femoral length in mm (different operators)</measure>
    <time_frame>Day 1</time_frame>
    <description>The intraclass correlation coefficient of the femoral length in mm measured from the 3D volumetric acquisitions of the same patient performed by two different operators will be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bland-Altman representation of the femoral length in mm (different operators)</measure>
    <time_frame>Day 1</time_frame>
    <description>A Bland-Altman representation of the femoral length in mm measured from the 3D volumetric acquisitions of the same patient performed by two different operators will be built.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">265</enrollment>
  <condition>Pregnancy Related</condition>
  <arm_group>
    <arm_group_label>Main study: 3D volumes acquisitions</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3D volume acquisitions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ancillary study: 2D and 3D acquisitions</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2D standard measurements and 3D volumes acquisitions</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>3D volume acquisitions</intervention_name>
    <description>2 abdominal volumes 2 thigh volumes 2 head volumes</description>
    <arm_group_label>Main study: 3D volumes acquisitions</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>2D standard measurements and 3D volumes acquisitions</intervention_name>
    <description>1 abdomen circumference measurement&#xD;
1 femur length measurement&#xD;
1 head circumference measurement&#xD;
1 bi-parietal diameter measurement&#xD;
1 abdominal volume&#xD;
1 thigh volume&#xD;
1 head volume</description>
    <arm_group_label>Ancillary study: 2D and 3D acquisitions</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  evolutive pregnancy with one fetus with a Gestational Age between 16 and 30 weeks&#xD;
&#xD;
          -  aged between 18 and 65 years.&#xD;
&#xD;
          -  social welfare benefit recipient&#xD;
&#xD;
          -  willing and able to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  under 18 years old&#xD;
&#xD;
          -  multiple pregnancy&#xD;
&#xD;
          -  over 18 years old and mentioned in French law articles L.1126-6 et L-1126-8,&#xD;
&#xD;
          -  fetal malformation or suspected fetal malformation&#xD;
&#xD;
          -  technical conditions that do not allow for standard fetal biometry (abdominal wall,&#xD;
             fetal position, BMI &gt; 25 kg/m2)&#xD;
&#xD;
          -  fetal biometry non indicated in the standard pregnancy follow-up&#xD;
&#xD;
          -  unwilling or unable to provide informed consent (e. g. physical, mental disability or&#xD;
             linguistic factor that compromises patient information)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gaëlle Gaëlle AMBROISE-GRANDJEAN</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHRU de Nancy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHRU de Nancy Brabois</name>
      <address>
        <city>Nancy</city>
        <zip>54511</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>September 6, 2018</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>April 13, 2023</last_update_submitted>
  <last_update_submitted_qc>April 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03812471
org study id: ICBE-2-24301
nct id: NCT03812471
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In the proposed clinical investigation, the investigational device (BabySize3D) will provide
      automated plane extraction and automated biometry measurements from 3D US volumes. The
      results obtained from the investigational software
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Bi-parietal diameter in mm.
time frame: Day 1
description: The bi-parietal diameter in mm will be obtained with three methods: (1) fully automated 3D volume processing and caliper placement, (2) manual 3D volume processing and caliper placement, (3) manual selection of the 2D view plane and manual caliper placement on the screen of the ultrasound system (corresponding to standard of care measurements). The values obtained with the three methods and the differences between these values will be reported.
measure: Head circumference in mm
time frame: Day 1
description: The Head circumference in mm will be obtained with three methods: (1) fully automated 3D volume processing and caliper placement, (2) manual 3D volume processing and caliper placement, (3) manual selection of the 2D view plane and manual caliper placement on the screen of the ultrasound system (corresponding to standard of care measurements). The values obtained with the three methods and the differences between these values will be reported.
measure: Abdominal circumference in mm
time frame: Day 1
description: The Abdominal circumference in mm will be obtained with three methods: (1) fully automated 3D volume processing and caliper placement, (2) manual 3D volume processing and caliper placement, (3) manual selection of the 2D view plane and manual caliper placement on the screen of the ultrasound system (corresponding to standard of care measurements). The values obtained with the three methods and the differences between these values will be reported.
measure: Femur length in mm
time frame: Day 1
description: The Femur length in mm will be obtained with three methods: (1) fully automated 3D volume processing and caliper placement, (2) manual 3D volume processing and caliper placement, (3) manual selection of the 2D view plane and manual caliper placement on the screen of the ultrasound system (corresponding to standard of care measurements). The values obtained with the three methods and the differences between these values will be reported
measure: Failure rate of the automated measurements
time frame: Day 1
description: Failure rate of the automated measurements
measure: Exam and post-processing duration
time frame: Day 1
description: Exam and post-processing duration
measure: Difference of scores of the 2D standard cephalic plane and cephalic plane extracted from the 3D volume, based on six criteria listed in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40)
time frame: Day 1
description: The cephalic plane extracted from the 3D volume and the 2D standard cephalic plane will be scored according to the six criteria described in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40). The scores and their difference will be reported.
measure: Difference of scores of the 2D standard abdominal plane and abdominal plane extracted from the 3D volume, based on six criteria listed in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40)
time frame: Day 1
description: The abdominal plane extracted from the 3D volume and the 2D standard abdominal plane will be scored according to the six criteria described in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40). The scores and their difference will be reported.
measure: Difference of scores of the 2D standard femoral plane and femoral plane extracted from the 3D volume, based on four criteria listed in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40)
time frame: Day 1
description: The femoral plane extracted from the 3D volume and the 2D standard femoral plane will be scored according to the four criteria described in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40). The scores and their difference will be reported.
measure: Difference of scores of (i) the 2D standard cephalic plane and of (ii) the frames of a sequence of 2D images including the fetus head (cine-loop), based on six criteria listed in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40)
time frame: Day 1
description: The 2D standard cephalic plane and the frames of a sequence of 2D images including the fetus head will be scored according to the six criteria described in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40). The scores and the score difference (standard view score - frame score) will be reported.
measure: Difference of scores of (i) the 2D standard abdominal plane and of (ii) the frames of a sequence of 2D images including the fetus abdomen (cine-loop), based on six criteria listed in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40)
time frame: Day 1
description: The 2D standard abdominal plane and the frames of a sequence of 2D images including the fetus abdomen will be scored according to the six criteria described in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40). The scores and the score difference (standard view score - frame score) will be reported.
measure: Difference of scores of (i) the 2D standard femoral plane and of (ii) the frames of a sequence of 2D images including the fetus femur (cine-loop), based on four criteria listed in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40)
time frame: Day 1
description: The 2D standard femoral plane and the frames of a sequence of 2D images including the fetus femur will be scored according to the four criteria described in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40). The scores and the score difference (standard view score - frame score) will be reported.
measure: Title: Intraclass correlation coefficient of the bi-parietal diameter in mm (same operator)
time frame: Day 1
description: The intraclass correlation coefficient of the bi-parietal diameter in mm measured from two different 3D volumetric acquisitions of the same patient performed by the same operator will be calculated.
measure: Bland-Altman representation of the bi-parietal diameter in mm (same operator)
time frame: Day 1
description: A Bland-Altman representation of the the bi-parietal diameter in mm measured from two different 3D volumetric acquisitions of the same patient performed by the same operator will be built.
measure: Intraclass correlation coefficient of the bi-parietal diameter in mm (different operators)
time frame: Day 1
description: The intraclass correlation coefficient of the bi-parietal diameter in mm measured from the 3D volumetric acquisitions of the same patient performed by two different operators will be calculated.
measure: Bland-Altman representation of the bi-parietal diameter in mm (different operators)
time frame: Day 1
description: A Bland-Altman representation of the bi-parietal diameter in mm measured from the 3D volumetric acquisitions of the same patient performed by two different operators will be built.
measure: Intraclass correlation coefficient of the head circumference in mm (same operator)
time frame: Day 1
description: the intraclass correlation coefficient of the head circumference in mm measured from two different 3D volumetric acquisitions of the same patient performed by the same operator will be calculated.
measure: Bland-Altman representation of the head circumference in mm (same operator)
time frame: Day 1
description: A Bland-Altman representation of the head circumference in mm measured from two different 3D volumetric acquisitions of the same patient performed by the same operator will be built.
measure: Intraclass correlation coefficient of the head circumference in mm (different operators)
time frame: Day 1
description: The intraclass correlation coefficient of the head circumference in mm measured from the 3D volumetric acquisitions of the same patient performed by two different operators will be calculated.
measure: Bland-Altman representation of the head circumference in mm (different operators)
time frame: Day 1
description: A Bland-Altman representation of the head circumference in mm measured from the 3D volumetric acquisitions of the same patient performed by two different operators will be built.
measure: Intraclass correlation coefficient of the abdominal circumference in mm (same operator)
time frame: Day 1
description: The intraclass correlation coefficient of the abdominal circumference in mm measured from two different 3D volumetric acquisitions of the same patient performed by the same operator will be calculated.
measure: Bland-Altman representation of the abdominal circumference in mm (same operator)
time frame: Day 1
description: A Bland-Altman representation of the abdominal circumference in mm measured from two different 3D volumetric acquisitions of the same patient performed by the same operator will be built.
measure: Intraclass correlation coefficient of the abdominal circumference in mm (different operators)
time frame: Day 1
description: The intraclass correlation coefficient of the abdominal circumference in mm measured from the 3D volumetric acquisitions of the same patient performed by two different operators will be calculated.
measure: Bland-Altman representation of the abdominal circumference in mm (different operators)
time frame: Day 1
description: A Bland-Altman representation of the abdominal circumference in mm measured from the 3D volumetric acquisitions of the same patient performed by two different operators built.
measure: Intraclass correlation coefficient of the femoral length in mm (same operator)
time frame: Day 1
description: The intraclass correlation coefficient of the femoral length in mm measured from two different 3D volumetric acquisitions of the same patient performed by the same operator will be calculated.
measure: Bland-Altman representation of the femoral length in mm (same operator)
time frame: Day 1
description: A Bland-Altman representation of the femoral length in mm measured from two different 3D volumetric acquisitions of the same patient performed by the same operator will be built.
measure: Title: Intraclass correlation coefficient of the femoral length in mm (different operators)
time frame: Day 1
description: The intraclass correlation coefficient of the femoral length in mm measured from the 3D volumetric acquisitions of the same patient performed by two different operators will be calculated.
measure: Bland-Altman representation of the femoral length in mm (different operators)
time frame: Day 1
description: A Bland-Altman representation of the femoral length in mm measured from the 3D volumetric acquisitions of the same patient performed by two different operators will be built.
arm group label: Main study: 3D volumes acquisitions
arm group type: Experimental
description: 3D volume acquisitions
arm group label: Ancillary study: 2D and 3D acquisitions
arm group type: Experimental
description: 2D standard measurements and 3D volumes acquisitions
intervention type: Device
intervention name: 3D volume acquisitions
description: 2 abdominal volumes 2 thigh volumes 2 head volumes
arm group label: Main study: 3D volumes acquisitions
intervention type: Device
intervention name: 2D standard measurements and 3D volumes acquisitions
description: 1 abdomen circumference measurement
1 femur length measurement
1 head circumference measurement
1 bi-parietal diameter measurement
1 abdominal volume
1 thigh volume
1 head volume
arm group label: Ancillary study: 2D and 3D acquisitions
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gaëlle Gaëlle AMBROISE-GRANDJEAN
role: Principal Investigator
affiliation: CHRU de Nancy
facility: 
country: France
responsible party type: Sponsor
sharing ipd: No