Optimization of Fetal Biometry With 3D Ultrasound and Image Recognition (EPICEA)

April 13, 2023 updated by: Philips Electronics Nederland B.V. acting through Philips CTO organization
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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
265

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nancy, France, 54511
        • CHRU de Nancy Brabois

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • evolutive pregnancy with one fetus with a Gestational Age between 16 and 30 weeks
  • aged between 18 and 65 years.
  • social welfare benefit recipient
  • willing and able to provide informed consent

Exclusion Criteria:

  • under 18 years old
  • multiple pregnancy
  • over 18 years old and mentioned in French law articles L.1126-6 et L-1126-8,
  • fetal malformation or suspected fetal malformation
  • technical conditions that do not allow for standard fetal biometry (abdominal wall, fetal position, BMI > 25 kg/m2)
  • fetal biometry non indicated in the standard pregnancy follow-up
  • unwilling or unable to provide informed consent (e. g. physical, mental disability or linguistic factor that compromises patient information)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Main study: 3D volumes acquisitions
3D volume acquisitions
Device: 3D volume acquisitions
2 abdominal volumes 2 thigh volumes 2 head volumes
Experimental: Ancillary study: 2D and 3D acquisitions
2D standard measurements and 3D volumes acquisitions
Device: 2D standard measurements and 3D volumes acquisitions
  • 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Bi-parietal diameter in mm.
Time Frame: Day 1
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.
Day 1
Head circumference in mm
Time Frame: Day 1
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.
Day 1
Abdominal circumference in mm
Time Frame: Day 1
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.
Day 1
Femur length in mm
Time Frame: Day 1
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
Day 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Failure rate of the automated measurements
Time Frame: Day 1
Failure rate of the automated measurements
Day 1
Exam and post-processing duration
Time Frame: Day 1
Exam and post-processing duration
Day 1
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
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.
Day 1
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
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.
Day 1
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
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.
Day 1
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
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.
Day 1
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
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.
Day 1
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
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.
Day 1
Title: Intraclass correlation coefficient of the bi-parietal diameter in mm (same operator)
Time Frame: Day 1
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.
Day 1
Bland-Altman representation of the bi-parietal diameter in mm (same operator)
Time Frame: Day 1
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.
Day 1
Intraclass correlation coefficient of the bi-parietal diameter in mm (different operators)
Time Frame: Day 1
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.
Day 1
Bland-Altman representation of the bi-parietal diameter in mm (different operators)
Time Frame: Day 1
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.
Day 1
Intraclass correlation coefficient of the head circumference in mm (same operator)
Time Frame: Day 1
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.
Day 1
Bland-Altman representation of the head circumference in mm (same operator)
Time Frame: Day 1
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.
Day 1
Intraclass correlation coefficient of the head circumference in mm (different operators)
Time Frame: Day 1
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.
Day 1
Bland-Altman representation of the head circumference in mm (different operators)
Time Frame: Day 1
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.
Day 1
Intraclass correlation coefficient of the abdominal circumference in mm (same operator)
Time Frame: Day 1
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.
Day 1
Bland-Altman representation of the abdominal circumference in mm (same operator)
Time Frame: Day 1
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.
Day 1
Intraclass correlation coefficient of the abdominal circumference in mm (different operators)
Time Frame: Day 1
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.
Day 1
Bland-Altman representation of the abdominal circumference in mm (different operators)
Time Frame: Day 1
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.
Day 1
Intraclass correlation coefficient of the femoral length in mm (same operator)
Time Frame: Day 1
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.
Day 1
Bland-Altman representation of the femoral length in mm (same operator)
Time Frame: Day 1
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.
Day 1
Title: Intraclass correlation coefficient of the femoral length in mm (different operators)
Time Frame: Day 1
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.
Day 1
Bland-Altman representation of the femoral length in mm (different operators)
Time Frame: Day 1
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.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Philips Electronics Nederland B.V. acting through Philips CTO organization

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gaëlle Gaëlle AMBROISE-GRANDJEAN, CHRU de Nancy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 23, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 11, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 17, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 6, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 23, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ICBE-2-24301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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