Clinical Data Collection for Obstetric Ultrasound Algorithms (MOBUS)

Caption Health

Status: Not yet enrolling

Conditions: Pregnancy

Treatments: Device: Research Ultrasound scan

Study type: Interventional

Funder types: Industry

Identifiers

NCT06742229

CAP-MOBUS-24-02

Details and patient eligibility

About

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

Full 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

Enrollment: 700 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Pregnant group (Group 1)

1. Participants aged 18 years or older at time of consent.
2. Participants with confirmed pregnancy (positive HCG urine test strip and/or a documented obstetric ultrasound scan.
3. Participants who are scheduled for or referred for a standard-of-care clinical obstetric ultrasound examination.
4. Participants who provide written consent.

Non-pregnant group (Group 2)

1. Participants aged 18 years or older at time of consent.
2. Participants who are not actively pregnant (confirmed using an HCG urine test strip).
3. Participants who provide written informed consent.

Exclusion criteria

• 1. Participants for whom participating in this study would delay or compromise care in any way.

2. Participants who are not able to understand or provide written consent.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

700 participants in 2 patient groups

Group 1: Pregnant Subjects

Other group

Description:

This group is for pregnant subjects. They will have two ultrasound scans performed- One will be the standard of care ultrasound scan and the other will be research scan

Treatment:

Device: Research Ultrasound scan

Group 2- Non pregnant Subjects

Other group

Description:

This group is for non-pregnant subjects. They will have one ultrasound scan performed- it will be the research scan

Treatment:

Device: Research Ultrasound scan