Research Ultrasound scan
DeviceBoth the study groups will be asked to undergo a research scan performed by an FDA approved ultrasound device
NCT Number: NCT06742229
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
Trial opening soon.
Get Notified18 year and older
Female
Interventional
Not applicable
University of Minnesota, Minneapolis, Minnesota, United States
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Pregnant group (Group 1)
Non-pregnant group (Group 2)
Exclusion criteria
Both the study groups will be asked to undergo a research scan performed by an FDA approved ultrasound device
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.
Contact information is provided by the study sponsor or research team.
Reshma Rajan-Joy, PhD
CONTACT
Yngvil Thomas
CONTACT
Caption Health, Inc.
Industry
Prospective Clinical Data Collection for Developing Machine Learning-assisted Obstetric Ultrasound (MOBUS) Screening Algorithms
Acronym: MOBUS
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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