Clinical trials: Ultrasonography, Prenatal
Antenatal Care, Maternal Health
AI Blind-Sweep Ultrasound for Antenatal Screening by Non-Specialist Health Workers in Rural DR Congo
FS2 evaluates the diagnostic accuracy and implementation feasibility of an AI-assisted blind-sweep obstetric ultrasound (SPAQ E-con AI), operated by trained non-specialist health workers, for antenatal screening in rural…
- Conditions
- Antenatal Care, Maternal Health, Gestational Age, Placenta Praevia
- Trial name
- FS2 (NCT07677670)
- Testing
- SPAQ E-con AI blind-sweep ultrasound
- Where
- Democratic Republic of the Congo
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- SOIK Corporation Sarl
Fetal Growth Complications, Pregnancy Complications
First-trimester Placental Ultrasound Study
An observational cohort study to assess the clinical utility of the OxNNet Toolkit for the prediction of adverse pregnancy outcomes.
- Trial name
- First PLUS (NCT05326191)
- Testing
- Ultrasound
- Where
- United Kingdom
- Volunteers
- 4,000 people
- Sponsor
- Perspectum
Ultrasonography, Prenatal
Instinct™ Ultrasound Device Safety, Efficacy and Usability
Mobile medical devices for self-patient-use, are a rapidly evolving component of telehealth. Study examines the feasibility of using the INSTINCT® device, a portable self-use ultrasound system attached to a commercial smartphone…
- Trial name
- NCT04399408
- Testing
- Obstetrics Ultrasound (non invasive)
- Where
- Israel
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- PulseNmore
Gather Feasibility Data and User Feedback on Use of a Device in Vivo on Pregnant Volunteers in Their 2nd and 3rd Trimester
Vscan Access R2 Feasibility Evaluation
This study is being done to evaluate if the Vscan Access R2 Ultrasound System can measure Fetal Heart Rate (FHR) in humans when compared against a reference device (GE Corometrics 170 Series Fetal Monitor), and to gather feedback…
- Trial name
- NCT03617419
- Testing
- GE VScan Access R2 Ultrasound System, GE Corometrics 170 Series Fetal Monitor
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- GE Healthcare
Small for Gestational Age Infant, Fetal Growth Restriction
Developing and Testing AI Models for Fetal Biometry and Amniotic Volume Assessment in Fetal Ultrasound Scans.
Routine fetal ultrasound scan during the second trimester of the pregnancy is a low-cost, noninvasive screening modality that has been proven to lower fetal mortality by up to 20%.
- Conditions
- Small for Gestational Age Infant, Fetal Growth Restriction, Oligohydramnios, Polyhydramnios
- Trial name
- NCT05059093
- Testing
- Classification and segmentation deep learning models
- Where
- 6 sites in Morocco
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- Deepecho
Pregnancy Related
Optimization of Fetal Biometry With 3D Ultrasound and Image Recognition
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
- Trial name
- EPICEA (NCT03812471)
- Testing
- 3D volume acquisitions, 2D standard measurements and 3D volumes acquisitions
- Where
- France
- Volunteers
- 265 people, healthy volunteers welcome
- Sponsor
- Philips Clinical & Medical Affairs Global
Congenital Heart Disease
Fetal Heart Ultrasound Suspicious Radiographic Finding Identification - Reader 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…
- Trial name
- NCT06392555
- Testing
- Device-Aided performances, Device-Unaided performances
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- BrightHeart
Pregnancy Related
Human Factoring Validation of Pulsenmore ES Device
The goal of this study is to conduct human factors validation testing with the Pulsenmore ES home Ultrasound device in the video-guided mode of operation (participants) and the clinician-guided mode of operation (participants and…
- Trial name
- NCT06567067
- Testing
- Pulsenmore ES home ultrasound
- Where
- 2 sites in United States
- Volunteers
- 57 people
- Sponsor
- PulseNmore