Fetal Heart Ultrasound Suspicious Radiographic Finding Identification - Reader Study

August 8, 2024 updated by: BrightHeart
Clinical performance of the device will be evaluated in a fully-crossed, multiple-reader multiple-case (MRMC) study. This study will be used to determine the impact of the device on reader performance in identifying suspicious radiographic findings in fetal heart ultrasound video clips recorded during 2nd trimester anatomic ultrasound examinations conducted during the second trimester of the pregnancy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

200

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

  • United States
    • New York
      • New York, New York, United States, 10128
        • MFM Associates, PLLC

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Ultrasound examinations conducted during the second trimester of the pregnancy, containing interpretable 4-chamber, LVOT and ROVT standard views of the fetal heart

Description

Inclusion Criteria:

  • ultrasound examinations conducted during the second trimester of the pregnancy
  • fetus between 18 and 24 weeks of gestational age
  • mothers 18 years old or older

Exclusion Criteria:

  • exams corresponding to multiple pregnancy
  • fetal heterotaxy
  • exams not containing video clips with interpretable 4-chamber (4C), Left Ventricular Outflow Tract (LVOT) or Right Ventricular Outflow Tract (RVOT) standard views

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Prenatal ultrasound examinations
Device: Device-Aided performances
Determination of the presence of the 8 findings suspicious of CHD by readers, aided by the device
Other: Device-Unaided performances
Determination of the presence of the 8 findings suspicious of CHD by readers, unaided by the device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC of the ROC curve for the presence of any suspicious finding
Time Frame: 1 month
AUC of the ROC curve for both reading conditions (aided vs unaided by the device) derived from the identification of any suspicious radiographic finding
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC of the ROC curve for the presence of each suspicious finding
Time Frame: 1 month
AUCs of the ROC curve for both reading conditions (aided vs unaided by the device) for identification of each finding.
1 month
Sensitivity and specificity for both reading conditions for the presence of any suspicious finding
Time Frame: 1 month
Sensitivity and specificity for both reading conditions (aided vs unaided by the device) for identification of each finding.
1 month
Sensitivity and specificity for both reading conditions for the presence of each suspicious finding
Time Frame: 1 month
Sensitivity and specificity for both reading conditions for the presence of each suspicious finding.
1 month

Collaborators and Investigators

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

Sponsor

BrightHeart

Investigators

  • Study Director: Christophe Gardella, PhD, Chief Technical Officer

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)

May 3, 2024

Primary Completion (Actual)

July 30, 2024

Study Completion (Actual)

July 30, 2024

Study Registration Dates

First Submitted

April 26, 2024

First Submitted That Met QC Criteria

April 26, 2024

First Posted (Actual)

April 30, 2024

Study Record Updates

Last Update Posted (Actual)

August 9, 2024

Last Update Submitted That Met QC Criteria

August 8, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • reader2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

no sharing of the IPD is planned

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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