NCT06742229

Clinical Data Collection for Obstetric Ultrasound Algorithms

Prospective Clinical Data Collection for Developing Machine Learning-assisted Obstetric Ultrasound (MOBUS) Screening Algorithms

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 700 (estimated)
• Sponsor: Caption Health, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to * Collect ultrasound data from pregnant and non-pregnant individuals presenting to multiple study sites. * Use the collected data and ultrasound images to train and validate Artificial intelligence algorithms developed by the Sponsor Consented participants will be asked to take part in a research ultrasound scan

Detailed description

In this study pregnant and no pregnant subjects will be recruited from Obstetrics and Gynecology clinics/hospitals or from Maternal and Fetal Medicine centers. The pregnant subjects will be in Group 1 and non pregnant subjects will be in Group 2. Pregnant subjects are only recruited if they are scheduled for an obstetric standard of care scan . Both the group will undergo research scan, which is a sweep protocol using handheld FDA approved ultrasound device like Vscan. Patient chart history (no PHI), standard of care scan ultrasound images (no PHI), and research scan ultrasound images (no PHI) would be obtained from Group 1 subjects. Patient history (no PHI), research ultrasound images (no PHI) would be obtained from Group 2 subjects The data collected from this study will be used by the sponsor to develop algorithms for screening various fetal health parameters such as gestational age, placenta location, fetal heart rate, number of fetuses, fetal positions etc Th

Conditions

• Pregnancy

Interventions

Type	Name	Description
DEVICE	Research Ultrasound scan	Both the study groups will be asked to undergo a research scan performed by an FDA approved ultrasound device

Timeline

• Start date: 2024-12-20
• Primary completion: 2025-09-30
• Completion: 2025-12-30
• First posted: 2024-12-19
• Last updated: 2024-12-19

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study