- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06392555
Fetal Heart Ultrasound Suspicious Radiographic Finding Identification - Reader Study
April 26, 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
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
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 Contact
- Name: Christophe Gardella, PhD
- Phone Number: +33669650566
- Email: christophe@brightheart.fr
Study Contact Backup
- Name: Cecile Dupont, MS
- Phone Number: +33783223446
- Email: cecile@brightheart.fr
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
|
Determination of the presence of the 8 findings suspicious of CHD by readers, aided by the device
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
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 (Estimated)
May 1, 2024
Primary Completion (Estimated)
July 1, 2024
Study Completion (Estimated)
July 1, 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)
April 30, 2024
Last Update Submitted That Met QC Criteria
April 26, 2024
Last Verified
April 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.
Clinical Trials on Congenital Heart Disease
-
University of UlsterBelfast Health and Social Care TrustCompletedCongenital Heart Disease | Congenital Heart Defect | Adult Congenital Heart DiseaseUnited Kingdom
-
Vanderbilt University Medical CenterEnrolling by invitationCongenital Heart Disease | Congenital Heart Defect | Congenital Heart MalformationsUnited States
-
Children's Hospital Medical Center, CincinnatiNational Heart, Lung, and Blood Institute (NHLBI)CompletedHeart Disease CongenitalUnited States
-
Assistance Publique Hopitaux De MarseilleRecruitingComplex Congenital Heart DiseaseFrance
-
University of PittsburghNational Heart, Lung, and Blood Institute (NHLBI); Boston Children's HospitalEnrolling by invitation
-
Universitas Sumatera UtaraIndonesia UniversityCompletedCyanotic Congenital Heart DiseaseIndonesia
-
Paul FinnCompletedPediatric Congenital Heart DiseaseUnited States
-
The Hospital for Sick ChildrenTerminatedCongenital Heart Disease (CHD)
-
The Hospital for Sick ChildrenCompletedCongenital Heart Disease (CHD)Canada
-
YHAlattarNot yet recruitingCritical Congenital Heart Disease
Clinical Trials on Device-Aided performances
-
Iterative Scopes, IncUniversity of MinnesotaCompleted
-
5 SantéGroupe 5 SantéCompletedChronic Obstructive Pulmonary Disease
-
Centre Hospitalier Saint Joseph Saint Luc de LyonCompletedSeptic Shock | Acute Respiratory Distress
-
Central Hospital, Nancy, FranceUniversity of LorraineUnknown
-
University College, LondonActive, not recruitingPolyps | Colon Polyp | Adenoma Colon | Colorectal PolypUnited Kingdom
-
Cairo UniversityRecruiting
-
Hospices Civils de LyonCompletedInfection, Bacterial | Infection ViralFrance
-
Singapore General HospitalCompleted
-
Centre Hospitalier Universitaire VaudoisCompletedEmergencies | Bleeding | Trauma Injury | Female | Blood Transfusion | Cohort Study | Prognosis | Adult | Male | Humans | Haemorrhagic Shock | Massive Transfusion | Massive Hemorrhage | Hospital Mortality | Bleeding Hemorrhage | Hemorrhage / Mortality | Models, Theoretical | Wounds and Injuries / MortalitySwitzerland
-
University School of Physical Education in WroclawKessler Foundation; Wrocław University of Science and Technology; Nencki Institute... and other collaboratorsUnknown