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NCT Number: NCT06742229

Clinical Data Collection for Obstetric Ultrasound Algorithms

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota, Minneapolis, Minnesota, United States

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About this study

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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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Pregnant group (Group 1)

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

Non-pregnant group (Group 2)

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

Exclusion criteria

  • 1. Participants for whom participating in this study would delay or compromise care in any way.
  • Participants who are not able to understand or provide written consent.

Treatment and study plan

Research Ultrasound scan

Device

Both the study groups will be asked to undergo a research scan performed by an FDA approved ultrasound device

Primary outcomes

  1. Research sweep Ultrasound Images (Vscan ) from the participants will be assessed for quality of images and comparing with patient chart history

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Reshma Rajan-Joy, PhD

CONTACT

[email protected]

445-221-3076

Yngvil Thomas

CONTACT

[email protected]

312-316-5632

Sponsors and collaborators

Lead sponsor

Caption Health, Inc.

Industry

Registry information

Official study title

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

Acronym: MOBUS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 19, 2024
Registry last updated
Dec 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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