Congenital Heart DiseaseNCT06392555
Fetal Heart Ultrasound Suspicious Radiographic Finding Identification - Reader Study
An observational study of Congenital Heart Disease, run by BrightHeart at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Device-Aided performances and Device-Unaided performances
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2024to 30 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Congenital Heart Disease
- Being tested
- Device-Aided performances, Device-Unaided performances
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device-Aided performancesDevice
Determination of the presence of the 8 findings suspicious of CHD by readers, aided by the device
Device-Unaided performancesOther
Determination of the presence of the 8 findings suspicious of CHD by readers, unaided by the device
| Study group | Role | What they receive |
|---|---|---|
| Prenatal ultrasound examinations | Not described Receives: Device: Device-Aided performances; Other: Device-Unaided performances |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC of the ROC curve for the presence of any suspicious finding
AUC of the ROC curve for both reading conditions (aided vs unaided by the device) derived from the identification of any suspicious radiographic finding
Measured: 1 month
Secondary outcomes (3)
AUC of the ROC curve for the presence of each suspicious finding
AUCs of the ROC curve for both reading conditions (aided vs unaided by the device) for identification of each finding.
Measured: 1 month
Sensitivity and specificity for both reading conditions for the presence of any suspicious finding
Sensitivity and specificity for both reading conditions (aided vs unaided by the device) for identification of each finding.
Measured: 1 month
Sensitivity and specificity for both reading conditions for the presence of each suspicious finding
Sensitivity and specificity for both reading conditions for the presence of each suspicious finding.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start3 May 2024
- Primary completion30 Jul 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- BrightHeart
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christophe Gardella, PhD, Study director, Chief Technical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06392555
- Sponsor's protocol ID
- reader2024
- Status last verified
- Aug 2024
- First submitted
- 26 Apr 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: no sharing of the IPD is planned
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Heart Ultrasound Suspicious Radiographic Finding Identification - Reader Study
- ClinicalTrials.gov ID
- NCT06392555
- Acronym / sponsor ID
- reader2024
- Conditions
- Congenital Heart Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- BrightHeartIndustry (pharma, biotech, devices)
- Study start
- 3 May 2024 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 30 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prenatal ultrasound examinations | – | Device: Device-Aided performances, Other: Device-Unaided performances |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Device-Aided performancesDetermination of the presence of the 8 findings suspicious of CHD by readers, aided by the device | Device | Prenatal ultrasound examinations |
| Device-Unaided performancesDetermination of the presence of the 8 findings suspicious of CHD by readers, unaided by the device | Other | Prenatal ultrasound examinations |
Primary outcome
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
3 secondary outcomes
AUC of the ROC curve for the presence of each suspicious finding
Time frame: 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 for the presence of each suspicious finding
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: No. no sharing of the IPD is planned
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christophe Gardella, PhD study director
Chief Technical Officer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease, run by BrightHeart at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC of the ROC curve for the presence of any suspicious finding (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.