Clinical Data Collection for Obstetric Ultrasound Algorithms

Not Applicable

Not yet recruiting

• Conditions: Pregnancy

• Registration Number: NCT06742229
• Lead Sponsor: Caption Health, Inc.

Brief 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

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Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-10
• Study First Submitted QC: 2024-12-17
• Last Update Submitted: 2024-12-17
• Study First Posted: 2024-12-19
• Last Update Posted: 2024-12-19
• Study Start: 2024-12-20
• Primary Completion: 2025-09-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 700

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Research sweep Ultrasound Images (Vscan ) from the participants will be assessed for quality of images and comparing with patient chart history	9 months	All the participant's research ultrasound image will be obtained. This image will be checked for image quality on various stages of pregnancy as well as for non pregnant subjects. These images will be used to develop algorithms for measuring gestational age, placenta location etc.

Trial Locations

Locations (2)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States